Make sure your office is in compliance with the FDA ban of ALL powdered exam and surgical gloves by January 18, 2017.
If you found yourself doing your best Faye Dunaway impression when you read the title to this months Practice Tips, give yourself a gold star. We wanted to express a sense of urgency for those of you who still use powdered gloves, because in just a matter of days, you will need to make sure your office is in compliance with the FDA's ban on them.
In December 2016, the Federal Register published that the FDA has officially banned use of all powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating surgeon’s gloves. This ban is scheduled to go into effect on January 18, 2017 and will affect devices currently in commercial distribution and already sold to the end user.
Early rumblings of this started back in March 2016 when the FDA issued a proposed rule to ban these devices, as they present “an unreasonable and substantial risk of illness or injury.” Risks associated with powdered gloves include: hypersensitivity reactions, allergic reactions, and severe airway inflammation.
The FDA found that the current state of the art of both surgeon’s and patient examination gloves includes numerous non-powdered alternatives that provide the same performance, level of dexterity, and protection with none of the risks that are associated with powdered gloves.
You can learn more about the ban at the Federal Register.
LEAVE A REPLY