vigilance guidance for specific devices tony sant/andy crosbie – mhra
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Vigilance guidance for specific devices Tony Sant/Andy Crosbie – MHRA. Presentation to the closed session of the Expert Group on Vigilance for Medical Devices – 15 Nov 2012. Background. MHRA has for some years issued advice on vigilance reporting for specific types of devices. - PowerPoint PPT PresentationTRANSCRIPT
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Safeguarding public health
Vigilance guidance for specific devicesVigilance guidance for specific devices
Tony Sant/Andy Crosbie – MHRATony Sant/Andy Crosbie – MHRA
Presentation to the closed session of the Expert Group on Vigilance for Medical Devices – 15 Nov 2012Presentation to the closed session of the Expert Group on Vigilance for Medical Devices – 15 Nov 2012
© Crown copyright 2009
BackgroundBackground
MHRA has for some years issued advice on vigilance reporting for specific types of devices.
Guidance is aimed at manufacturers and gives advice on notifying the MHRA of adverse incidents involving specific types of CE-marked medical devices under the medical devices vigilance system.
Guidance is intended to facilitate uniform application and implementation of Medical Devices Directive 93/42/EEC. It is supplementary to (and should be read in conjunction with) the latest version of European Commission Guidelines on the Medical Devices Vigilance System - MEDDEV 2.12-1
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UK device specific vigilance guidanceUK device specific vigilance guidance
VG 01 Joint replacement implants - July 2010 VG 02 Artificial heart valves - Nov 2008 VG 03 Breast implants - Oct 2009 VG 04 Coronary stents - Mar 2009 VG 05 IVD blood glucose meters for POCT or home use
- Dec 2008 VG 06 Inferior vena cava (IVC) filters - Mar 2009 VG 07 Intra-ocular lenses - Jun 2009 VG 08 Neurostimulators - Dec 2009 VG 09 Cardiac Ablation Catheters - July 2010
See:
http://www.mhra.gov.uk/Publications/Regulatoryguidance/Devices/Vigilanceguidanceforspecificdevices/index.htm
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What do the device specific vigilance What do the device specific vigilance guidance documents do?guidance documents do?
They provide technical / clinical detail to supplement the general guidance on vigilance reporting given in MEDDEV 2.12-1
Each MHRA guidance document lists the major recognised types of adverse incident associated with each specific type of medical device and then gives MHRA’s opinion on whether it is or is not usually reportable under vigilance as a “malfunction or deterioration in the characteristics and/or performance of the device”
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Summary table (see VG 06) of reportable/non-Summary table (see VG 06) of reportable/non-reportable individual adverse incidents under the reportable individual adverse incidents under the vigilance system for inferior vena cava filtersvigilance system for inferior vena cava filters
Note – for illustrative purposes only, this is not an exhaustive list
Reportable
•Complications during deployment and placement•Perforation/erosion•Partial or multiple fractures•Device migration•Progressive tilting/angulation•Recurrent/fatal pulmonary embolism•Retrieval difficulties•Labelling deficiencies•MRI induced events•Unanticipated events
Generally non-reportable
•Vascular access and device placement related problems•Inferior vena cava thrombosis/occlusion•Endothelialisation•IVC wall penetration•Infection•Adverse reaction
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Periodic summary reporting and trend reportsPeriodic summary reporting and trend reports
MEDDEV 2.12-1 includes provision for manufacturers to undertake periodic summary reporting and to submit trend reports to national competent authorities
Device specific vigilance guidance can be used to provide guidance on types of adverse incidents which may be suitable for these types of reporting (see for example VG 04 on coronary stents)
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Why should European device specific vigilance Why should European device specific vigilance guidance be developed?guidance be developed? Device specific vigilance guidance would
• supplement the general guidance in MEDDEV 2.12-1 on a Europe-wide basis
• Improve co-ordination of advice to industry and prepare for centralised reporting
• Harmonise use of PSRs and Trend reports in specific areas Minimise effort by concentrating on the lists of incident types to report
and not to report and when to use Trend and PSR reports The Commission and Member States are expected to improve co-
ordination (Dalli immediate action plan) Now that the MD Regulations have been proposed (Sept 2012) a
simple programme of development could begin
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Next stepsNext steps
Propose Vigilance MDEG discusses and agrees 1 or 2 device
specific guidance documents per meeting
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Safeguarding public health
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