Thursday, October 8, 2015

Clarification of the selection and use of BBP safety devices

May 5, 2008

Dr. H***
Texas A&M University
College Station, TX

Dear Dr. H***:

Thank you for your letter to the Occupational Safety and Health Administration's (OSHA's) Directorate of Enforcement Programs (DEP). Your letter requests OSHA's interpretation of several provisions under 29 CFR 1910.1030, the Bloodborne Pathogens standard. 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. For clarification, your specific questions are paraphrased below, followed by OSHA's responses. We apologize for the delay in providing our response.

Question 1: The OSHA Bloodborne Pathogens Standard requires employers to use engineering controls, such as appropriate "safety engineered" sharps. Can an employer select a device that is not expressly labeled by the manufacturer as a safety device and that does not have corresponding safety claims that have been cleared by the Food and Drug Administration (FDA)?

Response 1: As you know, employers are required to use engineering and work practice controls to protect employees [29 CFR 1910.1030(d)(2)(i)]. The standard defines engineering controls as ". . . controls (e.g., sharps disposal containers, self-sheathing needles, safer medical devices, such as sharps with engineered sharps injury protections and needleless systems) that isolate or remove the bloodborne pathogens hazard from the workplace." [29 CFR 1910.1030(b)]. With regard to safety-engineered devices used for preventing needlesticks and other sharps injuries, many circumstances would involve the use of safety-engineered devices which are expressly manufactured to replace conventional ones (i.e., sharps with safety engineered sharps injury protections, SESIPs). These devices generally bear a manufacturer's label indicating the type of safety feature along with specific instructions for use. However, the key to preventing needlesticks and other sharps injuries is the isolation or removal of the hazard, and in some circumstances, this may be achieved by completely removing the sharp (needleless technology) or substituting a safer alternative that is not necessarily labeled as such.

As an example, the use of plastic hypodermic syringes has largely replaced the use of glass syringes as an effective safer alternative. Plastic syringes are less prone to accidental breakage and, therefore, offer protection from potential percutaneous injuries from broken contaminated glass. Plastic syringes however, do not necessarily bear a legend of this safety benefit. Another example is the use of alternatives to glass capillary tubes which break easily. In a joint safety advisory on hazards associated with the use of glass capillary tubes, the FDA, NIOSH and OSHA recommended the use of capillary tubes that are not made of glass and glass capillary tubes wrapped in a puncture-resistant film. These alternatives also represent safety-engineered features in that they remove or isolate the sharps hazard.

It is important that employers perform a thorough hazard assessment and fully evaluate the feasibility and appropriateness for use of any engineering control before instituting its use [29 CFR 1910.1030(c)(1)(iv)(B)]. The substitution of a type of device or technology that does not bear a manufacturer's claim of safety must not introduce new hazards nor in itself create a hazard to employees. Additionally, employers should consult device manufacturers prior to making any after-market modifications to medical devices. Unauthorized modifications to medical devices may interfere with their intended use, may violate the FDA's approval of the device, or may create a greater hazard to patients and/or employees. You may wish to contact the FDA directly for additional information on the criteria which manufacturers must meet and the specific labeling requirements for all medical devices, including those with claims of safety-engineering features or capabilities.

Question 2: May an employer make an independent judgment that a device marketed with other claims and for other purposes provides the type of safety-engineered protection anticipated by the standard? If so, what level of documentation or testing is the employer required to have to demonstrate the validity of such judgments?

Response 2: As stated in response #1, the substitution of an alternative device or technology that does not bear a manufacturer's claim of safety must not introduce new hazards nor in itself create a hazard to employees. The requirement for evaluation and selection of a safety device is a performance-oriented provision which depends greatly on the specific medical device and medical procedure(s) in question. Devices must be evaluated for their ability to prevent occupational exposures to blood or other potentially infectious materials (OPIM) in each procedure. The final determination of what safer device is selected for use is a responsibility of the employer; however, when evaluating and selecting safer devices, employers must solicit input from non-managerial employees responsible for direct patient care who are potentially exposed to injuries from contaminated sharps [29 CFR 1910.1030(c)(1)(v)]. The input from affected employees must be factored into the employer's judgment of the appropriateness for use of a particular safety device.

With regard to the documentation needed to justify selection of safety devices, employers are required to have an exposure control plan which includes the initial exposure determination required by 29 CFR 1910.1030(c)(2) as well as the documentation of the methods of compliance, which includes implementation of engineering controls [29 CFR 1910.1030(c)(1)(ii)(A) and 1910.1030(c)(1)(ii)(B)]. The exposure control plan must be reviewed and updated annually to include documentation of the employer's consideration of newer technology [29 CFR 1910.1030(c)(1)(iv)(A) and 1910.1030(c)(1)(iv)(B)]. The standard does not specify the level of detail that must be included in this documentation; however, sufficient information must be provided to substantiate the facility's judgment. As discussed in the preamble of the Final Rule, consideration and implementation of safer medical devices could be documented in the Exposure Control Plan by describing the safer devices identified as candidates for adoption; the method or methods used to evaluate devices and the results of the evaluations; and justification for selection decisions. [See 66 Federal Register 5319, under discussion of paragraph 1910.1030(c)(1)(iv).]

Question 3: OSHA has previously clarified, in the context of Group Purchasing Organizations (GPOs), that price and contractual availability cannot be the sole basis for selecting a safety device. May other contractual requirements provide a basis for selecting a particular device? For example, if a multi-product manufacturer offers a contract that has a cost basis associated with being the employer's exclusive provider of a range of medical devices, and/or offers overall volume discounts that would be impacted by selecting another manufacturer's safety device, is a decision to use the contracting supplier's safety engineering sharps devices on this basis acceptable?

Response 3: 29 CFR 1910.1030 does not address contractual arrangements between employers and device manufacturers. Therefore, the standard does not specifically preclude the use of GPOs as long as the employer is still able to meet the intent of the standard. As stated in the response to question #2, non-managerial employees involved in patient care must be afforded the opportunity to provide feedback in the evaluation and selection of safer devices. If an employer enters into an exclusive contractual arrangement with a manufacturer, the availability and variety of devices may be restricted. As technology advances, it is difficult to determine whether a safer and more appropriate device might become commercially available from a competitor of the exclusive supplier. Employees may be limited in the variety of available safety devices, particularly with regard to equipment that has few available choices. Additionally, each employer must review and update the exposure control plan annually and the annual review must include documentation of the consideration of newer technology [29 CFR 1910.1030(c)(1)(iv)(A)]. Advances in technology might not be captured if an employer is bound by contract to only evaluate devices from a single manufacturer. Finally, 29 CFR 1910.1030(d)(2)(i) requires that employers eliminate or minimize, i.e., reduce to the lowest extent feasible, occupational exposure. Thus, irrespective of the arrangements used in obtaining safety devices, the determination of an employer's compliance will be based on whether the requirements of the standard are being met.

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