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In the medical device arena, recalls are a fact of life and competitors love to find out that you’ve had one. Regardless of recall classification (Class I, II, or III), a recall procedure is instrumental in working in concert with a company’s post-market surveillance and agreements with suppliers. Companies should not assume there is never going to be an issue with a product and not have these procedures in place up front.
Following is advice to help make decisions on whether or not to recall, to make the recall process as painless as possible and to avoid an FDA warning letter.
1. Conduct a post-market risk analysis and document the conclusion for any new product issue, or issue which may demonstrate that the data in the existing product risk analysis documentation is incorrect or out-of-date. Don’t be afraid to update your product risk analysis based upon this new data. We often see manufacturers assess risks too conservatively prior to product release and then realize that the hazard is not as significant as originally thought, or they do the opposite.
2. Document the decision to recall or not recall in a timely manner, based upon your post-market risk analysis. When the FDA suggests a recall should have been conducted or that your Class III recall should have been a Class I or II, you will have accurate documentation providing reasons behind your decision. Some companies fear this document, but during the impending inspection, this rationale will back you up.
3. Form a safety review board within your company comprised of a cross-functional team, including senior management and strong clinical representation (someone that is representative of a standard user of your products). When you have a post-market risk analysis, it should go to them for review. Clinical representation is important because those professionals will provide the evidence or rationale needed to support the risk analysis. Auditors will always look for clinical representation in these decisions.
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