If you rely on a piece of equipment as a part of your healthcare regimen, medical device recalls are a critical news item to monitor. In some cases it can truly be a matter of life or death.
Recalls occur when a manufacturer removes a product or device from the market. In most sectors, the recalls are related to safety concerns. Medical device recalls are especially important because of the increased risk of contamination or long-term damage when a defective piece of equipment is implanted or used during surgery.
It is crucial for physicians, patients, friends, and family members to stay up to date with the latest recalls and alerts relevant to their situation.
Why Are Medical Devices Recalled?
The market for medical devices in the United States is valued at more than $ [NUMBER]. Countless patients are saved by the nation’s advanced medical technology every year. Unfortunately, like any equipment, malfunctions and deficiencies can occur that the manufacturer failed to see.
Medical device recalls are made because the U.S. Food and Drug Administration (FDA) requests or requires a company to do so, or when manufacturers find a problem and voluntarily remove products. In the case of FDA recalls, the agency has statutory authority to require a company to pull a medical device from the marketplace if the risk is large enough.
There are various different levels to identify the severity of a recall, as well as several lower-level actions such as information alerts or announcements. These are often related to minor violations or issues pending further clarification, which serve to keep the public aware of potential risks without causing major disruption before it is warranted.
Different Levels of FDA Recall
The FDA breaks its drug recalls down into three categories: Class I, II, and III.
- Class I Recall – The device has an issue that could cause “serious adverse health consequences or death” if it used by the patient or a physician.
- Class II Recall – The device has an issue that could prompt “temporary or medically reversible adverse health consequences.” This level of recall can also be issued for more serious potential risks but where the probability of major consequences is remote.
- Class III Recall – The device has an identified issue but it is “not likely to cause adverse health consequences.”
Understanding these various classes of recall helps patients and device manufacturers to manage risks more effectively.
It is important to note that even with this system in place, some medical devices are only recalled after it is too late. When a problem has been identified, the equipment has often been is in general medical use for some time.
In these cases, a recall comes too late for some patients, who it is recommended contact a medical professional and seek legal advice, where appropriate.
The Latest Medical Device Recalls
As well as monitoring the latest Drug411 blog entries and Facebook posts, we recommend the feed below for the latest recalls announced by the FDA on Twitter.