Third Meeting of the WHO Technical Advisory Group on Health ...

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Third Meeting of the WHO Technical Advisory Group on Health ...

WH0/HSS/EHT/DIM/10.1820, AVENUE APPIA – CH-1211 GENEVA 27 – SWITZERLAND – TEL CENTRAL +41 22 791 2111 – FAX CENTRAL +41 22 791 3111 – WWW.ong>WHOong>.INTReportong>Thirdong> ong>Meetingong> ong>ofong> ong>theong> ong>WHOong> ong>Technicalong> ong>Advisoryong>ong>Groupong> on Health Technologyong>WHOong> Regional Office for ong>theong> Eastern MediterraneanCairo, Egypt20-22, June 2010This publication contains ong>theong> report ong>ofong> ong>theong> 3 rd ong>Meetingong> ong>ofong> ong>theong> ong>WHOong> ong>Technicalong> ong>Advisoryong> ong>Groupong> on Health Technologyand does not necessarily represent ong>theong> decisions or policies ong>ofong> ong>theong> World Health Organization


TABLE OF CONTENTS1. Background......................................................................................................................................................................51.1 Purpose............................................................................................................................................................................51.2 Participants......................................................................................................................................................................51.3 Organization....................................................................................................................................................................52. Opening session...............................................................................................................................................................52.1 Report ong>ofong> ong>theong> 2nd ong>Technicalong> ong>Advisoryong> ong>Groupong> ong>Meetingong> on Health Technology (TAGHT), November 2009..........62.2 The Egypt health technology story: accomplishments & challenges..........................................................................63. Tools and documentation status & baseline survey results ..........................................................................................74. Discussion on human resource development.................................................................................................................85. Medical device list review ..............................................................................................................................................86. First Global Forum on Medical Devices........................................................................................................................97. Country presentations................................................................................................................................................... 107.1. ong>WHOong> Regional Office for Africa (AFRO): regional and country presentations .....................................................107.1.1. Kenya ............................................................................................................................................................................107.1.2. Uganda ..........................................................................................................................................................................107.2. ong>WHOong> Regional Office for ong>theong> Eastern Mediterranean (EMRO): regional and country presentations ...................127.2.1. Egypt .............................................................................................................................................................................127.2.2. Iraq.................................................................................................................................................................................127.2.3. Jordan ............................................................................................................................................................................137.2.4. Sudan.............................................................................................................................................................................137.2.5. Tunisia...........................................................................................................................................................................147.3. ong>WHOong> Regional Office for Europe (EURO): regional and country presentations....................................................167.3.1. Albania ..........................................................................................................................................................................167.4 ong>WHOong> Regional Office for South-East Asia (SEARO): regional and country presentations...................................167.4.1. Nepal .............................................................................................................................................................................177.5 Observers: West Bank and Gaza Strip........................................................................................................................188. Working group results.................................................................................................................................................. 198.1 Regional advisers' perspective.....................................................................................................................................208.2 TAGHT advisers’ summary presentations .................................................................................................................219. Country action plans..................................................................................................................................................... 299.1 Country summary presentations (working group results).......................................................................................... 299.1.1 Albania ..........................................................................................................................................................................309.1.2 Egypt .............................................................................................................................................................................319.1.3 Jordan ............................................................................................................................................................................329.1.4 Kenya ............................................................................................................................................................................339.1.5 Nepal .............................................................................................................................................................................349.1.6 Sudan.............................................................................................................................................................................359.1.7 Tunisia...........................................................................................................................................................................369.1.8 Uganda ..........................................................................................................................................................................3710. General discussion........................................................................................................................................................ 3810.1 Topic 1: Resource mobilization..................................................................................................................................3810.2 Topic 2: Innovation .....................................................................................................................................................383RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 3


10.3 Topic 3: Sustainability .................................................................................................................................................3811. Conclusions................................................................................................................................................................... 39Annex 1: List ong>ofong> participants .................................................................................................................................................................. 40Annex 2: ong>Meetingong> agenda....................................................................................................................................................................... 44Annex 3: ong>Meetingong> evaluation .................................................................................................................................................................. 50Annex 4: Address by ong>theong> Regional Director ong>ofong> ong>theong> ong>WHOong> Regional Office for ong>theong> Eastern Mediterranean ...................................... 56Annex 5: Timeline.................................................................................................................................................................................... 593RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 4


The deliverables ong>ofong> ong>theong>se projects will be disseminated at ong>theong> First Global Forum on Medical Devices tobe held in Bangkok, Thailand in September 2010. This meeting needs to provide results that will feeddirectly to this event.2.1 Report ong>ofong> ong>theong> 2nd ong>Technicalong> ong>Advisoryong> ong>Groupong> ong>Meetingong> on Health Technology (TAGHT),November 2009Mr Ismael Cordero presented a summary ong>ofong> ong>theong> 2 ndTAGHT that was held 8-9 November 2009, prior to ong>theong>International Hospital Federation’s (IHF) 36th WorldHospital Congress in Rio de Janeiro, Brazil at which 29country representatives, 23 experts, and 16 ong>WHOong>/UNstaff participated.Key message:• Update participants on HTM toolsunder development• Current challenges and strategiesfacing pilot countries• More focus on primary health careThe main purpose ong>ofong> ong>theong> meeting was to follow up onong>theong> first TAGHT meeting on health technology conducted in April 2009 in Geneva, Switzerland and toreview ong>theong> progress ong>ofong> developing HT tools and guidelines.The objective ong>ofong> ong>theong> meeting was to review and adapt ong>theong> guidelines for ong>theong> formulation ong>ofong> NationalHealth Technology Programmes that are appropriate for specific diseases, public health conditions andexisting infrastructure and to review and adopt ong>theong> methodology and tools for health technologies, gapanalysis and prioritization models.Mr Cordero explained that ong>theong> meeting would:a) Update participants on ong>theong> health technology management tools underdevelopment since April 2009b) Review ong>theong> current challenges and strategies facing ong>theong> pilot countriesc) Hold an interactive session for ong>theong> group to present proposals for new tools based on informationgaong>theong>red from ong>theong> earlier presentations and discussions.The outcomes were 25 key messages including ong>theong> different tools and guidelines developed within ong>theong>scope ong>ofong> ong>theong> GIHT project. The meeting finally concluded that ong>theong>re should be more focus on primaryhealth care and more active involvement ong>ofong> country participants in ong>theong> development ong>ofong> HTM tools andstrategies.2.2 The Egypt health technology story: accomplishments & challengesProng>ofong>essor Ahmad Gaber started with a historical overview explaining that in 1972 medical equipmentsupport in Egypt was not different to many developing countries and no form ong>ofong> organized supportexisted.There was also a lack ong>ofong> prong>ofong>essional biomedicalstaff. In 1978, an agreement between ong>theong>Egyptian and British governments was signed,and based on this agreement, ong>theong> Department ong>ofong>Medical Equipment (DME) was established asong>theong> centre ong>ofong> ong>theong> Ministry ong>ofong> Health’s (MoH)engineering activities, serving both as a trainingdepartment for engineers and technicians and asa headquarters for ong>theong> bioengineering servicesoperated by ong>theong> MoH.Key messages:• The Department ong>ofong> Medical Equipment wasestablished in 1978 as headquarters forbioengineering and as a training centre• Biomedical engineering academic programs startedin Egypt in ong>theong> early 80s• Several challenges are preventing ong>theong>establishment ong>ofong> a well-organized HTM system inEgypt.3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 6


Biomedical engineering academic programs started in Egypt by ong>theong> early 1980s at Cairo University.Today nine public and private universities have established biomedical engineering programs followingong>theong> Cairo University model.By ong>theong> mid 1980s, ong>theong> MoH started recruiting additional biomedical engineers and technicians to staffthree satellite bioengineering servicing centres which were established in large hospitals in Cairo. Aregional ‘Repair and Maintenance Department’ was also established for one ong>ofong> ong>theong> country’s provinces,ong>theong> Giza Governorate, close to Cairo, providing services to all ong>theong> public health institutions in ong>theong>Governorate.Many international agencies participated in ong>theong>se developments, providing funds and occasionallytechnical assistance primarily for maintenance ong>ofong> facilities and equipment.The main challenges to establishing a well-organized HTM system in Egypt according to Dr Ahmad maybe summarized as follows:a) The lack ong>ofong> effective technical leadership at a suitably senior level within ong>theong> healthministries to influence ong>theong>ir policy with respect to engineering developments.b) The lack ong>ofong> adequate and suitably qualified staff for operational activities.c) The weak administration ong>ofong> government services generally, resulting from poor motivationbecause ong>ofong> low public-sector salaries and ong>theong> lack ong>ofong> incentives.d) Budgetary difficulties ong>ofong>ten faced by public services.e) The lack ong>ofong> control in ong>theong> process ong>ofong> equipment procurement which results in technologybeing sourced from multiple vendors.f) The geographical remoteness from ong>theong> equipment manufacturer which ong>ofong>ten results in longdelays in resolving even ong>theong> simplest ong>ofong> problems.g) The lack ong>ofong> any appreciation ong>ofong> ong>theong> concept ong>ofong> equipment obsolescence along withhaphazard allocation ong>ofong> resources for new purchases.3. Tools and documentation status & baseline survey resultsMrs Adriana Velazquez-Berumen presented ong>theong> tools and documents developed within ong>theong> first objectiveong>ofong> ong>theong> GIHT project in response to ong>theong> ong>WHOong> resolution on HT (WHA 60.29), which are now in ong>theong> finalstages ong>ofong> publishing. Mrs Velazquez-Berumen also explained that milestones and activities ong>ofong> ong>theong> GIHTproject have been conducted on time and according to ong>theong> original time plan as shown in Annex 5.She ong>theong>n went on to explain that medicaldevices are one ong>ofong> ong>theong> six major componentsong>ofong> any health system and that currently ong>theong>reare more than 8000 types ong>ofong> medical devicesused daily in different health facilities.More focus is needed on ong>theong> public healthcare system and on ong>theong> classification andlisting ong>ofong> medical devices according tocertain diseases. Health technologyKey messages:• All GIHT activities and milestones are on schedule.• More focus is needed on ong>theong> classification andlisting ong>ofong> medical devices by disease.• The base line country survey is ong>theong> first globalsurvey to give statistical evidence on ong>theong> status ong>ofong>medical devices.• Information about ong>WHOong>'s work on medical devicescan be found at:http://www.who.int/medical_devicesassessment, regulations and HTM are ong>theong> main tools and guidelines developed within ong>theong> GIHT andong>theong>refore this TAGHT meeting has primary focus on ong>theong>m.Mrs Velazquez-Berumen moved ong>theong>n to discuss ong>theong> baseline country survey, conducted as one mainGIHT activity, and explained that it is ong>theong> first global survey to provide statistical evidence on ong>theong> statusong>ofong> medical devices in different countries. She reported that, as ong>ofong> this meeting, 117 out ong>ofong> ong>theong> 1943RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 7


countries had responded to ong>theong> survey. 43% ong>ofong> countries who replied have HT policy, 67% have someform ong>ofong> authority to regulate medical devices and 52% have a nomenclature system. There has been agreat need for different HTM tools and guidelines such as donation guidelines to be followed andimplemented by donors and developing countries. Several bad experiences do exist in many developingcountries where donated equipment is received but never used because eiong>theong>r ong>theong>y were delivered in astate ong>ofong> disrepair or non functioning, were missing key support components such as user or repairmanuals, or ong>theong> receiver did not have ong>theong> skills or knowledge to maintain or use ong>theong> device. Some ong>ofong> ong>theong>HTM tools are already in ong>theong> final publishing stages, including ong>theong> Procurement and Health TechnologyAssessment (HTA) manuals. The e-documentation centre accessed through ong>theong> ong>WHOong> main webpage isalready active and different documents related to HT are available for download. The baseline countrysurvey and information regarding ong>theong> Call for Innovative Health Technologies are also available andaccessible through ong>WHOong> website as illustrated by Mrs Velazquez-Berumen.4. Discussion on human resource developmentThere are indeed many different names or titlesfor those that manage medical devices, and it isalmost impossible to identify all due to ong>theong>different expectations and responsibilitiesdescribed by ong>theong>ir supervisors or supervisinggoverning body.Key messages:• Training and retaining personnel for HTM, despiteong>theong> name ong>ofong> ong>theong> prong>ofong>essional, remains a challenge formany member states• The issue ong>ofong> Human Resources is complicated andinvolves different interrelated parameters• ong>WHOong> is advised to develop guidelines to assistmember states in HR strategy developmentHowever, it was agreed that training andretaining personnel for medical devicemanagement, despite ong>theong> name ong>ofong> ong>theong> prong>ofong>essional, remains a challenge for many member states due toseveral factors:• presence ong>ofong> a national or regional human resource development strategy,• sustainable implementation ong>ofong> such a strategy,• lack ong>ofong> skilled personnel available and ong>theong>ir willingness to undergo training,• difficulty in retaining individuals once trained.It was agreed that ong>theong> issue ong>ofong> Human Resources (HR) is complicated and involves different interrelatedparameters such as capacity building, etc. Therefore, for ong>theong> field ong>ofong> HT, it is advised to developguidelines to assist member states in HR strategy development.5. Medical device list reviewMedical equipment lists are essential whendoing heath facility planning ong>ofong> any level orcapacity. ong>WHOong> has provided lists for ong>theong>following types ong>ofong> facilities:• Health post• Health centre• District hospital• Provincial hospital• Specialized hospitalKey messages:• Medical equipment lists are very essential whendoing heath facility planning ong>ofong> any level or capacity• ong>WHOong> is in ong>theong> process ong>ofong> developing lists for severaltypes ong>ofong> facilities• ong>WHOong> should automate ong>theong> lists and expand ong>theong>mfurong>theong>r to include pre-installation requirements,technical information and pricesThe prepared lists include details for ong>theong> name ong>ofong> medical equipment, clinical area, units and subunits,nomenclature code...etc.3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 8


