Comments on Proposed Regulations on Powdered Latex Gloves
January 27, 2000
Comments by Sidney M. Wolfe, M.D., Director of Public Citizen's Health Research Group
Concerning FDA's Proposed Regulation ( 7/30/99) on Powdered Latex Gloves
Docket No. 98N-0313
In January, 1998, Public Citizen and Dr. Timothy Sullivan, Professor of Medicine at Emory and Head of the subsection of Allergy and Immunology at the Emory Clinic, petitioned the Food and Drug Administration to ban powdered latex gloves because of their significant dangers and because of the fact that safer alternatives are available. At that time, FDA had already been studying this issue for at least two years. When FDA published the July 30, 1999 Federal Register notice announcing the reclassification of powdered latex gloves, the agency also rejected our petition to ban powdered latex gloves.
These comments will elaborate on the reasons why a ban on powdered latex gloves — one which would take effect, for example, 18 months from now — coupled with the proposed reclassification as Class II medical devices for all surgical and patient examination gloves, is the most health-responsive action the Agency could take. Our comments will also discuss what, according to the agency's own data, are the dangers of allowing the powdered latex glove industry essentially to dictate the pace of phasing out these unquestionably dangerous and unnecessary medical devices.
Dangers of Powdered Latex Gloves
"FDA has long been aware that MDR's [mandatory device reports] received by the agency may account for as little as one percent of the actual events (Ref. 37). If true, the reports received for allergic reactions associated with medical gloves could represent as many as 43,500 allergic incidents during the 12-month period [including 38,045 people with systemic respiratory problems such as asthma — 10,272 of whom have problems with a duration of two months]. Because patients may often fail to connect an allergic incident to use of gloves, FDA believes that this estimate better reflects the true number of incidents associated with medical gloves." FDA Proposed Rule, 64 Fed. Reg. 41717. In the same one-year period, FDA estimated that 150 people would suffer allergic reactions serious enough to require very aggressive treatment and that about one-half of these people, 73 people a year, would exhibit long-term effects lasting two months.
"FDA has significant concerns about the role of glove powder as a carrier of airborne allergens, because NL [Natural Latex] allergens have been shown to bind to cornstarch. A number of published clinical and experimental studies support this conclusion (Refs. 10 to 14). In addition to the role of glove powder as a carrier of airborne allergens, FDA is also aware that glove powder contributes to a number of other adverse health effects. As particulate matter, it can cause foreign body reactions, resulting in inflammation, granulomas and adhesions of peritoneal tissues after surgery (Refs. 15 to 19). Glove powder may serve as an absorbent or adsorbent for unbound chemicals that may be irritants or chemical contact sensitizes. In addition, glove powder from nonsterile patient examination gloves may also support microbial growth and act as a carrier for endotoxins (Ref. 20)." FDA Proposed Rule, 64 Fed. Reg. 41710.
In a study published in the July, 1999 issue of the American Journal of Public Health (see attached), Dr. Timothy Sullivan (one of our co-petitioners in the January, 1998 petition to ban powdered latex gloves) and his co-authors reach conclusions even more grave than those of FDA as far as the damage done by the continued use of powdered latex gloves: "At a conservative 8% prevalence, 586,080 [American] health workers are sensitized to latex and are at risk for potentially serious and fatal allergic reactions... Once a worker is sensitized and has an allergic reaction, continued exposure to latex antigens can result in progressive morbidity, increased sensitivity to other antigens, and possibly mortality from anaphylactic reactions. The only known treatment for latex allergy is cessation of exposure." Of the 8% of employees routinely exposed to latex glove use who would develop latex allergy, "2.5% of this number [14,652 health workers] would develop latex-related asthma." In calculating the costs of switching to a "latex-safe" environment, that is, banning the use of powdered latex gloves as well as other latex gloves, the authors found that even with very low rates of permanent disability from these gloves (1%) or low partial disability rates (2%), it was more cost-effective to protect workers by going to a latex-safe environment. They included diagnostic and permanent (but not temporary) disability costs in their calculations, based on a tertiary care hospital, a community-based hospital and an outpatient clinic in Georgia. They concluded that "health care facilities, regardless of size, are likely to benefit financially from becoming latex-safe even if latex-related disability levels are extremely low."
