For medical and surgical procedures healthcare professionals wear gloves in order to reduce the risk of contamination transfer (from a surface to a patient or from healthcare professional to a patient; or even from patient to patient, although gloves should really be changed between patients). Whilst performing procedures, gloves should ideally be sanitized at regular intervals using a suitable antiseptic (such as chlorhexidine or an alcoholic spray.)
The types of gloves available vary. The gloves are composed of different polymers including latex, nitrile rubber, vinyl and neoprene. They also come unpowdered or powdered. The idea behind powdered gloves, using materials like cornstarch or calcium carbonate, is that the gloves are easier to put on and to take off. Before cornstarch, Lycopodium powder (derived from a type of moss) and talc were commonly used. Gloves can also be supplied as sterile or non-sterile. Sterility is only a transitory state; as soon as the glove contacts something non-sterile (that is, everything in the hospital) it ceases to be sterile.
The FDA announcement came on March 21. The Agency outlined its intention to ban the use of powdered gloves in the U.S., stating, via CNBC, that “they pose an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them.”
The decision would apply to powdered surgeon’s gloves and examination gloves, which are regulated as Class I–medical devices. Surgical gloves have more precise sizing.
The reason for the FDA announcement is because powdered gloves can present risks. For instance, the powder can become aerosolized and trigger allergic reactions. These reactions can affect both patients and healthcare workers. It could also be that the powder acts as a mechanism for transferring infection; and some studies have drawn links to serious conditions like carcinoma, as well as tuberculosis misdiagnosis.
Other risks include severe airway inflammation, wound inflammation, and post-surgical adhesions. No glove type presents a low risk. As the FDA statement goes on to indicate: “these side effects have been attributed to the use of glove powder with all types of gloves.”
The FDA indicates its decision is based on a review of medical evidence. One area likely to be excluded is the use powdered gloves for radiographic protection. This is due to the absence of any suitable alternative.
The FDA proposal is open for public comment and will remain so for 90 days. The decision will have a global impact because the large majority of medical gloves used in the U.S. are imported, running into billions of pairs per year.
