Recall Recovery: Turning A Negative Into A Positive
‘Recall Recovery’ is part of a Med Device Online guest expert series by Halloran.
You have just implemented a medical device recall — a topic we discussed in our last column — and you are worried about the negative impact it can have on your business. Somewhere along the design or manufacturing process, an issue occurred in quality system maintenance, sterility, design controls, or late adverse event reporting. Now, you must rely on your processes to perform a correction or removal from the market, all while remaining compliant with regulations.
In the eyes of many, this scenario brings negative attention to a medical device manufacturer. However, a recall can actually present an opportunity to turn a negative event into a positive force for improvement. So where do you begin making this positive change?
Experienced medical device manufacturers will recognize the opportunities when implementing a recall. They may study the event, risk management files, and product evaluations, using their findings to implement quality and reliability improvements. In some cases, it is necessary to evaluate the culture of the quality system and, if necessary, implement a cultural transformation to bring the quality system, product, and organization into regulatory compliance.
Don’t be mistaken. FDA will come knocking. Any company implementing a recall can be sure that the FDA will eventually take steps to verify that corrections have been put in place to eliminate the possibility of future recalls. Therefore, it is essential to show FDA that your improvements are focused and well-rounded; this approach requires consideration of every area in the design and manufacturing process. Organizations that focus on risk management to address recalls are best positioned to capture the impacted areas within the company.
Risk management is a concept that some organizations find challenging to understand, despite its being an important area of FDA focus when the agency reviews a recall. Therefore, your understanding of risk management is critical to effective and compliant change. Your risk management process should include, at a minimum:
- Identification of noncompliance root cause
- Effectiveness of results
- Ability to execute determined strategies
- Analysis of options for improvement
- Assessing the risks and benefits of the system as a whole
Furthermore, the FDA guidance document Factors to Consider Regarding Benefit Risk in Medical Device Product Availability, Compliance and Enforcement Decisions, finalized in December, provides many examples and worksheets while explaining the balances of FDA authority versus patient benefit.
Head to Med Device Online to read the full article.