In our original petition, a copy of which is attached to these comments, we cited several examples of hospitals which had made this kind of decision, not only for the above economic reasons but because they were losing valuable, experienced employees:
In 1993, Brigham and Women's Hospital, a Harvard teaching hospital in Boston, experienced a mysterious epidemic among operating room personnel, in which 12 to 14 employees a day were unable to complete their typical duties due to allergic reactions. An internal investigation, followed by the hiring of an environmental consultant, identified the source of the epidemic to be exposure to latex — especially to aerosolized glove powder, which bound the latex proteins . Following this experience, the hospital became powder-free. In other words, they no longer use powdered latex surgical gloves.
In December of 1995, Jackson Memorial Hospital in Miami also chose to convert to low allergen, powder-free gloves "after an epidemic of latex allergy, glove dermatitis and occupational asthma." The number of complaints of reactions to latex plummeted after the switch was made.
Following the lead of these hospitals, Methodist Hospital in Indianapolis eliminated all powdered gloves from their facility in late 1995 and early 1996, after more than 80 employees were identified as allergic to latex. As a result of the switch, none of the allergic employees needed to leave their jobs. "[M]ost of these [80 latex-allergic] employees [had] 10-20+ years of service with Methodist Hospital ... [some] employees had such severe respiratory symptoms that they had to be removed from their current working environments until changes could be implemented." Having identified the primary source of exposure as powdered latex gloves, the hospital eliminated the "latex laden powder." As a result, none of the employees originally diagnosed as allergic lost their job.
The experiences of these hospitals are part of a rapidly growing recognition of problems with cornstarch powdered gloves. In addition to the link with latex allergies noted above, evidence also indicates that cornstarch causes surgical complications. To protect patients and health care workers from the risks of exposure to cornstarch, FDA must follow the example of these hospitals by taking immediate action to ban the use of cornstarch as a lubricant for surgical and examination gloves.
A recent review of latex glove allergy workers compensation cases, mainly involving health workers, confirms the seriousness of the injuries caused by such exposure. (Mealey's Litigation Report, December, 1999). As of June 30, 1999, 13 states had reported decisions in latex-related workers compensation cases and 21 of 30 cases (70%) were deemed compensable, a significant number of which involved total and permanent benefits to the claimants. The number of such claims is rapidly rising. In addition, because this workers' compensation remedy often falls far short financially, especially for those totally and permanently disabled, a growing number of product liability lawsuits, currently estimated to be more than 500, are being filed against glove manufacturers, suppliers and distributors of these latex products.
Foreign Body Disease in Patients From Gloves
In addition to the problems which occur in health workers because of repeated exposure, patients also experience serious problems after exposure during surgery.
Scientific experimental and clinical studies confirm that cornstarch promotes disease in surgical patients by two different mechanisms. First, when deposited in the wound, it acts as a foreign body that elicits an exaggerated inflammatory response and interferes with the host's defenses against infection. When cornstarch contaminates soft tissues, it promotes the development of wound infection. The presence of small amounts of cornstarch promotes wound induration, bacterial growth, and wound infection. When cornstarch gains access to the peritoneal cavity, it can cause granuloma formation, adhesion formation and peritonitis. The development of cornstarch induced adhesions can produce intestinal obstruction, infertility, and pelvic pain. Other documented adverse reactions to cornstarch include endophthalmalitis, post-thoracotomy syndrome, meningismus after craniotomy, retroperitoneal fibrosis, and synovial inflammation.
