The United States Food and Drug Administration (FDA) has proposed a new rule that would ban powdered surgeon’s gloves and powder used for lubricating surgeon’s gloves after concluding that the powder presents too large of a safety risk. The powder, usually cornstarch, has been linked to allergic reactions in the respiratory system, lung inflammation, post-surgical adhesions, and possibly death. The powder is used to make surgical gloves easier to put on without damage.
The knowledge that the glove powder has been a health risk is not new. Different types of powder have been used for over 100 years, all of which were eventually found to cause granulomas and adhesions. The current standard of cornstarch has been in use since 1947. The FDA considered banning powdered medical gloves in 1997, but due to technological limitations at the time, a ban may have lead to a shortage of medical gloves. Instead, a draft guidance regarding powdered medical gloves was issued in 1999, in order to minimize risks.
The FDA’s most recent examination of the issue identified numerous alternatives to powdered medical gloves, all of which provide a similar level of protection and performance, with the only benefit of powdered gloves being the ease of which they can be put on. With all of the additional risks, the FDA declared that the products are not state of the art, finding significant technological advancement in medical gloves since 1998. Cost of non-powdered gloves was originally a concern, but is no longer the case.
See the FDA announcement here.
Patient safety is very important to The Law Offices of Larry H. Parker. We’ve seen all sorts of dangerous products actively promoted by negligent corporations attempting to make money at the expense of patient safety. If you or a loved one had been harmed by a faulty medical device, call us today at (800) 333-0000 or contact us online to schedule a free consultation at one of our locations in Long Beach, Los Angeles, Riverside, Orange County, Bakersfield, Phoenix, or Tucson. We provide the service of coming to you.