The powdered latex gloves frequently used by physicians and health care providers may soon be on their way out should a recent proposed ban from the Food and Drug Administration be approved. In the proposed ban, the FDA identifies three types of surgical gloves that the ban would apply to including: (1) Powdered Surgeon’s Gloves, (2) Powdered Patient Examination Gloves, and (3) Absorbable Powder for Lubricating a Surgeon’s Glove.
When discussing the ban Jeff Shuren, M.D, the director of the FDA’s Center for Devices and Radiological Health, said “this ban is about protecting patients and health care professionals from a danger they might not even be aware of.” The FDA has identified that the underlying problem with these particular gloves stems from the powder used to line the gloves. Initially, the powder was added to the gloves to make it easier for physicians and health care providers to put on and take off the gloves. Yet, over time, this powder can generate an unintended effect, leaving patients at risk for injury.
Some may view the ban on gloves as a unnecessary and overly drastic step. Typically, when dealing with a device that generates unexpected risks, the FDA will add a warning label to the device or limit the way the device may be used instead of ban it. Yet, in this case, the FDA has found that these surgical gloves “present an unreasonable and substantial risk of illness or injury and that risk cannot be corrected or eliminated by labeling or a change in labeling.” As such, the FDA appears to believe a ban may be the most appropriate step. In a press announcement the FDA explained the “aerosolized glove powder on natural rubber latex gloves . . . can carry proteins that may cause respiratory allergic reactions.” Some of the dangers identified by the FDA associated with the use of powdered gloves include severe airway inflammation, severe respiratory allergic reactions, wound inflammation, and post-surgical adhesions.
The FDA has stated it does not anticipate that a ban on the powdered latex gloves will significantly impact the medical field because many non-powdered glove options are currently available. The proposed rule is available for public comment until June 20, 2016 at www.regulations.gov. Given the injuries generated by this powder, it appears that this ban is a step in the right direction to protect patients and physicians alike.
David Rapoport is the founding and managing partner of Rapoport Law Offices. In his over 31 years as a full time trial attorney, he has won numerous multi-million dollar jury verdicts and settlements in personal injury and wrongful death cases. Mr. Rapoport is a member of the invitation only American Board of Trial Advocates (ABOTA), an association of premier trial attorneys who are dedicated to preserving the right to trial by jury. ABOTA's general mission is "to foster improvement in the ethical and technical standards of practice in the field of advocacy to the end that individual litigants may receive more effective representation and the general public be benefited by more efficient administration of justice consistent with time-tested and traditional principles of litigation." For over 20 years Martindale-Hubbell, through its Peer Review RatingsTM program, has consistently ranked David Rapoport as AV® PreeminentTM, its highest professional rating. This is a testament to Mr. Rapoport's abilities as an attorney and commitment to maintaining the highest ethical standards. Mr. Rapoport has also been selected by Thompson Reuters, another prominent legal publisher, as an Illinois “Super Lawyer” every year since the inception of the Super Lawyer program. Super Lawyer designation is limited to the top 5 percent of lawyers in a state in any given year. Since 1990, David Rapoport has been board certified* in Civil Trial Advocacy by the National Board of Trial Advocacy ("NBTA"), the oldest and largest not-for-profit American Bar Association accredited trial attorney certification program. Attorneys with NBTA certification have proven ability in their field through specialized written examinations and meeting rigorous criteria for trial experience and ethical ratings. Mr. Rapoport has proven his currency and substantial trial experience through NBTA recertification in 1995, 2000, 2005 and 2010. David Rapoport has served as a leader of the movement to encourage board certification for trial lawyers for more than twenty years. Currently he is the President of the National Board of Trial Advocacy and its parent organization the National Board of Legal Specialty Certification. He recently explained: "In this era of Wild West style minimally regulated lawyer advertising, it has never been more important for the public to have easy and reliable means of identifying members of the small fraction of practicing attorneys who truly have substantial experience trying cases. Board certification programs help consumers of legal services make more informed choices. Too many lawyers are out there claiming to have substantial trial experience when in truth they have never tried a case. Board certified trial lawyers have proven their substantial trial experience in ways the public can trust." Mr. Rapoport is a member of the President's Club and Leader's Forum of the American Association for Justice and the state trial lawyer associations in Illinois, Wisconsin and Kentucky. He is also a member of the Economic Club of Chicago. * Board certification is not required to practice law in Illinois and the Illinois Supreme Court does not recognize specialties in the practice of law.