WHO guidance on post-market surveillance - PowerPoint Presentation

Slide1

WHO guidance on post-market surveillance EMP Technical briefing seminar3 - 7 November 2014 Anita SandsPrequalification Team – Diagnostics Department of Essential Medicines & Health Products Slide2

About post-market surveillance Some issues related to quality, safety and performance may not be apparent during pre-market assessment or may only arise after a product is placed on the marketISO 9001:2000, ISO 13485:2003 and ISO 14971:2000 list the requirements on post-market activities to be performed by manufacturerPost-market surveillance is necessary to detect, investigate and act on any issuesSometimes leading to field safety corrective action by the manufacturer Slide3

WHO post-market surveillance of IVDs WHO prequalified product

Reactive PMS

Field Safety Notice

Complaints

Lot verification testing

Proactive PMS

Field Safety Corrective ActionSlide4

PMS roles and responsibilities Key stakeholdersEnd users (testers, procurers, implementers), manufacturers, NRAs, NRLs, WHO Each stakeholder ensures that post-market surveillance data is detected, assessed and properly acted upon End users are crucial as they usually first report problems; NRLs perform lot testing NRAs often lack capacity for post-market oversight;

WHO promotes

the practice of

PMS, ensures coordination of lot testing and ensuring manufacturers undertake appropriate investigation and any action, if required. Slide5

PMS: definitionsAdverse event (also called an incident) A product defect (i.e. malfunction or failure, deterioration in characteristics or performance, or inadequacy of labelling or of instructions for use) that, directly or indirectly, has led or might have led to serious medical consequences, namely death or serious deterioration in the state of health of the patient, user or another personMay be classified as mild, moderate, severeComplaintAny written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distributionSlide6

PMS: definitionsField safety corrective actionAction taken by the manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device that is already placed on the marketA FSCA is triggered when there is an unacceptable increase in risk associated with use of the deviceFSCAs may include:return of device to supplier, device modification, device exchange, device destruction, retrofit by purchased of device according to Mx modification\design control Slide7

Reactive PMS: definitionsField safety corrective action cont'dA device modification can include: permanent or temporary changes to the labelling or instructions for use;software upgrades including those carried out by remote access;modification to the clinical management of patients to address a risk of death or serious deterioration in state of health related specifically to the characteristics of the device. A FSCA should be notified to NRA (and WHO) through Field Safety Corrective Action ReportSlide8

PMS: definitionsField safety noticeA communication sent out by the manufacturer or its representative to the device users in relation to a field safety corrective actionIt tells their customers about a FSCA they are undertakingIt should be sent to all users for their attention and possible action It should be sent to all NRAs in the country of supply Slide9

Reactive PMS: complaint reporting for users User identifies problemUser documents the problem User reports problem to their NRA (or national IVD focal point)National IVD focal point Reports all complaints (including AEs) to manufacturerReviews trends for mild/moderate adverse events (AEs)Reports all serious AEs, and any change in trends of mild/moderate AEs to WHO Slide10

Reactive PMS: WHO complaint reporting for Mx Manufacturer receives complaint from national IVD focal point and/or WHO Investigates problem and takes appropriate action including root cause analysis, and if appropriate, any FSCAForwards initial and final investigation reports to WHOIf it is required, forwards FSCA report to WHOWHO will ensure that the manufacturer undertakes the appropriate investigation and, if required FSCASlide11

What will WHO do?WHO will monitor the manufacturer's investigation including risk assessment, and any required FSCACourse (the direction the investigation is taking)Conduct (how the investigation is being carried out)Progress (how quickly the investigation is being carried out)Outcome (whether the results of device analysis are satisfactory)WHO may inform other NRAs, may decide if WHO PQ status is affected, and may decide to take no further action WHO may issue an Information Notice for Users where the manufacturer has not undertaken an appropriate FSCA and/or has not issued a FSN, including if not done quickly Slide12

Proactive post-market surveillance of IVDs WHO prequalified productReactive PMS

Field Safety Notice

Complaints

Lot verification testing

Proactive PMS

Field Safety Corrective Action

Lot verification

testing by

users

independent

of the

manufacturer

Ensures

that only lots consistent with established

criteria (as determined during pre-market assessment, i.e. WHO PQ) are supplied to usersSlide13

Proactive PMS of IVDs: lot testingLot verification Through physical inspection of packaging, labelling and instructions for use; andTesting of samples from a lot against a characterised panel of specimensLot testing should be centrally performed by qualified laboratory Lot acceptance criteria must be in place (pass/fail)Slide14

Proactive PMS of IVDs: panels for lot testingSame panel of locally sourced specimens of known reactivity for each lot of the same IVDMinimum requirementsAnalytical sensitivity Clinical sensitivity Specificity Invalid ratesAnomaliesIncomplete clearing, high background, faint line, etc.Acceptance criteria for performanceSlide15

Proactive PMS of IVDs: sampling for lot testingPre-distributionSystematic or random sampling of lotsEasier to prevent delivery of poorly performing lots to the testing stiesRequires more resources Post-distributionRandom lots More difficult to recall defective lotsWhat to do for individuals already tested using those lotsLess resource-intensive

May use a risk-managed approach to decide on sampling interval, depends on size of lotSlide16

Proactive PMS of IVDs: physical inspectionWith each new lot: Inspection of packaging integrity may alert to mishandlingInspection of package contents will reveal labelling, inclusion errorsReview of instructions for use will detect any method changesKeep records Lot numbers and expiry dates, date of first use, all test results and band intensities, rates of invalid results, false positive rates

Cannot verify “error” without good recordsSlide17

Objective of WHO guidance on PMS

Narrative

Forms

IVD complaint reporting form

Manufacturer

investigation reporting form

Field

safety corrective action reporting form

Lot testing data collection form

Lot testing reporting form

Notices

Field Safety Notice