FDA's Naughty List

July may be known for fireworks and summer fun, but it also saw a flurry of medical device recalls. Katie Hobbins, Managing Editor of MD+DI, compiled a list of companies on the FDA's "naughty list" for July 2024, highlighting the reasons for these recalls and the potential risks involved. Here's a look at some of the key recalls:

• Inspire Medical Systems: The company recalled its Inspire IV Implantable Pulse Generator (IPG) model 3028 due to a manufacturing defect that could cause malfunctions after implantation, leading to electrical leakage in the sensing circuit. This defect could result in stimulation below therapeutic levels, early battery depletion, inconsistent stimulation, painful shocks, and even death. This case underscores the need for strong early warning systems to catch manufacturing flaws before they escalate.
• Philips North America: The recall of Philips' Sense XL Torso Coils was upgraded to Class I, requiring a correction rather than product removal. The company is updating use instructions to mitigate the risk of thermal injuries like burns that could occur due to the coils heating up during MRI scans. Effective communication about updated usage instructions is key to preventing harm without pulling a product off the market.
• Hamilton Medical: A software correction was issued for the Hamilton-C6 ventilator after reports of one injury and one death. The FDA found that the device may fail to restart ventilation after open suction if it enters "sensor fail mode" due to specific software versions and user actions. This failure could lead to hypoventilation, apnea, hypoxemia, bradycardia, hypercarbia, increased intracranial pressure, and death. Handling complaints and adverse event reports thoroughly can uncover critical issues in life-saving devices.
• Baxter International: Two separate recalls were issued by Baxter International in July. The first involved the Life2000 ventilators with an attached battery charger dongle. The recall was prompted by reports that a damaged dongle could fail to charge the ventilator's internal battery, potentially leading to oxygen desaturation episodes ranging from mild to life-threatening. Even seemingly minor components can have significant consequences, highlighting the need for comprehensive risk assessments.
• Baxter International (Volara System): The second recall involved certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly. The issue stemmed from the potential for the handset plug to disconnect from the blue ventilator adapter, causing an interruption or delay in care, reduced ventilation, and oxygenation.
• Bausch + Lomb/Synergetics: The companies recalled specific lots of their I-Pack Injection Kits due to potential non-sterility. Use of affected products could result in serious eye infections, vision loss, total eye loss, and death. However, no injuries or deaths have been reported so far. Ensuring sterility isn’t optional. Strong quality control systems are essential to prevent infections and maintain patient trust.
• Abbott Laboratories: A voluntary recall was initiated for a limited number of FreeStyle Libre 3 sensors distributed in the U.S. Internal testing revealed that certain sensors might provide incorrectly high glucose readings, potentially leading to patients taking too much insulin or making other incorrect treatment decisions. With software-integrated devices, vigilance around algorithms and user feedback is crucial.

Big Themes and Takeaways

Post-market surveillance requires proactive strategies rather than reactive measures. Surveillance systems need to identify emerging trends early, leveraging data analytics and fostering collaboration across departments. This approach helps to uncover potential issues before they escalate into major problems.

Clear communication plays a pivotal role in ensuring safety. Providing healthcare providers with concise, accurate instructions and updates can prevent misunderstandings that might otherwise lead to harm. Transparency is a crucial part of maintaining trust and ensuring proper usage of devices.

Risk management must adopt a holistic perspective. This means considering every component of a device, from its largest elements to its smallest accessories. Each part has the potential to impact the overall safety and effectiveness of the device.

Quality systems must move beyond being mere checkboxes. Sterilization processes, manufacturing controls, and audits need to be active and rigorous. Quality management systems should be ingrained within the organization, ensuring compliance and safety at every step.

As devices increasingly rely on software, the challenges of post-market surveillance evolve. Monitoring software updates, patches, and changes in user behavior is essential to address potential risks in this digital landscape. The dynamic nature of software demands a different kind of vigilance.

Finally, a safety-first culture is paramount. Teams must feel empowered to report concerns and collaborate openly without fear of repercussions. Leadership plays a vital role in setting this tone, prioritizing safety in decisions and resource allocation. By fostering a culture of transparency and continuous learning, organizations can enhance patient safety and device reliability.

Practical Steps You Can Take

• Strengthen Monitoring Systems: Use analytics to track adverse events and collaborate with engineering and quality teams.
• Dig Deep on Complaints: Treat every adverse report like a clue. Document thoroughly and address root causes.
• Communicate Clearly: Provide updated instructions and stay transparent with healthcare providers and regulators.
• Adapt to the Software Era: Monitor software updates and user behavior to stay ahead of potential risks.
• Cultivate a Quality Culture: Make safety a shared responsibility, with leadership setting the tone for continuous improvement.

Post-market surveillance isn’t static. It’s an evolving process that requires constant learning and adaptation. By embracing new technologies, fostering collaboration, and building a culture of safety, we can ensure that medical devices remain effective and safe for all patients.

Let’s stay vigilant, proactive, and committed to learning from every experience—for a safer future in medical devices.