The Food and Drug Administration (FDA) recently issued a ban on the use of powdered gloves in surgery and other medical and dental procedures. The FDA originally issued a proposal to ban the gloves in March of last year but has now made that proposal final. Health care professionals and facilities will no longer be allowed to use powdered exam gloves, pre-powdered surgeons’ gloves, or absorbable powder that is used for lubricating surgeons’ gloves. According to the FDA’s ban, all non-powdered gloves should have no more than two milligrams of residual debris or powder from the manufacturing process.
The use of surgical or medical gloves is a significant factor in patient protection, creating a barrier against the transmission of contaminants and infectious diseases. The powder on the glove is meant to lubricate the device to make putting on the gloves easier for wearers. But over the years, the powders used have been found to put both patients and healthcare providers in danger.
Multiple studies have proven just how unsafe powdered gloves are to patients, often resulting in serious adverse events. Some of the injuries associated with these gloves include allergic reactions, airway inflammation, asthma, granulomas, hypersensitivity reactions, lung inflammation, and peritoneal adhesions.
Medical Device Ban
In the majority of situations where a dangerous medical device is removed from the market, it is the manufacturer who initiates that removal. It is very rare that the FDA issues an outright ban on a medical device. Although the agency has the authority, this is only the second time since 1983 they have taken this action against, a very good indicator of just how perilous the exposure to these gloves could be for a patient.
This ban prohibits all doctors, hospitals, dentists, and veterinary providers from using the gloves. All sales, distribution, and manufacturing has also been banned.
Dangerous Medical Devices
Although many medical devices literally save millions of lives each year, there are far too many that prove to be dangerous – even fatal – to patients either due to design or some other type of defect. If you have suffered an injury or illness from a defective medical device, contact a seasoned Virginia personal injury attorney to see what legal recourse for your pain and loss. Our Virginia medical malpractice law firm has successfully represented many victims who were seriously injured by surgical and medical errors and are available to discuss your situation.