ISO 80369-6:2016 Neural Connector Devices To Reduce .

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ISO 80369-6:2016 neuralconnector devices to reducemisconnection errorsGuidelines for implementation in AustraliaDecember 2019

ContentsSummary3Introduction4Guideline principles6Implementation planning8ContextBackgroundObjectiveScopeBenefits and risksPrinciples for changeoverGovernanceProduct availability and procurementProduct identificationEducation and familiarisationPre-introduction planningCommunicationManaging the , planning and approvalChangeover DayPost-introduction feedback and s14References14Other useful resources15Appendix 116 Australian Commission on Safety and Quality in Health Care 2019

SummaryThe International Standard ISO80369-6:2016 Small bore connectorsfor liquids and gases in healthcareapplications – Part 6: Connectorsfor neuraxial applications wasintroduced with the aim of reducingerroneous, harmful administrationof fluids via intrathecal, epiduraland other neural routes andreducing erroneous administrationof substances intended for neuralroutes to other sites.1For the purposes of this document: Neural devices with connectors compliant withISO 80369-6:2016 shall be described as ‘ISO80369-6 devices’.Devices that use the Luer connector will bedescribed as ‘Luer devices’.The ISO 80369-6:2016 standard refers to‘neuraxial’ devices. However, devices forboth central and peripheral neural routesare impacted by the standard. Hence, theseguidelines are prepared for neural devicesdeveloped according to the ISO 80369-6:2016standard for neuraxial applications.In 2017, the Australian Commission on Safety andQuality in Health Care (the Commission) and theAustralian and New Zealand College of Anaesthetists(ANZCA) published a joint statement recommendingthat medical devices incorporating small-boreconnectors be adopted in Australia as part of aglobal initiative to improve patient safety. Neural,including neuraxial, devices with connectors arerequired to be compliant with ISO 80369-6: 2016 andsafe implementation must be carefully planned.2,3,4In this document, the Commission and ANZCAprovide information to facilitate the safeintroduction of neural devices with connectors thatcomply with ISO 80369-6:2016 across Australia. Thisincludes a guideline for implementation and a safetychecklist. ANZCA has also published a safety alertincluding an explanation of the new equipment withdiagrams and a list of impacted devices.5As ISO 80369-6 compliant devices are introduced,medical devices for neural procedures with Luerconnectors will be withdrawn. Expedient and wellconstructed change management plans will needto be introduced by all health services involved inneuraxial and regional anaesthetic procedures.ISO 80369-6:2016 neural connector devices to reduce misconnection errors 3

IntroductionErroneous neuraxial and peripheralneural administration (includingintrathecal and epidural) ofmedicines or fluids intended foradministration by other routesis a small but highly significantproportion of the number ofinjection errors in medicinesadministration. Moreover, theadministration of medicinesintended for neural procedurescan be erroneously given by otherroutes. These incidents can becatastrophic for patients and mayresult in serious permanent harmor death.Administration of a medicine by the wrong route isfacilitated by the interconnectivity of intravenousdevices with epidural, intrathecal, regional andperipheral nerve devices, including syringes,needles, filters, syringe caps and lines. These wrongroute medication errors have been made possibledue to the universal use of the Luer connector thathas no physical barrier to prevent unintentionalmisconnection of devices.6The International Organization for Standardization(ISO) developed a standard for neuraxialconnectors, ISO 80369-6:2016 to address this systemdeficiency.1 Devices compliant with this standard willonly connect with other ports for neural delivery ofmedicines. This reduces the risk of misconnectionsand wrong route administration of a medicineor fluid.ANZCA and the Commission recommended in a jointsafety statement that devices for neural procedurescompliant with ISO 80369-6:2016 be adopted inAustralia as part of this global initiative to improvepatient safety.24 Australian Commission on Safety and Quality in Health Care