The lists are ong>theong> start ong>ofong> a comprehensive medical device inventory for all different types ong>ofong> facilities,clinical specialities and disorders. They need to be developed furong>theong>r to include pre-installationrequirements, technical information and prices. It will also be useful to automate those lists and makeong>theong>m available for member states on line through ong>theong> ong>WHOong> website.6. First Global Forum on Medical DevicesMrs Adriana Velazquez-Berumen discussed ong>theong> forthcoming First Global Forum on Medical Devices inBangkok, Thailand on 9-11 September, 2010.The overall aim ong>ofong> ong>theong> forum is to:• Increase ong>theong> awareness ong>ofong> ong>theong>important roles ong>ofong> medical devices inhealth service delivery;• provide a platform for all stakeholdersto exchange knowledge andexperiences with high level policymakers.The objectives ong>ofong> ong>theong> forum are:Key messages:• The overall aim ong>ofong> ong>theong> first GHF on M.D is toincrease ong>theong> awareness ong>ofong> ong>theong> important roles ong>ofong>medical devices in health service delivery• The main objective ong>ofong> ong>theong> forum is to demonstrateevidence on ong>theong> need for appropriate tools &research strategies on MD, to share knowledge andbring togeong>theong>r all stake holders.• The expected outcomes are ong>theong> identification ong>ofong>recommended actions, compilation ong>ofong> bestpractices and creating a network ong>ofong> prong>ofong>essionals tosupport ong>theong> role ong>ofong> MD.• To demonstrate evidence on ong>theong> need for appropriate evaluation, prioritization,regulation, assessment, management and research strategies on medical devices;• To share knowledge on available resources: guidelines, tools, strategies, policies and bestpractices at national and regional levels and determine ong>theong> needs;• To bring togeong>theong>r policy makers, prong>ofong>essional organizations, funding agencies and keystakeholders to foster interdisciplinary partnerships and cultivate ong>theong> aim ong>ofong> reaching acommon goal ong>ofong> accessible medical devices.The expected outcomes ong>ofong> ong>theong> forum are:• The identification ong>ofong> recommended actions that can be taken for ong>theong> improvement inavailability, accessibility, appropriate selection, assessment, regulation, management, safetyand use ong>ofong> medical devices in line with ong>theong> World Health Assembly resolution (WHA60.29)on health technologies;• The compilation ong>ofong> best practices, available resources, tools and guidelines on medicaldevices for integration into national health plans;• A network ong>ofong> interdisciplinary prong>ofong>essionals who will continue to support ong>theong> role ong>ofong> medicaldevices in health systems.Mrs Velazquez-Berumen went on to present ong>theong> organizing committee membership, planning milestones,participant breakdown, ong>theong> scientific programme in detail, ong>theong> poster sessions, and available networkingtools (SpotMe). She concluded that ong>theong> First Global Forum on Medical Devices is an opportunity toengage leaders, demonstrate what we have and what we need, integrate very different stakeholders,promote work to donors, and impact level ong>ofong> care and health service delivery.3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 9


7. Country presentations7.1. ong>WHOong> Regional Office for Africa (AFRO): regional and country presentationsDr Jean-Bosco, ong>theong> AFRO regional adviser on health technology started by explaining that from 46AFRO countries, 22 (68%) submitted ong>theong> baselinecountry survey. And in general ong>theong> AFROcountries have a lack ong>ofong> resources and systemsrelated to health technologies.He also explained that in general ong>theong>re is a lack ong>ofong>HT policy and regulations and HTM is not wellintegrated into ong>theong> health system. Budgetaryallocation for maintenance ong>ofong> medical equipmentis random, very low, and insufficient.Additionally ong>theong>re is a lack ong>ofong> appropriatetechnical facilities such as workshops, andqualified personnel with adequate training aresimply not available.Key messages:• AFRO countries have lack ong>ofong> resources andsystems related to health technologies• There is accumulated experience in ong>theong> differentfields ong>ofong> HT in EURO countries but ong>theong>re is agap with newly independent states• There are several problems facing HTM inSEARO countries such as lack ong>ofong> HTM tools,infrastructure, manpower and transparency• EMRO countries are diverse and range fromcountries lacking any form ong>ofong> HTM system tocountries with fully automated HTM systemsimplemented on ong>theong> national level.The situation varies between countries, he explained, and Ethiopia for example has very strict rules forpurchasing medical devices but does not necessarily address need in ong>theong> most holistic way. For example,Ethiopian procurement policy dictates that ong>theong> lowest bid is taken into account first which, withoutevaluation, may or may not lead to ong>theong> most cost-effective purchase in ong>theong> long-term.He concluded that ong>WHOong> has a great role to play in providing technical assistance for African countries indifferent fields related to health technologies and expected to present formal action plans resulting fromthis meeting to ong>theong>m.7.1.1. KenyaKenya seems to have difficulties in ong>theong> technical support ong>ofong> medical equipment since HTM is notfully integrated, workshops are inadequate, budgetary allocations for maintenance are very lowand ong>theong>re is lack ong>ofong> HT policy and regulations. There is a great need for technical support such astraining, HTM tools, guidelines and standards related to medical devices. A solid plan is neededthat is based on GIHT developed tools and guidelines and tailor-made to fit individual countryneeds. Table 1, provided at ong>theong> end ong>ofong> this section, summarizes ong>theong> country presentation forKenya as delivered by Mr Martin M Owino.7.1.2. UgandaUganda, like Kenya, seems to have difficulties in ong>theong> technical support ong>ofong> medical equipment dueto reasons such as shortage ong>ofong> qualified staff and HTM tools as well as ong>theong> absence ong>ofong> regulationsand standards. Uganda is in need ong>ofong> technical support in all fields related to ong>theong> technical supportong>ofong> medical equipment such as relevant HTM tools and guidelines and standards related to medicaldevices. A well structured plan needs to be developed and tailor-made to fit individual countryneeds. Table 1, provided at ong>theong> end ong>ofong> this section, summarizes ong>theong> country presentation forUganda as delivered by Mr Sam S. B. Wanda.3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 10


Summary ong>ofong> AFRO country presentationsCountry Key Challenges Needs Expectations• Lack ong>ofong> Health TechnologyPolicy and a regulatory body forhealth technologies• Completion ong>ofong> health technologypolicy and enacting a HealthTechnology Act• ong>WHOong> to assist in completion ong>ofong> ong>theong> healthtechnology policy and preparation ong>ofong> ong>theong> HealthTechnology Act as this requires a lot ong>ofong> resources• HTM is still not fully integratedinto ong>theong> health system – TopManagers do not understand HTissues• Training and continuous skilldevelopment programmes• ong>WHOong> to assist in strengong>theong>ning ong>theong> capacityong>ofong> training institutions in order to improve ong>theong>quality ong>ofong> health technology human resourcesKenya• Budgetary allocation formaintenance and investment inhealth technology is very low andnot based on any data (HTA)• Adequate financial allocation toundertake HT programmes• Development ong>ofong> continuous short-termtraining programmes needed for skilldevelopment in new technologies• Inadequate facilities – lack ong>ofong>workshops, testing and calibrationequipment, technical/referencedocumentation• Awareness ong>ofong> HT issues in order tong>ofong>ully integrate into ong>theong> health system• Receive reference technical documents andtools for proper HTM• Inadequate training andcontinuous skill development• Availability ong>ofong> technicaldocuments/reference materials/ tools,testing and calibration equipment• Lack ong>ofong> needs assessment forPFP and PNFP health units• Tools and resources • Access to resources currently available• Shortage ong>ofong> trained techniciansfor maintenance• Access to adequate trainingprograms• Access to lists ong>ofong> recommended medicaldevices for specific proceduresUganda• Poor management ong>ofong> equipmentinventory – frequency and by who isnot properly controlled• More human resources – bothmedical and engineering• Access to equipment management song>ofong>tware• Lack ong>ofong> national standards andlists ong>ofong> recommended medicaldevices for specific procedures• Decision on common nomenclature formedical devices across member countries• Lack ong>ofong> equipmentmanagement song>ofong>tware3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 11


agencies and donor agencies remains ong>theong> only suitable source in emergencies and conflictsituations.7.2.3. JordanEngineer Hamed Alda’Ajeh from Jordan explained that ong>theong> Directorate ong>ofong> BiomedicalEngineering (DBE), a ong>WHOong> collaborating centre, was established to be responsible for all issuesrelated to medical equipment in all MoH centers and hospitals. Eng Hamed also explained that afully automated Clinical Engineering Systems (CES) application was developed by DBE toautomate all issues related to medical equipment throughout ong>theong>ir lifecycle.The CES includes:• An automated and continuously updated inventory management system• Fully paperless corrective maintenance (CM) and preventive maintenance (PM) systems• Automated contracts for high technology equipment• An efficient quality control system with key performance indicators monitoring issues suchas Down Time (DT), Mean Time to Repair (MTTR), Mean Time Between Failure (MTBF),Life Cycle Cost (LCC),…etc• Automated stores and spare parts order and management system• Continuously updated technical specifications ong>ofong> medical equipment that are made freelyavailable to vendors to ensure transparency• Efficient reporting system that produces reports about all issues related to any part ong>ofong> ong>theong>CES such as:o DT ong>ofong> any medical equipment at any location.o LCC ong>ofong> any medical equipmento Inventory list ong>ofong> medical equipment at any MoH locationThe automated CES implemented by DBE covers ong>theong> complete lifecycle ong>ofong> medical equipment,including all technical and administrative procedures, starting from ong>theong> planning stage beforepurchasing up to ong>theong> final stage when equipment is put out ong>ofong> service.Engineer Hamed concluded his presentation with ong>theong> statement that ong>theong> overall cost ong>ofong> ong>theong>complete CES implemented by DBE is 4% ong>ofong> ong>theong> total equipment cost at MoH, making ong>theong>system cost efficient in addition to being technically efficient and represents an ideal example foroong>theong>r countries to follow after tailoring according to local needs.7.2.4. SudanDr Mohamad Osman from Sudan started his presentation by explaining that ong>theong> general politicalsituation ong>ofong> Sudan, particularly ong>theong> unstable souong>theong>rn regions, affects all public issues includingthose related to health and health technologies.Most medical equipment comes into ong>theong> country through donations where ong>theong> user has no controlover ong>theong> technical specifications or oong>theong>r related procurement details. There are donationguidelines that are not yet implemented and much ong>ofong> ong>theong> donated medical equipment cannot getmedical technical support due to lack ong>ofong> local manufacturer representation.Generally ong>theong> technical support is provided by local suppliers when available. He furong>theong>rexplained that ong>theong>re is also a general problem in supplying needed spare parts to support medicalequipment.3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 13


Dr Mohamad concluded that a comprehensive strategic plan is needed to develop, implement andevaluate a national HTM system for Sudan.7.2.5. TunisiaDr Fredj Ben Mohamed Letaief from Tunisia explained that in his country ong>theong>re is a uniqueexperience regarding HTM since HT strategies have been implemented since ong>theong> mid 1980s.Several technical advisory committees ong>ofong> different medical specialties are created within ong>theong>MoH structure to advise on all issues related to ong>theong> specialty including HT issues. He also addedthat ong>theong> government has established a national centre to be responsible for issues related tomedical equipment throughout ong>theong>ir lifecycle. He explained that ong>theong> national centre gives adviceto ong>theong> MoH on all issues related to medical devices such as procurement, donations, technicalspecifications and corrective & preventive maintenance. Dr Letaief said that it is a commonprocedure in Tunisia to include maintenance services for medical equipment with ong>theong> initialequipment purchase. ong>Thirdong>-party private technical support ong>ofong> medical equipment is alsocommonly used in Tunisia but under ong>theong> control ong>ofong> this national institute for health technologies.Dr Letaief concluded that ong>theong> MoH seems to be satisfied with ong>theong> general performance ong>ofong> issuesrelated to HT in Tunisia and good results are achieved in ong>theong> technical support ong>ofong> medicalequipment.3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 14


Summary ong>ofong> EMRO country presentationsCountry Key Challenges Needs Expectations• Establishment ong>ofong> a national institute onHT• Establishment ong>ofong> a national HT policy• Access to certain specializedtraining programs• The application ong>ofong> realisticobjectives and practical action plans,including ong>theong> appropriate tools andresources.• Exchange ong>ofong> knowledge and experience withparticipants at ong>theong> 3 rd TAGHT meeting• Benefit from ong>WHOong> HT experts indeveloping effective action plans to implementJordan• Lack ong>ofong> comprehensive healthinformation system at ong>theong> MoH• Donor Agencies to support &promote DBE• Establishment ong>ofong> a HTA unit • More involvement with ong>WHOong>• Continued support ong>ofong> ong>theong> HT programs &activities from ong>WHOong> country ong>ofong>fice in Jordan• Involve DBE in future ong>WHOong> plans andactions in oong>theong>r developing countries• Need for harmonization ong>ofong> HTMprograms in all health sectors• Motivation ong>ofong> HT staff• Lack ong>ofong> established human resourcequalifications• Displacement ong>ofong> trained medical staff• Health sector reform • ong>Technicalong> assistance• Receipt ong>ofong> an update on ong>theong> development ong>ofong>tools and guidelines initiated in ong>theong> last meetings• Fragile health system in ong>theong> conflictaffected areas• Appropriate financial allocation• Assistance in implementation ong>ofong> ong>theong> toolsand policiesSudan• Establishment ong>ofong> HT units • Existence ong>ofong> tools and resources• Need for health technology policies, andregulations• Access to adequate trainingprograms, and more human resources• Lack ong>ofong> consistent procurement practiceand MD maintenance• Lack ong>ofong> awareness ong>ofong> HT and technicalspecifications• Improved quality control • Information on ong>WHOong> HT strategiesTunisia• Poor information control ong>ofong> equipmentfleet• More HTA and awareness• Lack ong>ofong> HTA • Testing & calibrations labs• Exchange ong>ofong> experience in Quality Control(QC) & metrology• Assistance with development ong>ofong> usertraining programmes.• Inconsistent calibration ong>ofong> medicalequipment• Improvement in health facilitymaintenance• Improved communication between MoH andong>WHOong>• Poor risk management• Need for maintenance ong>ofong> ong>theong> networkbetween local health directorates and ong>theong>central administration ong>ofong> ong>theong> NationalInformation Center for Health• Financial support to link ong>theong>district health departments to ong>theong>directorates ong>ofong> Health Affairs• Provision ong>ofong> ong>theong> latest modern technology inong>theong> field ong>ofong> information technology, data quality,and GIS.Egypt• Need for automation ong>ofong> HealthInfrastructure and Technology (HIT) unitsand connecting ong>theong>m with ong>theong> MoHInformation Technology (IT) network toreduce errors and enhance scrutiny• Establishment ong>ofong> ongoingmaintenance system ong>ofong> ong>theong> MoH ITnetwork• Strengong>theong>ning ong>ofong> ong>theong> network linking districong>theong>alth departments for quick and easy access todata and information• Need for unification ong>ofong> MoH IT systemsto ensure standardization• Implementation ong>ofong> workshops fordecision-makers to unify ong>theong>department systems• ong>WHOong> support for ong>theong> development ong>ofong> aHealth Information System and a web-basedmaintenance system(HIT)• Lack ong>ofong> training and follow-up• Determine a follow-up system toong>theong> health information system betweenong>theong> MoH and ong>theong> information centerdirectorates• Support for annual updating ong>ofong>ong>theong> Geographical Information System(GIS)• Support for training on HealthInformation Systems (HIS)3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 15


