Wednesday, January 18, 2012

Removal of Contaminated Needles Prior to Disposal

December 19, 2011

MEMORANDUM FOR: MARTHE B. KENT, REGIONAL ADMINISTRATOR

FROM: THOMAS GALASSI, DIRECTOR
DIRECTORATE OF ENFORCEMENT PROGRAMS

SUBJECT: Removal of Contaminated Needles Prior to Disposal

This is in response to your Regional Office's request for clarification on the Agency's enforcement policy concerning the practice of uncapping used/contaminated needles prior to disposal. In the situation you presented, it was asked whether the Bloodborne Pathogens standard (29 CFR 1910.1030) permitted employers (e.g., medical and/or dental practitioners) to remove contaminated needles from caps/sheaths before disposing of the needles following medical or dental procedures.

As you are aware, the standard strictly prohibits bending, recapping, or removal of contaminated sharps unless the employer can demonstrate that no alternative is feasible or that such action is required by a specific medical or dental procedure. [29 CFR 1910.1030(d)(2)(vii)(A)] The scenario you described clearly does not meet either of these exceptions. In the case of the first exception (i.e., one in which there is no feasible alternative), the obvious alternative is that the needle with the cap attached can be placed directly into the sharps container. In the case of the second (i.e., one in which there is a medical or dental need for the removal of the needle), it is evident that at the point of disposal, the medical or dental procedure has already been completed and thus the prohibited activity is not medically necessary. This activity is one which requires additional manual manipulation, which unnecessarily exposed employees to a greater risk of injury and would NOT be permitted under this provision of the Bloodborne Pathogens standard.


Wednesday, January 11, 2012

Safer work practices in medical labs

The CDC has produced guidelines that reinforce a common-sense approach to biosafety in day-to-day laboratory activities.

“Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories” address safe work practices in human and animal diagnostic laboratory, including microbiology, chemistry, hematology, and pathology with autopsy and necropsy guidance. The following is an introduction to this publication:

This report offers guidance and recommends biosafety practices specifically for human and animal clinical diagnostic laboratories and is intended to supplement the 5th edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL-5), developed by CDC and the National Institutes of Health (1). This document was written not to replace existing biosafety guidelines, but to 1) improve the safety of activities in clinical diagnostic laboratories, 2) encourage laboratory workers to think about safety issues they might not previously have considered or addressed, and 3) encourage laboratorians to create and foster a culture of safety in their laboratories. Should any of the guidelines provided herein conflict with federal, state, or local laws or regulatory requirements, the laboratorian should defer to the federal, state, or local requirements. This culture of safety is also supported by the Clinical and Laboratory Standards Institute (2). Work in a diagnostic laboratory entails safety considerations beyond the biological component; therefore, these guidelines also address a few of the more important day-to-day safety issues that affect laboratorians in settings where biological safety is a major focus.

The US Bureau of Labor Statistics estimates that there are approximately 500,000 human and animal diagnostic lab workers, and that “any of these workers who have chronic medical conditions or receive immunosuppressive therapy would be at increased risk for a laboratory-acquired infection (LAI) after a laboratory exposure.” But post exposure infection risks are unknown because of the difficulty in determining the source or mode of transmission and non national surveillance system is available.

Bacteria account for more than 40% of LAI, with more than 37 species “as etiologic agents,” says the report, but other microbes also present risks. For example, “Hepatitis B has been the most frequent laboratory-acquired viral infection, with a rate of 3.5–4.6 cases per 1000 workers, which is two to four times that of the general population,” according to the report. “Any laboratorian who collects or handles tubes of blood is vulnerable.”

Also, LAI surveys have found that laboratory staff “were three to nine times more likely than the general population to become infected with Mycobacterium tuberculosis.”

Monday, January 2, 2012

Acceptability of using a straight needle instead of a safety needle?

Thank you for your March 28, 2001 letter to the Occupational Safety and Health Administration (OSHA). Your letter was forwarded from OSHA's Milwaukee Area Office to the Directorate of Compliance Programs in Washington, DC for a response to your specific questions regarding the applicability of the Bloodborne Pathogens Standard (29 CFR 1910.1030) to the withdrawal of medications from a vial in a clinical setting. Your question is outlined below followed by OSHA's response. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question not delineated within your original correspondence.
The pharmacy and nursing staff (of our facility) use large bore needles to withdraw medication from a vial and then remove that needle, placing a smaller gauge safety needle on the syringe to administer the medication to the patient.

Do we have to use a safety needle to withdraw the medication from the vial even though it will not have contact with the patient?
In the situation that you describe, the practices your facility uses are compliant with the Bloodborne Pathogens standard and no further controls would be required. The standard applies to all occupational exposure to blood or other potentially infectious materials (OPIM). Therefore, during a procedure where there is no exposure to blood or OPIM, such as withdrawing medication or pharmaceuticals from a vial, it would not be necessary to implement the use of engineering controls.

If, during this procedure, the same needle used to withdraw the medication is also used to administer it to a patient through injection, OSHA would require the use of an appropriate engineering control (e.g., safer medical device, sharp with engineered sharps injury protection). As you have stated, you use a straight needle to withdraw the medication from the vial and then switch to a "safety" needle for administration; this is acceptable.


Sincerely,


Richard E. Fairfax, Director
Directorate of Compliance Programs