ContextBackgroundThe joint statement makes recommendationson the safe and strategic introduction of ISO80369-6 compliant devices within Australianhealth services to reduce the risk of patient harm.These ISO compliant devices facilitate dedicatedneural medicine delivery and a systems solutionto the wrong route hazard. System redesign andintroduction of physical barriers is the most effectivehuman factors engineering strategy to mitigate userelated hazards. However, potential improvementsin medication safety should not be negated byintroducing other risks. The implementation riskmust be considered and addressed proactively.The safe, controlled and appropriately managedintroduction of devices that comply with ISO80369-6:2016 will involve a wide range of products.A core set of medical devices within a completeinterconnected system should only be introducedwhen each of the elements can be supplied with aconnector that complies with ISO 80369-6:2016. Acomplete system with interconnectivity betweenmedical devices used for neural route proceduresmust include needles, syringes, epidural andneurosurgical catheter connecting devices andinfusion lines.Incomplete pathways of connection systems may bedetrimental to patient safety. Therefore, a core setof medical devices within a complete interconnectedsystem should only be introduced when each ofthe elements can be supplied with a connector thatcomplies with ISO 80369-6:2016 and that supply isguaranteed.Any introduction should be consistent withthe Commission’s National Quality and SafetyHealth Service (NQSHS) Standards,7 in particular,where these standards relate to governance andmedication safety. This includes the Nationalstandard for user-applied labelling of injectablemedicines, fluids and lines.8ANZCA’s safety alert published in August 2019includes diagrams of the new equipment withfurther information.5 A list of devices andcomponents impacted by the changeover is alsoavailable on the ANZCA website at www.anzca.edu.au/documents/sau neuraxial-productslist 20190816.pdf. Information around theintroduction of non-Luer neural medical devices inother jurisdictions is available from the Associationfor Anaesthetic and Respiratory Device Suppliers(Barema, UK)3 and the Global Enteral DeviceSupplier Association (GEDSA, USA).4 In addition, amulticentre clinical simulation evaluated a numberof devices with ISO 80369-6:2016 connectors as ‘fitfor purpose’.9Guidelines for the implementation of medicaldevices using connectors specified in the ISO 80369series have been proposed by ISO/TC 210 JointWorking Group 4.10 These guidelines have beenused as the principal source of information for thefollowing guiding principles and implementationsafety checklist (Appendix 1).ISO 80369-6:2016 neural connector devices to reduce misconnection errors 5

Guideline principlesGuideline principlesObjectiveBenefits and risksTo support health services plan the introduction ofneural devices compliant with ISO 80369-6:2016 toclinical practice in Australia.The universally used Luer device connection systempermits connection between medical devices usedfor fluid administration, breathing systems andsome monitoring equipment. This is convenientbut poses a high risk of unintended misconnectionsbetween medical devices and the possibility ofincorrect route medicine administration. In somecases, fatalities have occurred.ScopeThis guideline is intended for health serviceorganisations and service providers involved in thechangeover from medical devices for neural routeprocedures with Luer connectors to medical deviceswith ISO 80369-6:2016 compliant connectors. Inparticular, the guideline is provided for hospitalservices when or where neural procedures areconducted including anaesthesia, intensivecare, emergency services, surgery, radiology,haematology, oncology and pain medicine.This guideline considers the essential steps for thechangeover and includes: Governance ISO 80369-6 device availability and procurement ISO 80369-6 device identification Education and training Pre-introduction planning Communication Managing the introduction Post-introduction feedback and actions.The ISO 80369 series of standards for small boreconnectors aims to provide a safe engineeredsystem to reduce the risk of unintentional medicaldevice misconnection. This guideline covers neuraldevices compliant with ISO 80369-6:2016.The introduction of a series of small boreconnectors each for a specific clinical applicationrepresents a systems solution to reducing the riskof misconnections. For example, an ISO 803696 connector designed specifically for neuraxialprocedures physically prevents an intravenous linewith Luer connectors from being connected to anISO 80369-6 epidural catheter connector.Benefits will be realised when all end-to-end neuralprocedures use ISO 80369-6 compliant devices.However, implementation risk of changeover to thenew devices is readily identifiable and must be wellmanaged to reduce the risk of patient harm. Riskshave been identified where: 6 Australian Commission on Safety and Quality in Health CareTherapy is delayed if all components of an endto-end procedure are unavailableAdaptors are used to overcome componentunavailability. This negates the benefit ofchangeover to ISO 80369-6 devices and adaptorsmust not be usedPatient is transferred to a ward or other facilitynot yet converted to the ISO 80369-6 devices.Mistakes are made when selecting the ISO80369-6 devices instead of Luer devices in thesupply chain or in clinical useISO 80369-6 devices perform differently toLuer devices which may lead to a higher rateof technical failure in the early phase postchangeover as users become familiar withequipment.

