March 9, 1993

Alan A. Wanderer, M.D.
2696 South Colorado Boulevard
Suite 500
Denver, Colorado 80222

Dear Dr. Wanderer:

This is in response to your letter of November 9, in which you requested that the Occupational Safety and Health Administration (OSHA) review your ACCI-GUARD Reusable Holder for compliance with the requirements of 29 CFR 1910.1030, the "Occupational Exposure to Bloodborne Pathogens" standard. This reusable device is used in blood collection procedures.

As you correctly noted in your letter, the standard prohibits the recapping and/or removal of contaminated needles unless no alternative is feasible or it is required by a specific medical procedure. OSHA Instruction CPL 2-2.44C, "Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens Standard", gives examples of circumstances in which the recapping and/or removal of a contaminated needle may be necessary. These circumstances may include "removing the needles from a phlebotomy collection apparatus".

After reviewing your device and its accompanying literature, we believe that its intended use does not appear to violate the requirements of 29 CFR 1910.1030. While the device adds an extra step prior to removal of the contaminated needle, it appears to allow the needle to be recapped while it is retracted and in an unexposed position; it thus appears to adequately protect the fingers while recapping. Please bear in mind that OSHA does not endorse or approve products and that the final determination regarding compliance is made in the workplace by direct compliance officer observation of employee work practices and taking into account all factors pertaining to the use of such a device at the particular worksite.

We hope this information is responsive to your concerns and thank you for your interest in worker safety and health.

Sincerely,



Roger A. Clark, Director
Directorate of Compliance Programs




Ms. Ellen Roznowski
Division Chief
Office of Health System
N-3469
U.S. Department of Labor-OSHA
Washington, D.C. 20210

November 9, 1992

Dear Ms. Roznowski:

Re: ACCI-GUARD(R) REUSABLE HOLDER

Our company is manufacturing and marketing a safety reusable phlebotomy collection device referred to as the ACCI-GUARD(R) Reusable Holder. This product has been purchased by over 500 hospitals in the United States and Canada during the past two and one half years. Many hospitals have completely converted their entire hospitals to this product because of its many attractive features such as: (1) It provides protection at the point of use; (2) It is reusable and therefore very cost effective as well as reducing biohazard waste and (3) The contaminated needle can be recapped while the needle remains retracted and unexposed. Following this procedure the recapped needle can then be removed completely from the ACCI-GUARD Holder without contacting any part of the shielded needle, including the valve end of the needle.

In order to reuse this phlebotomy device, the user must recap a used needle. However it is important to realize that recapping with our product is performed on a retracted (unexposed) needle. Recapping with all other mechanical recapping devices is performed when the used needle is exposed. Despite this important difference we continue to encounter problems in interpretation of OSHA directives. For example, recently we received a call from South Miami Hospital which has been very satisfied with our product. One of their safety personnel decided to send a letter to the local OSHA representative, Mr. Dave Kendall, to determine whether recapping with the ACCI-GUARD Holder was in compliance with current OSHA regulations and directives. Mr. Kendall correctly informed personnel of South Miami Hospital that OSHA cannot endorse any product and in turn sent a copy of our instructions to someone in your office to obtain an opinion on our device. Unfortunately the result of his response to South Miami Hospital was that it potentiated doubts in the minds of the staff as to whether use of the ACCI-GUARD device was in compliance with OSHA.

We have encountered similar problems with other hospitals who in our opinion are misunderstanding current OSHA directives. I am aware of OSHA Instructions CPL 2-2.44C, page 19, section (d) which states that "recapping or removing a contaminated needle by hand is prohibited. However, certain circumstances may exist in which those actions are necessary, e.g. removing the needle from phlebotomy collection apparatus (e.g. vacutainer)." Since the ACCI-GUARD Holder is a reusable phlebotomy device, it is necessary to recap and remove a recapped contaminated needle from this device. Hence the user has no alternative but to recap a used needle while the needle remains retracted and locked inside the device. What makes our device safer than existing mechanical recapping devices or OSHA approved scooping recapping techniques is that the recapping with the ACCI-GUARD Holder is done on an unexposed retracted needle. Furthermore the recapped needle can then be removed completely from the ACCI-GUARD Holder without contacting any part of the shielded needle, including the valve end of the needle.

I have included our modified instructions for this device along with samples of ACCI-GUARD Holders with sterile Becton Dickinson needles. I believe when you and your staff review the instructions for use of this product you will also come to the conclusion that this device represents an excellent engineering control for disposing contaminated phlebotomy needles.

We understand that OSHA can not endorse this product. However it is important to understand that this product has become very popular with hospitals in the United States and in the next six months it will be represented and distributed nationally and internationally by a distinguished blood collection company located in the United States. We are therefore asking for your help to clarify that the use of the ACCI-GUARD Holder is in compliance with current OSHA regulations and directives.

At the very minimum we would appreciate a letter from your office that states that procedures associated with the ACCI-GUARD Holder are in compliance with current OSHA directives. Additionally, sometime in the near future we would recommend an addendum to the current OSHA directives that states: "if recapping and removing a contaminated needle is necessary, such as with a reusable phlebotomy collection device, an approved technique includes using a recapping mechanical device that permits recapping an unexposed contaminated needle".

We are receiving many questions from health care workers and health care facilities who would like to use our device. Your expeditious response would therefore be greatly appreciated.

I want to thank you in advance for your attentiveness to our concerns.

Sincerely,



Alan A. Wanderer, M.D.
Vice-President and Medical Director