Medical device recalls can be scary. Let’s explore what a medical device recall is, how to find out if a device has been recalled, and the steps you should take if your practice is impacted by one.
Under the Safe Medical Devices Act of 1990 (SMDA), manufacturers, user facilities, and importers are responsible for submitting medical device reporting (MDR) paperwork to the FDA if they’re aware of a serious event associated with a device. Manufacturers must also submit baseline reports and 30-day reports of deaths, serious injuries, and malfunctions associated with the device to the FDA. The act’s additional post-market surveillance and device tracking helps maintain traceability of certain devices to the user level so potential issues can be addressed quickly and effectively.
A recall is a corrective or removal action taken by a manufacturer when a medical device violates FDA law. Recalls are necessary when a medical device is defective or could be a risk to patients. The FDA monitors recalls closely and requires manufacturers to report any issues as soon as they’re aware of them. When a recall is initiated, the device manufacturer must identify the potential risks, explain the corrective steps needed to address them, and provide guidance for physicians to return or exchange the product.
A medical device recall is not always an indication that the product needs to be returned or stopped being used. In some cases, it may just need to be checked, adjusted, or fixed by the manufacturer. There are several types of actions that may be taken during a recall, including inspecting the device for problems, repairing the device, adjusting settings, re-labeling, destroying the device, notifying patients of a problem, and monitoring patients for health issues. A company may recall an entire lot, model, or product line if there’s a problem with a group of products, they can’t predict which individual devices will be affected to ensure that all potential risks are addressed.
Although the FDA can require a manufacturer to recall a device, it rarely happens since companies typically take proactive steps to ensure they’re devices are safe and effective. Under the SMDA, companies initiate a voluntary recall and notify the FDA once they become aware of a product’s violation. By taking proactive measures, medical device manufacturers can maintain public trust and avoid serious FDA penalties.
After learning of the recall action, the FDA evaluates the company’s proposed strategy to address the problem and assigns it a classification to indicate the risk level:
- Class I recalls are the most serious, involving products with a reasonable chance of causing serious health problems or death.
- Class II recalls involve products that may cause temporary or reversible health problems or those that have a slight chance of causing serious health problems or death.
- Class III recalls are for products not likely to cause any health problems or injuries.
The FDA continues to monitor the recall until confident that the product no longer violates the law or presents a health hazard.
The FDA informs the public about medical device recalls through the Medical Device Recall Database. The FDA updates the database when a company initiates a correction or removal action, classifies the recall, and terminates it. Physicians can also find press releases or other public notices about recalls, market withdrawals, and safety alerts that may potentially present significant risks to patients.
Once the FDA has classified a recall, they notify the public via their weekly Enforcement Report. In addition, Class I and some Class II and III recalls are posted to keep physicians and patients aware of potential health hazards associated with the product.
Patient labeling for medical devices isn’t always required, but it’s an FDA best practice.
When a medical device recall occurs, it can be a daunting process to identify and contact affected patients in an effective, timely manner. In case of a recall, implement a system for your practice that allows you to quickly identify and reach out to patients that use the device.
Next, schedule a meeting with the device manufacturer to make sure they’ve provided the necessary information needed to effectively treat and answer patient questions. Discussing the recall with the manufacturer also gives you the opportunity to clarify any confusion and ask for additional resources and support if needed.
Once you’ve met with the manufacturer, it’s time to develop a course of action for patients affected by the recall. Your plan should consider the nature of the recall, the limited scope of information available, and any financial concerns that may arise. Depending on the situation, your plan of action could include offering alternative treatment plans, providing resources for finding affordable replacements, or even organizing a fundraising campaign to assist patients with expenses.
At Remington Medical, we understand the importance of providing medical professionals with reliable devices. That’s why we’ve only had 10 medical device recalls in our 30+ years of service—and most of them were for labeling mistakes on our line of medical devices. Our team of experienced professionals provides ongoing guidance and support on medical device recall issues by taking the time to educate our customers about how to respond if a recall does occur and answer any questions they may have about the recall process. Remington also provides detailed information about how to return recalled products, identify if a product is part of a recall and how to handle any related paperwork. We’re committed to providing you with quality products and recall guidance as needed, so you can focus on what matters most: providing top-notch patient care.
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