Why We Favor a Ban on Powdered Latex Gloves in Addition to Restrictions on Latex Protein Content
As stated in our original petition, we strongly favor a ban on powdered latex gloves, which could be announced now — already four years after FDA started looking into this matter — but become effective in 18 months. The 18 months would, according to FDA's own reasoning, allow manufacturers adequate time to switch from manufacture of powdered to non-powdered gloves. 64 Fed. Reg. 41718. We also favor, but with a shorter time for implementation, FDA's proposal to reduce the permissible amount of latex allergen in latex gloves. FDA offers no reason why the time-frame for implementation of this aspect of its proposal should be two years, rather than one. Moreover, 1200 micrograms of latex protein per glove does not appear to be based on any safe scientific health assessment. Rather, it appears to be based on the analytical sensitivity of one particular test (not at all the most sensitive test) for measuring latex protein. Yet it is clear that much lower amounts of latex protein per glove can cause a reaction in latex-sensitized people. (J.All. Clin. Immunol. 1996;98:872-83)
It is quite extraordinary that one branch of the Department of Health and Human Services (HHS), the National Institute for Occupational Safety and Health (NIOSH), has taken a much stronger stand on this issue than is reflected in the weak proposal of FDA. NIOSH has recognized the danger that the continued use of these gloves poses to workers. A safety alert report released in June 1997, entitled "Preventing Allergic Reactions to Natural Rubber Latex in the Workplace," not only alerted the public, employers, and safety and health officials to the increase in allergic reactions to latex, particularly among health care workers, but also recommended that "[i]f latex gloves are chosen, provide reduced protein, powder-free gloves to protect workers from infectious materials." For this NIOSH recommendation to be effective in protecting already sensitized workers from debilitating and life-threatening injuries and to prevent new workers from becoming sensitized, FDA must not only significantly reduce the latex protein content in these gloves but also ban powdered gloves entirely.
In the July 1999 Federal Register Notice, FDA discussed alternatives to the proposed regulation and, with respect to our petition, said the following:
A ban of all powdered medical gloves has been requested in a citizen petition submitted to FDA. FDA considered banning powdered gloves because that action would meet the stated objective of eliminating airborne powder and greatly reducing exposures to airborne allergens associated with the use of medical gloves. However, FDA did not select this alternative because a ban would not address exposure to NL [natural latex rubber] allergens from medical gloves with high levels of NL proteins. Moreover, such a ban of powdered gloves might compromise the availability of high quality medical gloves and greatly increase the annual costs by almost as much as $64 million over the selected alternative.
Elsewhere, FDA stated that another reason for rejecting our petition was that an immediate ban might cause a disruption in the supply of medical gloves.
The stated reasons for rejecting our request for a ban are insufficient. First, although a ban on powdered latex gloves would not address exposure to NL allergens through non-powdered gloves, FDA offers no reason why a ban on powdered gloves could not be implemented in conjunction with a rule reducing the permissible amount of NL allergens in non-powdered gloves. Neither action would be exclusive of the other.
Second, a September 1997 FDA bulletin from the Center For Devices and Radiological Health (CDRH), entitled "Medical Glove Powder Report," considered various alternatives for addressing the problem of powdered latex gloves. Alternative #2 was:
Ban powdered medical gloves at some predetermined time in the future. Require manufacturers to convert to powder-free production or provide safety data, including foreign body and airborne allergen concerns, by a certain date.
Pro: Should not precipitate market shortage. Requires no education effort.
Offers a greater degree of protection from airborne natural latex allergens than Option 1.
(Option 1. was providing information to consumers.)
Con: Conversion date would have to be negotiated with industry to avoid market shortage.
The effect of powder-free gloves on user preferences and needs for qualities such as tactile sensation, etc. are largely unknown. Would most likely result in increased costs to the U.S. health care system. It is not clear that the amount of particulates need to be reduced to the "powder-free" level in order to offer an acceptable level of protection from adverse health effects. Does not address natural latex protein level. Would require a new regulation.
Thus, more than two years ago, FDA concluded that a ban, implemented at a predetermined date, would not lead to a shortage of supply. The agency's 1997 conclusion is supported by the commentary accompanying the July 1999 Proposed Rule, which suggests no reason why a ban made effective with an 18-month lead time would disrupt the supply of gloves.
In addition, each of the "cons" listed by FDA in 1997 is negated today by the widespread use of powder-free gloves; current estimates of the overall cost balance (such as worker disability), not just the increased cost of powder-free gloves; FDA's decision to add protein content to the standard, and FDA's decision to promulgate a regulation. In fact, in the July 1999 Proposed Rule, FDA states: "FDA is also considering a future requirement that all surgeons' and patient examination gloves marketed in the United States be powder-free."
We agree with the Agency that a standard addressing the level of protein in latex gloves should be implemented. We question the standard propsoed in the July 1999 Proposed Rule, as it does not seem to be based on a scientific assessment of a safe level. Most importantly, for the reasons stated in these comments and in our January 1998 petition, we again urge FDA to ban the use of powdered latex medical gloves. Based on the findings discussed in the Proposed Rule, such a ban should become effective 18 months after publication of a final rule. Finally, we urge FDA to issue a final rule as soon as possible.