Quality <strong>and</strong> safetycontinuedECRI alertsThe ECRI Institute is a non-profitorganisation that issues alerts fromfour sources: the ECRI InternationalProblem Reporting System, productmanufacturers, government agenciesincluding the US Food <strong>and</strong> DrugAdministration (FDA) <strong>and</strong> agencies inAustralasia, Europe <strong>and</strong> the UK as wellas reports from client hospitals.Some alerts may only involve singleor small numbers of cases, there is nodenominator to provide incidence <strong>and</strong>there is not always certainty about theregions where the equipment is supplied.This section can only highlight someof the alerts that may be relevant. It is theresponsibility of the hospitals to follow upwith the manufacturer’s representativesif they have not already been contacted.Flow rate inaccuracy in Bayer MRtubing sets used with Continuumpumps (designed for use in MRIenvironments)Bayer MEDRAD Continuum MR infusionsystem tubing may exhibit variations inflow when used with Continuum infusionpumps. There has been a recall of thetubing <strong>and</strong> continuum pumps that havebeen calibrated with the tubing.Accurate delivery of criticalmedications in the MR environment isdifficult without appropriate pumps.Although it is possible to the use“regular” volume or syringe pumps sittingoutside the field <strong>and</strong> to connect to thepatient with several extension tubing sets,the compliance <strong>and</strong> length of tubing mayaffect rate accuracy <strong>and</strong> responsivenessto rate changes. Other MR conditionalpumps are available.Cassette test failure alarm on loadingof Hospira PlumSet Administration Setonto pumpHospira has recalled its 104-inch LifeshieldPrimary PlumSet Administration Sets.A cassette failure alarm may occur whenthese sets are loaded onto the pump,possibly due to failure in welding of thecassettes. The cassette cannot <strong>and</strong> shouldnot be used. The main potential adverseoutcome is a delay in administration ofthe required therapy.Luer connection leak in COBE spectrablood warmer systems (Caridian BCT)If specific directions are not followed,a leak may occur at the return luerconnection to an elevated blood warmerpotentially resulting in air entrainmentinto the system.Caridian BCT has inserted anaddendum to the labelling: “Whenconnecting a blood warmer tubingset to the return line, ensure that thetubing connection is tight. Put the luerconnection no higher than 50cm abovethe return access to prevent the possibilityof air entering the tubing”.Dr Phillipa HoreCommunications <strong>and</strong> Liaison PortfolioQuality <strong>and</strong> Safety CommitteeGeneral alertsCoronial alertAn <strong>Australian</strong> coroner investigating thedeath of a patient undergoing repair of aclavicle recently highlighted his findingsthat a screw had been inadvertentlyinserted into the right subclavian vein.There was considerable haemorrhage,which was aggressively managed, butthe patient did not improve <strong>and</strong> couldnot be resuscitated. The possibilityof concomitant air embolism was alate diagnosis, probably due to theconcentration of the surgical <strong>and</strong>anaesthetic team on managing thehaemorrhage.While not critical of the team, thecoroner sought to highlight the possibilitythat whenever a large vessel is perforated,other causes of refractory resuscitationsuch as air embolism should beconsidered as well as the hypovolaemiathat results from massive haemorrhage.Dr Patricia MackayCommunications <strong>and</strong> Liaison PortfolioQuality <strong>and</strong> Safety CommitteeGreen armb<strong>and</strong>s in ophthalmicsurgery<strong>Australian</strong> anaesthetists should be awarepatients who have vitreo-retinal surgeryget a green wristb<strong>and</strong> if they have had gasinstilled in the globe of the eye.The b<strong>and</strong> remains on until the surgeonconsiders the gas has completely gone,usually 4-6 weeks. The administration ofnitrous oxide under these circumstancesmay be a potential risk to the eye <strong>and</strong>should be avoided.Safety of Anaesthesialatest report<strong>ANZCA</strong>’s Safety of Anaesthesia, a reviewof anaesthesia-related mortality reportingin Australia <strong>and</strong> <strong>New</strong> Zeal<strong>and</strong> 2006-2008is now available on <strong>ANZCA</strong>’s websiteunder resources. A web booklet versionwill be available soon <strong>and</strong> publicised inan upcoming <strong>ANZCA</strong> E-<strong>New</strong>sletter. Forqueries please contact <strong>ANZCA</strong>’s Quality<strong>and</strong> Safety Officer on qs@anzca.edu.au.44 <strong>ANZCA</strong> <strong>Bulletin</strong> <strong>June</strong> <strong>2012</strong>
