When are Medical Devices recalled?
Generally, a recall is a product that is removed from the market or a correction made to the product because it is either defective or potentially harmful. A recall is usually a voluntary act urged on by the manufacturers. In serious cases, however, medical device recalls may occur as a responsible way to protect the public from products that present a risk of injury or serious defect.
When we are talking about a medical device recall, the FDA has three different classifications of medical device recalls: Class I, Class II, Class III. Each varies in a degree of treatment and injury to the body.
When the FDA recalls a device, they work with the manufacturer to ensure that the device is taken off the market. In some cases, recalls may be necessary in order to comply with the laws and regulations administered by the FDA.
To know if a particular medical device has been recalled, you may also check with the Food and Drug Administration (FDA) as it oversees food and drugs as it pertains to public health for consumers. Specifically, consumers can check this website for classified recalls in FDA’s weekly Enforcement Report: http://www.fda.gov/safety/recalls/enforcementreports/default.htm.
What do I do with a recalled medical device?
A medical device recall may involve either a correction (addresses a problem with a medical device in the place where it was used/sold) or removal (the issues is dealt with by having a medical device by remved it from where it is used/sold). Your healthcare provider or pharmacy should notify you directly if you are affected by a medical device recall. You may also set up alerts on the FDA’s website for various types of recalls also.
Once you have discovered that a medical device has been recalled, there are several steps that you can take:
- Check with your doctor to see how you will be impacted. If the device is no longer working, you may need to review the available medical options such as additional surgery that may be required.
- Your health insurance company.
- An attorney. You may have legal grounds to sue the manufacturing company for injuries sustained or pursue compensation for an injury.
The Food and Drug Administration (FDA) has jurisdiction on medical device recalls. In some situations, firms must conduct recalls in a manner specified by FDA. Similarly, the FDA has the authority to order a firm to conduct a recall.
The FDA has Recall Authority to order recalls of medical devices where there is a reasonable probability that a medical device would cause serious, adverse health consequences or death.