7.3. ong>WHOong> Regional Office for Europe (EURO): regional and country presentationsMs Hayde Reynoso from EURO illustrated that 37 countries out ong>ofong> 53 European member states (70%)have responded to ong>theong> country survey. The newly independent states are facing difficulties in issuesrelated to HT, particularly ong>theong> technical management ong>ofong> medical devices.Ms Reynoso added that, in Europe, ong>theong>re is accumulated experience in ong>theong> different HT fields includingregulation, HTA and innovation, but ong>theong>re is a gap between western and eastern countries and newlyindependent states. It is also evident that ong>theong>re is no standardization between European countries in issuesrelated to medical devices such as inventory control, maintenance and support, planning andprocurement. Academic and prong>ofong>essional certification programs are also drivers but have nostandardization between countries.7.3.1. AlbaniaMrs Ledina Picari from Albania explained that ong>theong>re exists a comprehensive national policy forong>theong> management ong>ofong> medical devices that is not yet well implemented and that ong>theong>re are nonational standards or recommended lists for medical devices. Many challenges are facing ong>theong>management and maintenance ong>ofong> medical equipment including bad management practices andinsufficient financing.She explained that for ong>theong> first time ong>theong>re is a HT unit in ong>theong> MoH that is working on ong>theong>standards and maintenance ong>ofong> medical devices. Three sub-laws ong>ofong> ong>Technicalong> Regulations formedical devices are being prepared in full compliance with EU directives for medical devices. Abasic computerized inventory system for medical devices exists using Clingo® (UMS s.r.l.,Cerbaia, Italy) but it is not updated regularly.Human resources are a key challenge since ong>theong>re is no academic bachelors program for HT orbiomedical engineering in Albanian universities.The major capital investment on medical devices is coming from different donations that aremostly based on procurement guidelines adopted by donors. See Table 2 for a summary ong>ofong> ong>theong>Albania country presentation7.4 ong>WHOong> Regional Office for South-East Asia (SEARO): regional and country presentationsDr Geeta Mehta, SEARO regional adviser on health technology, started by illustrating that 11 countriesout ong>ofong> 24 member states (45%) ong>ofong> ong>theong> SEARO region have submitted ong>theong> baseline country survey. Thereare several problems facing health technology in ong>theong> SEARO region including but not limited to ong>theong> lackong>ofong> HTM tools, infrastructure, manpower and transparency. There are also many different disease-basedpublic health programmes, each with ong>theong>ir own procurement structure and with little cross-programmecoordination.Dr Mehta also explained that countries such as India are internally structured as many highly autonomousstates, and ong>theong>refore it is very hard to capture a summary picture through this baseline country survey.Indian states have a wide spectrum ong>ofong> achievement levels in ong>theong> field ong>ofong> health technologies and yes/nobased surveys with supporting statistics generally omits information. In ong>theong> SEARO region, ong>theong> memberstates vary greatly in terms ong>ofong> population, and ong>theong> percentage ong>ofong> those submitting ong>theong> baseline countrysurvey may not be a very accurate representation ong>ofong> ong>theong> region.Several discussions following Dr Mehta’s presentation concluded that ong>theong> baseline country survey is ong>theong>first global effort on statistical information concerning HT and medical devices. As such, this initialsurvey was kept simple to avoid confusion as it was determined that too many detailed parameters would3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 16


complicate ong>theong> issue and slow a country’s response. Follow-up surveys and research will provideadditional information. It was been suggested that ong>theong>se follow-up surveys include some performanceindicators such as ong>theong> usability ong>ofong> medical equipment, DT, LCC, MTTR, etc.7.4.1. NepalMr Bhanu Bhakta from Nepal explained that ong>theong> main challenges facing Nepal in ong>theong> field ong>ofong> HTmay be summarized as follows:• The organization ong>ofong> HTM and its related capacities are not sufficiently strengong>theong>ned• There is a lack ong>ofong> needs assessment for HT• Lack ong>ofong> a separate HT unit, financial and human resources, and a HT program at ong>theong> nationallevel• There is a need to develop a HT network at regional and district levels• There is difficulty in implementing a national Public Procurement Act and Regulation forhealth commodities.• There is a need for ong>theong> implementation ong>ofong> a web-based reporting and inventory system• There is a need for ong>theong> development ong>ofong> national level technical specificationsThe general needs ong>ofong> ong>theong> country include strengong>theong>ning organizational capacity and allocatingsufficient resources to build an effective HTM system. See Table 2 for summary ong>ofong> ong>theong> Nepalcountry presentation.3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 17


Summary ong>ofong> EURO and SEARO country presentationsCountry Key Challenges Needs Expectations• No national standard orrecommended lists for medicaldevices• Implementation ong>ofong> ong>theong> existing HTpolicyAlbaniaEURO• Bad management practices andinsufficient financing• Access to medical equipment lists• Finalization ong>ofong> ong>theong> legal framework concerningmedical devices in alignment with EU directives.• No academic bachelors programfor HT or biomedical engineering inuniversities• Assistance with medical deviceregulation• Support for human resources development• HTM and its related capacities arenot sufficiently strengong>theong>ned• Strengong>theong>ning ong>ofong> organizationalcapacities• Support for ong>theong> development ong>ofong> regulations formedical devices (MD)• Lack ong>ofong> national HTM unit• Allocation ong>ofong> sufficient resources tobuildup an effective HTM system• Support for ong>theong> development ong>ofong> different fieldswithin HTMNepalSEARO• Difficulty in implementation ong>ofong>Public Procurement Act andregulation for health commodities.• Difficulty in implementation ong>ofong>web based reporting and inventorysystem• Lack ong>ofong> national level technicalspecifications7.5 Observers: West Bank and Gaza StripMr Ibrahim Elian from ong>theong> West Bank and Gaza Strip explained that ong>theong> security, political constraints andobstacles imposed by Israeli occupation authorities affect all aspects ong>ofong> life in ong>theong> West Bank and GazaStrip including health technologies. One example given by him was ong>theong> delay ong>ofong> delivering importeddonated or purchased medical equipment. Mr Elian explained that medical equipment is received fromdifferent donors but in many cases ong>theong>re is no local representative for ong>theong> manufacturer which makestechnical support extremely difficult. Furong>theong>r aggravating this problem, ong>theong> already existing donorguidelines have never been implemented.There is a Microsong>ofong>t® Access based inventory management system used in ong>theong> West Bank and GazaStrip. However, ong>theong>re is no strategic stock ong>ofong> spare parts and procurement ong>ofong> ong>theong>se parts is extremelydifficult due again to ong>theong> occupation, ong>theong>reby making ong>theong> maintenance support ong>ofong> medical equipment verydifficult.The prong>ofong>ession ong>ofong> biomedical engineering was only recently separated from facility management.Programs such as health facility certification and ong>theong> development ong>ofong> a test laboratory for importedmedical equipment and supplies have been established.Mr Elian concluded that in general ong>theong>re is a shortage ong>ofong> biomedical engineers and technical support ismostly provided by local agents. Training is needed for existing engineers.3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 18


8. Working group resultsThis meeting included working group sessions that brought country representatives and technical expertsmuch closer to exchange views and knowledge about predefined topics related to HT (see Annex 2 for ong>theong>detailed agenda). Each HT topic was assigned to a technical adviser as follows:HT topics assigned to TAGHT expertsREGULATIONHT TopicTAGHT Adviser• regulatory systems• nomenclature• adverse reportingAlbert PoonBjörn FahlgrenNATIONAL HEALTH TECHNOLOGY ISSUES• health technology policy• health technology unit• needs assessment• medical device listJennifer JacksonRonald BauerHEALTH TECHNOLOGY ASSESSMENT• HTA concepts• ressources for HTAAdriana Velazquez-BerumenJosé AsuaHEALTH TECHNOLOGY MANAGEMENT• procurement• donations• technical specificationsDavid PorterMladen PolutaHEALTH TECHNOLOGY MANAGEMENT• maintenance• inventoryIsmael CorderoBassel TawfikThere were five working group sessions during which each group ong>ofong> countries (grouped by region) metwith ong>theong> designated TAGHT experts on that topic. Each country group and ong>theong>ir regional adviser rotatedthrough each topic. This gave experts ong>theong> chance to explain briefly ong>theong>ir topic expertise to countryrepresentatives and listen to ong>theong> specific individual country needs related to that topic.After ong>theong> working group sessions, ong>theong> technical experts presented a summary ong>ofong> country needs related toong>theong>ir topics. Country representatives also presented ong>theong>ir country needs and ong>theong>ir action plans. This willbe explained in more detail in ong>theong> next section.Participants in general seemed to prefer this meeting approach. See ong>theong> meeting evaluation in Annex 3.3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 19


8.1 Regional advisers' perspectiveThe regional advisers who attended summarized ong>theong>ir findings from ong>theong> working group sessions asillustrated in Table 5 .ong>WHOong> regional advisers and oong>theong>r participants felt thatong>WHOong> could look for centres ong>ofong> excellence and discoverways that ong>theong>y can collaborate with each oong>theong>r to buildon existing successful models and support oong>theong>rcountries according to ong>theong>ir individual needs.ong>WHOong> could also take more action with policies,accreditations, certifications, etc.Key messages:• ong>WHOong> is urged to look for centers ong>ofong>excellence and build on existing successfulmodels to support countries according toong>theong>ir individual needs• ong>WHOong> can advise focal points in countries onhow to raise funds• ong>WHOong> should work on advocacy and publicrelations to attract new partnersNational health plans are currently being revised, providing an opportunity for HT input. Furong>theong>rmore,having focal points in countries is valuable for both ong>WHOong> country programs and for collecting realinformation from countries. In addition ong>theong>y will help to obtain funding to execute any activity associatedwith including HT in national health plans. Resource mobilization at ong>theong> country level is necessary andong>WHOong> can help advise countries on how to fundraise to support local programmes.Resource mobilization is a big challenge at ong>WHOong> compared to oong>theong>r UN agencies such as ong>theong> UnitedNations Children's Fun (UNICEF) and ong>theong>refore ong>WHOong> could work on advocacy and public relations toattract new partners.The discussion needs to be taken beyond HT issues, to broader healthcare-related concerns, in order toengage a larger group ong>ofong> stakeholders. It could also be useful to have a list ong>ofong> regional resolutions to focuson resource mobilization.Regional advisers' perspectiveObjectiveEstablish a Health Technology Policy and Plan at country level for appropriate use ong>ofong>health technology, with a focus on primary health care· Assessment ong>ofong> country situations:- Involvement ong>ofong> technical focal points at country ong>ofong>fices and MoH.- Follow-up ong>ofong> ong>theong> baseline surveyShort-Term Goal· Completion ong>ofong> survey by those that have not yet submitted· Raising awareness at country level· Identify models at country level, success stories and regional centres ong>ofong> excellence· Knowledge sharing, country collaboration.Long-Term GoalsChallenges· Regional action plans to be developed; country focal points, MoH ong>ofong>ficials· Country plans with specific focus according to needs.· MoH for human and financial commitment· Link health technology areas ong>ofong> all vertical programmes· Advocate for focus on Health Technology as a basic building block for Health SystemsStrengong>theong>ning (HSS)· Advocate for Health technology programmes as an essential part ong>ofong> National Healthprogrammes· Political unawareness· Lack ong>ofong> resources· Non-existent leadership on HT at country levels3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 20


8.2 TAGHT advisers’ summary presentationsA full summary ong>ofong> all ong>theong> TAGHT expert presentations is found in ong>theong> table below. The data in ong>theong>presentations was based on ong>theong>ir meetings with country representatives during ong>theong> working groupsessions.The TAGHT experts made some general observationsregarding ong>theong> position ong>ofong> HT in different member states.They reported that ong>theong> presence ong>ofong> national HT policyvaries from strong to weak representation. Some havepublished very detailed policies which have not yetbeen implemented whereas oong>theong>rs have very fragmentedguidelines and procedures which entirely lack structure.Key messages:• Discussion with countries on implementationong>ofong> regulation was recommended for a futuremeeting• For national HT policies and HTM unitsong>theong>re is a range from complete absence tostrong presence at a national level• Most countries lack prong>ofong>essional needsassessment and updated medical device lists• There is a general lack ong>ofong> prong>ofong>essional humanresourcesThe experts also found that most countries performneeds assessment for medical devices and most haveformulated lists ong>ofong> medical devices. These lists are however ong>ofong>ten generated by physicians and represent awish list raong>theong>r than a careful assessment ong>ofong> need. Medical devices are ong>ofong>ten outdated, difficult to use andare monitored by non-HT staff due to a lack ong>ofong> HR.3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 21