Principles for changeoverGovernanceGeneral principles apply to the changeover fromLuer devices to ISO 80369-6 devices for safe neuraldelivery of medicines.The health service executive in collaboration withclinicians must take overall responsibility for thechangeover. Early in the process, an oversightgroup should be established and should includerepresentatives of the executive. ISO 80369-6 devices for neural use will replaceexisting Luer devices. Replacement is essentialand adapters are not appropriate for proceduresinvolving neural delivery of medicines. Riskassessment has shown adapters imply productsfor different purposes no longer misconnect andthe potential for mis-connection remains andmay even increaseAll medical devices in an interconnected endto-end procedure must be available beforechangeover of devices for that procedureA simple name or terminology for use in verbaland written communication is determined toclearly differentiate the new devices from theold. For example, ‘ISO 80369-6 devices’ or ‘NRFit devices’ISO 80369-6 devices must be easily identified anddifferentiated from the existing Luer devices.This identification may be through addition ofISO 80369-6:2016 wording and/or the NRFit logo by the manufacturer or through applicationof distinctive labelling on receipt and storage bythe health serviceApplication of colour-coding should be consistentwith the National standard for user-appliedlabelling of injectable medicines, fluids and lines(2015) 8Planning for replacement medical devices forneural use incorporates all procedures involvingneural delivery of injectable medicines, including‘off label’ useConsider medicines supplied in pre-filledsyringes and how these will be procured insyringes fitted with ISO80369-6:2016 connectors.Availability and use of ready-to-use pre-filledsyringes eliminates a number of steps inpreparation of injectables and greatly reducesthe risk of harm from a medicine.The composition of the group should reflect the sizeand complexity of the health service organisation.In hospitals, the group could comprise staff fromanaesthesia, intensive care, emergency medicine,perioperative care, pain medicine, obstetrics,oncology, radiology, haematology, neurology,neurosurgery, paediatrics, pharmacy, quality andsafety, procurement and medical engineering.The changeover should be managed by a multidisciplinary team across departments and wards.The team should include representatives from eachclinical situation where procedures involving neuralmedicine delivery are impacted by the changeover.A risk management strategy should be agreed andinclude plans to: Identify and analyse the risks prospectivelyDevelop, plan, initiate, and implement riskcontrol measuresCommunicate the risks and risk control measuresthrough education, training, and other methodsReview and amend existing clinical guidelines andprotocolsRegularly audit the safe handling of the newmedical devices, andProvide for public access to relevant patientsafety findings related to the changeover processand the use of the new medical devices.The health service executive must inform allimpacted employees of the changeover process andtiming along with the oversight groups managingthe changeover. Tasks and responsibilities shouldbe outlined at an early stage.ISO 80369-6:2016 neural connector devices to reduce misconnection errors 7

