May 17, 2001

Mr. Michael McDonnell
308 West Montgomery Avenue
North Wales, PA 19454

Dear Mr. McDonnell:

Thank you for your March 6 letter to the Occupational Safety and Health Administration (OSHA) regarding the "Needlestick Safety and Prevention Act," (NSPA) as it applies to OSHA's Bloodborne Pathogens Standard (29 CFR 1910.1030). While this Act mandated that OSHA include several new provisions into its standard, it did not change, but simply amplified, the importance of and requirements for the implementation of engineering controls (e.g., Sharps with Engineered Sharps Injury Protection) in healthcare and similar settings. For your information, we are enclosing a copy of the revised Bloodborne Pathogens Standard, 29 CFR 1910.1030, and OSHA publication 2056, All About OSHA.

We will restate your questions 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.

1.  Do hospitals and healthcare facilities have to use "engineered control devices" (e.g., safety needles)?

2.  When do these facilities have to have "engineered control devices" safety needles in their facilities, what date?

OSHA's Bloodborne Pathogens Standard, which became effective in March 1992, requires that every employer perform a workplace exposure determination in order to identify hazards and implement proper controls. Although the requirement to implement safer medical devices is not new, the revised standard (2001) further clarifies what is meant by "engineering controls;" it adds language to the definition section of the original 1991 standard that reflects the development over the last decade of safer medical devices.

The standard requires, "(e)ngineering and work practice controls shall be used to eliminate or minimize employee exposure." Engineering controls are defined as, "controls (e.g., sharps disposal container, self-sheathing needles, safer medical devices, such as sharps with engineered sharps injury protections and needleless systems) that isolate or remove a hazard from the workplace." Examples of engineering controls most applicable in healthcare are needleless intravenous systems, retractable needles, and other sharps with engineered sharps injury protection (SESIPs).

According to CPL 2-2.44D [CPL 2-2.69], Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens, where exposures to blood and other potentially infectious materials (OPIM) are reasonably anticipated and engineering controls will reduce employee exposure either by removing, eliminating, or isolating the hazard, they must be used. Consequently, you should already have safer devices in place. If you have not already evaluated and implemented appropriate and available engineering controls (safer medical devices), you must do so immediately.

(Correction 3/15/02)

The exposure determination, as well as the evaluation, implementation, and use of the engineering controls must be documented in the employer's Exposure Control Plan. The plan must be updated at least annually and must reflect changes in job tasks and procedures, and advances in technology.

3. Needles such as vial access needles that are used to fill syringes with either medication or flush fluid to be administered through a needleless adapter device, do they have to be a safety product?

The Bloodborne Pathogens Standard only applies where there is a reasonably anticipated employee exposure to blood or OPIM. In a case such as drawing medication from a vial which will be introduced to an area devoid of blood or OPIM, it would not be necessary to implement SESIPs.

4. Is the "Needlestick Safety and Prevention Act" enforceable? How?

Yes. As mentioned earlier, the Needlestick Safety and Prevention Act mandated changes to the Bloodborne Pathogens standard. OSHA published those changes on January 18, 2001. Therefore, enforcement of the new sections of the standard (i.e., additions to the Exposure Control Plan and recordkeeping) will be carried out just as the enforcement of any other OSHA standard would.

5.  If a facility states that it has no exposure problem or needlesticks with current conventional needles or catheters, do they still have to convert to safety products?

Yes. The standard and its revisions were mandated as a means of prevention. The obligation to implement proper engineering and work practice controls is not contingent on the existence of actual needlesticks in the workplace because the purpose of the Occupational Safety and Health Act (OSH Act) is to prevent the first incident. Where conventional needles are being used, an employer is responsible for evaluating SESIPs available on the market for each particular procedure where there is reasonably anticipated exposure to blood or OPIM and using appropriate, effective devices for those procedures.

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. Also, from time to time we update our guidance in response to new information. 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 Compliance Assistance at (202) 693-2190.

Sincerely,

Richard E. Fairfax, Director
Directorate of Compliance Programs

Enclosures