The Operating Theatre journal April 2021

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FDA is Investigating Reports of Infections Associated withReprocessed Urological EndoscopesAgency is taking action to remind health care providers about the proper way to clean certain devices for reuseToday, 1st April 2021 the U.S. Food and Drug Administration announcedit is investigating numerous medical device reports (MDRs) describingpatient infections and other possible contamination issues associatedwith reprocessing urological endoscopes, including cystoscopes,ureteroscopes and cystourethroscopes—devices used to view andaccess the urinary tract. Reprocessing these types of medical devicesinvolves both cleaning and high-level disinfection or sterilization so thedevices can be reused.“The FDA is investigating potential causes and contributing factorsassociated with reported infections and contamination issues fromreprocessed urological endoscopes. We are very concerned about thethree reported deaths—outside of the United States—associated withthese infections, and we’re acting fast to communicate with healthcare providers and the public about what we know and what is still anemerging issue,” said Jeff Shuren, M.D., J.D., director of FDA’s Centerfor Devices and Radiological Health. “While some reports indicatethe potential causes could be inadequate reprocessing or devicemaintenance issues, we’re also evaluating other possibilities, includingdevice design or the reprocessing instructions in the labeling. Althoughwe believe that the risk of infection is low based on available data,we’re reminding health care providers how important it is to follow thelabeling and reprocessing instructions to properly clean and reprocessthe devices, including accessory components. We take all reports ofadverse events seriously, and we encourage prompt reporting to theFDA to help us identify and better understand the risks associated withreprocessed medical devices.”Cystoscopes, cystourethroscopes and ureteroscopes are urologicalendoscopes that allow health care providers to see and access theurinary tract (e.g., urethra, bladder, ureters and kidneys) duringdiagnostic and therapeutic procedures.From Jan. 1, 2017 through Feb. 20, 2021, the FDA received over 450MDRs describing post-procedure patient infections or other possiblecontamination issues associated with reprocessing these devices. Inthose reports that provided the name of the device manufacturer,either Olympus Corporation or Karl Storz were cited. MDRs can besubmitted by mandatory reporters, such as manufacturers, importersand device user facilities, or by voluntary reporters.Olympus submitted three reports citing patient death from a bacterialinfection that occurred outside of the U.S. Two of those reports wereassociated with a forceps/irrigation plug, an accessory componentused to control water flow and enable access to the working channel ofthe endoscope. Lab tests confirmed the same infectious bacteria waspresent in both the forceps/irrigation plug and in the patient with theinfection. The third patient death report involved a cystoscope that didnot pass a leak test, indicating possible damage to the device, whichcould have been an underlying factor in the infection. It is unknownwhether or to what degree the reported infections or patient comorbiditiescontributed to the patient deaths.It is important to note that MDRs are not, by themselves, definitiveevidence of a faulty or defective medical device and cannot be used toestablish or compare rates of event occurrence. The FDA is continuingto investigate these reports, but, at this time the agency has notconcluded that any specific manufacturer or brand of these devices isassociated with higher risks than others.The Letter to Health Care Providers issued today providesrecommendations for reprocessing and using these devices, includingfollowing the reprocessing instructions, not using a device that hasfailed a leak test, developing schedules for routine device inspectionand maintenance, and discussing the potential benefits and risksassociated with procedures involving reprocessed urological endoscopeswith patients.Ensuring the safety of reprocessed medical devices, which are usedin multiple patients, is a shared responsibility among the FDA andother federal agencies, public health systems, state and local healthdepartments, medical device manufacturers, health care facilities,professional societies and others. The FDA is actively engaged to betterunderstand the causes and risk factors for transmission of infectiousagents and develop solutions to minimize patient exposure.The actions the FDA is taking on urological endoscopes today wereinformed by the agency’s experience with duodenoscopes. Since 2015,the FDA has communicated about and taken action on infections relatedto reprocessing of duodenoscopes, including requiring postmarketsafety studies and updating sampling