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What is the regulatory procedure when a medical device needs to be recalled from the market (Field Safety Corrective Action)?

MEDDEV 2.12-1 rev 6: GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
December 2009

4.6 FIELD SAFETY CORRECTIVE ACTION (FSCA)

A Field Safety Corrective Action is an action taken by a 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 market. Such actions should be notified via a Field Safety Notice.

The FSCA may include

  • the return of a medical device to the supplier;
  • device modification;
  • device exchange;
  • device destruction;
  • retrofit by purchaser of manufacturer’s modification or design change;
  • advice given by manufacturer regarding the use of the device (e.g. where the device is no longer on the market or has been withdrawn but could still possibly be in use e.g. implants or change in analytical sensitivity or specificity for diagnostic devices)

A 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. For example:

  • For implantable devices it is often clinically unjustifiable to explant the device. Corrective action taking the form of special patient follow-up, irrespective of whether any affected un-implanted devices remain available for return, constitutes FSCA.
  • For any diagnostic device (e.g. IVD, imaging equipment or devices) the recall of patients for retesting or the retest or review of previous results constitutes FSCA.
  • advice relating to a change in the way the device is used e.g. IVD manufacturer advises revised quality control procedure -use of third party controls or more frequent calibration or modification of control values for IVDs.

5.4.4 FIELD SAFETY CORRECTIVE ACTION

The Medical Device Directives require the MANUFACTURER to report to the National Competent Authority any technical or medical reason leading to a systematic recall of devices of the same type by the MANUFACTURER.

Those reasons are any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the instructions for use which might lead to or might have led to the death of a patient or USER or to a serious deterioration in his state of health.

The term “withdrawal” used in the AIMD is interpreted in the same way. This guideline uses the definition of a FIELD SAFETY CORRECTIVE ACTION as a synonym for recall or withdrawal since there is no longer a harmonised definition of these terms.

Removals from the market for purely commercial non-safety related reasons are not included.

In assessing the need for the FSCA the MANUFACTURER is advised to use the methodology described in the harmonised Risk Management standard EN ISO 14971: 2000. In case of doubt, there should be a predisposition to report and to undertake a FIELD SAFETY CORRECTIVE ACTION.

FSCA taken on a basis of INCIDENTs occurred outside the EEA and Switzerland and affecting devices covered by the MDD are included in this guideline.

FSCA should be notified to the customers via a FIELD SAFETY NOTICE.

Where a Notified Body was involved in the conformity assessment procedure of the device, it is recommended to inform them about the FIELD SAFETY CORRECTIVE ACTION.

5.4.4.1 NOTIFICATION TO NATIONAL COMPETENT AUTHORITIES

The MANUFACTURER should issue a notification to the Competent Authorities of all countries affected at the same time and also to the National Competent Authority responsible for the MANUFACTURER or AUTHORISED REPRESENTATIVE. Use the format recommended in annex 4.

This notification should include all relevant documents necessary for the National Competent Authority to monitor the FSCA, e.g.

  • Relevant parts from the risk analysis
  • Background information and reason for the FSCA (including description of the device deficiency or malfunction, clarification of the potential hazard associated with the continued use of the device and the associated risk to the patient, USER or other person and any possible risks to patients associated with previous use of affected devices.)
  • Description and justification of the action (corrective/preventive)

Advice on actions to be taken by the distributor and the USER (include as appropriate:

  • identifying and quarantining the device,
  • method of recovery, disposal or modification of device
  • recommended patient follow up, e.g implants, IVD
  • a request to pass the FIELD SAFETY NOTICE to all those who need to be aware of it within the organisation and to maintain awareness over an appropriate defined period.
  • a request for the details of any affected devices that have been transferred to other organisations, to be given to the MANUFACTURER and for a copy of the FIELD SAFETY NOTICE to be passed on to the organisation to which the device has been transferred.)
  • Affected devices and serial / lot / batch number range
  • In the case of an action concerning lots or parts of lots an explanation why the other devices are not affected
  • Identity of the MANUFACTURER/AUTHORISED REPRESENTATIVE.

MANUFACTURERs should also include a copy of the FIELD SAFETY NOTICE to the Competent Authorities along with the notification. This should be done before or at the same time as FSCA is being issued.

The MANUFACTURER or other responsible on his behalf should inform the coordinating Competent Authority once the FSCA has been completed in both, the EEA and Switzerland. This should include information on the effectiveness of the action per country involved (e.g., percentage of devices recalled)

It is recommended that MANUFACTURERs should provide a draft of the Field Safety Notification to a relevant National Competent Authority, e.g. where the MANUFACTURER or the AUTHORISED REPRESENTATIVE has his registered place of business, where most of the affected devices are on the market or any other appropriate National Competent Authority.

Normally, the MANUFACTURER should allow a minimum of 48 hours for receipt of comment on the Field Safety Notification unless the nature of the FSCA dictates a shorter timescale e.g. for SERIOUS PUBLIC HEALTH THREAT.

It is recommended to copy the FIELD SAFETY NOTICE to the Notified Body involved in the conformity assessment procedure of that device.