Medical device recalls are daunting in many ways—manufacturers dread them, competitors love them, and patients don’t always understand them. A medical device recall could be a response to patient safety concerns or to unanticipated negative trends. All manufacturers should assume it will happen at some point and do as much as possible to be prepared for it in advance.
Understanding what a recall is, how it affects your company, and the best practices for medical device recall management will help prepare you if a recall is needed.
What is a medical device recall?
In the U.S., a medical device recall is the voluntary correction or removal of a product that is currently on the market. A correction is defined as the “repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location.” For example, sending a new label to replace the existing one is a recall action that is classified as a correction. Removal is defined as “physically removing the product and moving it to another location, such as to repair or revise the device.” An example of this type of recall is a software upgrade that requires temporarily removing products from use in order to make the update.
A recall can be initiated by the manufacturer or the Food and Drug Administration (FDA). In either case, records that document the action must be maintained. Some of the reasons a manufacturer or regulator might require a recall include:
- False or misleading labeling
- Inadequate directions for use
- Violation of the Federal Food, Drug, & Cosmetic Act or noncompliance with FDA regulations
- Safety issues
- Adverse event or death
Regardless of the reason, when you have a recall plan in place, the process is much less intimidating.
What are the classifications of medical device recalls?
Recalls are categorized by class depending on the severity of the issue.
A Class I recall is the most severe in that there is a reasonable probability that the device will cause serious adverse health consequences or death.
A Class II recall is initiated when the use of the product might cause temporary or reversible adverse health consequences.
A Class III recall is the least severe in that use of the product isn’t likely to cause adverse health consequences. These recalls must be documented internally but don’t have to be reported to the FDA. However, the FDA might ask to review recall records during an inspection, and it's important to maintain the same level of documentation regardless of classification.
When it’s made aware of any classification of recall, the FDA will post it on its website.
What are some best practices for medical device recall management?
RQM+ has a lot of experience guiding manufacturers through medical device recalls, and we have learned some valuable practices along the way. Get your company recall-ready with these tips:
Avoid a recall in the first place.
Implement a risk management system that is in compliance with ISO 14971 to ensure that you have the processes and procedures in place to identify potential issues that can be corrected or avoided before a product goes to market. Once a product is in circulation, conduct a post-market risk analysis when new product issues arise and document the conclusion.
Document your recall decisions.
When deciding whether or not a recall is warranted, document your decision process and how you determined the classification for the recall. Justification and timing will be important when the FDA reviews your documentation—even if you decided that a recall wasn’t warranted—so include as much detail as possible.
Integrate with post-market surveillance.
Often, post-market surveillance (PMS) data doesn’t get passed on to other departments until something goes awry. Close this communication gap by creating feedback loops between PMS, quality, and risk management teams to get the full picture so you can make fast, informed decisions.
Have a recall leader.
Designate a person or team responsible for managing recalls and coordinating all of the departments that must be involved. This will be a critical function when the time arises, so it’s best to have the roles and responsibilities clearly outlined in advance.
Assemble a qualified team.
Your recall leader should assemble a safety review board with cross-functional team members. There should be a core recall team that is comfortable with coordinating the recall but depending on the product, you will have additional departments and people involved.
Most internal teams aren’t accustomed to interacting with members of other departments on a regular basis, so having the same core team of people for every recall ensures consistency throughout the process. Your team should include members with expertise in:
- Regulatory compliance
- Risk management
- Post-market surveillance
- Senior leadership
- Clinical work
- Product management
- Manufacturing management
Create systems and procedures
Having clear systems and procedures in place helps ensure that you follow the same process every time. Include the decision-making process, the steps required to initiate a recall, definitions of roles and responsibilities, and a process timeline. Include record-keeping conventions, requirements, and documents such as:
- Risk assessment
- Situation analysis
- Recall strategy
- Copies of signed notification letters
- Lists of notified customers
- Correspondence with regulatory agencies
- Destruction memo
- Internal recall closure memo
Refer to the FDA's guidance document for a full list of the required documentation.
Document supplier recall responsibilities.
The manufacturer isn’t the only affected party when there is a medical device recall. Include recall responsibilities in supplier and distributor agreements so it’s clear upfront what will happen in the event of a recall. The FDA looks for this during inspections, so add it to your contract templates and supplier checklists.
Implementing traceability into your processes allows you to recall specific components or batches so you can pinpoint the issue and target the recall. You should also use traceable methods for recall notifications—certified mail or FedEx—so you can prove that you did it and when.
Create a recall closure memo.
Finally, when a recall has been completed, create a recall closure memo that summarizes all of the activities that were performed. This will serve as a reference for future recalls and can also be used as supporting documentation for FDA inspections.
How can RQM+ help?
RQM+ is here to help you every step of the way for a recall of any classification. The first step is often to determine whether a recall is necessary, beginning with a health hazard evaluation.
If a recall is an appropriate path, we can help you develop the recall strategy and communication plan with both the FDA and end-users. It's important to get this right the first time and have clear documentation of your decisions.
If you don’t have the capacity to do it in-house, RQM+ can lead the recall team and coordinate your internal teams to align data, facilitate decision-making, and follow the necessary steps. We can also participate in the implementation of the recall as much or as little as you need, including preparing the recall submission to FDA, executing reporting requirements, providing internal record-keeping, updating risk management files, and so on.
No matter the scope of our involvement, you can always count on RQM+ to provide a risk-balanced strategy and an experienced team of leaders and medical device experts. If you’re currently facing a recall or want to proactively prepare for the next one, get in touch today to learn more about how RQM+ can help.