and culturing protocols. Theagency also updated its 2015 guidance to include more device typesthat need reprocessing validation data. The FDA has issued WarningLetters to manufacturers and safety communications to the public andhealth care providers and held a public Advisory Committee meetingseeking information on how to effectively reprocess medical devices. Inaddition, the FDA has encouraged manufacturers to transition to deviceswith features that eliminate the need for reprocessing and helpedmanufacturers modify and validate their reprocessing instructions.The problems the FDA has identified with urological endoscopes andduodenoscopes may apply to similar devices. Therefore, the agency isalso reviewing information on other types of endoscopes.The FDA will continue to keep health care providers and the publicinformed if new or additional information becomes available on adverseevents and other issues related to reprocessing urological endoscopes.The FDA, an agency within the U.S. Department of Health andHuman Services, protects the public health by assuring the safety,effectiveness, and security of human and veterinary drugs, vaccinesand other biological products for human use, and medical devices. Theagency also is responsible for the safety and security of our nation’sfood supply, cosmetics, dietary supplements, products that give offelectronic radiation, and for regulating tobacco products.Sustainable Operating Theatres Network Co-managers wanted!We have two volunteer positions available for one surgeonor surgical trainee and an operating department practitioneror theatre nurse to become our National SustainableOperating Theatres Network Co-Managers.The aim of the Sustainable Operating Theatres Network is toembed environmental sustainability into operating theatresand surgical pathways around the UK.Learn more about the role and how to apply,http://bit.ly/OTJSOT32126 THE OPERATING THEATRE JOURNAL www.otjonline.com
New Modular Ophthalmology Centre atMusgrove Park HospitalPress Release: New Modular Ophthalmology Centre at Musgrove Park HospitalFor Release – Embargo until 7 th April 2021HeadlineSomerset NHS Foundation Trust continues partnership with leading modular healthcare specialistModuleCo with the development of a new state-of-the-art, modular Ophthalmology CentreCopyModuleCo are just weeks from installing a state-of-the-art Ophthalmic Operating Theatre Suite forthe Somerset NHS Foundation Trust providing improved ophthalmology services for patients atbeing installed by ModuleCo at Musgrove Park Hospitaltheir Musgrove Park Hospital site.Somerset NHS Foundation Trust continues partnership with leading modular healthcare specialist ModuleCo with the development of a newstate-of-the-art, modular Ophthalmology CentreThe new modular facility will be one part of a standalone Ophthalmology Theatre Suite with dedicatedophthalmic operating theatres and linking to the rear of the existing Day Surgery Centre. The eye unit isthe Hospital’s busiest department, carrying out over 2,000 operations every year and providing nearlycontractors.”50,000 outpatient appointments.ModuleCo are just weeks from installing a state-of-the-art OphthalmicOperating Theatre Suite for the Somerset NHS Foundation Trustproviding improved ophthalmology services for patients at theirMusgrove Park Hospital site.The new modular facility will be one part of a standalone OphthalmologyTheatre Suite with dedicated ophthalmic operating theatres and linkingto the rear of the existing Day Surgery Centre. The eye unit is theHospital’s busiest department, carrying out over 2,000 operationsevery year and providing nearly 50,000 outpatient appointments.This development provides the Trust with additional operating LinkedIn pages. space, recovery space and dedicatedpatient areas allowing them to feel more comfortable when receiving care. Patients will be able to accessthe centre directly from the car park, without the need to pass through the main hospital. The Trust hopethat the additional capacity and forming of a dedicated Ophthalmology Centre will help reduce waitingtimes for routine treatment.This development provides the Trust with additional operating space,recovery space and dedicated patient areas allowing them to feel morecomfortable when receiving care. Patients will be able to access thecentre directly from the car park, without the need to pass through themain hospital. The Trust hope that the additional capacity and formingof a dedicated Ophthalmology Centre will help reduce waiting times forroutine treatment.Mr Pradeep Madhavan, orthopaedic consultant at Somerset NHS Foundation Trust, said:“This new unit will be a modern facility that will allow ophthalmic patients to continue with their surgicaltreatment safely and in time without being unduly affected by conditions in the rest of the hospital andcommunity.Mr Pradeep Madhavan, orthopaedic consultant at Somerset NHSFoundation Trust, said:“This new unit will be a modern facility that will allow ophthalmicpatients to continue with their surgical treatment safely and in timewithout being unduly affected by conditions in the rest of the hospital“The project is moving at pace and is a tribute to the team spirit within the department of ophthalmologyand expertise and leadership in various parts of our NHS trust.”and community.