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.
July 6, 1990
Mr. William M. Teringo
PDMP, Inc.
105 Loudoun Street, S.W.
Leesburg, Virginia 22075
Dear Mr. Teringo:
This is in further response to your letter of May 16 in which you requested information on the ability of your Nonmechanical Incapacitation Syringe Safety Needle Sheath to satisfy Occupational Safety and Health Administration (OSHA) requirements. Our response to your questions is as follows:
Question 1: Because of OSHA recommended guidelines as to
recapping of used syringes with original
needle guard, will the needle sheath
described, which is designed with a cone
shaped finger protector of three quarters
(3/4") diameter, be sufficient to satisfy
OSHA requirements?
OSHA Instruction CPL 2-2.44B, "Enforcement Procedures for Occupational Exposure to Hepatitis B Virus (HBV) and Human Immunodeficiency Virus (HIV)" clarifies OSHA's prohibition against recapping and expressly allows recapping by some method other than the traditional two-handed procedure, i.e. , the use of resheathing instruments, self sheathing needles, or forceps is permitted.
The finger protector described in your letter as being three-quarters of an inch in diameter does not adequately protect the hand holding the needle sheath from accidental puncture. Since the three-quarters of an inch diameter leaves much of the hand area uncovered, OSHA cannot consider it acceptable protection for use with a two-handed recapping procedure.
Question 2: Based on the current methods of handling used
syringes by encasing them in a plastic
container, can the needle sheath described be
considered as a waste container?
While disabling the syringe with adhesive appears to be a good idea, OSHA views its use as a temporary measure, suitable for use by emergency medical technicians or home health care workers. Since there is no guarantee of correct usage or proper function of the device, the needle should still be disposed of in a sharps container.
We hope this information is responsive to your concerns.
Sincerely,
Gerard F. Scannell
Assistant Secretary
Mr. William M. Teringo
PDMP, Inc.
105 Loudoun Street, S.W.
Leesburg, Virginia 22075
Dear Mr. Teringo:
This is an interim response to your letter of May 16 in which you requested information on the ability of your Nonmechanical Incapacitation Syringe Safety Needle Sheath to satisfy Occupational Safety and Health Administration (OSHA) requirements.
We are currently looking into this matter and expect to provide you with a full response shortly. Thank you for your patience.
Sincerely,
Gerard F. Scannell
Assistant Secretary
May 16, 1990
Mr. Gerard F. Scannell
Asst. Secretary of Labor
Occupational Safety & Health
US Dept. of Labor
200 Constitution Ave. N.W.
Washington, DC 20210
Dear Mr. Scannell:
I have had several discussions with personnel at OSHA who have been most helpful and have recommended that I contact your office.
Attached is a description of a new patented Nonmechanical Incapacitation Syringe Safety Needle Sheath.
I have two questions concerning this device and its ability to satisfy OSHA requirements.
1.) Because of OSHA recommended guide lines as to recapping of used syringes with original needle guard, will the needle sheath described, which is designed with a cone shaped finger protector of three quarters (3/4") diameter, be sufficient to satisfy OSHA requirements?
2.) Based on the current methods of handling used syringes by encasing them in a plastic container, can the needle sheath described be considered as a waste container? Please keep in mind that large generators should still follow normal final disposal requirements for used syringes.
I would appreciate your comments on the above questions and appreciate any other comments OSHA wishes to make.
I want to thank you in advance for your attention to is request.
Best regards,
William M. Teringo C/O PDMP, Inc. 105 Loudoun St. SW
Leesburg, VA 22075
WMT:js
Attachments 2
Nonmechanical Incapacitation Syringe Safety Needle Guard
The invention is comprised of a sheath, similar to a conventional needle guard, containing a fast curing colored liquid adhesive. A penetrable membrane which prevents flow and premature curing of the adhesive is inserted and secured within the sheath (needle guard) structure. There are several adhesives which will accomplish required end results.
The needle and luer lock portion of the syringe, after use, is immediately inserted into the sheath and the syringe plunger is pulled back and then pushed forward. The action of inserting the needle breaks the membrane, lodging the luer lock past the membrane when fully inserted and coating the outer surface of the luer lock with the adhesive. The action of pulling back the syringe plunger causes the adhesive to flow through the needle and into the space in the luer lock and into the syringe body, the flow of the adhesive being clearly visible due to the colored adhesive. It should be noted that the colored adhesive is preferred, but not required. When adhesive fills the syringe body enough to fix the plunger to the body the plunger is pushed forward to bring the rubber plunger tip in contact with the adhesive in the body. Note that the amount of adhesive in the sheath is enough to accomplish the above noted objective.
The end result is that the adhesive permanently adheres the sheath to the exterior surface of the syringe luer lock, the luer lock to the syringe body while filling the barrel in the needle and coating the exterior of the needle even though it is permanently encapsulated within the sheath. All components parts of the syringe assembly are adhered permanently together with the barrel of the needle completely filled, rendering the syringe and needle assembly completely inoperative and incapable of causing injury.
The device is manufacturable with molding and filling technologies which are currently available.
The device is designed (but not limited) to be a separate entity to avoid sterilization and FDA approval.
The device avoids the possibility of contamination by personnel during secondary handling at collection points.
The device can be used at user option and will work with secondary handling, collection and disposal requirements.
The device gives protection against secondary handling and disposal inadequacies.
The device also has an enlarged flange for guiding the needle and for preventing a needle puncture to the users hand during stress situations or inattentiveness.
Drying cycle does vary reflective of the type of adhesive and the amount of air contact. Upon first contact the curing process of the adhesive begins when the sheath is secured over the luer lock and becomes resistant to removal within seconds. The syringe and needle assembly is further rendered inoperative immediately the moment the adhesive is applied since removal of adhesive during the brief curing period requires equipments and solvents which would destroy the syringe plastic.