OSHA directive mandates move to safety needles
Update reflects new technology
In what may be the death knell of the market for basic needle technology, the Occupational Safety and Health Administration (OSHA) on Nov. 5, 1999, issued a promised compliance directive that mandates use of improved and safer needles. The directive will help minimize serious health risks faced by workers exposed to blood and other potentially infectious materials. Among the risks are human immunodeficiency virus, hepatitis B and C.
Goal: Reduce exposure
The new Bloodborne Pathogens Compliance Directive updates the agency’s 1992 directive and reflects the availability of improved devices, better treatment following exposure, and OSHA policy interpretations. Secretary of Labor Alexis M. Herman said the new directive "doesn’t place new requirements on employers, but it does recognize and emphasize the advances made in medical technology. And it reminds employers that they must use readily-available technology in their safety and health programs."
The directive guides OSHA’s compliance officers in enforcing the standard that covers occupational exposure to bloodborne pathogens and ensures consistent inspection procedures are followed.
The 1992 directive required only a review of the feasibility for using improved technology and better safety controls to avoid needlestick accidents and the potential for infection. The revision requires that improved needles and sharps must be used in order to "reduce employee exposure either by removing, eliminating, or isolating the hazard." Tougher wording in the latest the directive refers to "the growing market of safer medical devices that minimize, control, or prevent exposure incidents."
The directive does not mandate use of particular needle devices or specific needle technologies. Basically, it requires that health care facilities use the safer needles on the market. It includes detailed instructions to compliance officers on inspections of multi-employer work sites including home health services, employment agencies, personnel services, physicians and health care professionals in independent practices, and independent contractors.
To enforce compliance, health facilities must do annual reviews of their safety and compliance plans to evaluate whether they are making use of safer needle systems. Besides recording and reporting all incidents of accidental needlesticks, every employer must now establish an Exposure Control Plan that documents the evaluation and implementation of appropriate, commercially available, and effective engineering controls designed to eliminate or minimize exposure to bloodborne pathogens. Compliance will have the power to cite facilities that are not using upgraded safety devices or they may consult with regional bloodborne pathogens coordinators to determine whether or not a citation ought to be issued. The directive includes decontamination requirements, guidelines on hepatitis vaccinations and post-exposure treatments, and employee training.
OSHA inspectors are obligated to inspect for potential violations involving the hazard of occupational exposure to blood or other potentially infectious materials when: 1) The Exposure Control plan or employee interviews indicate deficiencies in complying with OSHA requirements; 2) Relevant formal employee complaints are received that are specifically related to such occupational exposure; and 3) an actual occupational exposure occurs.
The Exposure Control Plan must also identify and document all job classifications in which all employees have occupational exposure, and/or those job classifications in which some employees have occupational exposure.
OSHA requires the Exposure Control Plan to be reviewed and updated at least annually and whenever necessary to reflect new or modified tasks and procedures that affect occupational exposure and new or revised employee positions with occupational exposure.
The job classifications and employees who could be identified as having potential occupational exposure to bloodborne pathogens is extensive. OSHA identifies the potential group to include: physicians and physician’s assistants; nurses and nurse practitioners; dentists, dental hygienists, dental assistants, and dental laboratory technicians; home health care workers; emergency medical technicians, paramedics, and other emergency medical service providers; health care and diagnostic employees; fire fighters, law enforcement personnel and correctional officers; housekeeping, maintenance, custodial workers, laundry staff, and regulated waste collectors; medical equipment service and repair personnel; production facility workers; and support employees in health care and other facilities, such as physicians and dentists’ offices, various clinics, laboratories, blood banks and plasma centers, hemodialysis centers, nursing homes and long-term care facilities, educational, correctional facilities and public safety institutions, emergency first-aid facilities, and funeral homes and mortuaries. This covers virtually all of the health care employers and employees in the United States and suggests a dramatic increase in the demand for safety-engineered needles.
What are they saying?
Companies manufacturing sharps devices with improved safety features hailed the new directive in immediately issued press releases. Med-Design (Ventura, CA) issued a statement saying that the new directive would result in the "total conversion of the medical sharps market from conventional to safety-engineered devices in a short period of time."
James Donegan, chairman and CEO of the company, estimates the OSHA directive will save the lives of thousands of health care workers annually.
The company produces 21 safety needle products and predicts heavy demand for those and other products yet to be developed. Biomedical Disposal (Atlanta), issued a statement saying that, in the wake of the OSHA directive, it was launching a nationwide sales effort to promote its Sharpx sharps disposal system, and company president Michael Smith predicts "explosive growth" of company sales in the coming months.
The company also operates a Web-based "behavioral incident control system," and says it is readying the launch of a new safety needle technology. Specialized Health Products International (Bountiful, UT) produces 13 different systems for improving needle safety and says the directive would expand its current and future contracts. "The new OSHA mandate gives emphasis to our sense of urgency in bringing safety products to market," says company president and CEO David Robinson.
The revised guidelines are the result of OSHA’s request last year for ideas and recommendations on ways to better protect workers from contaminated needles or other sharp objects. OSHA administrator Charles Jeffress reports that the agency received nearly 400 comments in response to that request. According to Jeffress, the responses "told us that safe medical devices already available are effective in controlling hazards and that wider use of such device would reduce thousands of injuries each year." Copies of the new directive can be obtained by calling OSHA’s Publications Office at (202) 693-1888.
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