“The project is moving at pace and is a tribute to the team spirit withinthe department of ophthalmology and expertise and leadership invarious parts of our NHS trust.”A bespoke design has been developed, consisting of multiple modules of varying sizes to maximise theavailable site space, making up a 484m 2 footprint. The facility will be the first part of a specialistOphthalmic Theatre with ceiling mounted microscope and Why laser do we equipment. need this? This is supported by anintegral scrub, lay-up prep, anaesthetic room, dirty utility, 15-patient day ward, consultation rooms, andpeople with diabetes:various ancillary and staff areas.1. Hospital acquired hypoglycaemiaA bespoke design has been developed, consisting of multiple modules ofvarying sizes to maximise the available site space, making up a 484m2footprint. The facility will be the first part of a specialist OphthalmicTheatre with ceiling mounted microscope and laser equipment. This issupported by an integral scrub, lay-up prep, anaesthetic room, dirtyutility, 15-patient day ward, consultation rooms, and various ancillaryand staff areas.ModuleCo’s team are now in the midst of the factory assembly phase, and by completing 80% of theconstruction and fit out in the factory this minimises the disruption to the hospital estate. In just a matteroverall care.of weeks this cutting-edge facility will be being installed on site.ModuleCo’s team are now in the midst of the factory assembly phase,and by completing 80% of the construction and fit out in the factorythis minimises the disruption to the hospital estate. In just a matter ofweeks this cutting-edge facility will be being installed on site.Sales and Marketing Director for ModuleCo and project sponsor,Jonathan Brindley, said:Sales and Marketing Director for ModuleCo and project sponsor, Jonathan Brindley, said:“All of us at ModuleCo take great pride in our continued partnershipwith Somerset NHS Foundation Trust and supporting them to deliverspecialised care to their communities. This will be our 4th facilitydelivered to Musgrove Park and our project team has welcomed theopportunity to work the Hospital’s brilliant team once again. Thistheatre marks the 108th Operating Theatre that we have installed inExternal 3D render depicting the state-of-the-art Ophthalmic Theatre Suitethe UK, a number that is a testament to the world-class quality ofour facilities and the expertise of our designers, project managers andLive project updates from the scheme, and others critical schemesbeing delivered, can be found on the ModuleCo’s website, Twitter andHeadquartered in Cheltenham, ModuleCo is part of the BladeRoomGroup of companies which have delivered more than £500 million worthof mission-critical modular facilities to the UK and overseas markets,including data centres, healthcare and pharmaceutical facilities. Thegroup manufactures its industry-defining facilities at their 110,000sqftfactory in Mitcheldean, Gloucestershire.For further information about this story, please contact the ModuleCoSales & Marketing Team at salesteam@moduleco.comNational audit has demonstrated three distinct harms that continue to occur in hospitalised2. Hospital acquired DKA3. Drug errors and errors associated with insulin infusions.CPOC was tasked with producing a national joint standard and policy for the multidisciplinarymanagement of patients with diabetes who require surgery to limit these harms and improveWhat does it contribute?True ‘whole pathway’ guidance with authors including representatives from primary care,pharmacists, geriatric medicine, diabetes inpatient specialist nurses, patient groups,diabetologists, surgeons and anaesthetists.“All of us at ModuleCo take great pride in our continued pumps partnership and blood sugar targets. with Somerset NHS FoundationAdvice on guidance implementation, without which patient care and outcomes will notTrust and supporting them to deliver specialised care to their communities. This will be our 4th facilityimprove.delivered to Musgrove Park and our project team has welcomed the opportunity to work the Hospital’sPractical recommendations including the management of individual diabetes drugs, insulinComments and feedback are welcomedWhen responding to articles please quote ‘OTJ’Find out more 02921 680068 • e-mail admin@lawrand.com Issue 367 April 2021 27
Page 1 and 2: THE THETHESEPTEMBER APRIL 2020 2021
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Page 8 and 9: A £1.7M refurbishment of theatres
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