In an effort to increase safety and prevent disease, the United States Food and Drug Administration (FDA) released new recommendations regarding reusable medical devices. The announcement from the FDA was made following an outbreak of a bacterial superbug linked to the design of a specific piece of reusable medical equipment.
It has been several years since Michigan-based medical device manufacturer Stryker issued a voluntary recall of their Rejuvenate and ABH II modular-neck stem metal hip replacements, according to the U.S. Food and Drug Administration. The recall was made after many patients complained that the hip replacement was defective, causing them more pain and suffering than before the implant was surgically inserted.
Prescription drug manufacturers are responsible for proper development of their products and the marketing and labeling it presents to the public. If there is a chance that their drug is defective, it can result in a recall and, ultimately, harm to patients.
Arthritis can turn into a debilitating disease, no matter the age of the sufferer. However, arthritis patients can be medically treated to help continue with the performance of daily activities. One such arthritic treatment method is a hip replacement implant known as A.S.R. or the “articular surface replacement,” and it is manufactured by DePuy, a subsidiary of Johnson & Johnson.
Boston Scientific (BSX) recently announced that it received a subpoena on May 5 from the Department of Health and Human Services. The subpoena asked the company for information about the performance of its implanted defibrillators. Defibrillator devices are used to shock racing hearts back into a normal rhythm during cardiac emergencies, some of which may injure patients.
There is no shortage in advertisements seeking those who have been injured during the use of medications or medical devices. As a result, the FDA is pushing for stronger guidelines when it comes to the postmarket surveillance of these products in an effort to reduce the number of defective devices used by patients.
Drug companies have attempted to capitalize on a market of men interested in improving their libido and life satisfaction with a treatment known as Low-T testosterone therapy. But that treatment is raising eyebrows from the FDA.
The total number of defective medical device recalls in the past decade represents a significant increase, and it raises the question of whether more people are reporting issues or if there are simply more design defects putting patients at risk. Defective devices can injure patients and cause serious physical and mental repercussions when the device does not operate properly.
Doctors stated that veteran Eddie Creed’s death last year was the result of throat cancer, but some journalistic investigations have revealed that there may be more to the story regarding a defective medical device. Creed had been using a medical device called Infusomat, a device which had actually been recalled a month before he started using it.