Jan. 7, 1998

Powdered Latex Gloves Pose Serious Risks to Patients and Health Workers

Call for Ban on Dangerous Surgical and Examiniation Gloves Manufactured with Cornstarch Powder Coating

Millions of patients and tens of thousands of health workers throughout the country are at serious risk from latex gloves powdered with cornstarch, said Public Citizen?s Health Research Group in a petition to the Food and Drug Administration (FDA) today to ban such gloves.

The group, joined by co-petitioner Timothy Sullivan, MD, an allergist/immunologist from Emory University School of Medicine and an expert on latex allergy, called for an immediate ban by FDA on the use of cornstarch powder on latex surgical and examination gloves because of the serious dangers these gloves have caused medical personnel and patients. Cornstarch can inflame wounds and promote infection, and cornstarch-induced adhesions can produce intestinal obstruction, pelvic pain and infertility in patients operated on by medical personnel wearing cornstarch-powdered surgical gloves, said the group.

One of the most widespread dangers occurs because cornstarch also acts as a carrier for latex protein /allergens--these allergens becoming combined with the cornstarch during the manufacturing process. Well-documented and frequently reported adverse reactions to latex include rhinitis, asthma, and life-threatening anaphylactic shock, often caused by breathing in the cornstarch powder in the air. Many health care workers have experienced such serious reactions to latex they have been forced to give up work.

"These powdered latex gloves are a serious, unnecessary menace in hospitals and other health care facilities all over the country," said Dr. Sidney Wolfe MD, Director of Public Citizen?s Health Research Group. "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. As of last year, 26% of surgical gloves used in the United States were powder-free proving that this safer alternative is quite feasible."

Labels warning that powdered gloves should be washed--to remove cornstarch-- before use are routinely ignored by the vast majority of health workers. A 1992 study found that only 17 % of surgeons washed their gloves after donning. Most emergency physicians use gloves lubricated with cornstarch during their wound closure techniques.

Several major hospitals have already switched to powder-free gloves, including Harvard?s Brigham and Women?s Hospital in Boston and Miami?s Jackson Memorial Hospital. At the Brigham and Women?s, one of the leading hospitals in the United States, as many as 12 to 14 operating room hospital workers a day were unable to work or had to be reassigned to desk jobs because of their allergic reactions. Jackson Memorial began experiencing problems with latex allergies in 1994 and, by May 1995, 95 employees had been treated for problems related to the gloves.

Between August 1996 and August 1997 alone the FDA received over 300 reports of allergic or anaphylactic reactions associated with latex gloves (it is estimated that at most one out of ten adverse reactions which actually occur are reported to the FDA so the number during that last year is likely in the thousands or more), and a 1997 study showed that up to 21% of hospital nursing staff were sensitized to latex.

Apart from the human cost, sticking with powdered latex gloves can be expensive for hospitals, says Public Citizen. Latex allergies tend to strike health care professionals with the most experience, leading to costly absences and compensatory claims. At Jackson Memorial Hospital, two workers compensation settlements exceeded $100,000 each, and the ongoing expense in one case has already cost over $370,000.

"These powdered gloves are expensive for hospitals, dangerous for their patients and a serious occupational hazard for their employees. The FDA should act immediately to prevent further damage to the public?s health," said Dr. Wolfe. "The current FDA regulation, which went into effect on September 30, 1997, requires labels on all medical devices containing natural latex warning that the product contains latex ?Which may cause allergic reaction?. Whereas this is an admission of the problem, it is grossly inadequate compared with the additional action of banning powdered latex gloves which we are requesting today. If the FDA is to perform as a public health agency it must more definitively protect the millions of patients and tens of thousands of workers already allergic to latex. Unless definitive action is taken, not only will those people already allergic to latex continue to suffer serious, often life-threatening reactions, but the number of affected people will continue to rapidly increase as more and more exposure to airborne, latex-laden glove powder occurs."

You can view the petition, without attachments, on the Health Research Group site.

Complete copies of the petition to the FDA are available by calling 588-1000.

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