The FDA’s decision to ban powdered medical gloves marks a significant step toward enhancing patient and healthcare worker safety. For decades, these gloves were a common fixture in medical settings, but the risks associated with their use—including allergic reactions, respiratory issues, and post-surgical complications—became too substantial to ignore. While transitioning to non-powdered gloves requires adjustments in healthcare practices, the benefits far outweigh the drawbacks.
As healthcare facilities adapt to these changes, ensuring compliance with new regulations is crucial. The ban eliminates unnecessary health risks and promotes a safer environment for both medical professionals and patients. If you have experienced complications related to powdered gloves, you may have legal options. Contact us to learn more about how we can help you seek justice.
Background on Powdered Medical Gloves
Powdered medical gloves have been a staple in the healthcare industry for decades, primarily because they make it easier to don (put on) and doff (take off) gloves. The powder, often made from cornstarch or other materials, reduces friction, making the gloves more comfortable and convenient to use.
However, over the years, significant concerns have been raised about the potential health risks associated with these gloves. These risks include allergic reactions, severe airway inflammation, and the formation of post-surgical adhesions. Despite these concerns, powdered gloves continued to be widely used in the healthcare industry until the FDA’s decisive ban in 2017.
Safe Patient Examination Gloves are a Medical Necessity.
Standardization in gloves is a necessity in keeping patients safe from other patients and medical staff and patients safe from each other. Per the FDA, “Health care personnel rely on medical gloves as barriers against transmission of infectious diseases and contaminants when conducting surgery, as well as when conducting more limited interactions with patients.” Gloves keep not only patients safe, they protect the nurses, doctors, and surgeons we rely on to give us quality care. What happens though when gloves could be a contributing factor to a patient or provider’s illness?
Powdered gloves have been used by health care professionals since at least the late 19th century. At first, the gloves were covered in Lycopodium spores or ground pine pollen. By the 1930s, lycopodium spores and ground pine pollen were replaced by talc powder as Lycopodium powder was likely to cause wound granulomas and adhesion formation. Talcum powder didn’t last long as a substitute though, by the 1940s talc was also shown to contribute to postoperative adhesions and granuloma formulation. Modified cornstarch powder was presented as an absorbable and non-irritating glove powder in 1947, and by the 1970s, it surpassed talc usage.
Powdered gloves with modified cornstarch seemed to be a perfect solution until 1997, the FDA “found that glove powder could cause inflammation and granulomas” and “aerosolized glove powder on natural rubber latex gloves can carry allergenic proteins that have the potential to cause respiratory allergic reactions.” Not only do powdered gloves pose an allergen threat, but the inflammation that they cause can lead to cancer – such as the talc inflammation has been tied to ovarian cancer.
Powdered Gloves Provide a False Sense of Security and Allergic Reactions
In 1998, Public Citizen, a nonprofit organization lobbying for citizen interests in Washington, D.C., called on the FDA to ban cornstarch in latex surgical and patient examination gloves.
The FDA, finding that a ban on powdered gloves would create a shortage of regulation gloves while driving increased costs to the healthcare system, instead began recommending “that medical gloves have no more than 2 mg of residual powder or debris per glove,” highlighting the importance of reduced powder levels. This was a stark decrease from the 120-400 mg of residual particulates, mold release, and donning powder gloves generally contained.
After receiving three more petitions to ban cornstarch powdered gloves, the FDA has finally decided to ban powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove on the basis that the gloves, as a medical device, “present substantial deception or an unreasonable and substantial risk of illness or injury.” Gloves give healthcare professionals and patients a sense of security, the powder on these gloves are a deception to that sense of security in that they can cause more damage than many of the illnesses they seek to prevent.
Rather than banning products, the FDA often proposes changing the marketing on problematic medical devices. However, powdered gloves present enough of a substantial deception and unreasonable and substantial risk of illness or injury that a change of marketing would not suffice. The ban would benefit both healthcare professionals and patients from unnecessary complications and ailments. This ban will save lives and promote better quality of life for everyone involved. The FDA is currently seeking input from the public on this proposed ban, comments are accepted until June 20th, 2016. The FDA has proposed a ban on powdered gloves, but remain silent on the dangers of talcum powder.
FDA’s Proposal and Timeline
The FDA first proposed banning powdered medical gloves in March 2016, citing substantial evidence of serious risks to both patients and healthcare professionals. The proposed rule was open for public comment for 90 days, during which the FDA received over 100 comments, the majority of which supported the ban.
After a thorough evaluation of the risks and benefits associated with powdered gloves, the FDA finalized the ban on January 19th, 2017. This ban specifically targets powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder used to lubricate surgeon’s gloves, marking a significant step towards improving patient and healthcare worker safety.
Impact on Healthcare Industry
The ban on powdered medical gloves is poised to have a considerable impact on the healthcare industry. Healthcare professionals will need to transition to non-powdered alternatives, necessitating changes in procedures and protocols.
However, the FDA has determined that non-powdered alternatives offer similar levels of protection, dexterity, and performance as their powdered counterparts. The ban is also expected to reduce the number of adverse events linked to powdered gloves, which currently cost the healthcare industry an estimated $26.8 million to $31.8 million annually. This shift not only promotes safety but also presents a cost-saving opportunity for the industry.
Alternatives to Powdered Gloves
Non-powdered gloves are the primary alternative to powdered gloves, designed to reduce friction without the use of powder. These gloves are available in various styles and sizes, including surgeon’s gloves and patient examination gloves, ensuring that healthcare professionals can find suitable options for their needs.
Some manufacturers have also developed reduced-powder gloves, which contain lower levels of powder than traditional powdered gloves. However, the FDA has concluded that even these reduced-powder gloves pose an unreasonable and substantial risk to patients and healthcare professionals. Non-powdered gloves, therefore, remain the safest and most effective option.
Implementation and Transition
The implementation of the ban on powdered medical gloves will require a transition period for both healthcare professionals and manufacturers. The FDA has provided detailed guidance on the transition process, including information on the classification regulations for these gloves.
Manufacturers must ensure that their products comply with the new regulations, while healthcare professionals will need to update their procedures and protocols to incorporate non-powdered alternatives.
The FDA has also established a docket for public comments and background documents related to the ban, which can be accessed online, ensuring transparency and support throughout the transition.
Protecting Your Rights After Exposure to Hazardous Medical Products: Contact Hollis Law Firm Today
If you or a loved one experienced health complications due to powdered gloves, you may have legal options. At Hollis Law Firm, we understand the dangers associated with defective medical products and are committed to holding manufacturers accountable for the harm they cause. The FDA’s ban on powdered gloves underscores the serious risks these products pose, and those who have suffered as a result deserve justice. We can help you assess your case, gather necessary evidence, and pursue compensation for medical expenses, pain, and suffering.
Our team has extensive experience handling cases involving unsafe medical products, and we stay up to date on the latest scientific research and regulatory changes. With our knowledge of both law and science, we can provide the legal support you need to navigate this complex process. To discuss your case with a dedicated attorney, call us at (800) 701-3672 or fill out our contact form today.
