March 19, 2003

Spencer Atwater, MD
President
Joint Council of Allergy, Asthma and Immunology (JCAAI)
50 N. Brockway Street, Suite 3-3
Palatine, IL 60067

Dear Dr. Atwater:

Thank you for your August 6, 2002 letter to the Occupational Safety and Health Administration (OSHA) regarding the requirement to use engineering controls [e.g., sharps with engineered sharps injury protection (SESIPs)] under the bloodborne pathogens standard [29 CFR 1910.1030(b) and (d)(2)(i)]. After many conversations with you and Becky Burke of your staff, we have tailored our response to specifically address your needs with respect to injection types used in allergy and immunizations. 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. Your question is outlined below followed by OSHA's response.

Scenario: Allergists give millions of injections, including subcutaneous and intradermal injections, every year using small bore (26- or 27-gauge) needles.

Question: Must allergists comply with the requirement to use engineering controls [e.g., sharps with engineered sharps injury protection (SESIPs)]?

All employers with employees who have occupational exposure to blood or other potentially infectious materials (OPIM) must comply with all applicable provisions of the bloodborne pathogens standard (the standard). Potential exposure must be determined by assessing the processes and procedures being performed in each individual workplace.

Employees giving injections, regardless of the needle type or size being used, have occupational exposure to blood; the employer must use engineering controls to eliminate or minimize those exposures [29 CFR 1910.1030(d)(2)(i)]. Engineering controls [e.g., sharps with engineered sharps injury protection (SESIPs) and needleless systems - see definitions in 29 CFR 1910.1030(b)] must be evaluated, selected, and put into use based on feedback from employees responsible for direct patient care [29 CFR 1910.1030(c)(1)(v)].

Engineering controls must be selected based on their appropriateness for the specific procedures being performed and their effectiveness in reducing worker exposures to blood and contaminated sharps. If engineering controls (e.g., SESIPs) are commercially available and feasible (e.g., use does not compromise patient safety, worker safety, or the medical procedure) for a specific procedure, they must be evaluated and implemented.

There are dozens of commercially available syringes with engineered safety features for intramuscular and subcutaneous injections. When giving these types of injections, SESIPs must be selected and used as a means to control exposures.

We understand that currently appropriate controls for intradermal injections may be more limited. Therefore, it is important to identify safer options that may exist, evaluate them for effective safety and appropriateness for the procedures being conducted, and select one based on employee feedback. This must be done on an annual basis as a part of the employer's evaluation of his or her exposure control plan [29 CFR 1910.1030(c)(1)(iv)]. If, based on thorough evaluation, a SESIP is not appropriate to use for intradermal injections, based on the criteria listed above, that fact must be documented in the facility's exposure control plan (ECP). It is then the individual employer's responsibility to evaluate new commercially available devices the following year.

Please be aware that compliance is assessed on a facility-by-facility, instance-by-instance basis, therefore each employer at each facility must determine the appropriateness and effectiveness of the use of SESIPs for the specific procedure being conducted. Selection and implementation should not be done on a broad, national basis, unless that employer can ensure that the selection of devices is unique to the procedures being done in each of the facilities and that employees have the opportunity to provide feedback on the selection of the engineering controls.

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 Enforcement at (202) 693-2190.

Sincerely,



Richard E. Fairfax, Director
Directorate of Enforcement Programs