TAGHT Advisers Summary ong>ofong> Working ong>Groupong> DiscussionHT Regulations SummaryMajor gaps and obstaclesSuccesses that can be sharedRecommendationsfor existing documentsRecommendationsfor additional assistance• Some countries have neiong>theong>r regulation, regulatornor capacity Publish ong>theong> choice ong>ofong> medical devices resulting fromtender procedures as a reference for oong>theong>r sectors,including ong>theong> private sector, GPs etc. CD with regulatory training material. ong>WHOong> to support minister withpolicy on regulation For some countries regulation exists but people arenot aware ong>ofong> that and regulation has not been fullyimplementedNational donation guidelines ong>WHOong> to facilitate development ong>ofong>quality control reference documents. Provide model legalframework. Applicability to private sector (procurement and sale) Certified labs at national level Existing documents are sufficient: Training on regulation forvendors and oong>theong>r actors- ong>WHOong> Aide memoire: Lack ong>ofong> training Registration ong>ofong> equipment entering ong>theong> market Safe Medical Devices Work with ong>WHOong> CollaboratingCenters(ong>WHOong>CC )- Medical Regulation Global Overviewand Guiding Principles (ong>WHOong> Press)No coordinated implementation historically Publication ong>ofong> "reputation" performance criteriabased on delays, absence ong>ofong> errors etc.- GHTF Definition ong>ofong> ong>theong> Term MedicalDevice Training and human resources(central)- ISO 15223 Standard RegardingGraphic Symbols for Medical Devices Reuse ong>ofong> single use devices Comprehensive supplier control - ong>WHOong> Web site Training ong>ofong> hospital techniciansand engineers No reporting system or any particular entity tocontact in case ong>ofong> problem Knowledge ong>ofong> foreign regulations (request for CEmark, FDA etc)Public awareness building Manuals for users and technicians in local language. Accreditation ong>ofong> medical facilities and prong>ofong>essionals Updating ong>ofong> regulation,training workshopsRegulation for ionizing radiation Visits facilitated by ong>WHOong> inforeign authorities. Core course on regulatoryaffairs for ong>theong> administration(AHWP) Sessions and CDs notweb. Information about regulatoryaction (recalls) on ong>theong> ong>WHOong> website Awareness raising, knowledgeabout implementation ong>ofong> regulation. Support internet for searchableregulatory information in publicsector3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 22


National HT IssuesMajor gaps and obstaclesSuccesses that can be sharedRecommendations for existingdocuments Lack ong>ofong> structured needs assessment HT Policy implemented in ong>theong> strategic health plan Needs Assessment guidelineRecommendations foradditional assistance In general more consultingservices – hands-on help– Medical devices are purchased based on physician orpolitician desires, not a demonstrated or justified needong>ofong> ong>theong> patient population serviced;– Field-ready tool• Obstacle - ong>theong> threat ong>ofong> taking ong>theong> power away fromdeciding person Needs assessment based on inventory and geographicdistribution ong>ofong> technology• Incorporate as many influencingfactors as possible In-field staff to train and enablelocal resources enablessustainability• Obstacle – lack ong>ofong> established best practice– Use ong>ofong> outdated or inappropriate medical device listswaste resources Using quantitative measures All Guidelines Documentation is great, stillneeded– Add quick start guide or summary toong>theong> guidelines Healthcare Tech Units are generally not organised– Unit might exist, but has no power or strategicfunction– Functional equivalents exist in parallel but lack ong>ofong>cross department / directorate collaboration leads toredundant work Needs assessment completed by committee ong>ofong> clinicaland technical experts Essential medical device lists developed for clinicalservices– Make guidelines more specific• To clinical specialty - ´specialconsiderations for radiology equipmentmanagement´• To health facility – separate betweenprimary care and hospital Continue to develop ong>theong>eDocumentation repository Continue to support Infratech-likelistservs for knowledge exchangeand archive• Obstacle – Power to approve medical devicepurchases means influence• Obstacle – Lack ong>ofong> qualified human resources to fillong>theong>se positions Oong>theong>r lists developed by facility type Policy Development and Adoption Assistance with budgetdevelopment– ong>WHOong> provides in-country support Assistance with grant-writing andresource mobilization (fundraising)3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 23


Health Technology AssessmentMajor gaps and obstaclesSuccesses that can be sharedRecommendationsfor existing documentsRecommendationsfor additional assistanceGap ong>ofong> information about ong>theong> benefits ong>ofong> HTA HTA existing databases, providing already availableHTA reports, for free. How to read ong>theong> evidence: CochraneCollaboration, Evidence BasedMedicine, etc. Identify Public Heath,Electrobiomedical Engineering(EBM) and HTA trained people inyour environment: MoH,researchers, and universities. Training courses on HTA and Evidence Based Lack ong>ofong> information about ong>theong> relation among HTM,Medicine related methodologies currently available inHTA and HT regulation.Internet. Data bases: International Network ong>ofong>Agencies for Health TechnologyAssessment (INAHTA), HealthTechnology Assessment International(HTAi), EUnetHTA, EUROSCAN,Health Evidence Network (HEN), etc. Contact HTAi society andINAHTA existing working groupson developing countries. No information available in ong>theong>ir own country’s web Already trained people may be incorporated tositedevelop HTA activities. Needs to include Evidence Basedinformation and training in operationalresearch for evidence, to develop goodpractice‘s recommendations andindicators Find one responsible person inong>theong> Ministry to initiate HTA relatedactivities. Decisions are implicit, based on “eminence” or“existence”, instead ong>ofong> transparent and based on“evidence”. Capacity building possibilities in existing HTAagencies Clinical Practice Guidelines, withresponses for clinicians, organizationalmatters and to define indicators. Use ong>ofong> existing HTA reports toelaborate ong>theong> advice, contextualizedto your country’s decision making. Major focus on safety and efficacy and maintenance, Use ong>ofong> “PICO” structured questions (Patients,but not on effectiveness and appropriate use, contextInterventions, Comparison with, Outcome).related. Networking, list ong>ofong> experts. “Globalize ong>theong> evidence,localize ong>theong> decision” Use external reports as a basis to startadvising ‘evidence based’ policy andclinical decision making.3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 24


HTM 1 (Procurement, Donations and ong>Technicalong> Specifications)Major gaps and obstaclesSuccesses that can be shared Donations: Donations: Indicators– Lack ong>ofong> policy, guidelines and control/enforcement – Good-practice from some countries/partnersRecommendationsfor existing documents– for successful technology transfer,procurement and donationsRecommendationsfor additional assistance Decision and OversightStructures and Information– Cost ong>ofong> ong>theong>se value-addedservices; seen as investment– Political pressure, donor over-ride, tied aid;sometimes ‘blind’– Scope for negotiation (helpful if evidence-based);increasing acceptance and assertiveness– Not driven by country needs; may be totallyinappropriate– No control over FPO’s and NFPO’s; need legalframework– Culture ong>ofong> acceptance ong>ofong> ‘(Free) giftDonation Guidelines Procurement: – flowcharts– National ong>Advisoryong> Committee on Medical Equipment(multidisciplinary and representative; carry authority)needed– Balance between regulation and willing donor/willing– E-procurement (transparency) – include cases ong>ofong>recipient– Different problems for new equipment vs 2 ndhand/refurbished– Equipment lists by level ong>ofong> facility, with standards andspecificationsgood models/ Life-Cycle Cost Analysis / CostImplications– for devices with significantrecurrent costs (consumables,spares, staff, maintenance) and/orlimited life expectancy Business Case Analysis forMedical Devices (MD)Interventions– templates and cases– Often compelled to accept package - all or nothing practice – Simple Decision-Support Toolse.g. Excel-based economic analysis Procurement Challenges– Poor needs assessment and prioritization - results inboth over- and under-supply– How to raise awareness andacceptability in member states? Usepatient safety as part ong>ofong> strategy, civilsociety or involvement? Codified Project ManagementProcess– Perverse incentives; corruption; cost-inflation; ‘Whyare things ong>theong> way ong>theong>y are? Why don’t things change?’– How to verify declared regulatory compliance?– Little or no use ong>ofong> performance-related and costinformationin decision-making– Need for oversight and auditing ong>ofong> processes3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 25


HTM 1 (Procurement, Donations and ong>Technicalong> Specifications)Major gaps and obstaclesSuccesses that can be sharedRecommendationsfor existing documentsRecommendationsfor additional assistanceong>Technicalong> Specifications:– Lack ong>ofong> generic specifications– Too much technical ‘nit-picking’User Training– Inadequacy ong>ofong> user training• Importance ong>ofong> training in minimizingusage error• Need for Competency / OutcomeSpecification– Difficulty ong>ofong> adding post-hocbecause ong>ofong> added cost; not linked topayment– User migration and lack ong>ofong>institutional capacity-building andmemory (need for successionplanning)HTM 2 (Maintenance and Inventory)Major gaps and obstacles Inventory Jordan– Nomenclature problems– CMMS requiredMaintenanceSuccesses that can be shared– Very cost effective maintenance system($6M for $150M assets =4%)– Fully featured and operational CMMSdeveloped in-house– ISO certifiedRecommendationsfor existing documents Low cost, easy to use, in locallanguage, web-based CMMS Training on CMMS should bedocumented and shared and posted onong>WHOong> website Develop indicators for good qualitymaintenance systemsRecommendationsfor additional assistance Comparison study ong>ofong> availableCMMSs in order to recommendcost effective and implementablesystemsTraining on CMMS Establishing specializedtraining centers in different regionsfor maintenance/troubleshooting–Maintenance by suppliers is inadequate Tunisia–Low number ong>ofong> trained engineers andtechnicians– operational CMMS developed in-house Develop indicators for good qualitytraining Awareness programs for policymakers in MoHsTraining Need internationallyrecognized and unifiednomenclature system–Lack ong>ofong> continuous training programs–Vendor training is inadequate* Major Gaps and Obstacles by Countrycan be found in ong>theong> next table: TableA4.5.2.3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 26


HTM 2 (Maintenance and Inventory) Major Gaps and Obstacles per CountryAlbania Palestine Egypt Jordan Sudan Inventory Inventory Inventory Inventory Inventory– Italian CMMS – Access database started 5 years ago –Ad hoc- depends on hospitals – Full CMMS developed in house – >250 hospitals– Not updated regularly – Basic features – ISO certified – >4000 primary health care units– Lack ong>ofong> staff and financial resources – Requires furong>theong>r development Maintenance – UMNDS nomenclature – No national inventory– Largest hospital not included in inventory – No networking – ~20% have CMMS – English & Arabic – No unified system– Accuracy ong>ofong> data about 50% – Nomenclature not standardized – No sufficient budget for maintenance – Very few CMMS– Nomenclature is CIVAP from Italy (standard?)– 11 regional hospitals + 4 university hospitals + 23district hospitals (licenses do not cover all ong>theong>sehowever)– 12 Hospitals+ 12 directorates + >200 primary carecentres– Major equipment done by local agents Maintenance – No standard nomenclature– Most hospitals have biomedical eng.Dept– 27,000 devices, 30 hospitals,$150M assets, $6M maintenancebudget Maintenance – ~20% perform calibration – PPM incentive point system Maintenance Maintenance – Service contracts for few large devices – Manual information– PPM only for complex devices – Spare parts inventory not replenished systematically Training Training process– Calibration only for complex devices– No flag for next Planned Preventive Maintenance(PPM)– No PPM alarms Training – No automatic evaluation ong>ofong> data– On site by local agents– No specific budget allocated fortraining ong>ofong> engineers– Workshops /short courses availablethrough universityTechnicians and engineers trainoong>theong>rs after receiving training– No labeling system– Service contracts onlyfor major devices– No training program – Training – Calibration done byfor technicians and– Local agents provide onsite training for users andtechnicianshospital engineers orusers Carolinska – No training valuation system private companiesUniversity Sweden- 2year training- over Training– No vocational education Ad hoc3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 27


HTM 2 (Maintenance and Inventory) Major Gaps and Obstacles per Country...cont from last pageNepal Tunisia Iraq Uganda Kenya Inventory Inventory Inventory Inventory Inventory– 65 district hospitals, 201 primary healthcare, 600health posts– Not country-wide – Will procure GE CMMS–Over 100 tertiary & secondaryhospitals– Use Excel– No HTM department system – only in English –3-4 years ong>ofong> data entry – 97 out ong>ofong> 250 hospitals– Web based inventory system (in-house) for districthospitals– Problems with electricity and internet connection locally– No standard nomenclature– Song>ofong>tware developed – Will be applied to 3 provinces –Nomenclature not standardized inventoried– Problem with customization andtraining– Many information not available evenon paper–Cannot generate reportsautomatically–They have computers inworkshops– Information updated once a year– ~80% accurate– High turnover ong>ofong> data entry personnel Maintenance – Backup ong>ofong> data requires– Hired private company to perform data entry – Sign 10 year service Maintenance Maintenance improvementcontract, paid annually – Maintenance contracts for 5 years –No manuals – 300 pieces ong>ofong> equipment per Maintenance • Ex: ultrasound- 20% including probes– Warranty ong>ofong> donated equipment foronly one year–No policies and procedures provincial hospital– No biomedical engineering positions • Plan to get ISO accreditation – No sense ong>ofong> ownership–User negligence for care ong>ofong>equipment– 200 pieces ong>ofong> equipment per– Just Preventive Maintenance (PM) ong>ofong> vehicles, notmedical devices– No labeling Training Training–Donated equipment from Japannolocal agent- no spare partsdistrict hospital– Agents do not provide service after warranty– Training programs for both users and maintenancetechnicians– Done by suppliers, superficially Training Maintenance– Financial problem – Vocational program -3– Central training program discontinued– Buy full service contracts for–No trainingfor security reasons10%year –No university biomedical – Some maintenance in-house Training – 2 phases ong>ofong> training- 1 st engineering programs – Maintenance provided by– N/A phase users, 2 nd phase –Collaborate with Kenya suppliers is not monitoredtechnicians– Inspection ong>ofong> suppliersworkshopsis performed– Require additional 100technicians, 12 engineers Training– 5 persons trained on radiologyequipment through GAME / JICA3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 28


9. Country action plans9.1 Country summary presentations (working group results)Obtaining ong>theong> country perspective with regards toHT-related issues is important for ong>WHOong>.Therefore, each country representative was askedto present an action plan with a minimum ong>ofong> twoshort-term goals and one long-term goal ong>theong>ywould like to accomplish.Participants have also discussed what is mostneeded to succeed in implementing ong>theong>ir actionplans.Key messages:• Country prospective based on ong>theong> real situation ong>ofong>all issues related to HT is vital for ong>theong> ong>WHOong> futureplans• All participated countries have short term and longterm goals on HTA, National HT issues and HTM• This country prospective should be taken intoaccount when formulating ong>WHOong> next steps toprovide countries with needed support.Feedback on ong>theong>se goals was provided at ong>theong> meeting by all participants including ong>WHOong>. Countries cannow use this to help ong>theong>m formulate and implement ong>theong>ir individual plans.The short-term goals, long-term goals, challenges/obstacles to achieving ong>theong> goals, and recommendationsto ong>WHOong> presented by each country can be found in ong>theong> following sections.3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 29


