Needlestick Safety and Prevention Act and the requirement to include safety- engineered sharps devices in pre-packaged surgical kits and trays.

February 20, 2003

Ms. Wendy Gallart
Senior Marketing Manager
BD Advanced Protection Technologies
Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes, NJ 07417

Dear Ms. Gallart:

Thank you for your October 29, 2002 letter to the Occupational Safety and Health Administration (OSHA) regarding the requirement for employers to use engineering controls (e.g., safer medical devices) under the bloodborne pathogens standard [29 CFR 1910.1030]. Your question is restated below followed by OSHA's response. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question not delineated within your original correspondence.

Does compliance with the updated bloodborne pathogens directive enforced by the Needlestick Safety and Prevention Law require that pre-packaged kits include safety-engineered devices?

Note: These pre-packaged kits or trays may be prepared by outside vendors specifically for physician specialists in operating rooms and surgical centers.

The Needlestick Safety and Prevention Act (NSPA) was signed into law in November 2000. It mandated OSHA to revise its bloodborne pathogens standard to include specific additional definitions and requirements. OSHA published "Revision to OSHA's Bloodborne Pathogens Standard -- Technical Background and Summary -- Needlestick Fact Sheet (2001, May 9)," which clearly details the changes to the standard. We have attached it for your convenience. It is also available on our website, along with other informative outreach materials on the hazards associated with exposure to blood and other potentially infectious materials (OPIM), see [the Bloodborne Pathogens Technical Links Page].

The Needlestick Safety and Prevention Act is not enforceable on its own, but rather the Occupational Safety and Health Act of 1970, which requires compliance with OSHA standards. The OSHA bloodborne pathogens standard requires the institution of safety measures in workplaces where there is occupational exposure to blood or other potentially infectious materials (OPIM). Under the standard, as revised by the NSPA, employers are required to evaluate, select, and use engineering controls (e.g., sharps with engineered sharps injury protections or needleless systems) to eliminate or minimize exposure to contaminated sharps [29 CFR 1910.1030(d)(2)(i)].

In healthcare settings this requirement is easily interpreted to mean that employers must implement the use of "safety-engineered devices" or sharps with engineered sharps injury protection (SESIPs) when performing medical procedures with sharps, regardless how they are packaged or supplied. If, during surgical procedures, as your letter specifies, 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. Employees using these devices must have the opportunity to provide feedback on appropriate and effective safer devices [29 CFR 1910.1030(c)(1)(v)].

We understand that physician specialists (e.g., surgeons, anesthesiologists, etc.) often are not employees of healthcare facilities where they have staff privileges. Under OSHA's bloodborne pathogens compliance directive (OSHA Instruction CPL 02-02-069 [formerly CPL 2-2.69]) the status of the physician as an employer or employee is important to establish in order to determine the application of OSHA standards. According to the paragraph XI.D. in the directive, physicians "... may be cited if they create or control bloodborne pathogens hazards that expose employees at hospitals or other sites where they have staff privileges in accordance with the multi-employer worksite guidelines of CPL 02-00-124 [formerly CPL 2-0.124], Multi-Employer Citation Policy."

Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA requirements are set by statute, standards, and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. To keep apprised of such developments, you can consult OSHA's website at http://www.osha.gov. If you have any further questions, please feel free to contact the Office of Health Enforcement at (202) 693-2190.

Sincerely,


Richard E. Fairfax, Director
Directorate of Enforcement Programs 

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