Business Wire07.12.16
Mölnlycke Health Care has confirmed its support of the U.S. Food and Drug Administration’s (FDA) proposed ban on most powdered medical gloves due to safety concerns by posting a docket submission during the 90-day public comment period. 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
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 percent2 over the last 12 months, and down 40 percent 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, Va. "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 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.
Mölnlycke Health Care is a provider of single-use surgical and wound care solutions used by clinicians and patients in all healthcare settings, from hospitals to homes. Established in 1849 in Sweden, Mölnlycke supplies medical products under the brand names of Biogel, Hibiclens, Tortoise, Mepilex, Mepitel and Mepiform. Mölnlycke’s U.S. regional headquarters is located in Norcross, Ga.
References:
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.
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 percent2 over the last 12 months, and down 40 percent 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, Va. "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 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.
Mölnlycke Health Care is a provider of single-use surgical and wound care solutions used by clinicians and patients in all healthcare settings, from hospitals to homes. Established in 1849 in Sweden, Mölnlycke supplies medical products under the brand names of Biogel, Hibiclens, Tortoise, Mepilex, Mepitel and Mepiform. Mölnlycke’s U.S. regional headquarters is located in Norcross, Ga.
References:
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.