By Patricia Anderson
A medical device recall is action taken to remove or correct a problem with a device on the market because it contains some defect, poses some risk to users, or otherwise violates regulatory law. Naturally, manufacturers go to great lengths to prevent recalls from happening with all the research conducted before a device ever comes to market. However, you may wonder exactly how recalls work – both in the US and outside the US. While countries handle recalls differently, this article contains an overview of three examples of how countries handle recalls: recalls in the UK, the EU and the US.
In the UK:
Recalls in the UK are conducted and regulated by The Medicines and Healthcare products Regulatory Agency (MHRA), which is a government organization that was established in 2003. Prior to this, the MHRA existed as aspects of two separate organizations, Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). The role of the MHRA in medical device recalls includes withdrawing a product from the market, issuing alerts when a recall occurs, suspending production, prosecuting a manufacturer or distributor, regular inspections, annual routine sampling of around 3,000 marketed medicines, reports and review of new evidence, commissioning research, assessing labeling for misleading information, and looking for illegally manufactured medicines and devices.
The MHRA works closely with the European regulator, the European Medicines Agency (EMA) and collaborates with other international regulators such as the FDA, the National Patient Safety Agency (NPSA) in the UK and the National Institute for Health and Clinical Excellence (NICE) in the UK.
From a patient perspective, a product containing a new medicine, vaccine, or a new indication for an existing medication will have a black triangle on the label for up to 2 years after it comes to market. This black triangle is designed to encourage healthcare professionals to report any side effects. If the MHRA issues a recall, an alert is issued which can be found publicly and is sent to pharmacies as well as the manufacturer or distributor so that the recalled device will be removed from pharmacy shelves.
In the EU:
The European Medicines Agency (EMA), established in 1995, is a decentralized agency of the European Union (EU). The EMA operates in 28 EU Member States, which is an estimated market of over 500 million people. In the EU, the EMA is a main governing body that handles recalls of medicinal products.
The EMA follows a process for analyzing reports of product defects that may result in the decision to recall the product. When a product defect is reported, the EMA strives to determine the root cause(s) of the quality defect to ensure it is not user error and to consider the risks to the public. Before issuing a recall, they also consider how widely the product was distributed, what the risk to users/patients is, the impact to the market if the product was recalled, and whether or not there are other options on the market or if there will be a shortage situation. Finally, if a recall is deemed appropriate, it must fall into one of three categories: Class I recall (potentially life threatening), Class II recall (could cause illness or mistreatment) and Class III recall (no significant hazard). Class I recall typically occurs at the patient level and is the most urgent type of recall, and Class II and Class III recalls are typically recalled at the distributor or pharmacy level.
Once a product is recalled, the products are stored separately until a formal decision is made about what to do with them. At that point the EMA begins to monitor the effectiveness and progress of the recall to make sure rules are being followed and everyone is safe.
Authorities from the country initiating the recall may send an urgent alert to other authorities in other countries. This alert is called a “rapid alert,” and is typically only used for very serious/urgent alerts.
In the US:
Recalls in the US can be either “firm initiated” or “FDA requested/mandated.” In the US manufacturers and/or distributors may initiate a recall on their own. These recalls are called “firm initiated” or “voluntary.” Manufacturers and/or distributors may also initiate a recall following notification of a problem by the FDA, in response to a formal request by FDA, or as ordered by FDA. These recalls are called “FDA requested” or “FDA mandated.”
The FDA as an organization has a number of responsibilities regarding recalls. The FDA can:
- Initiate recall – Voluntary, FDA requested, and FDA mandated.
- Determine an action is a recall
- Notification and public warning
- Monitoring and auditing the recall
- Terminate a recall
- Take regulatory action if or when a firm fails to recall
Similar to recalls in the UK, once a recall is issued, patients can find that information publicly, and the combination product will disappear from pharmacy shelves. The general public can access a database created and maintained by the FDA, in which they can look up specific information about recalls for medical devices that have occurred since 2002. Information available includes the reason for the recall and the number of commercial units affected.
The Medicines and Healthcare products Regulatory Agency. 2008, 2012. “Medicines & Medical Devices Regulation: What you need to know.” Retrieved from: http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con2031677.pdf
The Food and Drug Administration. 2013. “Regulatory Procedures Manual.” Chapter 7 Recall Procedures. Retrieved from: https://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074312.pdf
Brendan Cuddy. 2012. “Dealing with reports of suspected defective medicinal products.” Retrieved from: http://www.ema.europa.eu/docs/en_GB/document_library/Standard_Operating_Procedure_-_SOP/2009/09/WC500003189.pdf
European commission: Health and consumers directorate-general. 2014. “The rules governing medicinal products in the European Union.” Volume 4 EU guidelines for good manufacturing practice for medicinal products for human and veterinary use. Chapter 8: Complaints, quality defects and product recalls. Retrieved from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2014-08_gmp_chap8.pdf