The FDA can be a thorn in the side of many medical device companies. The regulations could make your head spin. However, the FDA has only gone on to ban one medical device in its history - well now, two. The ban of a product would seem to be appropriate for devices that are extremely harmful to consumers, but the FDA has banned an unlikely candidate - powdered gloves.
On December 19th, the FDA published its final rule on the ban of powdered gloves. The medical device is said to pose a serious risk to patients, although it may not seem that obvious. This includes allergic reactions, inflammation of the airway and post-surgical adhesions.
The first Medical Device Ban was prosthetic hair fibers in 1983. This ban was brought about after the hair fibers, used for implants, caused infection and alopecia. There is now a third proposed ban on electrical stimulation devices used to treat self-injurious or aggressive behavior. This ban is currently pending.
Benefits of the Ban
The dangers posed by cornstarch and latex have long been known in the medical community. The medical device ban on powdered gloves was called for as early as 1998 and has since been a hot topic. Bureaucracy and red tape have caused delay on the issue, but finally the FDA has acted to the benefit of many patients.
Powdered gloves are powdered in order to make the gloves easier to put on. In contrast, the health risks to patients associated with the gloves seems to far outweigh the benefit. The lack of comfort of non-powdered gloves did not seem to sway the FDA in its decision-making.
If you have questions or Concerns about FDA Medical Device compliance or more FDA related questions Contact Bustos Law Group.
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