The dangers ofself-inflatingresuscitation bagsSelf-inflating resuscitation bagsare essential but rarely usedadjuncts to the anaesthesiamachine, a vital back upwhen the oxygen supply oranaesthesia machine fails.They are also essential itemsof equipment in the postanaesthesiacare unit (PACU),on cardiac arrest trolleys <strong>and</strong>in emergency departments.However, a number of hazards areassociated with the use of these bags, bothre-usable <strong>and</strong> disposable models, many ofwhich will be well known to anaesthetists<strong>and</strong> intensivists.Dr Jane Torrie, the Director of theSimulation Centre for Patient Safety inAuckl<strong>and</strong>, has identified an issue with oneparticular bag <strong>and</strong> reports:“Our usual bag valve mask productstocked in our university medicalsimulation centre was recently replacedwith the L670 BVM single use productmade by Allied Healthcare, Missouri, <strong>and</strong>imported by Care Medical.”“During teamwork research over threedays in late February <strong>2012</strong>, we videoed25 teams (anaesthetist, post-operativecare nurse <strong>and</strong> anaesthetic assistant)managing highly-realistic simulated casesof deteriorating patients in a post-operativecare area. All team members wereclinically experienced <strong>and</strong> work in largelocal medical institutions where similarbag valve mask systems are stocked<strong>and</strong> used.“The research team observing the casesnoticed that in 11 out of 25 cases (44 percent), a member of the team disconnectedoxygen tubing from the manikin’soxygen face mask <strong>and</strong> connected it tothe manometer port of the L670 BVMafter removing the white port cap. Inall 11 cases, none of the team membersdetected the error during the remainder ofthe simulated case, <strong>and</strong> the oxygen wasdelivered at maximum flow rate (12-15 lpm)into the port for several minutes.“The research team felt that barotraumawas a possibility in these cases, so atthe end of the research simulations weconnected a two-litre test lung bag to theL670 BVM, connected oxygen tubing tothe manometer port <strong>and</strong> turned gas flowsto 12 lpm.“It was apparent that the test lungbag exp<strong>and</strong>ed alarmingly to a volumeof several litres <strong>and</strong> that there was nopressure relief system functioning toprotect patient lungs from O2 supplypressure in this device configuration.A photo is attached. This behaviourcould also be reproduced using a br<strong>and</strong>new L670 BVM found in an operatingroom at Auckl<strong>and</strong> City Hospital, but notconsistently. There is no visible differencebetween the two BVMs.“Patients whose lungs are ventilated viaa closed system (endotracheal tube) wouldbe at high risk of life-threatening lungbarotrauma if the L670 manometer portwas connected to oxygen tubing.“It is obvious that this connection errorwill also reduce the inspired O2 in mostcases, as the reservoir bag does not filldespite high O2 flow rates. A secondphoto is attached demonstrating this.“While we are aware that this is notthe intended configuration of the L670, weobserved a large proportion of experiencedhealthcare professional teams, who wereusing it for the intended purpose, actuallyassemble it in a hazardous configuration.Even more concerning, the error wasnot apparent to them <strong>and</strong> thus was notcorrected.”The problem was reported to Medsafe(the authority responsible for regulatingtherapeutic products in <strong>New</strong> Zeal<strong>and</strong>),which did not think it appropriate totake formal action as it understood thisparticular product had already beenwithdrawn from the market; the issue wasone of incorrect use rather than devicefailure; <strong>and</strong> there had been no adverseevents arising from such incorrect useof this or similar products.Despite this, MedSafe is keen thatword of this potential hazard is distributedto all anaesthetists.This is a timely reminder that thereare many hazards associated with thesebags. Some hazards – such as the facilityfor incorrect assembly rendering themuseless <strong>and</strong> foreign material such as vomitaccumulating in the old black Ambu bags– have largely been eliminated, or at leastreduced by improved design.A further series of problems is associatedwith the use of a filter between the bag <strong>and</strong>the patient. This is, of course, unnecessaryif a disposable bag is used but severalbr<strong>and</strong>s of re-usable bag are still available.This is not the forum to discuss the pros<strong>and</strong> cons of disposable devices but someof the hazards are as follows:• High pressure oxygen could be connectedto the CO2 monitoring port of the filterresulting in exactly the same issues thatDr Torrie had in the simulation centre.• The same port can be left open or evenbroken off, resulting in a large leak <strong>and</strong>totally inadequate ventilation.• The filter can be blocked by patientsecretions.• There are other disposable devices withports between the bag <strong>and</strong> the patient.All anaesthetists should be aware of theseproblems <strong>and</strong> take the following actions:• Check the self-inflating resuscitationbags in your clinical area frequently.• Never use a filter with a disposabledevice.• Make sure the O2 tube is connected tothe end of the bag away from the patient.(It should be stored in this configuration,which will prevent the last minuteincorrect assembly experienced byDr Torrie’s subjects.)• Educate nursing <strong>and</strong> other staff atevery opportunity on the safe useof these devices.Dr Joe Sherriff, F<strong>ANZCA</strong><strong>ANZCA</strong>’s National Quality <strong>and</strong> SafetyOfficer, <strong>New</strong> Zeal<strong>and</strong>45