April 2003
To: JCAAI Members
Re: OSHA Response to JCAAI Letter on Safe-Needle Use

JCAAI recently received a response to its inquiry to OSHA regarding requirements for safe needle use in the allergy setting. JCAAI asked OSHA whether safe needles were required when giving immunotherapy or intradermal injections using small bore (26 or 27 gauge) needles.

Immunotherapy Injections

OSHA's position on subcutaneous allergy immunotherapy injections is that they must be used. The agency stated:
There are dozens of commercially available syringes with engineered safety features for intramuscular and subcutaneous injections. When giving these types of injections, SESIPs [sharps with safety engineered sharp injury protection] must be selected and used as a means to control exposures.
This position is consistent with OSHA's advice last year to the American Academy of Pediatrics which was reported on the JCAAI website.

Intradermal Injections

With respect to intradermal injections, OSHA offers more flexibility. The Agency acknowledges that the availability of safe needles for intradermal injections may be limited. Although employers must still evaluate new safe needle devices for intradermal injections.
[I]f, based on a through evaluation, a SESIP is not appropriate to use for intradermal injections, based on the criteria listed above [i.e.not commercially available, compromises patient safety, worker safety, or the medical procedure] that fact must be documented in the facility's exposure control plan (ECP).
Thus, if an intradermal injection cannot be done safely or effectively using commercially available safe needles, allergy practices are not required to use them. However, each practice must conduct its own evaluation and document its findings.

JCAAI Recommendations

JCAAI urges allergists who have not yet implemented OSHA requirements to do so immediately in order to avoid an OSHA inspection and possible fine. In addition, JCAAI reminds members that OSHA obligations are ongoing and that each office must have an exposure control plan which must be updated annually. This means that each group must, at least once a year, review its bloodborne pathogen exposure control plan with its employees and conduct an evaluation of any new safety needles or other appropriate devices which are commercially available to determine whether they should be implemented. If your group has not performed such an evaluation or reviewed its bloodborne pathogen plan with employees in the last year, you should do so immediately.

June 10, 2002
TO: JCAAI Members
RE: OSHA requirements for safe-needle use

OSHA has recently clarified the rules regarding the new safety engineered syringe/needle combinations. This was in response to a series of questions presented by the American Academy of Pediatrics (AAP). They had objected to the requirement for safety engineered devices as harmful to broad vaccination programs. I will summarize their remarks below, but if you wish to access the entire opinion, you can find it at http://www.OSHA.gov; scroll down the page to “Regulation and Compliance” and click on “Interpretation”. Then search for the opinion dated November 26, 2001 entitled “Response to American Academy of Pediatrics Regarding the Needlestick and Prevention Act”.

In a nutshell, it appears from this opinion you MUST shift to the newly engineered safety syringe/needle combinations unless using a safer medical device “compromises either patient safety or medical integrity.”

The AAP asked that an exemption be granted for use of the new devices until a study was carried out in ambulatory health care facilities where childhood immunizations are provided. In specifically denying this request, OSHA said, “It would be particularly inappropriate to grant an exemption to the requirement …. The very purpose of the Act, was to make sure SESIP’s (Sharps with Engineered Sharps Injury Protection) are used as part of an overall blood pathogen program to reduce accidental Sharp injuries. Congress found that ‘depending on the type of device used and the procedure involved, 62-88% of Sharp injuries can potentially be prevented by the use of safer medical devices.”:

OSHA then responded to the AAP request to allow front-line employees to conduct their own risk assessments and make the choice of a SESIP optional. OSHA also rejected this approach stating that “Non-managerial employees responsible for direct patient care must have input into employer decisions about WHICH engineering controls to adopt, not whether or not to adopt them. The standard does not give the employer the option to forgo appropriate, commercially available and effective engineering controls… If the employer feels that a particular device is cumbersome or awkward, employees may need additional practice or training until they feel comfortable with a new and different device…. Again, if appropriate and effective safer options are commercially available for specific medical procedures where there is reasonably anticipated exposure to blood or OPIM, they must be used.”

OSHA also refused to further delay implementation of this rule which they date to December, 1991 as the first articulation of the rule.

Finally, while not specifically covered in this response, our consultants continue to strongly believe that needle destruction devices will not be acceptable as a choice in place of a safety engineered syringe, even though they are recognized as effective needle destruction systems. We believe this rule must be implemented immediately and urge you to do so in order to avoid an OSHA inspection and fine.

Sincerely,

David F. Graft, MD
JCAAI President

Donald W. Aaronson, MD
Executive Director