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

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