Recall of Medical Devices

There are thousands of medical devices on the market to be used in hospitals, by doctors, or in patients’ homes. Unfortunately, medical devices can sometimes be defective and can cause injury to users. The following is some additional information about medical device recalls in the U.S.

Three Levels of Action by the Federal Government

It is a common enough occurrence that medical tools and devices need to be recalled that the Federal Food and Drug Administration (FDA)1 has varying levels of recalls – ranging from the most serious to those of lesser urgency. The following are brief descriptions of the three tiers of recalls:

  • Class one recalls are the most serious because any further use of the product will cause serious health consequences or death to the patient who uses the medical device or tool.
  • Class two recalls mean that usage is likely to cause temporary or otherwise reversible medical consequences but that chances of more serious health consequences are remote.
  • Class three recalls are the lowest level of urgency, as they are announced when there is a defect but that use of the product will not likely cause any adverse health consequences.

Improper Warnings

Market withdrawals and medical device safety alerts by the manufacturer are of different legal classifications and do not communicate the risks involved to the physicians and surgeons who use them or recommend their usage.

On December 14, 2016, the FDA published an announcement2 that it plans on creating an even earlier warning system to essentially supplement and ultimately enhance the medical device system currently in place. The aim is to enhance the early warning system and alert the public about certain hazards associated or correlated with certain medical devices. Hopefully, this will let the public know of potential defects in medical devices earlier and thus save lives, prevent further injuries, and save money that would be spent on medical costs. The decision by the FDA came after a string of high-profile medical device recalls, including several with body replacement parts such as metal hip replacements and a bladder sling for women who suffer from urinary incontinence.

A brief review of the FDA page dealing with recalls

3 of various medical devices shows how commonplace these recalls can be. More importantly, you can see how many people are potentially affected by these recalls. For example, on January 3, 2017, the FDA issued a class one recall4 of syringes because of potential contamination by a potentially lethal bacteria. It involves almost 400,000 affected syringes, distributed over the course of seven months. More importantly, the recall came three months after the last affected syringe was distributed. This is only one example of the importance of medical recalls and how they can prevent injuries.

 

Contact a New Port Richey, Florida Products Liability Attorney Today

You should be able to trust that a manufacturer designed and assembled your medical device so that is safe for use. Any minor defect of a medical device can be catastrophic. The team of attorneys at the Dolman Law Group have the experience to understand the exact nature of your medical issue, as well as the engineering flaws of your medical device to determine the best course of action for your case. If you would like to schedule a free consultation, please call our personal injury lawyers at (727) 853-6275 or by contacting us online.

Dolman Law Group
5435 Main Street
New Port Richey, FL 34652
(727) 853-6275

https://www.dolmanlaw.com/new-port-richey-product-liability-attorney/

1http://www.fda.gov/

2http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm479248.pdf

3http://www.fda.gov/medicaldevices/safety/default.htm

4http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm535293.htm

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