FDA Finally Moves to Ban Dangerous Powdered Surgical and Medical Exam Gloves
Health Letter, July 2016
By Michael Carome, M.D.
On March 22, the Food and Drug Administration (FDA), prompted in part by a 2011 petition from Public Citizen, proposed banning powdered surgical and medical examination gloves from the market, because they pose unacceptable dangers to both patients and health care workers, and because safer alternatives exist. If finalized, this action — remarkably — would mark just the second time that the agency has banned a medical device. (Forty years ago, Congress gave the FDA the authority to ban medical devices that present an unreasonable and substantial risk of illness or injury.)
The hazards of powdered surgical and medical examination gloves have been well recognized for more than two decades. Citing extensive evidence of the harms caused by powdered latex gloves, Public Citizen in 1998 first petitioned the FDA to ban all such gloves, but the agency denied the petition in 1999. As a result of the FDA’s reckless inaction, many health care workers and patients have suffered preventable, often life-threatening adverse reactions.
History of powdered medical gloves
Medical gloves have played a crucial role in protecting both patients and health care providers for more than a hundred years. In particular, they act as barriers against transmission of infections between health care workers and patients during surgery and patient examinations.
The first medical gloves were made from natural latex rubber obtained from latex-producing trees. Nonlatex medical gloves made from synthetic materials have become increasingly available over the past few decades.
Since the late 19th century, various powders have been used to lubricate gloves so physicians can don them more easily.[1] The first powders used were composed of spores from a type of evergreen plant called lycopodium or club moss. By the 1930s, the powders made from club moss spores had been found to cause inflammation and scar tissue formation in surgical wounds. Talcum powder was subsequently used as a glove powder, but in the 1940s it too was linked to these same adverse reactions.
In 1947, cornstarch powder was introduced as a glove powder, and by the 1970s it had largely replaced talc as a lubricant for surgical gloves. However, by the 1990s, it had become clear that cornstarch powder was not a safe alternative.
Dangers of powdered gloves
In its 1998 petition to the FDA calling for a ban on powdered latex surgical and examination gloves, Public Citizen’s Health Research Group highlighted two major types of adverse effects of these products. First, cornstarch powder from surgical gloves can inflame wounds, promote infections and trigger scar tissue formation following surgery, leading to multiple complications. For example, in patients undergoing abdominal or pelvic surgery, cornstarch powder can lead to formation of band-like scar tissue called adhesions, which can cause intestinal obstruction, abdominal and pelvic pain, and infertility.
Second, cornstarch powder from latex gloves causes well-documented allergic reactions, including rhinitis (nasal allergy), asthma and life-threatening anaphylactic shock. These serious adverse reactions occur because small amounts of latex protein, a common allergen, combine with cornstarch powder during the glove manufacturing process. Cornstarch powder linked to latex becomes airborne when gloves are donned and then can be inhaled by health care workers, patients and others, triggering allergic reactions in latex-sensitive individuals. Many health care workers have experienced such serious reactions to latex they have been forced to give up work.
Safer alternatives
Importantly, at the time of Public Citizen’s 1998 petition, powder-free latex gloves were widely available. For example, data from 1997 indicated that one-quarter of surgical glove sales in the U.S. were for powder-free latex gloves. By 1996, several major hospitals, including Harvard’s Brigham and Women’s Hospital in Boston and Miami’s Jackson Memorial Hospital, had completely switched to powder-free surgical and medical examination gloves because of widespread allergic reactions related to powdered latex gloves in hospital employees.
“These powdered latex gloves are a serious, unnecessary menace in hospitals and other health care facilities all over the country,” said Dr. Sidney Wolfe, founder and then-director of Public Citizen’s Health Research Group, on Jan. 7, 1998. “Safer alternatives such as powder-free gloves are easily and currently available, but too many hospitals are willing to cut corners and risk the health of their patients and employees.”
Although the FDA acknowledged that there was scientific evidence in 1998 that powdered surgical and medical examination gloves were hazardous to both patients and health care workers, the agency refused to grant Public Citizen’s petition. In denying the petition, the agency cited concerns about the market availability, quality and costs of non-latex powder-free gloves.[2],[3] The FDA instead proposed in 1999 a regulation that would have required additional warnings on the labels of powdered gloves and more stringent agency review of these products. But even this proposed rule was never finalized.[4]
Public Citizen, others try again
In 2011, Public Citizen again petitioned the FDA to ban all surgical and patient examination gloves lubricated with cornstarch powder. The petition cited additional evidence of the health hazards posed by these gloves and noted that more than 70 hospitals in the U.S. had transitioned to using only powder-free gloves by 2000.
Petitions to the FDA for a similar ban also were submitted in 2008 by a group of doctors and medical scientists and in 2009, by the director of scientific affairs and clinical education of a major medical glove manufacturer.
The FDA’s March 22 proposal to finally ban all powdered surgical and patient examination gloves acknowledged that these three petitions prompted the agency “to evaluate new data on the risks of using powdered gloves, to consider new information regarding the current availability and costs of alternatives to glove powder for glove lubrication, and to reassess the frequency of use of powdered medical gloves.” Based on this evaluation and reassessment, the agency concluded that:
- The risks posed by powdered gloves — including the risks of allergic reactions to latex and wound inflammation and adhesions following surgery — outweigh the benefits of these products;
- These risks cannot be eliminated by labeling changes; and
- Safer, nonpowdered alternative products now are available.
The rule banning powdered gloves likely will not be finalized for more than a year. The agency now must undertake the typically lengthy process of reviewing public comments on the proposed ban and writing a final rule. The FDA proposed that once the final rule is issued, the ban on marketing of powdered surgical and medical examination gloves would take effect after 30 days.
Unfortunately, the FDA’s proposed action comes too late for the many patients and health care workers who have experienced avoidable serious adverse reactions to powdered gloves. Had the FDA proposed a ban on powdered gloves in 1998, as requested by Public Citizen and others, glove manufacturers no doubt would have rapidly shifted production to powder-free gloves. And to prevent any shortage of surgical and medical examination gloves at that time, the agency could have granted manufacturers a two- to three-year transition period to switch production to powder-free versions.
“The fact that it took the FDA 18 years to propose banning powdered surgical gloves from the market highlights how recklessly negligent the agency is,” said Wolfe, now senior adviser of the Health Research Group. “There is absolutely no new scientific information today that we didn’t have in 1998 about the dangers posed by cornstarch powder and by latex when used in surgical and patient examination gloves.”
References
[1] Food and Drug Administration. Banned devices; proposal to ban powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove. 81 FR 15173-15188. March 22, 2016. https://www.gpo.gov/fdsys/pkg/FR-2016-03-22/pdf/2016-06360.pdf. Accessed May 9, 2016.
[3] Food and Drug Administration. Medical glove powder report. September 1997. http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm113316.htm. Accessed May 10, 2016.
[4] Food and Drug Administration. Banned devices; proposal to ban powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove. 81 FR 15173-15188. March 22, 2016. https://www.gpo.gov/fdsys/pkg/FR-2016-03-22/pdf/2016-06360.pdf. Accessed May 9, 2016.