The recent FDA proposal to ban powdered medical gloves is a great step forward that has been a long time coming. A leading voice on the issue of the use of powder was Dr. Richard Edlich, who advocated a powder-free future and made tremendous contributions toward this cause. Studies and research conducted by Dr. Edlich helped to recognize the risks associated with powdered gloves and created a foundation for educating both the FDA and public. Ultimately, he authored a Citizen’s Petition to the FDA in 2008, along with numerous other petitions, articles and books, and began training young surgeons on the risks of using powder in the operating room (OR). While Dr. Edlich’s work is perhaps the most cited within the context of the current proposed ban, the reality is the genesis for it actually dates back more than four decades.
To appreciate current advances in surgical gloving and understand the forces that led to the proposed ban, it helps to look at the past. Historically, powder has been used as a donning agent. Dr. William Halstead, a surgeon at Johns Hopkins Hospital, introduced the first sterile, latex and reusable glove in the OR in 1894. Early gloves proved difficult to put on, so an initial powder of lycopodium spores mixed with talc became the lubricant of choice. Through the years, new types of gloves and powders emerged, as did allergic reactions in some patients and clinicians. In the 1970s, clinicians began asking if powder was posing a risk, which led to initial research on the topic.
Today, it’s clear that using powdered medical gloves poses a risk to both patients and clinicians. In patients, aerosolization is a risk. During the donning of powdered gloves, minute particles fill the air. After donning, particles can continue to fall away from the gloves as the surgery proceeds. In addition, powdered gloves have been identified as the largest single contributor to latex aeroallergen levels in healthcare facilities. Powder also heightens latex sensitivity, which affects an estimated 8 – 12 percent of healthcare workers. Powder can delay wound healing and contribute to such post-operative complications as adhesions, infections and granulomas. The potential risks of powder to clinicians are clear as well: it contributes to compromised skin health and Irritant Contact Dermatitis (ICD), which causes dry, itchy and irritated skin.
Given the potential risks associated with using powder, why is it still used today? Change can be hard. But, the standard of care is shifting as powder-free is the choice of thought leaders such as the ACS, AORN, ANA, CDC and others. In fact, AORN has changed its recommended practices to reference only powder-free gloves in the intraoperative setting.
Powder is also 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 the technology has evolved to the point where powder-free gloves not only are as easy to put on and use as powdered gloves, but they also offer the comfort, safety and options surgeons need.
Now that the ban appears to be imminent, it is important to remember that the impact on the OR will be positive from a safety standpoint and mildly disruptive in the short term from a conversion perspective. It will behoove ORs and supply chain to work together to convert to powder-free surgical gloves as soon as possible. Here are some things to consider:
- Work with suppliers to determine the powder-free alternatives.
- Trial the options to see the difference and prepare your organization in a manner that will ensure you do not experience a supply disruption.
The recent proposal by the FDA is moving forward an important initiative that started years ago. It’s the right thing to do to help make the OR safer for patients and clinicians. Though Dr. Richard Edlich is not here today to witness the most recent proposal by the FDA, the FDA’s actions are a fitting tribute to the man who so tirelessly advocated and worked to eliminate powder. A mentor to many and a vigorous patient advocate, Dr. Edlich’s work and memory lives on as the industry takes a step closer towards a powder-free future.
Robert D. Zura, M.D., is a board-certified orthopedic surgeon and an advisor to Cardinal Health in the areas of orthopedics and surgical gloves.
Filed Under: Industry regulations