Post Market Surveillance (PMS): National Competent Authority Report (NCAR) Exchange Programme under IMDRF
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1 Post Market Surveillance (PMS): National Competent Authority Report (NCAR) Exchange Programme under IMDRF SAMED Conference, 2-3/12/2015 Dr Isabelle Demade
2 What is IMDRF? Introduction - established in Medical Device Regulatory Officials from: the Americas: Canada, USA, Brazil Asia/Pacific: China, Japan, Australia Europe: EU, Russia. - to accelerate international medical device regulatory harmonization and convergence. 2
3 Introduction What is the NCAR Exchange Programme? = a program allowing the timely exchange of serious public health issues identified in post market between IMDRF MC Regulators. - only concerns devices with global distribution.
4 Achieved NCAR Exchange Programme - State of Play- IMDRF NCAR WG/ N14 Fin: NCAR Exchange Criteria and Report Form- = a guidance for NCAR Exchange between IMDRF MC Regulators. Implementation Materials will be used for training
5 NCAR Exchange Programme - State of Play - On going : Transition phase Oct March 2016 from GHTF IMDRF NCAR Exchange Program training existing members testing the Exchange Programme
6 NCAR Exchange Programme - IMDRF N14 : KEY FEATURES NCAR Exchange: to exchange information relating to significant concerns or potential trends that NCAs have observed in their jurisdictions but have not yet resulted in recalls or field safety corrective actions.
7 NCAR Exchange Program -Exchange criteria- Events leading or highly likely to lead to unanticipated serious public health threat. unanticipated: not considered in the risk analysis during the design and development phase. serious public health threat: = death, serious injury or imminent risk of death or serious injury prompt remedial action.
8 Examples of Unanticipated Serious Public Health Threat Reports of a serious eye infection potentially causing permanent damage to sight The reports are for the same type of eye lubricant drops Results of testing reveals that the eye drops have the same bacteria Further investigation finds that the sterilization process was not checked and the handling procedures were not followed The manufacturer makes large batches of this eye drop and has distributed the batch globally
9 NCAR Exchange Programme -Exchange criteria- Observations from national trend analysis. when frequency of the AE (Adverse Event) significantly higher than: - the frequency in the Manufacturer(MFR) s file - the frequency with similar devices. (+) AE serious public health threat
10 Revision rate (%) Example of National Trend Analysis NCA informs other agencies about a hip prosthesis that is having a higher than average revision rate. Analysis of information is that the implant is being revised due to metal sensitivity Revision rate becomes significant and is increasing rapidly after 3years of implantation Country of origin of NCAR is also taking action to prevent further use Trend for ABC hips and all hips Year 1 Year 3 Year 5 Year 7 Year 9 ABC Hip All hips
11 NCAR Exchange Programme -Exchange criteria- Request and/or sharing of information specific devices or class/group of devices may concern: - event (s) - increased frequency/ seriousness - major weaknesses/deviations in MFR s Product Management/Quality Management system. (+) may lead to serious public health threat
12 Example of Sharing Information Information is being shared about an adverse event and the solution in case action is required elsewhere A death was associated with the failure of a physiological monitor to alarm when a patient on telemetry hook-up had an irregular heart beat. Investigation revealed that the monitor s alarms would not be triggered if it was not able to detect a rhythm from the telemetry unit when the telemetry unit was more than 3 meters away. The monitor was interpreting interference or absent transmission as though no patient was connected. The outcome of the investigation was that the frequency used between the monitor and telemetry unit be switched to another frequency which was 12 appropriate for telemetry use.
13 Example of Requesting Information A NCA has had reports of problems with a particular hip replacement. There are a number of issues with a particular model. The NCA isn t sure if there is an issue with the implant or an issue more locally. As the investigation is ongoing the requesting NCA has indicated that the request is confidential. The NCA sends out an NCAR requesting information from other NCAs that it has a confidentiality agreement with about any adverse events, complaints or other information that will assist in its investigation. 13
14 NCAR Exchange Programme - Participants- Limited to IMDRF Management Committee (MC) members (Regulators) Pilot phase: only those who were participating in the previous GHTF NCAR Exchange. MC Regulators not involved in the former GHTF NCAR Exchange Programme: inform the Management Committee of their wish to join.
15 NCAR Exchange Programme - Participants- All participants will be required to review implementation materials - on key elements of the exchange, - on definitions and confidentiality. must ensure they have confidentiality arrangements with other participating National Competent Authorities (NCAs). 15
16 NCAR Exchange Progr.: Confidentiality Confidential/non confidential information: - no defined criteria - decision based on the authoring country s classification of confidential information.
17 NCAR Exchange Programme: Confidentiality (cont.) NCARs classified as confidential only distributed to Exchge Progr. Mbers with whom authoring NCA has confidentiality agreement. NCARs classified as non confidential circulated to ALL participants to the Exchange Program by the Secretariat.
18 NCAR Exchange Programme: Secretariat Overall task: - to facilitate and monitor the exchange of NCARs - to be the recipient & repository of all NCARs Specifics: - statistical analysis/reports - support training - organize bi-annual conf. with participants.
19 Conclusion The whole is greater than the sum of the parts Aristotle (384 BC 322 BC) The more information shared via the Programme, the more valuable the Exchange. 19
20 Thank you for your attention! More info at: Contact: 20
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