APIC to OSHA: TB was stopped without respirators
Early identification, isolation, and treatment
In a formal letter to the Occupational Safety and Health Administration (OSHA) regarding its recently announced tuberculosis requirements, the Association for Professionals in Infection Control and Epidemiology (APIC) made the following key objections to the action:
Nosocomial TB controlled prior to respirator use:
The resurgence of TB seen in the late 1980s and early 1990s has been attributed to numerous demographic, epidemiologic, and clinical factors. In health care facilities, outbreaks of tuberculosis were controlled and prevented by early identification of cases, prompt isolation, and appropriate treatment. These outbreaks were controlled prior to the use of particulate respirators and fit-testing, when masks were the standard for protecting health care personnel. There is no evidence that respirators are necessary to control infectious diseases (due to the nature of infectious aerosols: particle size, electrostatic forces, etc.). The hierarchy of controls: early identification, prompt isolation, and appropriate treatment controlled transmission of TB with the use of submicron masks (not a respirator and not fit-testing).
Unreliable fit-testing methods:
Prior to 1995, respirator certification procedures included a fit-testing component. This is no longer the case and should be reinstated. Rather than placing the responsibility on every employer and user, the regulatory process for manufacturers should include a fit-test component; only respirators with good facial fit characteristics should be certified and information regarding facial fit characteristics should be made available to employers and users. Priority should be given to the development and assurance of enhanced fit characteristics for particulate respirators for all uses under the General Industry Respiratory Protection Standard regardless of the applicability of this general standard to health care exposures to patients. Various methods of fit-testing have been described, yet the validity, reliability, reproducibility, and effectiveness of fit-testing and fit-testing methods have not been established. Numerous studies have been published that would suggest that different methods produce different results, and the provision of fit-testing does not necessarily correlate with proper donning of respiratory protection in the work setting. In addition, the incremental benefit of fit testing is dependent upon the fit characteristics of the device itself (i.e., if the respirator has inherently good fit characteristics, the incremental benefit is minimal).
In early 2000, Congress commissioned a third-party study of the proposed TB rule by the Institute of Medicine (IOM). Throughout the Dec. 31, 2003, withdrawal notice, OSHA refers to important findings in the IOM study that reinforce the agency’s decision to withdraw the proposed TB rule. It is interesting to note, however, that OSHA chooses not to cite the IOM’s concerns on the subject of annual fit-testing of respirators, choosing instead to impose this requirement through an already-existing regulatory mechanism, for no apparent or justified reason. Had OSHA considered the IOM’s conclusions on this subject, we are sure that the agency would again have found the CDC’s recommendations completely adequate for addressing respiratory protection. In its report Tuberculosis in the Workplace, IOM concluded the following, with respect to fit-testing of respirators:
"Modeling studies suggest that the benefits of respiratory protection are directly proportional to the presence of risk. In facilities that admit only the occasional individual with tuberculosis or that have a policy of transferring such individuals, workers are likely to see no or very marginal additional protection from an extensive respiratory protection program. Administratively, a program for fit-testing of personal respirators requires trained personnel to conduct a complicated series of tests. Scheduling for an annual fit test must allow time for the test as well as time for workers to get to and from the test site (which may be on another floor or in another building).
A requirement for annual retesting multiplies the number of people who must be scheduled and tested each year. The more workers who are covered by an employer’s respiratory protection program, the more complex will be the employer’s administrative burden and the greater the expense. For large medical centers that treat substantial numbers of tuberculosis patients, annual fit-testing can be a major undertaking that involves thousands of workers."1
- Institute of Medicine — Committee on Regulating Occupational Exposure to Tuberculosis. Tuberculosis in the Workplace. Washington, DC: National Academy Press; 2001.