May 01, 2017
Area(s) of Interest: Public Health Licensing & Regulatory Issues
The U.S. Food and Drug Administration (FDA) recently issued a final rule that bans the use of powdered medical gloves. The ban took effect January 18, 2017, after the FDA determined that powdered surgeons' gloves, powdered patient examination gloves and absorbable powder for lubricating surgeons' gloves present an unreasonable and substantial risk of illness or injury to both patients and health care personnel.
After a thorough review of all currently available information, the FDA concluded that the use of powder on medical gloves present numerous risks, including sensitization to natural rubber latex allergens, surgical complications related to peritoneal adhesions and other adverse health events not necessarily related to surgery, such as inflammatory responses to glove powder. The FDA also cited additional risks of inflammation, granulomas and respiratory allergic reactions related to the use of powdered gloves. It concluded that these risks cannot be corrected or eliminated by labeling or a change in labeling and consequently, is banning its use.
To read the FDA's rule, click here. For more information, see CMA On-Call documents #6307, "Injury and Illness Prevention Programs," and #3666, "Occupational Illness and Injury." CMA On-Call documents are available free to members in CMA's online health law library at CMA Health Law Library. Nonmembers can purchase documents for $2 per page.