ANZCA Bulletin - June 2009 - Australian and New Zealand College ...

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Quality & SafetyAustralian Commissionon Safety and Qualityin Health Care –Medical DevicesIncidents WorkshopMeeting highlightsThe aim of this workshop, held on March29, 2009, was to improve the sharing ofincident information nationally and tobetter understand medical device safety,both in design and technical complianceand in the evaluation of the role ofhuman factors and training in minimisingincidents with medical devices. Participantsincluded government representativesof health services, clinicians, nurses,quality assurance managers and industryrepresentatives. Among the clinicians,anaesthetists were well represented.Need for better reportingThe keynote speaker was Dr Larry Kelly,head of Office of Devices, TherapeuticGoods Administration (TGA) who reportedon the TGA Medical Device IncidentReporting Investigation Scheme (IRIS).The role of TGA is to regulate and monitorthe supply and manufacturing controls ofmedical devices and drugs and to evaluateadverse events associated with the use ormisuse of a medical device. It is mandatoryfor a manufacturer to forward any detailsof reports it has received on a device thatdid or could have resulted in an adverseevent. TGA has considerable regulatoryauthority to investigate all such reports andif necessary to mandate a recall. However,there is no such control on users as there isno obligation to report. Thus, an importantissue is the under-reporting of problemseither to TGA or the supplier.Dr Kelly presented figures for the 1317reports considered in 2008. Suppliersissued 1090 reports whereas hospitals,clinicians and nurses contributed only 190.The responses by TGA to the 1317 reportsreceived in 2008 indicated 20 recalls and30 alerts while improvement in design anduser education were a major outcomein a further 160 instances.The take-home message was that thereis urgent need for better reporting by userseither through the suppliers or directlyto TGA.Need for better designs and systemsA biomedical approach to medical deviceincidents was presented by Mr PatrickO’Meley, Area Director, BiomedicalEngineering, Sydney South West AreaHealth. He believes that incidentmanagement is poorly managed withinadequate documentation and that currentpractices are not solving problems.While falls, drug errors and diagnosticerrors in hospitals are now welldocumented, reports on equipment failureare “buried”. There is an assumptionamongst users that modern devices aresafe, yet there is often a lack of experience,poor choice in selection and inadequateeducation or foresight. To date, the mainfocus has been on electrical safety andother factors overlooked are multiplicityof devices, a design which overlooks theusage environment, and the possibility offatal configuration or user mistakes thatare difficult to eliminate. Other problemsinclude outmoded standards, poor serviceand support, while human factors areoverwork, distraction, increased complexityof devices and overload of information.Mr O’Meley’s message was the need forbetter designs and systems along with thedevelopment of best practice guidelinesfor configuration and selection.Pump infusion errorsIn a paper on pump infusion errors,Dr John Lambert, FANZCA, FJFICM,Director of Critical Care, Orange HospitalNSW suggested there was an increasingawareness that TGA approval is not the onlyrequirement for safe equipment choice asapproval may not meet reasonable clinicalstandards or expectations.With regard to infusion pumps there isa wide variety of designs on offer withdramatically different form factors anduser interfaces and many designs are notimmediately intuitive. In addition, thereis considerable variety in technologicalawareness by what is a relatively smallgroup of users, mainly nurses and doctors.Examples of the ability of clinicians to“innovate” at the bedside include the abilityto creatively bypass safety mechanismsand restrictions built into devices, thewillingness to use devices with nounderstanding of how they work and theability to justify the purchase of expensiveequipment as mandatory with limitedevidence of the benefit of such equipment.In a search of international data for pumperrors using free text, the reports wereclassified as medication incidents, medicaldevices and clinical management. Theoutstanding issue was pump setting errorswith less frequent reports of syringe/drug/fluid mix-up, errors in the use of infusiondevices or order error. Surprisingly, therewere free running line errors despitea “forcing function”. About 10-15% ofincidents involved the use of the wrongchannel on multi-channel devices, wrongpumps with multiple pumps in use and linemix-ups with lines swapped, mislabeled ornot tracked correctly.Of real concern was that the majority ofthese errors occurred in intensive care units.Suggestions for improvement includedavoidance of multi-channel devices,standardisation of devices to minimize userinterface difference errors, consideration ofthe use of unique devices for particularlydangerous infusions such as inotropes,epidurals, PCAs and possibly chemotherapyand the