FDA reported 975 recalls for medical devices in 2023

The medical device industry offers solutions that improve longevity and quality of life for millions of people globally. Given the critical nature of these products, manufacturers are subject to stringent accountability and regulatory oversight.

In 2023, the U.S. Food and Drug Administration (“FDA”) reported 975 recalls for medical devices, affecting everything from simple instruments to complex implantable devices.The impact of these events extends far beyond financial losses for manufacturers. A recall can tarnish brand credibility, constrain healthcare providers ability to provide services, and, most importantly, compromise patient health and safety. These repercussions highlight the necessity for stringent quality control measures and proactive recall management strategies.

It is important for medical device manufacturers to understand the FDA’s impetus beyond calling for a recall readiness plan and how organizations can leverage mock recalls to optimize recall execution.

Understanding the FDA’s call for recall readiness
The FDA mandates a comprehensive recall plan for medical device manufacturers per its March 2022 guidance document, Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C. The FDA’s guidance on “Recall Readiness” outlines specific steps for preparation, initiation, notification, strategy development, execution, monitoring and reporting progress, and conducting effectiveness checks. The urgency of this requirement is underscored by research indicating that prompt recall execution can significantly mitigate health risks associated with defective devices.

Common obstacles in recall execution
Executing a recall in the medical device industry is fraught with challenges. One of the primary obstacles is maintaining an accurate and up-to-date customer list. In many cases, devices move through several hands before reaching the end user, complicating the traceability process. For example, a recall of pacemakers in 2019 demonstrated the difficulty in tracing implantable devices, with manufacturers struggling to contact all affected patients directly.

Another challenge is managing multiple concurrent workstreams. During a recall, medical device companies must communicate internally and externally; manage interactions with health authorities; and address customer and patient questions. At the same time, they also need to determine and execute an appropriate reimbursement policy and handle disposition of returned items.

These challenges highlight the importance of robust traceability systems and the need for manufacturers to invest in advanced technologies and methodologies to enhance recall effectiveness.

What does a mock recall entail?
A mock recall involves simulating a scenario in which a device is presumed defective or harmful, and going through the processes that would be implemented in a real event. Most participants are not told in advance that it is not a real scenario.

The process typically includes several key steps:

• Identifying a product batch as the focus of the mock recall.
• Notifying internal teams and, in some cases, external partners about the recall as part of the drill.
• Tracking and documenting the path of the product from manufacture to delivery.
• Simulating the recovery process of the recalled product.
• Evaluating the effectiveness of communication and logistical operations during the mock recall.

These exercises engage all relevant stakeholders, from manufacturing to distribution, and highlight potential weaknesses in recall plans that might not be obvious from a single department’s perspective.

The crucial role of mock recalls
The importance of mock recalls in the medical device industry cannot be overstated. They are a foundational element of a holistic risk management strategy, requiring manufacturers to thoroughly pressure-test their recall procedures. This hands-on approach is essential for ensuring that every facet of a recall plan is not only theoretically sound but also practically effective.

Key advantages of integrating mock recalls into an organization’s practices include:

• Engaging all relevant stakeholders, from manufacturing teams to quality assurance, regulatory affairs, and distribution partners, ensures a thorough review of recall procedures and uncovers potential weaknesses that might not be evident when viewed from a single department’s perspective. This collaborative approach is essential for a comprehensive evaluation and enhancement of the recall process.
• Conducting mock recalls plays a crucial role in identifying and addressing gaps in recall plans. These exercises can uncover vulnerabilities in communication, logistics, or data management that could hinder an effective real-world recall. Proactively tackling these issues allows manufacturers to enhance their recall strategies, preparing them to act quickly and efficiently should an actual recall be necessary instead of having to adjust on the fly during a real crisis.
• Mock recalls also provide an invaluable opportunity to assess the readiness of the team responsible for executing recalls. It’s a chance to evaluate the team’s responsiveness, communication effectiveness and operational efficiency under pressure, and provides insights into training needs and areas for improvement.
• Through the iterative process of conducting mock recalls, along with implementing recall metrics, manufacturers can significantly improve the speed and efficiency of their recall processes. Ideally mock recalls should be conducted at least once a year. These drills allow teams to fine-tune logistical and operational aspects, streamline communication strategies, and ensure that all necessary resources are readily available and efficiently utilized. The learning garnered from mock recalls can dramatically reduce the time taken to initiate and execute a recall, reducing the financial impact on the company and minimizing potential harm to customers and patients.

Most importantly, the practice of conducting mock recalls underscores a manufacturer’s commitment to patient safety and regulatory compliance. It’s a tangible demonstration of the company’s dedication to exceeding, regulatory standards, not just meeting them, and prioritizes the well-being of end users above all else. This commitment fosters trust among stakeholders, including regulatory bodies, healthcare providers and patients, reinforcing the manufacturer’s reputation as a responsible and reliable entity within the medical device industry.

Conclusion
The practice of conducting mock recalls in the medical device industry is not just a practice recommended by regulators. It is a vital component of risk management and patient safety. By preparing for the worst-case scenario, manufacturers can minimize the impact of recalls, protect patients, and preserve their reputation. As the industry continues to evolve with technological advancements, the complexity of medical devices—and their recalls—will increase. This underscores the importance of robust, tested recall strategies. Ultimately, mock recalls do more than test compliance procedures. They demonstrate a commitment to the highest standards of quality and safety. FTI Consulting