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Annet Muetstege
Postmarket Surveillance made simpel|
Westervoort, 06 July 2013
6 Jul 2013 ACS PMS 2
Reportable Adverse Event?
• Serious?
• Device related?
• Unanticipated?
6 Jul 2013 ACS PMS 3
Medical Devices: a diverse sector
6 Jul 2013 ACS PMS 4
Medical Device Regulation Proposal -
Postmarket Surveillance
″ Proportionate to the risk class and the type of device, manufacturers …shall institute and keep up to date a systematic procedure to collectand review experience gained from their devices placed on the market… and to apply any necessary corrective action, hereinafter referred to as ‘post-market surveillance plan’.
• “Post-market clinical follow-up, … a continuous process to update the clinical evaluation referred to in Article 49 and Part A of this Annex and shall be part of the manufacturer's post-market surveillance plan… the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which is authorised to bear the CE marking, within its intended purpose … with the aim of confirming the safety and performance throughout …”
6 Jul 2013 ACS PMS 5
Medical Device Regulation Proposal -
Postmarket Clinical Follow-up
″ … PMCF shall be performed pursuant to a documented method laid down in a PMCF plan …
″ specify general methods and procedures, such as gathering of clinical experience gained, feedback from
users, screening of scientific literature and of othersources of clinical data …
″ The notified body shall periodically, at least once every 12 months, carry out appropriate audits and assessments to make sure that the manufacturer applies the approved quality management system and the post-market surveillance plan.”
6 Jul 2013 ACS PMS 6
PMCF - Vigilance
″ … European system for the notification and
evaluation of incidents and field safety corrective
actions …
• Advantage
►Existing company system
►Low additional cost
• Challenges
►Reactive
►Issues late in the game
(1) MEDDEV 2.12-1 rev 8
6 Jul 2013 ACS PMS 7
PMCF - Literature review
″ The process of reading, analyzing, evaluating, and summarizing scholarly materials about a specific topic.”
• Options►Review relevant sources at regular intervals, e.g. PubMed
►Conferences
► Journal alerting Services
• Advantage►Relatively cheap
►Access to data world wide
• Challenges►Reactive
►Data typically limited and heterogeneous
6 Jul 2013 ACS PMS 8
PMCF - Studies
• Options
►Non-interventional – registries
″ A collection of clinical data where all subjects receive the standard hospital treatment and have a parameter of interest in common
►Interventional – RCT
″ Clinical study where participants receive treatment's or test's different from standard practice because of study participation. Such treatment may concern randomization.
6 Jul 2013 ACS PMS 9
PMCF – Registry
• Options – several
►Paper/ EDC forms
►Single/ multi center
►…
• Advantages
►Value for money
►Low site threshold
►…
• Challenges
►No efficacy/ added value data
6 Jul 2013 ACS PMS 10
PMCF – Interventional Study
• Options
►Small scale single arm
►RCT
• Advantages►Efficacy and/ or added value
►RCT is gold standard
• Challenges►Not daily practice
►Huge investment
►Blinding
6 Jul 2013 ACS PMS 11
Postmarket Surveillance -
Conclusion
• PMS under new MDR
►More stringent, and controlled
• Various options
►Standard company processes
►Literature review
►Registries
►Randomised Controlled Studies
►…
6 Jul 2013 ACS PMS 13
Applied Clinical Services BV
• Co-founded by Annet Muetstege
• Mission► To contribute to better patient outcomes in health care by partnering with medical
device industry and ensuring that product safety & efficacy claims are supported by
adequate clinical evidence in the most cost-effective manner
• Core services
►Strategic Clinical Evidence PlanningWhat, where, when, how
►Clinical evidence communicationReports, abstracts, M&S material and training
►Clinical project managementProject design, progress, and (co-)monitoring
