Massachusetts Defective Medical Device Attorney

What is a Medical Device? 

The U.S. Food and Drug Administration (FDA), which also regulates other medical products such as pharmaceutical medications, is the legal body which governs what is classified as a medical device and how these devices are proposed, approved and manufactured for the consumer market. The FDA defines a medical device by the manufacturer’s intention with it in regards to the body of a human or animal.

It is any item that purports to have a non-consumption-based and non-chemical effect on the physical body; involves treating, diagnosing or otherwise dealing with diseases; or is listed in either the U.S. Pharmacopoeia or the National Formulary. Products as simple as a sterile swab or as complex as a heart rate monitor are both considered and regulated as medical devices.

Medical Device Recalls

In 2015 alone, more than 30 medical devices were recalled from the consumer market after having been found to cause unintended consequences in those who used them, according to the FDA. Although the FDA has worked to establish strict standards for the production and distribution of all medical devices, there are still risks associated with medical items that cause rare reactions, carry bacteria that can lead to infection or lead to more complex health issues.

Among those 2015 recalls was an artificial hip replacement accessory called the Zimmer Kinectiv that was found to have potentially harmful levels of a sticky substance attached to it. Another faulty medical device that was pulled off the market is the Insulet OmniPod Insulin Management System for patients with diabetes. The product was reported on several occasions as not correctly administering the insulin to the patient, posing a serious and possibly dangerous risk.