Aug. 17, 2001



Mr. Alan Kirschenbaum
Hyman, Phelps & McNamara, P.C.
700 13th Street NW Suite 1200
Washington, DC 20005-5929

Dear Mr. Kirschenbaum:

Thank you for your May 24 letter to the Occupational Safety and Health Administration's (OSHA's) Directorate of Compliance Programs regarding the applicability of the Bloodborne Pathogens Standard (29 CFR 1910.1030) to nuclear medicine, specifically to the use of injectable therapeutic radiopharmaceuticals. Your letter follows a meeting that you and members of the Council on Radionuclides and Radiopharmaceuticals (CORAR) had with members of the Office of Health Compliance Assistance.

Your letter poses questions relating to the revised Bloodborne Pathogens standard (January 18, 2001) as amended by the Needlestick Safety and Prevention Act. The revised standard includes specific language regarding the requirement for employers to select safer needle devices, as they become available, for procedures where occupational exposure to blood and other potentially infectious materials (OPIM) is reasonably anticipated.

One of the new provisions of the standard is the requirement for employers to solicit input from non-managerial employees to identify, evaluate, and choose appropriate safer medical devices. The solicitation must be documented in an employer's Exposure Control Plan, which must be updated annually and as changes occur. Because the practice of nuclear medicine is unique, you are requesting an interpretation specific to this field of medicine.

Your questions are 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 questions not delineated within your original correspondence.

Question: Should employers in healthcare facilities who handle radiopharmaceuticals take into account the hazards of radiation exposure when they conduct periodic reviews for appropriate, commercially-available safety syringes?

Yes. When evaluating safer medical devices, the employer must consider the appropriateness of each device for each procedure. In the administration of radiopharmaceuticals, the radiation itself poses an occupational hazard to employees. This must be accounted for in the evaluation and implementation of devices. The safer device must not compromise employee protection from the radiation hazard.

Question: Should such employers seek the input of nuclear pharmacists, nuclear physicians, or radiation safety officers in the evaluation and selection of safety syringes?

Yes. When employers are seeking input from employees regarding the selection of safer medical devices, the employees selected should represent the range of exposure situations encountered in the workplace (e.g., pediatrics, nuclear medicine, emergency department, etc.). The solicitation of employees who have been involved in the input and evaluation process must be documented in the employer's Exposure Control Plan.

Question: When conducting reviews for appropriate, commercially-available safety syringes to be used with radiopharmaceuticals, would it be prudent for healthcare employers to utilize [certain] criteria to determine the appropriateness of currently available safety syringes?

The criteria that you describe in your letter, which are used by some nuclear medicine practitioners to select safer medical devices, include such items as: ensuring that the “safety syringe” fits snugly into a radiation shield, ensuring that the syringe can be operated without displacing the radiation shield, and determining that the syringe does not leak or project radioactive material. In using these criteria, if a “safety syringe” fails to meet one or more of these items, it is not chosen. Using additional guidelines may also be useful. For example, “Sharps Feature Evaluation Forms” intended to be used for the evaluation of safer medical devices are available from the Training for Development of Innovative Control Technologies (TDICT) Project at http://www.tdict.org and http://www.osha.gov.

An employer's criteria for choosing appropriate medical devices are specific to each employer, facility, process, and procedure. Again, when choosing a safer medical device, it is important that the devices chosen do not cause employees to be exposed to additional hazards (e.g., radiation).

Question: What are a healthcare employer's obligations if, upon review of available safety syringes, the employer determines that there are no syringes currently on the market that are appropriate for use with radiopharmaceuticals?

How should a healthcare employer document its considerations and decisions regarding whether commercially-available safety syringes are appropriate for use with radiopharmaceuticals?

If there are currently no safer medical devices (safety syringes) available on the market for a specific procedure, the employer must document this in his or her Exposure Control Plan. As stated in OSHA's 2001 Frequently Asked Questions,

“A key element in choosing a safer medical device, other than its appropriateness to the procedure and effectiveness, is its availability on the market. If there is no safer option for a particular medical device used where there is exposure to blood or OPIM, you are not required to use something other than the device that is normally used. During your annual review of devices, you must inquire about new or prospective safer options and document this fact in your written Exposure Control Plan. With increasing medical technology, more devices are becoming available for different procedures. If no engineering control is available, work practice controls shall be used and, if occupational exposure still remains, personal protective equipment must also be used.”

Question: For states and territories that operate federally-approved occupational safety and health plans, must such plans permit healthcare employers to decline to use safety syringes with radiopharmaceuticals if no appropriate syringes and syringe-radiations shields are commercially available?

As mentioned in our previous response, if no safer options are currently available, it must be documented in the facility's Exposure Control Plan. This would apply in Federal OSHA states, as well as OSHA state-plan states. Please be aware that OSHA state-plan states administer their own occupational safety and health programs under plans approved and monitored by Federal OSHA. States are required to have regulations that are “at least as effective” as the federal standards, but may also be more stringent. States are expected to adopt a standard equivalent to the revised federal standard by October 18, 2001. Employers are responsible for determining the regulations that apply in their particular states. For a list of Federal and state-plan states, log onto OSHA's website at https://www.osha.gov.

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 https://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