The FDA is considering ban on powdered medical gloves due to health issues: On Monday, the FDA announced a plan to ban powdered latex gloves due to the presence of harmful powder. The gloves were commonly used by health care workers in the United States but can harm both patients and doctors. The use of powdered latex gloves is already falling. According to the FDA, right now only six registered manufacturers of powdered latex gloves are left in the U.S.
Ban On Powdered Medical Gloves
The FDA has been considering the same ban since early 1990’s but at the time 75% of the health industry in the US was using powdered latex gloves. Also due to the scarcity of glove alternatives at the time, the proposal was benched.
It is believed powder carries latex proteins to the airways 10 times faster than normal. Latex proteins cause breathing allergies, inflammations and infections. If the ban proposal is approved, powdered gloves will be completely removed from the U.S. market. Natural Rubber Latex (NRL) gloves, powdered synthetic surgeon’s gloves and synthetic patient examination gloves are involved in the ban.
The FDA is reviewing all possible evidence against the gloves. An online register, called Federal Register Notice, collecting views and comments from doctors and physicians about the gloves was opened by the FDA once before in 2011. The register is open for comments regarding the issue from anyone related to the health industry.
The register will close after 90 days on 20th June. The comments generated will decided the fate of powdered gloves.
The FDA also ordered an economic impact analysis to find out the effects of pulling powdered gloves from the market. Different alternatives to powdered gloves already exist so a major impact is not expected.
The only exception is powdered radiography gloves since no other options are available. Besides, such gloves do not lead to any serious health complications.
Since latex gloves without powder are harmless, they will remain Class I medical devices. The FDA believes the ban will not increase the current $144 million budget of the U.S. health industry.
What Is Glove Powder?
Powder is coated on gloves to make it easier for health practitioners to put them on and take them off. The proteins present in the powder of the gloves are critical to health for a variety of reasons. The powder is basically made up of corn starch, but it acts as an allergen carrier.
Since the powder is aerosolized i.e., it disperses in the air. The natural latex proteins bind to corn starch and are delivered to the airways of humans nearby. The powder also carries allergens through skin contact. Other than latex proteins, the powder can also carry allergens used during industrial production of gloves.
Latex proteins have been known to cause serious respiratory and skin allergies. The powder may also lead to airway inflammation, wound inflammation/infection, and post-surgical adhesions. The formation of post-surgery adhesions is a critical condition.
Fibrous scar tissues form in the internal cavity between organs and tissues, which can lead to healing problems and prove fatal. Powdered gloves also increase latex-induced hypersensitivity.
Background — Ban On Powdered Medical Gloves
The momentum against powdered gloves first started back in the 1990’s. In 1997 an extensive report called ‘Medical Glove Powder Report’ was published by the FDA. The report highlighted the pros and cons of powdered gloves. In the report the FDA mentioned all possible alternatives to powdered gloves. The report concluded that the powder acts as an airborne carrier of natural latex proteins.
Similarly, in 1998, Dr Sidney M Wolfe started a petition to ban powdered latex gloves. According to the petition, latex allergies cause occupational, emotional and professional sufferings and can even lead to disability and death. Complete avoidance of powdered latex gloves was cited as the perfect solution to the issue.
In 2000 a Starch peritonitis outbreak was reported when a new brand of latex gloves were introduced. The condition caused fever, abdominal pain, and ileus in those infected. Steroids were used to treat the affected people.
The most recent research on the adverse effects of powdered latex gloves was carried out in 2003. It was concluded latex proteins are transferred to the body via inhalation, skin contact or contact with mucous membrane. The role of corn starch powder as an allergen carrier and inducer of hypersensitivity was established with experimental proof.
The FDA started an online registry in 2011 which collected data on the basis of comments about powdered gloves. The registry was called the Federal Register Notice. Finally, the proposal to ban powdered latex gloves was conceived by the FDA in December 2014. Since then the proposal has been under review and finally a press release was issued on the 21st March, 2016.
Why Was The Ban Delayed?
The motion to ban powdered gloves has existed for nearly two decades. Even though the FDA was aware of the health risks of powdered gloves, the question is why they were not banned.
According to the FDA, in the 1990’s only two alternatives to powdered gloves were present. Chlorinated gloves were the main alternative to powdered gloves back then. However, using chlorine caused physical damage to gloves. Chlorine treatment of gloves also changed the physical properties of latex gloves.
The FDA feared swapping powdered glove with chlorinated gloves would compromise the critical medical procedures. The shelf life, grip and durability of latex gloves were also in danger as a result of chlorine treatment.
The other option was polymer coating of the gloves for lubrication. However, polymer coating was an expensive method at the time and would have increased costs of health care systems.
An FDA report also concluded the ban of powdered gloves in 1997 would cause market shortage. In 1997, 75% of medical practices were using powdered gloves. So it took FDA a number of years before reconsidering the ban again.
The FDA has admitted they always meant to ban powdered gloves at the right time in the future. Since suitable alternatives to powdered gloves are more immediately available, the ban has better chances of success now.
The market is filled with new alternatives to powdered gloves. Some new varieties of synthetic gloves have been found which do not require powder.
The non-latex synthetic gloves include vinyl gloves, nitrile gloves, polyisoprene gloves, neoprene gloves, black copolymer gloves and polyurethane gloves. Similarly, an advanced medical method such as ASTM method ensures powder is reduced or not used on latex gloves.
Economic Impact Analysis
After examining all the costs and access issues, if the current ban is approved it can be concluded the economic impact will not be huge. Even the FDA has suggested the proposed rule will not have a significant impact on the health industry. They have assessed all the costs and benefits of the ban.
The health division cost the U.S. government $144 million in 2014. The FDA does not believe the ban on powdered latex gloves will lead to any extra expenses.