Medical Clearance for Respirator Use: Sensitivity and Specificity of a Questionnaire George P. Pappas, MD, MPH, 1 Timothy K. Takaro, MD, MPH, 1 Bert Stover, BA, 1 Nancy Beaudet, CIH, 1 Mary Salazar, RN, 1 John Calcagni, MD, 2 Douglas Shoop, CIH, 3 and Scott Barnhart, MD, MPH 1 Background OSHA regulations require that workers receive medical clearance prior to respirator use, and recently, a detailed questionnaire has been provided to assist with this purpose. However, there are limited published data on the sensitivity and specificity of self-administered questionnaires for identifying individuals who may safely wear a respirator. Methods We tested 474 consecutive workers at a Department of Energy complex. After completing the self-administered questionnaire, all workers received a standardized physician evaluation including interview, physical examination, and spirometry. The outcomes of the questionnaire assessment were compared to the outcomes of physician evaluation. Results Data for analysis were available from 413 of workers (87%). All workers received medical clearance; only 10 workers (2.4 %) received work restrictions. The questionnaire demonstrated 100% sensitivity in identifying workers who required work restrictions, but had specificity of only 19%. Compared to physician evaluation, the questionnaire had modest sensitivity to the detection of chronic medical conditions. Conclusions These data suggest that the rates of medical clearance for respirator use are very high, and that a self-administered questionnaire may be appropriate for medical clearance in certain settings. It is recommended that the policy of routine physician evaluation and spirometry for respirator clearance be re-examined. Am. J. Ind. Med. 35:395–400, 1999.  1999 Wiley-Liss, Inc. KEY WORDS: occupational medicine; respiratory protective devices; medical surveillance INTRODUCTION Respiratory protective devices (respirators) minimize inhalational exposures to particulates, fumes, mists, gases, radioactive materials, and biological agents. However, wear- ing these devices can impose physiologic and psychologic stress (Dahlback and Balldin, 1984; Dubois et al., 1990; Harber, 1984; Harber et al., 1996, 1982; Hodous, 1986; Louhevaara et al., 1985; Louhevaara, 1984; Morgan, 1983). Although wearing a respirator is well tolerated by most individuals, persons with underlying medical conditions or limited cardiopulmonary reserve may be at risk for adverse health events as a result of use of these devices. The United States Occupational Safety and Health Administration (OSHA) and the American National Standards Institute (ANSI) mandate that all workers required to wear a respira- tor receive medical clearance for respirator use (OSHA, 29 CRF 1910.134; ANSI, 1992). Thousands of these evalua- tions are performed annually; however, the criteria for appropriate medical evaluation and safe respirator use have not been determined. The recent OSHA Respiratory Protec- tion Standard provides a detailed questionnaire for purposes 1 University of Washington, Seattle, WA 2 Hanford Environmental Health Foundation, Richland, WA 3 Fluor Daniel Hanford Inc., Richland, WA *Correspondence to: Timothy Takaro, MD, MPH, University of Washington, Occupational & Environmental Medicine Program, 4225 Roosevelt Way NE Suite 100, Seattle, WA 98105; E-mail: ttakaro@u.washington.edu Grant sponsor: Comprehensive Occupational Health Surveillance; Grant num- ber: RO1 OH1 2031; Grant sponsor: Department of Energy Cooperative Agree- ment; Grant number: DE-FC01–9JEWSJ084 Consortium for Risk Evaluation with Stakeholder Participation. Accepted 30 November 1998 AMERICAN JOURNAL OF INDUSTRIAL MEDICINE 35:395–400 (1999)  1999 Wiley-Liss, Inc.