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By manufacturing and providing a medical device, you are taking on a big responsibility. If your product experiences medical device failure, a patient could receive an inaccurate diagnosis or treatment, get injured, or even lose their life. Medical devices in the U.S. are regulated by the Food and Drug Administration (FDA) to ensure patient safety and limit the risk of faulty medical devices causing harm. Tapping into the expertise of an experienced medical device engineering firm can help you avoid medical device failure, recalls by the FDA, and damage to your business and reputation.
An FDA medical device recall is when the FDA removes or corrects products that violate federal law. It is usually voluntarily performed by a manufacturer to ensure they are protecting public health and well-being from products that could present a risk of injury or gross deception or are otherwise defective. A Medical Device Correction and Removal requires manufacturers and importers to “make a report to (the) FDA of any correction or removal of a medical device(s) if the correction or removal was initiated to reduce a risk to health posed by the device or to remedy a violation of the Act caused by the device which may present a risk to health.” These regulations are outlined in the Code of Federal Regulations Title 21.
Just alike how the FDA regulates medical devices,it also classifies its recalls into classes. Class I is where a reasonable probability exists that the product will cause serious harm to the patient’s health or end in death.Class II is when a device could cause temporary or medically reversible health consequences, or that it’s possible but unlikely the patient will experience those adverse health consequences. And Class III is when the FDA has received complaints but found a negligible risk of harm due to medical device failure. In 2020, there have been several famous medical device failures including failure of products that administer insulin and other medications and fluid, remove blood clots from the brain and restore blood flow, map the brain to assist during surgery, treat brain aneurysms, and help patients with Cyanotic congenital heart defects.
Working with a team of experienced medical device engineers can help alleviate the risk of medical device failure and FDA recalls. Navigating the murky waters of regulatory requirements, and knowing which ones your device is subject to, can be daunting, even for the most established medical device manufacturers. And the stakes are even higher if you are facing a failure of your product or recall, where expertise is essential to save time, money, and your company’s hard-earned reputation.
