Needle-Eater sharps device and bloodborne pathogens standard

August 28, 1996

[Name Withheld]
Dear [Name Withheld]:

This is in response to your letter dated December 5, 1995, concerning the SPS "Needle-Eater" and accessory sharps "transfer container." As we have discussed, the "Needle-Eater" was referred to us by OSHA regional staff who raised concerns about its use and the safe handling of sharps.

This letter provides our interpretation of the Bloodborne Pathogens Standard, 29 CFR 1910.1030 as it pertains to this device. In general, the Occupational Safety and Health Administration (OSHA) does not review products as you have requested. The final determination of compliance must take into account all factors pertaining to the use of the device at a particular worksite. This must include an evaluation through direct observation of employee work practices as well as an evaluation of the equipment or device alone. In this case, however, we must inform you that the device does not meet the intent of the Bloodborne Pathogens Standard (29 CFR 1910.1030).

The Bloodborne Pathogens Standard addresses reusable sharp containers at paragraph (d)(4)(iii)(A)(4):

Reusable containers shall not be opened, emptied, or cleaned manually or in any other manner which would expose employees to the risk of percutaneous injury.

Based on our review of the device and accompanying literature, we must interpret the "transfer carrier" to be a reusable container designed to temporarily hold used sharps. The "transfer carrier" must be opened twice, once for inserting a single contaminated sharp and again when the sharps are dumped into the "Needle-Eater" for grinding. Another concern is that when the "Needle-Eater" is jammed or blocked it must be "unplugged" by hand.

For the reasons identified above, we conclude the device fails to achieve the intent of the Bloodborne Pathogens Standard. For your information, the container must be approved by the Food and Drug Administration (FDA) as a sharps container and the "Needle-Eater" must also receive FDA approval. We have been informed by the FDA that the Needle-Eater and the sharp container have not been approved by FDA.

If you have further questions on this issue, please feel free to contact this office (202) 218-8036. We appreciate your interest in worker safety and health.

Sincerely,
Ruth McCully, Director
Office of Health Compliance Assistance

[Supplementary product and agency materials reproduced on OSHA page; omitted here.]