By Jake Brown, Halloran Consulting Group
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 a removal from the market, all while remaining compliant with regulations.
In the eyes of many, this scenario brings negative attention onto 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 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
- Assessing risks and benefits of the system as a whole
- Analysis of options for improvement
- Ability to execute determined strategies
- Effectiveness of results
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.
Now, take a moment to think about what you are actually improving. Do you need to issue a recall if you’re making an improvement to your device? Pay close attention if you have any uncertainty. A common industry mistake is to overlook regulatory considerations while making product improvements. So common, in fact, that FDA developed a guidance document to address such regulatory concerns, Distinguishing Medical Device Recalls from Medical Device Enhancements. This valuable resource details FDA’s position on the following:
- Distinguishing recalls from enhancements
- Whether or not a product change would result in a field corrective action
- Clarification of when a change to a device constitutes a medical device recall
- Clarification of reporting requirements under 21 CFR Part 806
Interestingly, this guidance document is the only FDA resource that completely defines “product enhancements.” Product enhancements are defined as changes to improve the performance or quality of a device. More importantly, they are not changes made to remedy a violation of the FD&C Act or associated regulations enforced by FDA. Note this example from the guidance document:
A change is made to a newly released device to improve handpiece ergonomics. This improvement was determined necessary because the device was originally difficult to use. By making the device easier to use, the device risk did not change. It is therefore considered a product enhancement. A regulatory assessment is still required to determine if a submission is necessary. A change to the device design, labeling, and marketing materials may represent a need to initiate a recall.
An important takeaway from this example is that changes made to a device to address a recall event may require careful review to determine whether the change necessitates a premarket submission. Gathering the right people together (such as stakeholders and regulatory body representatives) and following compliance guidance documents help to ensure you are conducting a quality review.
Now that we have a better understanding of enhancements, don’t run off and forget about your quality system! Enhancements aren’t the only way to correct an internal error that has resulted in field corrective action. As previously mentioned, a correction can be identified as a need to improve the quality system in part or as a whole. This is an excellent time to reassert your organization’s positive mindset and consider any efforts to streamline, harmonize, and benchmark best practices for quality system process improvements, especially where risk has been identified.
How can your organization achieve an effective quality culture? Look to your top leadership. They must provide clear messaging (both internally and externally) about the commitment to rebuild organizational and customer confidence through these procedural and product improvement efforts. This is where companies often struggle.
Leadership’s top priority is to focus on the balanced design solution. They must see the effect that overall change has across the organization, encompassing their own people, processes, and partnerships. One way to ensure that the effects of change have been considered at all levels of a company is to engage external resources. Companies frequently utilize external resources, such as consulting firms, to support and drive these transformation efforts. Such third-party resources can drive the strategy, engage all levels of personnel, and implement monitoring tools from an outside, unbiased perspective.
Overall, the name of the game for recall and enhancement events is control. Manufacturers must demonstrate their capability for maintaining control and transforming systems, as well as revising processes and products to reduce the risk of recalls. Cultural transformation often follows recalls and becomes a vehicle for successful manufacturers to showcase their commitment to a better culture of quality and quality control.
Even in the midst of a recall, there is an opportunity for positive change and a positive impact on your organization and customers. Whether you are in the beginning stages of implementing a recall, right in the middle of one, or wondering how your last event could have gone more smoothly, take the time to ensure that your organization develops good practices. Make your organizational and customer commitments clear by preparing yourself for a recall before one occurs.
About The Author
Jake Brown joined Halloran Consulting Group in 2016. He has experience in quality management systems and compliance, clinical research and development, regulatory strategy, and business operations. He works with Halloran’s audit team and focuses on quality assurance activities for pharma, biotech, and medical device clients. Jake previously worked for Nemucore Medical Innovations and CYTO Consulting. He holds a bachelor’s degree in biology and biotechnology, and is pursuing a master’s degree in business management from Worcester Polytechnic Institute.