Infection prevention

Mölnlycke® Health Care posts docket submission in support of FDA’s Proposed Ban on Most Powdered Medical Gloves

By: Mölnlycke Health Care, July 13 2016Posted in: Infection prevention

Mölnlycke® Health Care confirmed its support of the Food & Drug Admnistration’s proposed ban on most powdered medical gloves due to safety concerns by posting a docket submission during the 90-day public comment period on the ban.

The company also cited customer purchasing data which shows readiness to move away from powdered gloves to alternatives already available in the marketplace, including its own Biogel® surgical gloves, the world’s first powder-free surgical glove.

The FDA issued its proposed ban recommendation on March 21, 2016, citing safety concerns about powdered gloves and their potential risks for health care providers, patients and others who may be exposed to them.  

Mölnlycke’s docket submission cites the  following documented risks to clinicians and patients as clinical evidence[1]:

Hazard

Harm

Powder exposure via inhalation

Airway inflammation

Powder deposits in patient tissue during surgery or invasive examination

Granuloma formation

Tissue adhesions

Wound inflammation and infection

Powder adherence to latex allergenic proteins and subsequent aerosolization and exposure via inhalation

Inflammatory response

Hypersensitivity reactions

Allergic reactions

 

Powder has historically been used in medical gloves to facilitate ease of donning and doffing.  It may also decrease the tackiness of gloves that are packaged together.  In today’s marketplace, numerous powder-free alternatives exist and have been shown to be suitable and readily available. For more than 30 years, the proprietary Biogel coating has made donning surgical gloves easier, eliminating the need for glove powder.

”Powder-free surgical gloves are a critical safety measure for both patients and clinicians in the surgical as well as other medical settings. Customers have demonstrated through their glove purchasing that they are ready to move away from powdered gloves,” said Rob Rayl, President of Mölnlycke Health Care’s U.S. business. ”Powdered surgical glove purchases are down 15%[2] over the last 12 months, and down 40% since 2010.[3]

”Powder on gloves is a left over from the days when still damp hands would not fit into thick latex gloves and some gloves were reused.” said Dr. David Reines, Vice Chair of Surgery at Inova Fairfax Hospital in Richmond, Virginia.  ”As we have gained in knowledge that talc causes problems, and as our glove and hand washing techniques have improved, we no longer need the adjunct that powder gives us to allow ease of entry into the newer surgical gloves.”

Mölnlycke® Health Care fully supports the proposed ban in its entirety and agrees with the FDA’s proposal to make any final rule based on this proposed rule effective 30 days after the date of its publication in the Federal Register, as any further delay in instituting such a ban would only facilitate continued exposure to the serious and unnecessary risks of glove powder.

 

For Media Inquiries:
Debbie Bolding
Mölnlycke Health Care, U.S. Communications
Phone: (412) 327-5540
Email: debbie.bolding@molnlycke.com



[1] Truscott, Wava.  Citizen’s Petition to the Food and Drug Administration to Ban Cornstarch Powder on Medical Gloves, February 24, 2009.

[2] GHX Data Q12016.

[3] GHX Data 2010-2015.

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