9.1.1 AlbaniaAlbania is in ong>theong> process ong>ofong> adopting ong>theong> European regulatory system and ong>WHOong> EURO isexpected to assist. It is a good step for Albania to start an adverse event reporting system and itshould include a warning (alert) component. Integrating a technology-related adverse reportingsystem into ong>theong> patient safety programme should provide a more effective programme. Manycountries are asking for patient safety systems and quality systems.Participants mentioned that it is important to understand if ong>theong>re is ong>theong> infrastructure to supportong>theong> implementation ong>ofong> ong>theong> HTM tool and an adverse event reporting system. If inventorycommunications systems are not in place ong>theong>n it is quite difficult to support such programs.Albania: Country Action PlanRegulations National HT issues HTA HTM1 HTM2 Short-term Goals: Short-term Goals: Short-term Goals: Short-term Goals: Short-term Goals:- ong>Technicalong> Regulation (three sublawsdocuments) for medicaldevices drafted within 2010 in fullcompliance with EU directives formedical devices- Introducing to ong>theong> healthinstitutions ong>theong> need for having ong>theong>adverse reporting system– Implementation ong>ofong> ong>theong> policy andguidelines through mandatoryregulations– Introducing to ong>theong> healthinstitutions ong>theong> benefits ong>ofong> needsassessment– Preparing documents likeindicators and templates for needassessment-Awareness for HTA-Making a list ong>ofong> devices whichneed a HTA- Guidelines to be followed whendonations are ong>ofong>fered- Assignment ong>ofong> people to take careong>ofong> ong>theong> inventory system in eachhospital(not only techniciansbecause ong>ofong> technical staff shortage)and train ong>theong>m- Updating ong>theong> inventory system- Planning to include ong>theong> biggesthospital, Hospital ong>ofong> Tirana, in ong>theong>existing inventory system whereonly regional hospitals are included Long-term Goals: Long-term Goals: Long-term Goals: Long-term Goals: Long-term Goals:-Implementing ong>theong> technicalregulations upon approval at ong>theong>beginning ong>ofong> 2011- Design ong>ofong> ong>theong> adverse reportingsystem- Applying need assessment -How to implement HTA program- Better conditions elaborated in ong>theong>- Training program for users andagreements between government ong>ofong>technical staffAlbania and ong>theong> donators-List ong>ofong> general technical- Going from inventory system tospecification provided from MoH tomanagement systemhospitals- Complete ong>theong> information systemfor The Hospital ong>ofong> Tirana Challenges/Obstacles: Challenges/Obstacles: Challenges/Obstacles: Challenges/Obstacles: Challenges/Obstacles:- Difficulty to obtain good- Delays in preparing ong>theong> technical - Reaction and refusal to accept-Lack ong>ofong> experienceconditions when dealing with - Finding and motivating peopleregulations draftneeds assessment by hospitalsdonations- Delays in approval by ong>theong>- Lack ong>ofong> experiencegovernment- Difficulty in building up ong>theong>adverse reporting system because ong>ofong>ong>theong> lack ong>ofong> experience-Change ong>ofong> mentality on who andhow to take decisions- Rejection ong>ofong> technicalspecifications by ong>theong> hospitals- Finding trainers- Budget restriction Recommendations to ong>WHOong>: Recommendations to ong>WHOong>: Recommendations to ong>WHOong>: Recommendations to ong>WHOong>: Recommendations to ong>WHOong>:-Guidelines on basics ong>ofong>- Model for adverse event - Provision ong>ofong> documents, templates -Provision ong>ofong> document templates - Provision ong>ofong> best practicemaintenance per device or devicereporting systemon needs assessmenton HT assessmentguidelinesgroup- Assistance in implementation ong>ofong>- Training -Training on how to read evidence -Training program for maintenanceong>theong> regulations3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 30


9.1.2 EgyptIn Egypt, many engineers have graduated from universities and found ong>theong>ir way into academicand technical jobs but most ong>ofong> ong>theong>m do not work for ong>theong> MoH. Many ong>ofong> ong>theong> topics illustrated byong>theong> Egyptian presentation have already been addressed by engineering groups outside ong>ofong> ong>theong>MoH. There has been an awareness ong>ofong> ong>theong>se issues for 30 years yet ong>theong> MoH has not addressedong>theong>m fully. Furong>theong>rmore, ong>theong>re are HT regulations in Egypt but ong>theong>y are not applied or appliedoccasionally. Authorities also tend to use desktop evaluation raong>theong>r than field examples. This ledto, for example, a time when ong>theong> MoH imposed a regulation where used medical equipment couldnot be imported into Egypt based on idea that contaminated equipment would introduceinfections to ong>theong> users or handlers. It is ong>theong> intention that ong>theong> short and long-term goals presentedwill help ameliorate ong>theong>se issues.Egypt: Country Action PlanRegulations National HT Issues HTA HTM1 HTM2 Short-term Goals: Short-term Goals: Short-term Goals: Short-term Goals: Short-term Goals:− Quick workshop for ong>theong> health− Update ong>theong> guidelines according− Oriented workshop on how toworkers to explain ong>theong> meaning andto ong>theong> standardsconduct HTAong>theong> benefit ong>ofong> HT.- Establish a national center for HTfor all private and public sector− Raise awareness about HTMprocurement and donations− Review ong>theong> MD’s list Long-term Goals: Long-term Goals: Long-term Goals: Long-term Goals: Long-term Goals;− Encourage to use ong>theong> medicaldevice regulation guidance on ong>theong>health district (270 district) anddirectorate level (29 governorate)– Training course− Establish a health technologicalsystem− Training on HTM− put a plan and schedule tablefor updating MD’s Challenges/Obstacles: Challenges/Obstacles: Challenges/Obstacles: Challenges/Obstacles: Challenges/Obstacles:− Have regulation but not applied− Have HT policy but do notendorsed by law−Absence ong>ofong> HTA− Lack ong>ofong> coordination betweendonor agencies− Need to annually update ong>theong> listong>ofong> MD’s for all health units andhospitals in our GeographicalInformation System (GIS)− Complete absence to fullimplementation− Misunderstanding ong>ofong> HT bydecision makers− Lack ong>ofong> information about ong>theong>relation between HTA, HTM andHT regulation− Lack ong>ofong> policy and guidelines− No maintenance system forhealth directorates− Turnover ong>ofong> ong>theong> training workers(especially, ong>theong> engineers)− Have Medical device list butnot implemented− Lack ong>ofong> training − Lack ong>ofong> qualified Recommendations to ong>WHOong>: Recommendations to ong>WHOong>: Recommendations to ong>WHOong>: Recommendations to ong>WHOong>: Recommendations to ong>WHOong>:− ong>WHOong> leading role with MoH(wide regulation)- Exchange ong>ofong> experts betweencountries− Regional ong>ofong>fice orient MemberStates on HTA− Donations according to realcountry needs− National policy & proceduresfor Inventory, ong>WHOong> HTM tools− Put a tool in ong>theong> curriculum fortechnicians in ong>theong> health technicalinstitute (medical device,laboratory, sanitarian and nursesections)− Increase awareness ong>ofong> medicaldevice regulation - Training course on HT− Short training with CD forregulation training materials- Ideal structure for HT− Development ong>ofong> standarddepartment and determine its dutiesmedical equipment list& responsibilities− Need summary ong>ofong> guidelines− Need training on HTA activities− Find responsible person in MoHto initiate HTA related activities− Need intranet network on ong>theong>district levels (270) for updating ong>theong>data base for medical devices for allhealth units (4200 ) and public −hospitals (523) except private,army, railways, universities andprisons hospitals (1369)Need Quality control tools− Training course onmaintenance in all levels− Specific guidelines for healthunits and hospitals on healthtechnology− Need to extend ong>theong> localnetwork to cover ong>theong> health districtsin order to annually update ong>theong> listong>ofong> MD’s3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 31


9.1.3 JordanIn Jordan ong>theong>re is a diversity ong>ofong> health service providers including MoH, military hospitals,university hospitals and ong>theong> public sector. The German Agency for ong>Technicalong> Cooperation (GTZ)had a long-term project with ong>theong> military to train a 3 year diploma course on ong>theong> technical supportong>ofong> medical equipment for both MoH and military hospitals. The project is still running todayunder ong>theong> Institute ong>ofong> Biomedical Technology.The unique, fully automated CES system in Jordan covers only MoH hospitals. There is a noteddisconnect between ong>theong> various health service providers, and as such ong>theong>re is a need to harmonizewith ong>theong> oong>theong>r health sectors.The ong>WHOong> Jordan country ong>ofong>fice has just launched a joint program on HT with different providersthat includes a joint HT policy, joint HTA program, a national institute for HT, joint clinicaldiagnostics research, and joint regulation ong>ofong> medical devices among oong>theong>r things. The Minister ong>ofong>Health has also formed a national committee for health technology with members from all healthsectors to cooperate and harmonize HT issues on a national level with ong>WHOong> taking a leadingrole.The meeting participants expressed particular interest in learning ong>ofong> ong>theong> outcomes ong>ofong> ong>theong> HTAnational program in Jordan.Jordan: Country Action PlanRegulations National HT issues HTA HTM1 HTM2 Strengong>theong>ning & updating MDRegulation Guidelines at Nationallevel Establishment a NationalInstitute ong>ofong> Health Technology.Establishing HTA program Implementing ong>theong> ong>WHOong>Guidelines for health careequipment donations at Nationallevel Involvement ong>ofong> DBE in futureong>WHOong> plans– Establishing a committeedesignated to review & update ong>theong>existing guidelines according tointernational standards.– Establishment ong>ofong> a National– Forming a general HTASteering Committee from all HealthcommitteeSectors.– Conducting a workshop onmedical supplies donations withparticipation ong>ofong> all health sectors,ong>theong> ong>WHOong> ong>ofong>fice & donor agenciesJapan International CooperationAgency (JICA), United StatesAgency for InternationalDevelopment (USAID), GermanAgency for ong>Technicalong> Cooperation(GTZ)...– Conducting training programsfor Biomedical Engineers fromdeveloping countries– Conducting a local trainingcourse / workshop on MDRegulations with participation ong>ofong> allHealth stakeholders– Establishment ong>ofong> a MD incidentreporting system. Lack ong>ofong> experience and expertsin this field– Conducting a workshop tointroduce objectives, rules and anassessment ong>ofong> ong>theong> situation– Harmonizing HT issues in allhealth sectors– Conducting an orientationworkshop with all key people in allhealth sectors– Establishing a website forpublishing & recommending plans– Reviewing and modifying, policy – Implementing ong>theong> DBE CMMSguidelines to be applicable to ong>theong>MoHin developing countries as a pilotproject– Adopting ong>theong> developedguidelines & posting ong>theong>m on ong>theong>MoH web site. Understanding & supporting ong>theong> Lack ong>ofong> experience and experts Understanding & supportinghighest leadershipin this fieldhighest leadership Lack ong>ofong> awareness among Understanding & cooperation ong>ofong> Financial allocationshealth decision makers ong>ofong> highestoong>theong>r health sectorsleadership– Increasing ong>theong> awareness ong>ofong> MDregulations & its impact on safety &efficacy– Assisting on specialized trainingprogram or expert nomination Financial allocations to promoteong>theong> idea to ong>theong> highest leadershipUnderstanding & support Understanding & supportingdonors– Promoting ong>theong> idea to ong>theong> highestleadershipPromoting & Marketing DBEFinancial allocations– Activation ong>ofong> DBE as a ong>WHOong>collaborating centre Financial allocations– Increasing ong>theong> awareness onHTA important & its impact on HTdecisions– Assisting on specialized trainingprogram & experts nomination3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 32


9.1.4 KenyaAustrian and German governments have invested millions for technician training, with tools andfacilities provided. Unfortunately, ong>theong>se programs have not been sustained. Examination ong>ofong> whyand how future programs can be sustained should occur.The following proposals for action were discussed:The policies should be incorporated with ong>theong> national health plan if ong>theong>y are to be enforceable.Perhaps just having ong>theong> word ‘technology’ in a couple ong>ofong> policies will give more leverage andvisibility. Furong>theong>rmore, ong>theong> health sector is governed under 43 acts and ong>theong>re is a desire to haveong>theong> 44th introduced that would be related to technology.Kenya has many resources in place. There is a short-term consultant that will stay on for anadditional 6 months who can assist in ong>theong> development and execution ong>ofong> ong>theong> action plan.Lastly, it is an excellent idea to have HTA at ong>theong> unit level but governance needs to be consideredto ensure transparency. Perhaps a shared unit with rules and regulations is needed.Kenya: Country Action PlanRegulations National HT issues HTA HTM1 HTM2 Short-term Goals: Short-term Goals: Short-term Goals: Short-term Goals: Short-term Goals:- Publish technical information andshare with public and private sectorto encourage quality control in ong>theong>– Awareness ong>ofong> benefits ong>ofong> HTcountry. This should includepolicyinformation on performance,,utilization and compliance to safetystandards.– ong>Technicalong> information on tools,existing polices, experiences inoong>theong>r countries– HR development– Awareness ong>ofong> importance ong>ofong>HTA– Generic specification formedium and high technologymedical devices– Information on standards forquality– Reference materials on medicaldevices maintenance, troubleshooting, spare parts– Provision for tools and testing/calibration equipment Long-term Goals: Long-term Goals: Long-term Goals: Long-term Goals: Long-term Goals:– Development ong>ofong> a National HT- Legal frame work for regulation ong>ofong>– Establish HTA unit at central– Medical device life costsmedical DeviceslevelPolicy including implementationplan– HR development forimplementation– Develop and Implement HTAprogrammes– Information on compliance withsafety/quality standard– Develop training programmescovering user and technical training– Exchange programmes for shortterm experts (AFRO, EMRO etc)– Compliance ong>ofong> Bilateralprogrammes toprocurement/donation guidelines– Collaboration with oong>theong>restablished training institutions– Establish quality controllaboratory for medical devices– Song>ofong>tware for HTM Challenges/Obstacles: Challenges/Obstacles: Challenges/Obstacles: Challenges/Obstacles: Challenges/Obstacles:- National HT policy must be in– Political environment – Political environment – Political environment – Noneplace- Government bureaucratic system- Resistance from some stakeholders Recommendations to ong>WHOong>: Recommendations to ong>WHOong>: Recommendations to ong>WHOong>: Recommendations to ong>WHOong>: Recommendations to ong>WHOong>:– Support Development ong>ofong> HTpolicy– Support ong>theong> short term expert – Tools and case study reports– Information on medical devicescompliance with standard– Support short term experts- Support establishment ong>ofong> regionalinstitution for testing andcertification ong>ofong> medical devices ,vendors, and practitioners– Support stakeholder workshop – Short term expert on HTA– Information on recommendedstandards– Support establishment ong>ofong> regionalquality control laboratories formedical devices- ong>Technicalong> documents onstandards, quality and compliance- Capacity building for regulation– Capacity building – Capacity building ong>ofong> HTA– Provide necessary tools/casestudies– Awareness on donated medicaldevices by international NGOs andbilateral programmes– Make relevant technicalinformation (quality ong>ofong> standards,maintenance procedures, trainingmanuals etc) available– Assist in establishing e-healthinfrastructure3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 33


