Product Recall Guidelines

There is increasing interest in achieving the safe use of products through post-marketing systems and techniques, including the recall mechanism. An obligation to have a written recall mechanism has been contained in The Guide to Good Manufacturing Practice for Medicinal Products for many years. Directives on medical devices include obligations to have systematic procedures to review experience gained from products in the post-production phase and to implement appropriate means to apply any necessary corrective action, as well as notifying competent authorities of particular malfunction or deterioration in the characteristics and/or performance of a device, as well as notifying any systematic recall. ISO 9001 specifies that the supplier shall establish, document and maintain procedures for investigating the cause of non-conforming product and taking corrective action needed to prevent recurrence, as well as initiating preventive actions. Directive 92/59/EEC on general product safety includes an obligation on the producers of consumer products to take appropriate action, including if necessary withdrawing a product from the market. Proposals are currently being made by Directorate-General XXIV of the European Commission that this obligation should extend to recalling products from consumers and users after they have been sold.

Initiatives to produce guidelines on product recalls have recently emerged in draft from the UK’s Department of Trade and Industry (DTI) relating to consumer products and Medical Device Agency (MDA) relating to medical devices. Industry is currently being consulted on these draft guidance documents. The focus of the DTI’s draft is to assist small and medium-sized companies who do not have the relevant experience about how to plan for and manage a product recall. It stresses the need to consider all post-marketing risks in advance and to establish a plan under which a recall can be successfully and efficiently operated. It is made clear that whilst certain techniques can be described in general, decisions on what is going to work for each company, given its resources and particular type of product, will be a matter for each company to decide. The company will need to have urgent access to information on how many products of a specific type might be affected by a particular problem and how best to notify those holding or using products of the problem. The DTI stresses that advance planning by a company in its record keeping and marking of individual batches or products can save a great deal of time and money in limiting the extent of a recall.

The MDA’s draft Guidance takes a slightly different approach, in view of the fact that competent authorities and notified bodies are involved in this product sector, whereas they are not always involved in general consumer products. The focus of the MDA’s Guidance is, therefore, on the information which a company should provide to these regulatory bodies and the advisability of liaison with them.