In a perfect world, every kink would be worked out of every product before it hit the market. Of course, we live in an imperfect world.  Despite even the best quality management systems, imperfect products can get into the hands of the public. While product recalls can be a challenge for any company, they’re especially problematic for medical device companies where product defects could have serious consequences.

In 2019, the FDA reports that there were 49 medical device recalls, a 42% increase from the previous year. And while 49 may not sound like a whole lot, keep in mind that this involves hundreds of millions of units. So, how do medical device companies issue recalls?

What Are Medical Device Recalls?

Medical device recalls involve the removal or correction of a product on the market after learning of a problem (or potential problem) that violates FDA law. Generally, a company directly involved in the production or distribution of the medical device will voluntarily initiate the recall and notify the FDA, usually to perform one of the following:

  • Inspect the device for problems
  • Repair the device
  • Adjust settings on the device
  • Re-label the device
  • Destroy the device
  • Notify patients of a problem
  • Monitor patients for health issues

Although very rare, a company may refuse to recall a device voluntarily; in these instances, the FDA can legally require them to do so if the device could cause serious health problems or even death.

Notifying the FDA of Medical Device Recalls

Once a company has made the decision to recall their medical device, a recall team should follow the recall procedures outlined by FDA’s 21 CFR Part 7 to maintain compliance with FDA guidelines for recalling medical devices. Once the FDA is notified about a company recall, they will take the following five steps:

  1. Review the medical device company’s findings
  2. Assess the health dangers presented by the product
  3. Determine whether the issues violate FDA medical device recall law
  4. Assign a recall classification based on the degree of risk the device poses
  5. Review the medical device company’s proposed solution/course of action

 

The FDA’s recall classification system has three levels:

  • Class I: A situation where there is a reasonable chance that a product will cause serious health problems or death.
  • Class II: A situation where a product may cause a temporary or reversible health problem or where there is a slight chance that it will cause serious health problems or death.
  • Class III: A situation where a product is not likely to cause any health problem or injury.

Additional Steps to Take During a Medical Device Recall

Along with notifying the FDA, there are other steps medical device companies need to take when issuing a product recall. Medical device startups and small businesses without a knowledgeable recall team may want to seek recall guidance from the FDA on medical devices. Considerations include:

  • Notifying Additional Parties. While the FDA will do its part to get the word out about a recall, posting information about the action in the Medical Device Recall Database and issuing press releases about Class I (and sometimes Class II) recalls, the medical device company needs to do it’s part.  That can entail automatically or manually notifying everyone from sales representatives to healthcare providers.
  • Tracing Components. Some recall issues only affect a certain number of products. Tracing the SKUs, lots, and serial numbers of parts used in a medical product is critical for managing the recall after the discovery of a defect, especially if the device has been implanted in patients. This will help to identify where the component was used and make it easier for healthcare providers to determine whether it should be removed or if it’s safer to leave in place.
  • Removal and Destruction of Product. Defective products need to be removed from the market and subsequently destroyed; documentation in a recall report that this has taken place is federally required, and companies will once again need to track SKUs, lots, or serial numbers of products that are defective so they can be separated from non-affected product (if they exist), removed from market, and destroyed. Only then can the recall be closed out.

Creating a Medical Device Recall Execution Team

When a medical device company is preparing to manufacture or release a new product, it’s important to establish a recall execution team to meet the FDA’s Current Good Manufacturing Practice (CGMP) regulations. Creating this team can be difficult for a startup or small medical device company that doesn’t have the human capital, so bringing in consultants may be necessary.

This medical recall team should have clearly defined roles and responsibilities and represent the organization in terms of medical, legal, quality, operations, and manufacturing. This way, if a recall needs to be initiated, the company can act swiftly to mitigate financial and brand damage.

Instituting a quality management system (QMS) for startup medical companies, in accordance with FDA and ISO best practices, is another great option. There are systems designed especially for the medical industry and for startups, such as Qualio, that your recall team may want to check out.

Need help getting your medical device company off the ground? Contact Diberin Solutions. We bring in experienced experts with the goal of making sure your medical device startup reaches its full potential!

 

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