The United States Food and Drug Administration (FDA) announced this week that the agency has filed a consent decree against a medical device manufacturer for repeatedly failing to correct identified violations related to an implantable drug infusion pump. A consent decree is a type of legal settlement in which the manufacturer agrees to follow the court-ordered directives without acknowledgement of fault or guilt.
Every year, more than 7 million patients receive home health medical care under the direction of their medical providers. Many such cases require the use of medical devices in the home to treat or maintain a wide variety of conditions. The devices are put to use by the patient directly, or with the help of a caregiver or family member.
An influential health insurer trade group has called for more stringent rules related to the approval and tracking of medical devices. The request follows revelations of gaps or loopholes in the federal regulatory procedures which allow potentially dangerous medical devices to be put on the market with minimal safety and performance testing.
When discussing the safety of medical devices or prescription drugs, it is not uncommon to hear about various recalls and safety alerts being issued. The announcement of a safety recall by manufacturers or government regulators may seem extremely ominous, but it is important to understand that a recall does not necessarily mean a product cannot be used at all.
There has been substantial media attention and reaction from affected patients regarding metal-on-metal hip implants over the last decade or so. Of course, one of the most famous examples is the articular surface replacement, or ASR, implant which was manufactured by DePuy Orthopaedics, a subsidiary of Johnson & Johnson. Tens of thousands of the devices were implanted in patients before injuries, immobility, and even metal poisoning led to their recall in 2010.
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.
When most patients go in for surgery—especially serious surgeries like knee replacements—they are not concerned with the materials that doctors use. Most patients trust that their doctor is the expert, and will do what is necessary to ensure that the patient can recover quickly and well. Yet sometimes shady business deals are at fault for surgeries gone wrong, and doctors are helpless to remedy them.
The benefits and risks of mammography screening have long been debated in the scientific community. According to the National Cancer Institute, while screening may be effective in reducing the number of deaths from breast cancer through early detection of a cancerous tumor, it can, at the same time, cause harm to the woman who is participating.
A Colorado food processing company which failed to include peanuts in an on-label ingredient list blamed the incident on an “inadvertent packaging error.” The mistake could lead to severe, and possibly fatal, allergic reactions in millions of people.
In mid-January the U.S. Food and Drug Administration approved a first-of-its-kind device to treat obesity, according to a FDA press release. The device, known as the Maestro Rechargeable System, realigns nerve pathways between the brain and the stomach. It’s the first FDA-approved device to fight obesity since 2007, and is approved for patients who have a body mass index of 35 to 45, with at least one other obesity-related condition. One such condition would be Type 2 diabetes.