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• Standard Number: 1910.1030

March 26, 1997

Barry Benton, Manager
Needle Safe, L.L.C.
4150 S. 100th E. Avenue
Suite 305
Tulsa, Oklahoma 74146

Dear Mr. Benton:

This is in response to your letter of April 2, 1996. Please accept out apology for the delay in responding to your inquiry regarding the "Needle Ease 4501." This product was designed to disintegrate a needle (contaminated sharps) by subjecting the needle shaft to an electric charge. Your specific inquiry concerns the remaining syringe and hub (and plungers) and whether or not the requirements of the Bloodborne Pathogen standard (CFR 1910.1030) for disposal of contaminated waste still apply once the needle has been destroyed. You also have asked if the "Needle Ease fits within the regulation."

The five questions you have posed will be answered. However, I would remind you that the Occupational Safety and Health Administration (OSHA) does not approve or endorse products. The "Needle Ease" is a medical device that requires evaluation and approval by the Food and Drug Administration (FDA). The FDA and OSHA often have overlapping regulations and we at times work together to ensure employee safety and health has been fully considered. The FDA has no record of an application for approval of the "Needle Ease" at this time. If this information is incorrect, please send me a copy of your approval.

There are electrical safety issues that may not be in compliance with OSHA standards. The advertisement did not mention any location restrictions with the "Needle Ease," nor did it state that this device was approved by an OSHA Nationally Recognized Testing Laboratory (NRTL). See 29 CFR 1910.7. Hospital patient rooms may have oxygen stored or used in them. Hospital labs can have any number of flammable or combustible gases available. As such, the "Needle Ease" may be a source of ignition and cannot be used in these areas. Another concern is the reaction between various drugs pooled in the hollow of the needle and the high temperature the drugs will be exposed to. It does not seem that this has been throughly tested to ensure hazardous gases would not form. The one test you sent from APOSE Inc. is not adequate to make the claim in your advertisement that "after disposal... the particulate is far below acceptable concentrations..." plus there is no mention of gases or fumes. It is also recommended that you consider using a HEPA-filtered vacuum to clean out the ash since the ash particles could be so small that the ashes could penetrate an ordinary vacuum bag and be dispersed in the air.

In your first question, you ask about the proper disposal method of the syringe and hub once the needle is destroyed. A contaminated sharp such as a used needle is defined as any contaminated object that can penetrate the skin. Once the needle has been completely destroyed by high heat, the hazard of contaminated sharps is eliminated. However, the remaining hub, syringe and plunger would still be "regulated waste" if the inside of the syringe contained blood or other potentially infectious materials (OPIM). For example, when blood is drawn into a syringe and used to transfer blood to test tubes, liquid or semi-liquid blood remaining in the syringe would make this regulated waste by OSHA's definition and must be disposed of in a container that meets the requirements listed under (d)(4)(iii)(B). Another example where the syringe is regulated waste would be when a health care worker is administrating an intramuscular or subcutaneous injection. It is good practice to pull back on the syringe to ensure it is not in a blood vessel. If blood backs up into the syringe, the injection is stopped and the syringe containing this mixture of drugs and blood must be disposed of as regulated waste. Two other sources of contamination, while not related to blood or OPIM, are worth mentioning. That is where the needle and syringe are used to administer chemotherapy drugs or radioactive dyes. These materials are extremely hazardous and require special handling, both the needle and syringe. An employer using the "Needle Ease" must continue to dispose of all contaminated waste in accordance with OSHA standards. Sharps containers would need to be readily available, since there are many kinds of "sharps" beside needles such as glass tubes and knives.

The syringe and hub are not automatically considered decontaminated by virtue of destroying the needle with high heat. The explanations provided in the above paragraph indicate that such a determination is totally dependent on whether that syringe contains liquid or semi-liquid blood or OPIM, hazardous drugs or radioactive dyes. The employer must decide on a case-by-case basis if the syringe, hub, and plunger are safe and can enter the regular waste stream.

Once the needle has been destroyed, you ask are the syringe and hub required to be disposed of in a "Sharps Disposal Container?" The answer is no, since the hazard presented by a contaminated sharp has been eliminated. However, to answer the fourth question concerning "regulated waste," the answer is yes, if the syringe and hub contain liquid or semi-liquid blood or OPIM (as described above), the standard requires disposal in a regulated waste container.

The final question you asked is, does high heat destruction of needles, using a one handed technique "fit within the regulation?" The standard has a number of provisions on how to dispose of contaminated needles. These include prohibitions against bending, recapping (except in certain circumstances), removal, shearing, or breaking of contaminated needles. This device is a total destruction of the needle, a disposal method that was not considered when the standard was written. The "Needle Ease 4501" is a contaminated needle disposal system that would aid in minimizing the hazard associated with sharps, especially for downstream handlers such as housekeeping and custodial staffs. However, until FDA approval and NRTL approval are obtained, and the problems that have been identified are corrected, the "Needle Ease" does not meet OSHA's standards.

Your interest in safety and health is appreciated. If you have further questions, please feel free to call Wanda Bissell of my staff at (202) 219-8036 ext. 36.

Sincerely,



John B. Miles, Jr., Director
Directorate of Compliance Programs


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