As of today, the U.S. Food and Drug Administration is banning all use of powdered gloves by medical professionals in healthcare settings. The ban, announced in December, is the result of a debate that stretches back decades.
To learn more about the history of patient safety concerns related to powdered gloves and to get a sense of where the healthcare field goes from here, Surgical Products interviewed Mary Cross, RN, MBA, CWCMS, senior consultant of clinical operations for surgical gloves at Cardinal Health.
Can you provide insight on the latest action by the U.S. Food and Drug Administration (FDA) related to powdered gloves?
The FDA recently announced a ban on the marketing, sale, and distribution of powdered surgeon’s gloves, powdered examination gloves, and absorbable dusting powder used for lubricating surgeon’s gloves. The ban goes into effect on January 18, 2017.
Were you surprised by this ban? And, do you think surgical glove users were prepared?
We were not surprised by this ban, as it has been a long time coming and the potential risks associated with powder are not new. Let’s take a look at the history and some milestones along the way:
• 1971 – The FDA issues the first caution statement relating to powder
• 1997 – The FDA publishes the Medical Glove Powder Report
• 1999 – The first Citizen’s Petition to the FDA to ban cornstarch on powdered gloves
• 2008 – The second Citizen’s Petition to the FDA to ban cornstarch on powdered gloves
• 2013 – AORN updates their recommended practices to only reference powder-free gloves in the intraoperative setting
• 2016 – FDA proposes a ban on powdered medical gloves
• 2017 – FDA’s ban goes into effect
As far as users being prepared, in the ban itself the FDA shared that they believe “this ban would likely have minimal economic and shortage impact on the healthcare industry. Thus, a transition to alternatives in the marketplace should not result in a detriment to public health.” In addition we’ve seen powdered surgical glove usage decrease dramatically in recent years, dropping from 18.6 percent of all surgical glove use in 2013, to only 8.3 percent in 2016.
How do the powder-free surgical gloves available today compare to powdered gloves?
Historically, powder was used as a donning agent because early gloves proved difficult to put on. Today, powder is no longer needed as a donning agent. Today’s powder-free technology and manufacturing advances allow for more versatility to improve glove performance, such as the ability to meet specific surgical needs with stronger thickness and grip, which powdered gloves can’t offer. The reality is there are many powder-free options now available, and new technology has produced powder-free gloves that are not only as easy to don and use as powdered gloves, but that offer the comfort, safety and options surgeons need.
How is Cardinal Health working with customers to help them with the transition to powder-free?
As an industry leader, Cardinal Health continues to help customers make the transition to powder-free surgical gloves by offering a full portfolio of powder-free surgical gloves along with educational programs, clinical resources, and excellent customer service.
Filed Under: Industry regulations