Core Practices: OSHA Cites Hospitals Based On Medical Kit Interpretation

Suppose your hospital receives a kit containing equipment for an epidural anesthetic and in the kit is a syringe lacking an engineered sharp protector. May you lawfully use the syringe?

The Occupational Safety and Health Administration (OSHA) has interpreted its Bloodborne Pathogens Standard, 1910. 1030, to require healthcare employers to supplement medical device kits containing sharps without engineered protection with commercially available sharps that have engineered 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."

In 2002, Becton, Dickinson & Co. wrote to OSHA inquiring whether OSHA's 2001 amendment to the standard, which was required by the Needlestick Safety and Prevention Act, "require[s] that pre-packaged kits include safety-engineered devices?" Becton, Dickinson's letter to OSHA noted that "these pre-packaged kits or trays may be prepared by outside vendors specifically for physician specialists in operating rooms and surgical centers."

OSHA's Interpretation

OSHA responded by letter on February 20, 2003. Its reasoning started with the proposition, drawn from paragraph (d)(2)(i) of the standard, that "employers are required to evaluate, select, and use engineering controls (e.g., sharps with engineered sharps injury protections, needleless systems) to eliminate or minimize exposure to contaminated sharps." From this, it leaped to the conclusion that, "[i]n healthcare settings, this requirement is easily interpreted to mean that" sharps must have engineered sharps protection "regardless how they are packaged or supplied." Hence, it stated, if "physician specialists or other healthcare personnel are using medical instruments supplied in pre-packaged kits, those packages must include engineering controls appropriate for the specific procedures being performed."

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. OSHA's letter also noted that surgeons, anesthesiologists and physicians with hospital privileges must use devices with engineered sharp protection to prevent injuries to not only themselves but to other hospital employees, such as surgical assistants and nurses. The upshot of this interpretation is that healthcare 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.

Although OSHA's letter was issued in February 2003, it was not until October 2004 that it was (at our suggestion) posted on OSHA's Web site. The letter's existence does not appear to be well known within the health care industry, and citations based on it have caught at least two hospitals by surprise. These 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 and Puerto Rico), which suggests that the interpretation is known to OSHA inspectors generally.

Healthcare providers such as hospitals should therefore be on the lookout for medical kits with unprotected sharps, and should, when they annually review their exposure control plans, state in the plans that this issue has been considered for the current year. To see a copy of OSHA's interpretation letter, go to OSHA's Web site at: www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=24917.

Arthur G. Sapper is a partner in the OSHA Practice Group of McDermott Will & Emery LLP, a former adjunct professor of OSHA law, and the former deputy general counsel of the Occupational Safety and Health Review Commission. Eric J. Conn is an associate in the group. They are contributing editors to Occupational Hazards.

For more information about the OSHA Group at McDermott Will & Emery LLP, go to: www.mwe.com/index.cfm/fuseaction/experience.detail/object_id/2bea70b2-1157-4b5c-bcce-4ebd44dc4a39/long/1.cfm.

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