The Food and Drug Administration’s “Medical Glove Powder Report” in 1997 documented adverse health effects that can result from glove powder.1
Most recently, in March 2016 the FDA announced a proposed ban on powdered medical gloves. As stated on its website, the FDA determined that, “While the use of powdered gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury to healthcare providers, patients and other individuals who are exposed to them, which cannot be corrected through new or updated labeling.”2
Some of the potential risks associated with using powder include:
- Delaying wound healing and contributing to post-operative complications such as adhesions, infections and granulomas.3-5
- Potentially contributing to longer hospital stays and increased healthcare costs.6-12
- Compromising skin health and contributing to Irritant Contact Dermatitis (ICD), which causes dry, itchy and irritated skin.13
While powdered surgical glove usage is declining as a result of the FDA proposal to ban powdered gloves, as of 2015 powdered gloves still accounted for 15 percent of U.S. surgical glove sales.14 A Cardinal Health survey of healthcare workers (surgeons, operating room managers and purchasing managers) found the most common reasons given by those using powdered gloves were that the gloves had worked well in the past and no serious adverse effects had been observed personally.15
Professional associations advocating the use of powder-free gloves include the American College of Surgeons (ACS), AORN, AAAAI and the American Nurses Association (ANA).16,17 In addition, the United Kingdom and Germany have banned powdered surgical gloves.18
- Food and Drug Administration, Medical Glove Powder Report, September 1997. http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm113316.htm
- FDA proposes ban on most powdered medical gloves. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm491466.htm
- Edlich R., Watkins F. Glove powder – Facts and fiction. Surgical Services Management, February 1997; 3(2): 47-50.
- Hunt T., et al. Starch powder contamination of surgical wounds. Archives of Surgery 1994; 129: 825-828.
- FDA 21 CFR Parts 878, 880, and 895. Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves and Absorbable Powder for Lubricating Surgeon’s Gloves. II. Evaluation of Data and Information Regarding Glove Powder 15176–15183. Federal Register, Vol. 81, No. 55, March 22, 2016. Available at: https://federalregister.gov/a/2016-06360. Accessed May 2016.
- Cost to have staff on disability due to latex – Halasnik, Stephen, Travel Staffing News, March 2010.
- Cost of OR teardowns – Estimates from Donna McDaniel, Director of Surgical Services and Carol Miller, Peri-operative Services Education. Face-to-face interview, June 2011. Available at: http://ortoday.com/a-latex-free-approach-to-operating-room-savings/
- Cost to treat anaphylactic reaction due to latex – Herman, Bob, 11 Statistics on Average Hospital Costs per Stay, Becker’s Hospital CFO, December 2013. Mustafa, Shahzad, MD., Anaphylaxis Treatment & Management, Medscape, March 2014.
- Cost to remove powder – Edestam, G., Arvanius, L., Karlsson, G., Glove powder in the hospital environment – consequences for healthcare workers. International Archives of Occupational and Environmental Health, Vol. 74 (4) p. 267-271.
- Average cost of surgical site infection – Eyal Zimlichman, MD, MSc, Health Care–Associated Infections: A Meta-analysis of Costs and Financial Impact on the US Health Care System, JAMA Intern Med. 2013;173(22):2039-2046. Available at: http://archinte.jamanetwork.com/article.aspx?articleid=1733452.
- Cost to treat a sharps injury – CDC: Preventing Needlesticks and Other Sharps Injuries. O’Malley, E. et. al., Costs of Management of Occupational Exposures to Blood and Body Fluids, Infection Control and Hospital Epidemiology, Vol. 28, No. 7, July 2007.
- Cost to treat a sharps injury – Studies show that double-gloving may lower the risk of sharps injury and infection. AORN 2015 Guidelines for Perioperative Practice: Guideline For Prevention of Transmissible Infections. Recommendation VI.b. Pg 428.
- NIOSH. NIOSH Publication No. 97-135: Preventing allergic reactions to natural rubber latex in the workplace. Available at: http://www.cdc.gov/niosh/docs/97-135/. Accessed May 2016.
- 2015 GHX Data on file with Cardinal Health
- Survey conducted by The Key Group. On file at Cardinal Health.
- Chapin, D. Surgical gloves: Make the right choice. PR Nurse, October 2007.
- Edlich, R. et. al., Dangers of constarch powder on medical gloves: Seeking a solution, Ann Plast Surg. July 2009, 63(1):111-5