Reporting Medical Device Adverse Events: Why does it matter?
In July 2020, people living with Parkinson’s disease and using a deep brain stimulator were warned by the Food and Drug Administration of a possible loss of coordination during water-related activities. Seven months earlier, 2,909 VNS (vagus nerve stimulation) therapy systems for seizure management were recalled due to a reset error in the medical device. In 2019, the FDA issued an alert to healthcare providers and end-users to be aware of a potential premature battery depletion safety issue with some pacemakers. Product alerts and recalls may happen infrequently but when they do it is a testament to an important element of the FDA’s mission; Safety.
The mission of the FDA among other things includes safety, efficacy and security in medical devices. Also, within the scope of the agency is to help “the public get the accurate, science-based information they need to use medical products.” To that end, FDA closely monitors the products under their purview to meet this obligation. One way they do so is post-market surveillance. Those living with medical conditions and their healthcare providers who use devices, therapies and treatments regulated and monitored by the FDA can play a critical role.
The fine print in the labeling can be daunting to read before the use of any device or medical product. Like the DBS, VNS and pacemaker examples, knowing the issues about a device can help mitigate a problem later. On the other hand, safety concerns of a new device may not surface until a large number of people have used it. Post-market surveillance including direct reporting to the FDA can identify unknown risks.
Reporting to the FDA
Consumers and healthcare professional can inform regulators of adverse events or reactions while using a medical device including product quality and use errors. It is mandatory for medical device manufacturers to report to the FDA but for consumers (patients) and healthcare professionals, the process is voluntary. The agency tries to make it as easy as possible to file a report through their MedWatch program. It allows you to file an issue online, via phone or even mailing a form. There are also Consumer Complaint Coordinators to help with the process. They are assigned by state and phone numbers are listed publicly including a relay service.
The FDA receives thousands of Medical Device Reports (MDR) per year. Without the reporting, they may not be aware of hazards that exists. They also make the information public through the MAUDE database, Manufacturer and User Facility Device Experience. Reporting statistics are now easy to interpret through the new openFDA API website with graphics and explanations. https://open.fda.gov/apis/device/event/
Information about medical device safety issues
Cornerstone to its mission, the FDA medical devices center — better known as CDRH — has their own department for Medical Device Safety to monitor adverse events and other problems with medical devices. Adverse events in medical devices are unexpected events that occur during or as a result of using a medical device. The Medical Device Safety department issues an escalating means of notifications and monitoring mechanisms to adhere to safety concerns. The first line of safety monitoring is safety communications. As FDA monitors reported issues, they will release a safety communication to the medical device company. It is also listed publicly to notify users and potential users of devices. Think of the safety communications as the warning ticket issued by a law enforcement officer. It is a message of observed bad behavior and a warning to correct the issue before it becomes a larger problem. Along the same lines, FDA may issue a letter to healthcare providers which is also an alert warning but specifically for medical devices used in a health care facility.
Beyond safety communications or alerts, there may be a recall of the device. This is an indication that the devices may be defective, a risk to health or both. In reality, the FDA rarely recalls a medical device even though the agency has the legal right to do so. In most cases, the device manufacturer initiates the recall for correction or removal from the market and notifies the FDA. Upon notification the FDA will review the evidence and mitigation strategy then issue a classification for the recall; Class I to Class III. The former is the most severe causing serious health issues or death and Class III indicates an unlikely but possible cause of a health problem.
In the case when the FDA deems that the device is substantially deceptive or is an unreasonable or substantial risk, then the device can be banned. Banned devices are totally prohibited from current and future sales, distribution, and manufacturing in the U.S. This rarely happens, but one did occur for a stimulation device in 2020. In March, the FDA issued a final ruling to ban electrical stimulation devices used for self-injurious or aggressive behavior. In the public notice, FDA stated, “The medical literature shows that ESDs present risks of a number of psychological harms including depression, PTSD, anxiety, fear, panic, substitution of other negative behaviors, worsening of underlying symptoms, and learned helplessness.” They also reported that ESD devices present the physical risks of pain, skin burns and tissue damage. With this ruling, the devices can no longer be available. A public list of banned medical devices are available. https://www.fda.gov/medical-devices/medical-device-safety/medical-device-bans
The FDA MedWatch is a valuable resource for people considering the use of a neurotech or any medical device. It is also a vehicle to report adverse events and use errors. It is easy to be excited about new medical technology breakthroughs. It is all the more important to understand the risks and report issues when they surface.
Here are some resources to be an informed consumer and an active participant for public safety.
- Medical Device Safety within the FDA — https://www.fda.gov/medical-devices/medical-device-safety
- How consumers can report an adverse event or serious problem to the FDA — https://www.fda.gov/safety/reporting-serious-problems-fda/how-consumers-can-report-adverse-event-or-serious-problem-fda
- MedWatch Learn: https://www.accessdata.fda.gov/scripts/MedWatchLearn/
- Maude Database: https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/manufacturer-and-user-facility-device-experience-database-maude
- Device Recall: https://www.fda.gov/medical-devices/medical-device-recalls/what-medical-device-recall
- FDA Patient engagement: https://www.fda.gov/patients/learn-about-fda-patient-engagement
- Division of Industry and Consumer Education: https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice
- The Public’s Stake in Adverse Event Reporting: https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/publics-stake-adverse-event-reporting
The content for this article was provided by Neurotech Network.