use of a forcing function for doublecheck when changing settings or lines.Case reportsOther case reports included the very fullinvestigation by Queensland Health onadverse events with PICC lines (wherethe outcome of ongoing discussions withTGA and the manufacturers are pending),the safety of endoscopic vascular repairof aortic aneurysms and incidents withpleurocaths.Of particular interest was a presentationfrom Stella Robinson of South AustraliaHealth on hospital bed safety. Overseas datapresented indicated that bed entrapmentwas a significant cause of mortality in theelderly. A state-wide audit of hospital bedsin South Australia revealed that 84% ofbeds in that state presented a variety ofentrapment hazards, importantly includingundersized mattresses, presumablyintroduced for reasons of economy.We now await initiatives that may followthis workshop.Dr Patricia MackayVictoria46The ANZCA Bulletin June 2009
Trauma, surgery,obstetrics and bleedingdisordersAnaesthetists and intensivists usuallyhave good access to blood and the bloodproducts they most commonly use and to aready source of advice from a haematologistor blood transfusion service whenuncommon issues arise.A previous article in the Bulletin (March2009) summarized the National BloodSupply Contingency Plan 2008. Newlyreleased is information relevant to the careof patients known, or suspected to have ableeding disorder and who suffer trauma,require surgery or are pregnant.The technical information comes with theauthority of the National Blood Authority(NBA) Australia, the Australian BleedingDisorders Registry (ABDR), the AustralianHaemophilia Centre Directors’ Organisation(AHCDO), the Haemophilia FoundationAustralia and all Australian governments.Websites include www.nba.gov.au; www.haemophilia.org.au and www.ahcdo.org.au.At this last website, under “publications”are “Surgery guidelines” and “Guidelinesfor the Management of Pregnancy”.Information provided by the ABDR includesa list of the different types of bleedingdisorders (36 in all), the usual “trigger” fordiagnosis (including trauma and surgery),the treatment regimen (on demand,prophylaxis, tolerisation and secondaryprophylaxis) and the products available,including suppliers.Patient details registered with the ABDRwill be entered into a database aimed atproviding accurate information to theauthorities tasked with ensuring thatagents used for patient care are availablein Australia in quantities sufficient fordemand. This information is not currentlyaccurate, which is why the registry isbeing revitalized.While Fresh Frozen Plasma (FFP),cryoprecipitate, platelets, DDAVP andTranexamic Acid are available generally,patients with specific bleeding disordersmust be registered on the ABDR inorder to be treated with the morespecialised products.As an aside, anyone wanting to use thisarticle as a stimulus for a CPD project couldinvestigate the latest information to befound on FFP, cryoprecipitate and plateletsthrough to more exotic products and theiruse for an increasing variety of bleedingdisorders, now including nine varieties ofvon Willebrand’s disease. Just a thought.Prof Garry PhillipsSouth AustraliaAudible oximeter tonesand alarmsIn 2008 ANZCA revised ProfessionalStandard 18, Recommendations onMonitoring during Anaesthesia 1 . Thisstandard now requires having an audiblevariable pulse tone from the oximeter. Italso requires an audible low limit alarm.“…the variable pulse tone as well as the lowthreshold alarm shall be appropriately setand audible to the practitioner responsiblefor the anaesthesia.”Correctly used monitoring tones and alarmspromote safety for our patients. Monitorsettings need to be checked at the beginningof a list and whenever there is a changeof anaesthetist. Inappropriate use ofmonitors puts patients at grave riskof undetected hypoxia.The US Anesthesia Patient SafetyFoundation has documented three casesof death and profound brain damagein healthy ASA1 patients due to lack ofappropriate monitoring 2 . These casesare recommended reading for allanaesthetists.Dr Rod TaylerEditorial Advisory BoardQuality and Safety CommitteeANZCA1. www.anzca.edu.au/resources/professionaldocuments/professional-standards/ps18.html2. www.apsf.org/resource_center/newsletter/2004/winter/03turn_on.htmThe ANZCA Bulletin June 2009 47
Page 3 and 4: 12 27 20 36ContentsThe ANZCA Bullet
Page 5 and 6: NewsSafety of AnaesthesiaReportThe
Page 7 and 8: Simulation-based sedationcourse for
Page 9 and 10: anzca Research AwardThe Lennard Tra
Page 11 and 12: Annual General MeetingminutesMinute
Page 13 and 14: 4. Declaration of the PollsCouncil
Page 15 and 16: Snapshot1657 Full registrants 152 F
Page 17 and 18: The ANZCA Bulletin June 2009 15
Page 19 and 20: The College Ceremony; Dr James Sart
Page 21 and 22: ASM photo galleries and videosof th
Page 23 and 24: Leading the debate onthe future of
Page 25 and 26: BroadeningrolesDr Vanessa BeavisWe
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Page 43 and 44: profileDr Vanessa Beavis:From South
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Page 51 and 52: Changes to medicaloxygen connection
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