Implementation planningImplementation planningProduct availability andprocurementIn all clinical areas, make a comprehensive inventoryof all equipment used to access and/or delivermedicines to the central or peripheral nervoussystem that have a Luer connector. These will beimpacted by the changeover. In the audit considerthe following: The names describing different procedures andvariation in clinical practice to identify if someprocedures use small-bore connector devicesunlicensed for that purpose or are used ‘off label’Ready-to-use pre-filled syringes that may beimpacted. These reduce medication error andshould be sourced fitted with the ISO 80369-6compliant connectors to maintain this level ofsafetyDocumentation to identify the ISO 80369-6compliant device manufacturer(s) and productidentification codes. These codes should bedifferent for the ISO 80369-6:2016 and LuerdevicesAll medical devices within an end-to-endprocedure which are not fitted with a connectorbut which are indispensable and necessary tocomplete the procedure (from here on referredto as components)Who holds responsibility for procurement andthe authorisation process to change supplier, foreach inventory item.The following information should be collected anddocumented: 8The departments, wards and areas impactedThe clinical situations where procedures involvingneural delivery of medicines are impactedThe medical devices and ready-to-use pre-filledsyringes used across departments, including thesterile kits or packs containing neural devicesand related consumables such as those used inpatient controlled epidural analgesiaStock levels for all medical devices, noting thecriticality if the device were unavailable and theanticipated demand or supply levels for each ISO80369-6 device Australian Commission on Safety and Quality in Health Care The demand and supply patterns for each ISO80369-6 device impacted by the changeover,including medical devices and all components toperform the end-to-end procedure. This shouldinclude consideration of any clinical impactby changing supplier of any of the procedurecomponents.For each end-to-end procedure check the availabilityof the ISO 80369-6 devices and componentswithout a connector. Good communication isneeded between hospitals within the health serviceand manufacturers/suppliers. All parties mustbe mindful of the terminology used to define thedevices and procedures involved. If only a smallnumber of procedures or devices are impacted,the procurement for a changeover process may besimple. If many medical devices are impacted at thesame time, then it will be critical to ensure adequateand timely communication and planning for allimpacted employees and departments.Usability testing and familiarity handling should bethoroughly conducted by relevant, clinical end usersconversant with the intended use of the devices.Usability testing should involve scenario basedsimulation in conjunction with education to avoidproblems when handling the ISO 80369-6:2016devices. They should be tested before ordering.Changeover should only be started and executed: When all the corresponding ISO 80369-6compliant devices and components are availableand have been testedWhen all staff are informed and educated to astandard set by the implementation group.

Product identificationpractical implementation of the ISO 80369-6 devicesand connectors.ISO 80369-6 devices must be clearly differentiated.The devices may be marked with ‘ISO 80369-6:2016’and/or the NRFit logo to indicate the productincorporates an ISO 80369-6 connector. It is notmandatory for products to carry the NRFit logo.Therefore, each health service should devise a wayto consistently differentiate old Luer devices fromthe new ISO 80369-6 devices and components,depending on the range of devices used in thatfacility. Preferably the differentiation would bestandardised across health services.Pre-introduction planningEducation and familiarisationHealth services need to identify all staff whowill be impacted by the changeover to facilitatecommunication and coordinate familiarisation withISO 80369-6 devices before implementation. Thedocumentation should include staff affiliation, forexample ward, role, and department.The number of sample sets of the ISO 80369-6devices and components required for testingand familiarisation will need to be estimated andordered.Education activities for all impacted staff shouldfocus on competency and familiarisation throughsimulation processes. These should: Be held prior to the changeover process multipletimesBe held close to the scheduled changeoverInclude practical handling of the new ISO 803696 devices and components.Using sample sets of the new ISO 80369-6 devicesand components, staff should be given thechance to see, touch and try out the new devices.Sample sets of the new ISO 80369-6 devicesand components should be made available indesignated wards, departments and perioperativeareas as appropriate.Conduct a risk assessment with the staff involved inprocedures involving neural delivery of medicinesto identify training requirements. Document andcommunicate the results of this risk assessment andtraining delivery.Timelines for changeover should be available andupdated as necessary in all departments concerned.The documentation should indicate the currentstage of planning and implementation. It should beclearly communicated and understood when thenew ISO 80369-6 devices and components will arriveand the date of changeover.The changeover process can be carried out invarious ways. Implementation may be on a smallscale with sequential changeover in individualdepartments or the entire hospital or health servicemay changeover on a designated date and time. Thepreference is a single day facility wide changeoveras evidenced by introductions in other jurisdictions.11It is recommended that the changeover process isdocumented in an action plan to: Participation in these events should be documented.Additional individual education and familiarisationshould be held. This is particularly necessary forstaff who were absent during changeover, includingnight staff.An e-learning module could be developed tosupport the education and familiarisation.Manufacturers may produce videos or othermaterials to educate staff on the ISO 80369-6devices and connectors and their use.Nominated qualified staff should be availableduring and subsequent to the changeover. These,health services staff will have the competence andexpertise

ISO 80369-6:2016 shall be described as ‘ISO 80369-6 devices’. Devices that use the Luer connector will be described as ‘Luer devices’. The ISO 80369-6:2016 standard refers to ‘neuraxial’ devices. However, devices for both central and peripheral neural routes are impacted by the standard. Hence, these

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