OSHA latex warning raises storm of protest
OSHA latex warning raises storm of protest
Critics fear bulletin is disguised regulation
The U.S. Occupational Safety and Health Administration has issued a controversial technical bulletin alerting compliance officers to latex hazards for health care workers, despite a storm of protest from organizations and individuals accusing the agency of promoting fraudulent science and fueling hysteria.
OSHA officials insist the bulletin is only an advisory and not a new regulation. Medical officer Angela C. Presson, MD, MPH, says the bulletin was developed in response to "numerous questions" from compliance officers who inspect health care facilities, in an effort to provide background information.
Opposition to the proposed OSHA bulletin converged at a hastily called Congressional subcommittee hearing recently. The Subcommittee on Oversight and Investigations of the House Education and the Workforce Committee, chaired by Rep. Peter Hoekstra (R-MI), heard testimony from both critics and supporters of the document, which had not been released at that point.
Testifying before the Congressional subcommittee, Presson said the bulletin is "only advisory; it is not a new regulation or a standard, and its purpose is to assure that our field staff have accurate information on this issue."
To reduce worker exposure to natural rubber latex (NRL) proteins, OSHA recommends hospitals follow general administrative procedures, including the following:
• in selecting latex gloves for worker use, designate NRL as a choice only in situations requiring protection from infectious agents;
• choosing NRL gloves with lower protein content, as well as powder-free gloves offering the additional benefit of reducing systemic allergic responses;
• providing alternative non-NRL gloves as choices for worker use (and as required by OSHA’s bloodborne pathogens standard) for workers allergic to NRL gloves.1
Attempt to circumvent rulemaking?
OSHA had developed and sent to stakeholders several versions of the bulletin during the past two years, each time revising it according to comments received. Nevertheless, some critics charge that OSHA is attempting to disguise rulemaking in the form of an information bulletin.
F. Samuel Eberts III, associate general counsel for latex glove manufacturer Allegiance Healthcare Corp., in McGaw Park, IL, called upon the panel to address "OSHA’s circumvention of the federal notice and comment rulemaking procedures under the guise of issuing its proposed bulletin." Allegiance is a market leader in latex glove sales and also produces a smaller line of non-latex alternatives.
Also speaking against the bulletin were former U.S. Surgeon General C. Everett Koop, MD, and Charles E. Reed, MD, retired head of the division of allergic diseases and internal medicine at Mayo Clinic in Rochester, MN. Same-Day Surgery has learned from several sources that both are paid consultants to Allegiance Healthcare Corp., although the company would not confirm this.
Both Koop and Reed claim that the OSHA document will unnecessarily frighten health care workers into abandoning universal precautions or even their careers.
Many HCW symptoms are actually due to "anxiety attacks" rather than latex allergy, Reed states.
Koop, testifying by videotape, said powdered latex gloves have come under attack in the past few years due to "hysteria" that is "reminiscent of the hysteria surrounding AIDS in the early years."
OSHA has "fueled this hysteria by interjecting itself into latex glove regulation," Koop charges. He predicts the bulletin will undermine universal precautions, with a "spin-off" of undermining latex condom use, as well.
Although the debate within the national regulatory arena continues, day-surgery program managers are focusing on their patients and their own staffs. While there is a systemwide task force to address latex allergies among employees and patients at the Moses Cone Health System in Greensboro, NC, the ambulatory surgery program focuses on patient safety, says Sandra W. Caudle, RN, CNOR, assistant director of the day-surgery center.
"We don’t have any staff members with latex allergies, but we do have latex-free products available for them to choose," Caudle says.
To protect patients, the staff make sure that patients with latex allergies are scheduled as the first case in an operating room. "We also order a latex-free bin that contains a variety of gloves, catheters and other latex-free items for use during the case," she explains. The patient’s room and chart are clearly marked for the allergy and all latex supplies are either removed or covered in the operating room to make sure latex products are not accidentally used, she adds.
"We have also educated our staff about latex allergies through inservice programs," adds Caudle.
The more education, the less hysteria’
Presson responds that the OSHA bulletin is intended to quell fears, not fuel them.
"We believe that the more education that is out there, the less hysteria there will be," Presson says.
Other critics claim that OSHA is entering Food and Drug Administration territory by issuing the bulletin. However, both OSHA and FDA deny any conflict.
"We and the FDA both explained that very well at the hearing," Presson says. "OSHA has worked collaboratively with the FDA . . . to assure coordinated activities in addressing the health hazards associated with exposure to natural rubber latex."
So far, FDA regulatory activity related to latex has focused on promulgating a rule requiring labeling statements on medical devices and device packaging containing NRL.2 Labeling information allows sensitized people to avoid further exposure and enables users to make informed choices about gloves and other products.
Those testifying in favor of the bulletin included Robert G. Hamilton, PhD, associate professor of medicine at Johns Hopkins University School of Medicine in Baltimore and developer of the first reliable puncture skin test reagent for diagnosing latex allergy. The test is currently awaiting FDA approval.
After considerable study and investigation, Johns Hopkins Hospital decided to eliminate latex gloves last year, Hamilton told the subcommittee. The transition has been accomplished with minimal increased cost.
The Washington, DC-based American Nurses Association (ANA) also advocates OSHA’s action. Testifying before the subcommittee on behalf of the ANA and a coalition of HCW labor unions, Susan Q. Wilburn, RN, MPH, senior occupational health and safety specialist, said latex allergy is increasing among HCWs.
ANA research shows that up to 200,000 registered nurses are allergic to latex.
"Chronic exposure to latex in an allergic worker can lead to permanent pulmonary and cardiac diseases and premature death," Wilburn said.
Congress takes no action
Since the hearing, Congress has taken no further action to delay release of the bulletin, which recently was sent to OSHA field offices and compliance officers.
The congressional panel’s main concern in calling a hearing was whether the OSHA document was helpful or confusing. More importantly, Congress is worried that informal rulemaking is occurring, says Gary Visscher, general labor counsel for the workforce committee.
"The concern was whether OSHA has reviewed all the evidence, as they would have to in the regulatory process. There is no assurance of that in an informal process," he says.
[Editor’s note: The technical information bulletin is available on the OSHA Web site at http://www.osha.gov. Most of the Congressional hearing testimony is available on the Web at http://www.house.gov/eeo/hearings/106th/oi/latex32599/wl32599.htm. Wilburn’s testimony is available at http://www.nursingworld.org/gova/federal/legis/testimon/1999/latx0325.htm.]
References
1. Sussman G, Gold M. Guidelines for the Management of Latex Allergies and Safe Latex Use in Health Care Facilities. Arlington Heights, IL: American College of Allergy, Asthma, and Immunology; 1996.
2. Department of Health and Human Services, Food and Drug Administration. Natural rubber-containing medical devices; user labeling. 62 Fed Reg 51,021 ( Sept. 30, 1997).
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