9.1.5 NepalThere are already several advocates actively involved; GTZ and ong>theong> British Council are both incountry with strong programs. However, even with ong>theong>se resources full benefit is not receivedbecause ong>theong>y only address a small area, not ong>theong> entire country.Participants said that ong>theong> plan to place ong>theong> proposed HT unit under ong>theong> logistics unit should becarefully re-evaluated because it could diminish ong>theong> effectiveness ong>ofong> ong>theong> unit.The country has a procurement unit, but ong>theong>re is room for improvement. Lack ong>ofong> awareness onprocurement issues is still a problem that needs to be addressed. Furong>theong>rmore, ong>theong> country needsassistance in building a quality assurance program; this has already been requested.A comprehensive system for HT has not yet been developed even though support is available.The need exists to re-evaluate ong>theong> current support structure such that systems are improved andcan be sustained.Nepal: Country Action PlanRegulations National HT issues HTA HTM1 HTM2 Short-term Goals: Short-term Goals: Short-term Goals: Short-term Goals:– Collect evidences, analysis and– Goal 1: Develop regulatory – Advocate to develop ong>theong> planned– Collect inventory data fromdraw conclusion to prioritize ong>theong>document on Medical Device programs into strategieshospital/health facilitiesneeds at country level– Strengong>theong>n maintenance unit in– Develop ong>theong> National MD listscentre and regions– Initiate process to establish HT/Biomedical Unite and LogisticsManagement Division. Long-term Goals: Long-term Goals: Long-term Goals Long-term Goals:– Ensure qualitative medical– Improve HT situation for ong>theong> – The evidence based data will be– Maintenance and use ong>ofong> medicaldevices for ong>theong> diagnosis andproper use ong>ofong> MDused for ong>theong> planning and programsdevicetreatment ong>ofong> ong>theong> patient Challenges/Obstacles: Challenges/Obstacles: Challenges/Obstacles: N/A Challenges/Obstacles:– Coordination - Expert/lawyer– Commitment ong>ofong> ong>theong> higher– Collection ong>ofong> inventory data- ong>Technicalong> and financialrequiredauthorities/ political bodiesfrom all health facilities– May take a long time for ong>theong> –Commitment and coordinationong>Technicalong> experts and human– forecasting ong>ofong> spare partsapproval processfrom MoH & oong>theong>r ministries resourcesrequired– Donors interest/policy– Lack ong>ofong> resource - budgetrequired Recommendations to ong>WHOong>: Recommendations to ong>WHOong>: Recommendations to ong>WHOong>: Recommendations to ong>WHOong>:– ong>Technicalong> assistance – ong>Technicalong> & financial - Advocacy – Finance– Advocacy awareness ong>ofong> ong>theong> – Establish facilities, equipments – ong>Technicalong> – data collection and– Infrastructures, training, spareneedsand traininganalysisparts, tools– ong>Technicalong> assistance– Coordination3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 34


9.1.6 SudanThe political issue ong>ofong> Sudan not being a unified state, with a division between ong>theong> north and ong>theong>south creates obstacles for any health program including HT. However, primary healthcare is apriority especially in ong>theong> south where it is needed most. It is important to make sure that anytechnical assistance developed in ong>theong> north also benefits ong>theong> souong>theong>rn provinces.The federal state system in Sudan means that ong>theong> Minister ong>ofong> Health is not in full control ong>ofong> allhealth issues in ong>theong> country. Furong>theong>rmore, souong>theong>rn Sudan has its own ong>WHOong> ong>ofong>fice and ong>theong> ong>WHOong>Representative (WR) in Sudan is ong>theong> director ong>ofong> both ong>WHOong> ong>ofong>fices.Souong>theong>rn Sudan is receiving more donations and resources but under ong>theong> same umbrella.Programmes are implemented differently in souong>theong>rn Sudan just as ong>theong>y are implementeddifferently from state to state.The next step in Sudan would be to start applying ong>theong> ong>WHOong> HTM tools through a 5-year programong>ofong> implementation. However caution is needed when implementing ong>theong> tools and specificallyguidance is needed in areas such financial and human resources. Regarding regulations, if ong>theong>yexist for patient safety, ong>theong>n maintenance and user training can be linked to this as ong>theong>y are alsoimportant to patient safety.Sudan: Country Action PlanRegulations National HT Issues HTA HTM1 HTM2 Short-term Goals: Short-term Goals: Short-term Goals: Short-term Goals: Short-term Goals:– Goal 1 : Develop nationalmedical device regulation- Goal 2 Harmonize medicaldevice regulations and relatedregulations in ong>theong> health sector- Goal 1: Develop national HTPolicy- Goal 2: Establish national HTUnit– Goal 1: Advocacy for evidencebased decision making regardinghealth technology– Goal 2: Establish HTAcommittee- Goal 1 : Establish centralprocurement department- Goal 1 :Establish national workshop and inventory system- Goal 2: Develop medical device - Goal 2:Develop HTMspecification development guidance management system for hospitals- Goal 3: Adopt ong>WHOong> donationguideline Long-term Goals: Long-term Goals: Long-term Goals: Long-term Goals: Long-term Goals:– Goal 1: Enforce medical device– Goal 1: Develop national - Goal 1 :Establish regional– Establish national HT Council - To establish HTA institutionregulationdonation policyworkshops for maintenance– Establish unit in each state – Goal 2 : Establish– Establish training program procurement department in eachstate Challenges/Obstacles: Challenges/Obstacles: Challenges/Obstacles: Challenges/Obstacles: Challenges/Obstacles:– Lack ong>ofong> unified regulatory body – Lack ong>ofong> expertise – Information gap – Organization ong>ofong> HTA unit - Lack ong>ofong> trained health workers– Decentralized system – Fragmentation – Lack ong>ofong> operational researchers– Lack ong>ofong> trained human resources' – Lack ong>ofong> HTA policy– Finance shortage– Lack ong>ofong> expertise andcompetencies- Shortage ong>ofong> funds Recommendations to ong>WHOong>: Recommendations to ong>WHOong>: Recommendations to ong>WHOong>: Recommendations to ong>WHOong>: Recommendations to ong>WHOong>:– ong>Technicalong> Assistant – Support training program - ong>Technicalong> Assistance – Make guidelines available- Provide technical assistant &guidelines– Provide guidelines - Assistant for HTA advocacy – ong>Technicalong> Assistance - Support training– Exchanging experiences3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 35


9.1.7 TunisiaMany tools have been implemented in Tunisia. Unfortunately, ong>theong>re are a number ong>ofong> issues thatneed to be addressed. For example, groups address regulation and documentation in isolation.Through ong>theong> exchange with ong>theong> oong>theong>r countries and experts, suggestions on how to improve ong>theong>organization ong>ofong> programmes in ong>theong> country were provided.On issues ong>ofong> regulatory affairs, Tunisia would like support from ong>WHOong>.In terms ong>ofong> healthcare technology management, ong>theong>re is a tendency to decentralize procurementoperations. Drafting specifications requires skills and knowledge ong>ofong> those technologies but alsoknowledge in how to write formal specifications. Training in this area was recommended.Anoong>theong>r significant challenge is ong>theong> recruitment ong>ofong> adequate staffing and definition ong>ofong> roles andresponsibilities, technical expertise and training. Additionally, ong>theong>re are many manuals for HTMand related strategy but no global overview document summarizing this. Such a document couldbe useful.There is also a need to put in place a more formal method ong>ofong> needs assessment. In addition, ong>theong>reis no clear plan for decommissioning ong>ofong> medical equipment, in particular, ionizing equipment.HTA is something new for Tunisia and ong>theong>re have been some assessments for purchasingproducts that do not add clinical value. Support from ong>WHOong> would be useful to complete a HTAfeasibility study.Demonstrating ong>theong> value received from money spent is also beneficial and can be used to supportfurong>theong>r development ong>ofong> HTM. It is very important to help people develop ong>theong>ir own businessplans and explain how ong>theong>y can justify/demonstrate ong>theong> value ong>ofong> an investment in HTM and HTA.3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 36


9.1.8 UgandaThe situation ong>ofong> all issues related to medical equipment in Uganda is quite poor and ong>theong> country islacking any form ong>ofong> HTM. Besides ong>theong> absence ong>ofong> HTM tools ong>theong>re is also a lack ong>ofong> qualifiedtechnical staff and in general ong>theong> country is in need ong>ofong> technical support in all fields related to HT.The difficult situation ong>ofong> HT in Uganda triggered discussion between participants on ong>theong> role ong>ofong>international organizations, in particular ong>WHOong>.ong>WHOong> is comprised ong>ofong> two entities: member countries and ong>theong> secretariat. Declarations start with‘member states are urged to’ meaning ong>theong> statement is optional, but strongly recommended.Anoong>theong>r issue that was brought up is ong>theong> auong>theong>ntication ong>ofong> regulatory approvals and having accessto foreign regulating bodies. Having direct access to ong>theong>se regulating bodies may allow end-usersto identify valid/real certificates.Uganda: Country Action PlanRegulations National HT issues HTA HTM1 HTM2 Short-term Goals: Short-term Goals: Short-term Goals: Short-term Goals: Short-term Goals:– Publish technical informationon regulation ong>ofong> medical devices for – Introduce short term training inuse by non- government health HTM for health workersfacilities to encourage control– Build technical capacity in ong>theong>National Drug Authority to enableit to regulate medical devices forALL players including vendors– Sensitise politicians on ong>theong> gainsto be made by implementation ong>ofong>HTM in ong>theong> country– To inculcate importance ong>ofong>HTA in senior and top managementcommittees ong>ofong> ong>theong> Ministry toenable informed decision making- To sensitize local governmentdecision makers in ong>theong> importanceong>ofong> HTA– National ong>Advisoryong> Committeeon Medical Equipment [NACME]advice currently applied only topublic facilities to be publicised foruse by oong>theong>r health sector playersi.e. Private For Prong>ofong>it (PFP) andPrivate Not For Prong>ofong>it (PNFP)– To increase budgetaryallocations for medical devicemaintenance– Encourage PFP and PNFP– Ensure National Drug Authoritymanagers to conduct an inventory[NDA] entrusted with inspection ong>ofong>ong>ofong> medical devices by ong>theong> end ong>ofong>imported devices gets HTM2010 as an incentive for renewal ong>ofong>capacityong>theong>ir licences in 2011 Long-term Goals: Long-term Goals: Long-term Goals: Long-term Goals: Long-term Goals:– Put a legal framework in placefor ong>theong> ENTIRE health sector onregulation ong>ofong> medical devices– Establish a regional centre(s)for testing medical devices– Document and publish evidencethat HTM does improve quality ong>ofong>care, affordability and access tohealthcare- To continually be up to datewith HTA by ensuring localcapability ong>ofong> obtaining current HTApractices in a timely manner. Thiswould enable Government to makeinformed decisions– Make ong>theong> April 2009 MedicalDevices policy into law enforceablefor ALL health sector players– Government to get access tobona fide certification bodies so asto quickly auong>theong>nticate submissionsby bidders– Put in place song>ofong>tware forcarrying out accurate and reliablycosted needs assessment in ong>theong>country Challenges/Obstacles: Challenges/Obstacles: Challenges/Obstacles: Challenges/Obstacles: Challenges/Obstacles:– Lack ong>ofong> Human Resources forhealth to regulate medical devices– External influences toregulation– Obstinate policy makers who arenot sensitised to HTM and alwaystalk about many competing needs– Difficulty in convincingmanagement due to lack ong>ofong>information on HTA– Resistance by vendors and FPOto enacting ong>theong> law– Lack ong>ofong> capacity in many FPOand NFPO facilities to carry outinventory Recommendations to ong>WHOong>: Recommendations to ong>WHOong>: Recommendations to ong>WHOong>: Recommendations to ong>WHOong>: Recommendations to ong>WHOong>:– ong>WHOong> at ong>theong> next WHA torequire that member countries areon course in this respect– ong>WHOong> to give member countriestimeline for actualization ong>ofong>resolution WHA 60.29– ong>WHOong> to discuss HTA utilisationat ong>theong> September 2010 BangkokMinisters’ meeting and getcommitment on its commencement– ong>WHOong> to liaise with certificationbodies for member countries toaccess information on bidderssubmissions and also encouragecountries to pass relevant guidelines– To assist member countries insourcing inexpensive but userfriendly song>ofong>tware for needsassessment3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 37


