A field safety corrective action (FSCA) 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 an IVD that is already placed on the market. It is triggered by information about any problem with an already distributed IVD that poses an unacceptable increased risk when that IVD is used. Such problems include malfunction or deterioration affecting the performance or operational characteristics of an IVD, as well as any inadequacy in the instructions for use which might lead or might have led to the death of a patient, user or other individual or to a serious deterioration in his/her state of health. Such information may be collected during pre-distribution or post-distribution lot testing, from reports from the field, during review of IVD design, or during changes in production or component specifications.

In assessing the need for a FSCA, it is advisable that the manufacturer apply the methodology described in ISO 14971:2007 Medical devices – Application of risk management to medical devices and Implementation of risk management principles and activities within a quality management system (GHTF/SG3/N15R8).

If the need for a FSCA of an IVD is been established, the manufacturer of the affected product assumes the responsibility for recovery of the goods and implementation of the corrective action. WHO and the relevant national regulotory authorities may assist by monitoring the overall action.

Action linked to a FCSA

A FCSA may stipulate:

• return of an IVD to the manufacturer or its representative
• IVD modification
• IVD exchange
• IVD destruction (in which case the relevant national regulatory authority(ies) (NRAs) should ensure that a record of disposal of the affected product is kept and inform the manufacturer accordingly so that it can reconcile records of the product distributed and product destroyed)
• advice given by the manufacturer regarding the use of the IVD (e.g. if the IVD is no longer on the market or has been withdrawn but could still be in use).

Communication and reporting

A FCSA is communicated through a field safety notice.

The manufacturer is required to notify any FSCA related to a WHO-prequalified IVD to WHO, and to the relevant NRA(s) in whose juridictions the IVD is supplied. (See recommended template below.) 

A FSCA report should include the following information:

• name of the manufacturer
• product name, product code and lot number of the affected IVD:
  • if the FSCA relates to certain lots only, an explanation as to why the other lots are not affected should be included
• list of all countries affected
• background information and reason(s) for issuing the FSCA:
  • including a description of the IVD deficiency or malfunction, clarification of the potential hazard associated with continued use of the IVD and the associated risk for the patient, user or any other person, and any possible risks to patients associated with previous use of the IVD
• relevant elements of the risk analysis
• description and justification of the corrective and/or preventive action
• advice on the actions to be taken by the distributor and the user,  e.g.:
  • identifying and quarantining the IVD
  • method of recovery, disposal or modification of the IVD
  • recommended patient follow up
  • a request to forward the attached field safety notice (FSN) to anyone who should be aware of it.

Follow-up FCSA report

A follow-up report should be submitted by the manufacturer to WHO within 30 days from the initial notification of the FSCA. It should provide:

• • an update on the progress of reconciliation of the FSCA and estimated timescales for completion
• confirmation, where practical, that users have received the FSN.

Final FCSA report

A final report should be submitted to WHO and other relevant NRAs after implementation of the FSCA. This should include information on the effectiveness of the action per country involved (e.g. percentage of IVDs to which FSCA was applied). If the FSCA stipulates:

• return of affected stock to the manufacturer
• an update of the instructions for use
• or modification/update of existing IVDs on- or off-site

the records of completed actions should be fully reconciled against distribution records so that progress of the FSCA can be monitored.

The final report should describe the:

• final outcome of the reconciliation of the FSCA
• root cause of the problem, if known, and proposed action (e.g. redesign, update in the field, improved instructions for use) to reduce the likelihood chance of recurrence.