FDA bans medical device for the only the second time

For only the second time, the U.S Food and Drug Administration (FDA) has proposed to ban a medical device.

The device, powdered surgeon’s gloves, including powdered patient examination gloves and absorbable powder for the gloves, have been deemed dangerous due to a number of reasons.

Powder is applied to a small number of latex gloves to help medical workers put them on and take them off. However, even though the use of powdered gloves is decreasing, the material still poses a risk to patients.

Aerosolised glove powder on natural rubber latex gloves can carry proteins that may cause respiratory allergic reactions. The devices are related to a number of dangerous events such as inflammation and post-surgical adhesions.

To make the decision the FDA considered all available scientific literature and comments to review the proposed dangers of powdered gloves.

Evidence was presented in 1998 and 2011 about the dangers of powdered gloves but the FDA didn’t ban the devices then as it would have been too disruptive to the market, Fox News reports. Public Citizen's Health Research Group called the 18-year delay “reckless-negligence”.

Jeffrey Shuren, director of FDA’s Centre for Devices and Radiological Health said: “This ban is about protecting patients and health care professionals from a danger they might not even be aware of. We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”