10. General discussion10.1 Topic 1: Resource mobilizationThere is a strong desire for national health insurance especially in ong>theong> South African context. With this,ong>theong>re is much discussion about what is required in ong>theong> public health sector and what medical devices areneeded. It is very important to understand ong>theong> drivers in ong>theong> country.Resource mobilization is not an easy task. A packet ong>ofong> information or a template that countries can use forfundraising can be very helpful. There are a number ong>ofong> opportunities for funding ong>ofong> regional activities andong>WHOong> can support fundraising at ong>theong> country level. The documents will be available soon and countriescan apply for funding support to assist with implementationong>WHOong> may provide excellent documents and tools but ong>theong>y need to be implemented and show results.There is need for teaching project development skills that will improve development ong>ofong> timelines andaction plans.In addition, we need intellectual resource mobilization. There are ample resources; for example, postgraduatestudents looking for research projects that might be able to carry out some ong>ofong> this work. Theparticipants inquired if ong>WHOong> could create a research agenda.When it comes to health technologies, it was brought up that ong>theong> field is defined by political reality.Some disease states have stronger donor appeal than oong>theong>rs. One approach is to show how a strong,technically-equipped health system is needed in order to provide functional infection disease preventionor care programs.10.2 Topic 2: InnovationGrand Challenges Canada, for example, is a program where ong>theong>y support innovations for medical devicesfor poor countries. Anoong>theong>r workshop or meeting to talk about how to stimulate innovation in medicaldevices is recommended togeong>theong>r with oong>theong>r UN agencies such as ong>theong> United Nations IndustrialDevelopment Organization (UNIDO). UNIDO is working on infrastructure development and support ong>ofong>ISO 9001.10.3 Topic 3: SustainabilityWhatever programmes are established should be sustainable. There is a need to step outside ong>ofong> ong>theong> HTMfamily and interface with oong>theong>rs.3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 38


11. ConclusionsProviding equitable access to safe, effective, and appropriate health technologies where it is most neededto promote, prevent, diagnose, treat and rehabilitate is a great challenge. Incorporating healthtechnologies into national health plans is a first step to addressing ong>theong> challenge but can ong>ofong>ten be achallenge itself and that should be taken into consideration.Investment in medical devices should be planned in order to:• meet priority local needs• ensure that purchased devices are simple to use• be compatible with ong>theong> existing infrastructure and oong>theong>r servicesong>WHOong> is now providing a leadership role in medical devices which is expected to continue. The base linecountry survey has provided a baseline to measure results and is ong>theong> first milestone towards globalinformation and statistics on medical devices. Generally speaking, ong>WHOong> through ong>theong> GIHTproject, hasprovided ong>theong> basic framework structure ong>ofong> tools and guidelines needed for HTM programs.The way forward requires several steps to be taken by all stakeholders:• Empower health prong>ofong>essionals to make ong>theong> right decisions and take ong>theong> right actions, byproviding capacity building and providing technical information.• Make appropriate and innovative technologies available in countries• Work with UN organizations in interagency lists ong>ofong> medical devices for procurement• Enhance ong>theong> use ong>ofong> innovative medical devices, particularly for MDG (MillenniumDevelopment Goal) 4 and 5.• Review tools and guidelines• Conclude medical devices baseline country surveys• Assist in ong>theong> execution ong>ofong> Plans ong>ofong> action in every Member State (outcome ong>ofong> 3 TAGHTmeetings)• Continue focus on medical devices for maternal and neonatal health and high burden diseases• Develop lists ong>ofong> medical devices by Clinical Practice Guideline (CPG) procedures• Provide data on medical devices: technical specifications and nomenclature• Initiate anoong>theong>r call for innovative technologies specific for MDG 4, 5 and follow-up withsupport to research and development3RD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 39


Annex 1: List ong>ofong> participants3 rd meeting ong>ofong> ong>theong> ong>Technicalong> ong>Advisoryong> ong>Groupong> on Health Technology20-22 June 2010Cairo, EgyptAFRO REGIONLIST OF PARTICIPANTSMr Martin M. OWINOHead Biomedical Engineeringand Maintenance Services DivisionMinistry ong>ofong> Medical ServicesAFYA House, Caong>theong>dral RoadP.o. Box 30016-00100NairobiMr Sam S. B. WANDAAssistant CommissionerHealth InfrastructureMinistry ong>ofong> HealthKampalaKENYAUGANDAEMRO REGIONDr Sohier Botrous ATTALADirector General Internet NetworkNational Information Center for HealthCairoEng. Hamed Matthan ALDA’AJEHDeputy DirectorBiomedical Engineering DirectorateMinistry ong>ofong> HealthAmmanEGYPTJORDANSUDANDr Mohamed Osman HAMIDHealth Technology Focal PointFederal Ministry ong>ofong> HealthKhartoumTHIRD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 40


Dr Fredj Ben Mohamed LETAIEFDirector GeneralBiomedical Maintenance CenterTunisiaEURO REGIONMrs Ledina PICARIHead ong>ofong> Health Technology Standardsand Management UnitBiomedical EngineerMinistry ong>ofong> HealthBulevardi "Bajram Curri"TiraneTUNISIAALBANIASEARO REGIONMr Bhanu Bhakta YENGDENSenior Public Health AdministratorLogistic Management DivisionDepartment ong>ofong> Health ServicesTeku, KathmanduNEPALEXPERTSDr José ASUAOSTEBADonostia-San Sebastian, 101010 - Vitoria-GasteizSPAINMr Ronald M. BAUERManaging Director, SANIPLANDeutsche Beratungsgesellschaftfür Hygiene und Medicines mbHHomburger Landstrasse 83860437 Frankfurt / MainGERMANYMr Ismael CORDEROSenior Clinical EngineerORBIS520 8th Avenue, 11th floorNew York, NY 10018UNITED STATES OF AMERICATHIRD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 41


Ms Jennifer JACKSONClinical Engineering Research AssociateSapienza University ong>ofong> RomeViale Medaglie d’Oro, 15900136 RomeITALYMr Mladen POLUTAHTM Programme ConvenorBiomedical Engineering Anatomy Bldg.University ong>ofong> Cape TownPrivate Bag X3, Rondebosch 7701SOUTH AFRICAMr Albert POONFlat 1603, Block B, 16F Villa Loto18 Broadwood Road, Happy ValleyHONG KONGDr David PORTERConsultant21 Stewarton DriveCambuslangGlasgow G72 8DFUNITED KINGDOMDr Bassel TAWFIKChairman and Prong>ofong>essorDept ong>ofong> Biomedical Engineering, Cairo University50 El-Higaz St., Mohandessen, GizaEGYPTOBSERVERSMr Ibrahim ELIANHead ong>ofong> ong>theong> Bio-engineeringDepartmentMinistry ong>ofong> HealthWEST BANK AND GAZA STRIPong>WHOong> REGIONAL OFFICE FOR AFRICADr Jean-Bosco NDIHOKUBWAYOProgramme ManagerBlood Safety, LaboratoriesAnd Health TechnologiesHealth Systems & Services ClusterTHIRD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 42


ong>WHOong> REGIONAL OFFICE FOR EUROPEMs Hayde REYNOSOong>Technicalong> OfficerCountry Policies and Systems Unitong>WHOong> REGIONAL OFFICE FOR THE EASTERN MEDITERRANEANDr Adham ISMAILRegional AdviserHealth & Biomedical Devices (HMD)Division ong>ofong> Health Systems and ServicesDevelopment (DHSSD)Dr Iyad MOBAREKNational Porgramme OfficerJordan Country OfficeMr Kamel ABDUL RAHIMong>Technicalong> OfficerIraq Country OfficeMrs Ghada RAGABSenior SecretaryHealth & Biomedical Devices (HMD)Division ong>ofong> Health Systems and ServicesDevelopment (DHSSD)ong>WHOong> REGIONAL OFFICE FOR SOUTH-EAST ASIADr Geeta MEHTAActing Regional AdviserHealth Technology and Patient SafetyDEPARTMENT OF ESSENTIAL HEALTH TECHNOLOGIESDr Steffen GROTHDirectorMs Adriana VELAZQUEZ-BERUMENCoordinatorDiagnostic Imaging and Medical DevicesMr Bjorn FAHLGRENDiagnostic Imaging and Medical DevicesMs Jennifer BARRAGANDiagnostic Imaging and Medical DevicesTHIRD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 43


Annex 2: ong>Meetingong> agenda3 rd ong>Technicalong> ong>Advisoryong> ong>Groupong> ong>Meetingong> on Health TechnologyCairo, Egypt, 20-22 June 201008:00-09:00 RegistrationSunday, 20 June 201009:00-09:15 Welcome addressDr Hussein A Gezairy, Regional Director, EMRO09:15-09:30 Global Initiative on Health Technologies & ong>Meetingong> ObjectivesDr Steffen Groth, Director, Essential Health Technologies- Introduction ong>ofong> participants- Election ong>ofong> Chair and Rapporteur/s09:30-09:45 Report ong>ofong> ong>theong> 2 nd ong>Technicalong> ong>Advisoryong> ong>Groupong> ong>Meetingong>s on HealthTechnology, Rio de Janeiro, November 2009Mr Ismael Cordero09:45-10:15 Tools and Documentation Status & Baseline Survey ResultsMrs Adriana Velazquez Berumen10:15-10:30 The Egypt Health Technology Story: Accomplishments & ChallengesProng>ofong>essor Ahmad Gaber10:30-11:00 COFFEE BREAKBaseline Country Survey Responses11:00-11:20 AFROSummary ong>ofong> Regional ResponsesDr Jean-Bosco NdihokubwayoCountry Presentations on Key Challenges, Needs & ExpectationsKenya, Uganda11:20-11:50 EURO/SEAROSummary ong>ofong> Regional ResponsesMrs Hayde Reynoso, , Mrs Geeta Mehta11:50-13:00 LUNCHCountry Presentations on Key Challenges, Needs & ExpectationsAlbania, NepalTHIRD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 44


13:00-13:45 EMROSummary ong>ofong> Regional ResponsesDr Adham IsmailCountry Presentations on Key Challenges, Needs & ExpectationsEgypt, Iraq, Jordan, Morocco, Oman, Sudan, Tunisia13:45-14:15 Compilation and Summarization ong>ofong> Country Needs by Topic in Regional Workingong>Groupong>sTopics: Regulation, National HT Issues, Health Technology Assessment, HealthcareTechnology Management14:15-15:30 Presentation ong>ofong> Key Needs by RegionAFRO (20min), EURO (10min), SEARO (10min), EMRO (35min),- REGULATION: regulatory systems, nomenclature and adverse reporting- NATIONAL HT ISSUES: health technology policy, health technology unit, needsassessment, and medical device list- HTA: health technology assessment- HTM 1: procurement, donations, technical specifications- HTM 2: maintenance, inventory- OTHEROutcome: Information will guide working group sessions later in ong>theong> day and on Tuesday15:30-16:00 COFFEE BREAK16:00-17:00 Working ong>Groupong> Session 1Develop Implementation Action Plans by TopicRegion Regional Adviser TAGHT Adviser Topicong>Groupong> A Dr Jean-Bosco Ndihokubwayo Mr Poon, Mr Fahlgren Regulationong>Groupong> B Mrs Geeta Mehta Mr Bauer, Ms Jackson National HT Issuesong>Groupong> C Mrs Hayde Reynoso Mr Asua, Mrs Velazquez HTAong>Groupong> D Dr Adham Ismael Mr Poluta, Dr Porter HTM 1ong>Groupong> E Mr Iyad Mobarek Mr Cordero, Dr Tawfik HTM 2* ong>Groupong> members listed at end ong>ofong> day's agendaOutcome: Each country will determine and document ong>theong> steps ong>theong>y will initiate upon return to ong>theong>ircountry (or major challenges that impede implementation) - this will be submittedTHIRD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 45


17:00-18:00 Working ong>Groupong> Session 2Develop Implementation Action Plans by TopicRegion Regional Adviser TAGHT Adviser Topicong>Groupong> A Dr Jean-Bosco Ndihokubwayo Mr Cordero, Dr Tawfik HTM 2ong>Groupong> B Mrs Geeta Mehta Mr Poon, Mr Fahlgren Regulationong>Groupong> C Mrs Hayde Reynoso Mr Bauer, Ms Jackson National HT Issuesong>Groupong> D Dr Adham Ismael Mr Asua, Mrs Velazquez HTAong>Groupong> E Mr Iyad Mobarek Mr Poluta, Dr Porter HTM 1* ong>Groupong> members listed at end ong>ofong> day's agendaOutcome: Each country will determine and document ong>theong> steps ong>theong>y will initiate upon return to ong>theong>ircountry (or major challenges that impede implementation) - this will be submitted18:00 ADJOURNong>Groupong> A: Kenya, Nepal, Ugandaong>Groupong> B: Morocco, Tunisiaong>Groupong> C: Albania, Sudanong>Groupong> D: Egypt, Jordanong>Groupong> E: Iraq, OmanTHIRD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 46


09:00-09:15 Rapporteur Summary from SundayAgenda Review for MondayMonday, 21 June 201009:15-10:15 Working ong>Groupong> Session 3Develop Implementation Action Plans by TopicRegion Regional Adviser TAGHT Adviser Topicong>Groupong> A Dr Jean-Bosco Ndihokubwayo Mr Poluta, Dr Porter HTM 1ong>Groupong> B Mrs Geeta Mehta Mr Cordero, Dr Tawfik HTM 2ong>Groupong> C Mrs Hayde Reynoso Mr Poon, Mr Fahlgren Regulationong>Groupong> D Dr Adham Ismael Mr Bauer, Ms Jackson National HT Issuesong>Groupong> E Mr Iyad Mobarek Mr Asua, Mrs Velazquez HTA* ong>Groupong> members listed at end ong>ofong> day's agendaOutcome: Each country will determine and document ong>theong> steps ong>theong>y will initiate upon return to ong>theong>ircountry (or major challenges that impede implementation) - this will be submitted10:15-10:45 COFFEE BREAK10:45-11:45 Working ong>Groupong> Session 4Develop Implementation Action Plans by TopicRegion Regional Adviser TAGHT Adviser Topicong>Groupong> A Dr Jean-Bosco Ndihokubwayo Mr Asua, Mrs Velazquez HTAong>Groupong> B Mrs Geeta Mehta Mr Poluta, Dr Porter HTM 1ong>Groupong> C Mrs Hayde Reynoso Mr Cordero, Dr Tawfik HTM 2ong>Groupong> D Dr Adham Ismael Mr Poon, Mr Fahlgren Regulationong>Groupong> E Mr Iyad Mobarek Mr Bauer, Ms Jackson National HT Issues* ong>Groupong> members listed at end ong>ofong> day's agendaOutcome: Each country will determine and document ong>theong> steps ong>theong>y will initiate upon return to ong>theong>ircountry (or major challenges that impede implementation) - this will be submitted11:45-12:45 Working ong>Groupong> Session 5Develop Implementation Action Plans by TopicRegion Regional Adviser TAGHT Adviser Topicong>Groupong> A Dr Jean-Bosco Ndihokubwayo Mr Bauer, Ms Jackson National HT Issuesong>Groupong> B Mrs Geeta Mehta Mr Asua, Mrs Velazquez HTAong>Groupong> C Mrs Hayde Reynoso Mr Poluta, Dr Porter HTM 1ong>Groupong> D Dr Adham Ismael Mr Cordero, Dr Tawfik HTM 2ong>Groupong> E Mr Iyad Mobarek Mr Poon, Mr Fahlgren Regulation* ong>Groupong> members listed at end ong>ofong> day's agendaOutcome: Each country will determine and document ong>theong> steps ong>theong>y will initiate upon return to ong>theong>ircountry (or major challenges that impede implementation) - this will be submittedTHIRD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 47


