United States: OSHA Interpretation Regarding Commercially Sold Medical Kits

The Occupational Safety and Health Administration (OSHA) has interpreted its Bloodborne Pathogens Standard, 29 C.F.R. § 1910.1030, to require employers to supplement a medical device kit containing a sharp lacking engineered protection with a commercially available version of the sharp that has engineered sharp protection.

Paragraph (d)(2)(i) of the Standard requires employers to use engineering controls to eliminate or minimize employee exposure to bloodborne pathogens. Paragraph (c)(1)(iv)(B) requires an employer’s exposure control plan to "document annually consideration and implementation of appropriate commercially available and effective safer medical devices designed to eliminate or minimize occupational exposure."

With respect to medical device kits, OSHA has interpreted these requirements to mean that employers must (1) examine the contents of commercially sold medical kits they use that contain sharps; (2) determine whether each unprotected sharp contained within the kits can be replaced by commercially available devices with engineered sharp protection (i.e., a protected sharp); (3) supplement each kit with a protected sharp by, for example, taping the protected sharp to the outside of the kit; and (4) require their employees, including staff physicians, and physicians with hospital privileges to use the protected sharps when they open the kits.

Under OSHA’s interpretation, it would not matter that a kit came pre-packaged with an unprotected sharp or that kits would now have to be custom ordered.

Although the interpretation letter was issued on February 20, 2003, the agency has yet to make it available on its website, and its existence does not appear to be well known within the health care industry. Nevertheless, at least two hospitals have already received citations reflecting this new reading of the Standard. The citations were issued by area offices in two different administrative regions of OSHA (Region I, covering New England, and Region II, covering New York/New Jersey/Puerto Rico), which indicates that the interpretation is well known to OSHA inspectors nationwide.

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