In the final weeks of 2016, the world stood still when powdered medical gloves received the ultimate legal boot. Or, at least, parts of the world were surprised. The FDA ruled that the powder posed an “unreasonable and substantial risk of illness or injury” to patients by way of airway inflammation, tissue hypersensitivity, allergic reactions, and asthmatic triggers. For context, let’s go through all the other medical devices banned by the FDA:
- Synthetic Hair Fibers (effective 1983)
That’s it, that’s the whole list.
Thirty years without a banned medical device bodes unexpectedly well for the safety of healthcare technology. What a treat it is, seeking healthcare without going through revolving doors of experimental contraptions that must be slapped away with bans left and right. It’s no coincidence the powdered glove ban (and potentially another ban*) arrive alongside the rise of the information age. Decades of research and case studies are catching up to methods once thought to be sufficiently harmless. More importantly, it emphasizes that the FDA doesn’t issue these bans willy-nilly—the 1983 ban arrived seven years after the FDA had the authority to halt medical device distribution. Something as invasive as manufactured hair is the type of thing you’d expect to see on this list… but powdered gloves? How could they pose threats as dramatic as foreign substances sewn into the head?
The ban’s reference documents include a study by two New Zealand doctors from all the way back in 1974, which discourages the use of powdered gloves. They found the powder (made from cornstarch) to be considered “inert” by many doctors, yet as the number of reported cases of reactions to powder-contact grew, few medical practitioners were aware of those incidents and continued using powdered gloves. The study acknowledged that while unfavorable infections or irritations from glove powder were reported infrequently, many cases likely went undiagnosed, as symptoms could take anywhere from a few days to 2-4 weeks to develop.
Another reference document in favor of the ban stated that while sales of powdered medical gloves were in decline around the year 2000, total glove sales were and continue to be on the rise. By the time the ban was proposed in 2016, it’s estimated that powdered gloves made up about 7% percent of total glove sales (Global Industry Analysts Inc., 2008). To the FDA’s credit, their intervening justice didn’t rely on the number of people affected, but rather on their ability to protect patients from a well-documented and avoidable device.
According to the ban document itself (available for free reading at www.federalregister.gov), some were less than thrilled to wave powderless goodbyes to their once-trusty supplies. In a 30-day comment period preceding the ban, objectors cited hyperhidrosis, double gloving difficulties, tear-prone worries, exposure to patient fluids, comfort/dexterity, and heightened costs as reasons to reconsider a total ban. The FDA swiftly denied each of these claims, asking those who opposed the ban to recall that patient safety outweighs any allegiance to glove features whatsoever. You tell ‘em, FDA!
Here at Clinical Supply, we supplied powdered gloves to a very few number of customers before the ban. After the fact, we helped them make the transition to powderless, recommending gloves like our classic Posi-Prene and Posi-Prene Edge, as well as the Posi-Shield nitriles and latex. Almost a year later, the world keeps on turning smoothly, even without the lubricational aid of powder.
*electric shocking devices – proposed April, 2016