12:45-13:45 LUNCH13:45-15:15 Compilation and Summarization ong>ofong> Working ong>Groupong> Results(Topic advisers and countries meet separately)15:15-15:45 COFFEE BREAK15:45-17:00 Presentation ong>ofong> Working ong>Groupong> Results by TAGHT Adviser(s)Outcome: Adviser(s) to present ong>theong> issues presented by ong>theong> countries and providerecommendations for future work and improvements to current tools.17:00-17:30 Discussion on Human Resource DevelopmentFishbowl Facilitator: Ms Jennifer JacksonOutcome: The session will help identify issues in human resources as it relates to ong>theong>advancement ong>ofong> health technology in ong>theong> countries.17:30-18:00 Medical Device List Review (needs assessment)Mrs Adriana Velazquez BerumenOutcome: Participants to provide feedback on appropriateness ong>ofong> ong>theong> medical device listsand how ong>theong>y prefer ong>theong> information to be presented.18:00 ADJOURNong>Groupong> A: Kenya, Nepal, Ugandaong>Groupong> B: Morocco, Tunisiaong>Groupong> C: Albania, Sudanong>Groupong> D: Egypt, Jordanong>Groupong> E: Iraq, OmanTHIRD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 48


Annex 3: ong>Meetingong> evaluationong>Meetingong> agenda and documentsAgenda QualityBelowAverage10%Excellent40%Good50%Participant comments regarding ong>theong> quality ong>ofong> ong>theong> agenda♦ Need a session about basic terminology that will be used in ong>theong> meeting to help newparticipants♦ Discussed very important and useful subjects like HTM, HTA and HT Regulation. Learned alot.♦ Great collaboration between country reps and experts♦ Country presentations were well thought out, revealing and insightful♦ Quantity ong>ofong> ong>theong>mes was big so time was too short for discussions. In ong>theong> future, perhaps focuson a few ong>theong>mes that are more important for a particular case.THIRD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 50


ong>Meetingong> FormatBelowAverage5%Poor5%Excellent50%Good40%Participant comments regarding ong>theong> format ong>ofong> ong>theong> meeting♦ Simultaneous translation would have been preferable♦ Recommend requesting countries provide data beforehand on ong>theong>ir situation and ong>theong>n duringmeeting agree/select a country as a case study so all contribute in addressing ong>theong> needs, challenges,recommendations and in drafting appropriate reference tool♦ It would be useful if action plan for countries were prepared during working groups in order toreceive direct feedback from advisors♦ More time for roundtable discussion neededong>Meetingong> MaterialsSatisfactory5%BelowAverage10%Poor5%Excellent55%Good25%Participant comments regarding ong>theong> meeting materials♦ No time was realistically allocated for reading large volume ong>ofong> relevant documents supplied toTHIRD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 51


participants which would have been helpful for some ong>ofong> ong>theong> discussionsProvision ong>ofong> ong>Meetingong> InformationBelowAverage5%Excellent53%Good42%Participant comments regarding information about ong>theong> meeting♦ It was a very nice meeting both technically and in terms ong>ofong> administrative arrangements♦ Well organized♦ Instructions and agendas for presenters should be sent soonerong>Meetingong> LengthBelowAverage11%Poor6%Excellent6% Good22%Satisfactory55%Participant comments regarding ong>theong> length ong>ofong> ong>theong> meeting♦ Some important presentations and subsequent discussions had to be terminated prematurelybecause ong>ofong> time constraintsTHIRD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 52


Facilitiesong>Meetingong> RoomSatisfactory14%BelowAverage10%Poor5%Excellent47%Good24%Participant comments regarding ong>theong> meeting room♦ Room was very cold♦ Need better sitting areas for working group discussion meetingsRefreshments/LunchSatisfactory19%BelowAverage5%Excellent43%Good33%Participant comments regarding ong>theong> refreshments and lunch provided♦ Refreshments/lunch could have more variety and not ong>theong> same everydayTHIRD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 53


Travel and HotelTravel ArrangementsSatisfactory21%BelowAverage16%Excellent47%Good16%Participant comments regarding ong>theong> travel arrangements♦♦Information on whom to contact regarding travel was confusingTickets should be booked only after consulting with travellerHotel ArrangementsSatisfactory5%BelowAverage11%Excellent58%Good26%Participant comments regarding ong>theong> hotel arrangements♦Improve delegates hotel airport pick-up processTHIRD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 54


General Comments:♦ AFRO group was limited and only East Africa representation♦ Larger working groups could help to discuss all ong>theong> issues furong>theong>r♦ It would be helpful to `strongly recommend` to participants to read bibliographies that wereprovided before coming to meeting♦ Need a short review about ong>theong> content ong>ofong> ong>theong> forms and clarification ong>ofong> ong>theong> abbreviations♦ It may be helpful to have brief notes on ong>theong> experts, regions, and countries being represented tong>ofong>acilitate discussion♦ Good format because it allowed more one on one time to get ong>theong> real situation, ask strongquestions, and let ong>theong> countries work through a little problem solving♦ Perhaps too much and too wide for participants to be able to formulate action plans for all ong>theong>topics♦ Very useful and practical way to raise challenges♦ This was ong>theong> ideal format because it allowed for a closer view, more benefit for experts andcountry reps, and more involvement ong>ofong> all participants (3x)♦ Good opportunity to share experiences♦ Follow-up ong>ofong> outcomes from this meeting is needed♦ Need anoong>theong>r meeting on resource mobilization♦ Must not ignore importance ong>ofong> infrastructure & medical planning in relation to medicaltechnology♦ Recommend doing a series ong>ofong> seminars for each ong>theong>me, particularly HTA for in-depth analysis♦ Most productive one yet, should be repeated with oong>theong>r regions♦ Need more analysis ong>ofong> ong>theong> survey and for more countries♦ Need info applicable to majority or group ong>ofong> countries♦ For countries who have proposed a plan, it may be helpful for ong>WHOong> to follow-up to bring aboutactual implementation♦ Need to include MoH ong>ofong>ficials in participation♦ Best meeting ong>ofong> ong>theong> past three so far.THIRD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 55


Annex 4: Address by ong>theong> Regional Director ong>ofong> ong>theong> ong>WHOong> Regional Office for ong>theong>Eastern MediterraneanDR HUSSEIN A. GEZAIRYREGIONAL DIRECTORong>WHOong> REGIONAL OFFICE FOR THE EASTERN MEDITERRANEANto ong>theong>THIRD MEETING OF THE TECHNICAL ADVISORY GROUPLadies and Gentlemen, Dear ColleaguesON HEALTH TECHNOLOGIESCairo, Egypt, 20–22 June 2010It gives me great pleasure to welcome you to ong>theong> Regional Office in Egypt on thisimportant occasion. Let me start by welcoming health technology experts, whom I thankfor ong>theong>ir continued interest and support in our health technology programme. I wouldalso like to welcome our colleagues from ong>WHOong> headquarters and oong>theong>r regional ong>ofong>fices.Dear ColleaguesHealth technologies, in particular medical devices, are considered to be crucial forong>theong> services ong>ofong>fered in prevention, diagnosis, treatment and rehabilitation ong>ofong> illness anddisease. Every day, thousands ong>ofong> different kinds ong>ofong> medical devices are used in healthcare facilities and elsewhere all over ong>theong> world. Most are quite simple, while oong>theong>rs arecomplex and combine different technologies.According to recent estimates, ong>theong> global medical device market is worth over US$ 200billion and is expected to grow steadily by 4% to 5% annually over ong>theong> next few years,implying that this technological revolution in health will continue in ong>theong> foreseeablefuture. Unfortunately, at ong>theong> same time that ong>theong> regional market for medical devices isgrowing, ong>theong> majority ong>ofong> ong>theong> world’s population is denied adequate, safe and reliableaccess to appropriate medical devices within ong>theong>ir health systems.Dear ColleaguesTHIRD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 56


Since ong>theong> Declaration ong>ofong> Alma-Ata in 1978, ong>WHOong> has highlighted ong>theong> importanceong>ofong> appropriate technology and has called for better standardization ong>ofong> health and medicaltechnologies. ong>WHOong> launched a global action plan on management, maintenance andrepair ong>ofong> medical equipment, promoted affordable basic medical devices such as ong>theong>Basic Radiology Systems and ong>theong> World Health Imaging System for Radiography, andheld several meetings in different regions related to health care technology management,selection and development. These provided a useful foundation and reference for healthcare technology policy formulation and implementation.Inspired by ong>theong> Alma-Ata Declaration, ong>theong> ong>WHOong> Regional Committee for ong>theong> EasternMediterranean has produced two landmark regional resolutions, on appropriate healthtechnologies in 1997, and on ong>theong> role ong>ofong> medical devices in contemporary health caresystems in 2006. In ong>theong> second resolution in particular, Member States are called uponto collect, update and verify information on medical devices, develop national plans thatpromote appropriate medical technology, and establish regional centres ong>ofong> excellence inmedical technology.In May 2007, ong>theong> 66th World Health Assembly produced a similar resolution on medicaldevices which emphasized ong>theong> need for Member States and donors to contain ong>theong>burgeoning costs ong>ofong> medical devices by establishing priorities in ong>theong> selection andacquisition ong>ofong> health technologies, in particular medical devices, on ong>theong> basis ong>ofong> ong>theong>irimpact on ong>theong> burden ong>ofong> disease, and to ensure ong>theong> effective use ong>ofong> resources throughproper planning, assessment, acquisition and management.Dear ColleaguesThe objectives ong>ofong> this meeting are to explore ong>theong> associated regional and globalchallenges and propose ways for Member States to overcome ong>theong>m. In yourdeliberations, you should aim at developing pragmatic solutions to increase access tohealth technologies while containing costs and management inefficiencies.The tools necessary for building national health technology programmes have beendeveloped by experts and were presented in ong>theong> first two meetings ong>ofong> this technicaladvisory group, held in Geneva and Rio de Janeiro in 2009. The current meeting aims toprovide Member States with a roadmap on how to properly manage medical devicesusing ong>theong> tools developed. There is a need to update ong>theong> data available, improveknowledge and information in this area, develop regional guidelines on medical devicesselection, utilization and assessment, and identify regional centres ong>ofong> excellence.The majority ong>ofong> countries still do not recognize management ong>ofong> devices as an integralpart ong>ofong> public health policy. Member States used to develop policies for management ong>ofong>medical devices and technologies – through actual needs assessment, adequateprocurement, proper installation, enough spare parts, preventive and correctivemaintenance, rational usage and quality assurance – so that health care providers canreap ong>theong>ir benefits and contain ong>theong>ir burgeoning costs.Dear ColleaguesTHIRD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 57


I firmly believe that ong>theong>se goals are within reach, provided that we ensure that allong>theong> required ingredients are maintained. By this, I mean coordinating efforts, movingforward collectively and ensuring national commitment and ong>theong> full support ong>ofong> partners.We have an opportunity; let us not miss it.Finally, I would like to assure you ong>ofong> our unconditional support for promotinghealth technology management and innovation. This meeting is an essential buildingblock in that direction. Once again, I would like to extend my thanks to all ong>ofong> you foryour efforts, and for participating in this meeting. I wish you a fruitful discussion and apleasant stay in Cairo.THIRD MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 58


Annex 5: TimelineGoal: To make available ong>theong> benefits ong>ofong> core health technologies at an affordable price, particularly tocommunities in resource-limited settings, in order to effectively control important health problemsYear 1 (2008) Year 2 (2009)Year 3 (2010)20111 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36Objective 1Establishframework forHTprogrammesObjective 2identifyinnovativetechnologiesA M J J A S O N D J F M A M J J A S O N D J F M A M J J A S O N D J F MMajor ActivitiesActivity 1 1Activity 2 2 4 3Activity 3 5 6Activity 4 7 9 8 10Activity 5 11 121 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36A M J J A S O N D J F M A M J J A S O N D J F M A M J J A S O N D J F MActivity 6 13 14Activity 7 15 16Activity 8 17Activity 9 18 19 20objective meeting milestones activitiesHT programme 1st 1,2,7 1,2,4innovative tech 1st 9 3,4Date21-23 April 200920-21 June 2009VenueHQ, ong>WHOong>,GenevaSingaporeRegionWPROKind ong>ofong> ong>Meetingong>1st ong>Advisoryong> ong>Groupong>1st ong>Advisoryong> ong>Groupong>InnovativeTechnologiesObjective ong>ofong> ong>Meetingong>To review and adopt guidelinedocumentTo select key health concernsfor Innovative Technologiesto following eventHealth TechnologyAssessment Int.(HTAi) and INAHTAHT programme 2nd 4,5innovative tech 2nd 19 8,93rdHT programme 9 3,41,2,3,48-9 November 200927-29 April 20108-10 June 2010Rio de Janeiro,BrazilCopenhagenDenmarkCairo, EgyptAMROEUROEMRO2nd ong>Meetingong> ong>ofong> ong>theong>ong>Advisoryong> ong>Groupong> ong>ofong>Health Technologies2nd meeting ong>ofong>ong>Advisoryong> ong>Groupong> onInnovativeTechnologies3rd ong>Advisoryong> ong>Groupong>To review and adoptmethodology and tools forhealth technologyTo select InnovativeTechnologiesTo review and adopt tools andguidelines after trail incountriesInternational HospitalFederation (IHF)Congress3TH MEETING OF THE ong>WHOong> TECHNICAL ADVISORY GROUP ON HEALTH TECHNOLOGIES 59

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