January 12, 2006

Mr. William A. Hyman
Professor
Texas A&M University
Department of Environmental Engineering
233 Zachry Engineering Center
3120 TAMU
College Station, TX 77843-3120

Dear Mr. Hyman:

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 response.

Question 1: Is there an obligation for employers to assure the accuracy and meaningfulness of the information that is reported on a facility's sharps injury log?

Response 1: The purpose of the log, which is required by paragraph (h)(5) of the standard, is to aid in the evaluation of devices being used in the workplace and to quickly identify problem areas in the facility. The standard implicitly requires that the information be accurate. Furthermore, any person who makes any false statement in any document required to be maintained under the Occupational Safety and Health Act of 1970 may be punished by fine or imprisonment [29 U.S.C. §666(g)].

Employers must include the type and brand of device involved in the incident, the department or work area where the exposure incident occurred and an explanation of how the incident occurred so that the intended evaluation of risk and device effectiveness can be accomplished. Complete information regarding the type and brand of the device is crucial; this is especially true for the proper documentation of device evaluations required by paragraph (c)(1)(iv) of the standard. Entries on the sharps log need to be complete enough for evaluators to determine accurately which particular product was actually being used when the incidents occurred. Because manufacturers frequently have several product lines, the log entries for "brand" must include, in addition to the manufacturer's name, the specific product in order to accurately describe which particular device was being used. In fact, in many cases, if only the manufacturer’s name were entered on the log, it would be difficult to know exactly which device was being used. As stated in OSHA's compliance directive, Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens, CPL 02-02-069, XIII.H.3, employers are encouraged to write as much information as is necessary to aid in the evaluation of problem areas; however, the confidentiality of the injured employee must be maintained throughout the process. Employers may include information in addition to that which is required by the standard, but may not include information that would identify the employee involved in the incident. However, for incidents, such as a housekeeper being stuck through a trash bag, where determining the type and brand of the device would increase the potential for additional exposure, the type/brand may be recorded as "Unknown" [CPL 02-02-069, XIII.H.3].

Question 2: Is the employer required to include an analysis of the data contained on the "sharps injury log" as part of the annual review of the facility's Exposure Control Plan? Should this information be presented so as to indicate whether one or more specific area(s) or issue(s) require action in order to reduce the incidence of sharps injury?

Response 2: Although an analysis of the log required by (h)(5) is not mandated, a review of the sharps log can be very instrumental in identifying the causes of exposure incidents and serve as a valuable tool for reducing future sharps injuries. It may also indicate where further training is needed and identify ineffective devices which may need replacement. As stated in the response to Question #1, the purpose of the sharps injury log is to aid in the evaluation of devices and in the identification of problem areas in the facility. Therefore, OSHA recommends that the log be reviewed periodically and as part of the annual review and update of the exposure control plan. As you know, employers are required to review and update the exposure control plan at least annually and whenever necessary to reflect new or modified tasks and procedures which affect occupational exposure [29 CFR 1910.1030(c)(1)(iv)]. Employers are additionally required to annually document their consideration and implementation of appropriate commercially available and effective safer medical devices [29 CFR 1910.1030(c)(1)(iv)(B)]. They are also required to document exposure incidents [29 CFR 1910.1030(f)(3)(i) and (ii)].

Question 3: Employers are required in their annual review of the exposure control plan to reflect changes in technology and document annual consideration and implementation of commercially available and effective safer medical devices. Should this review include reconsideration of technologies not currently selected even if they are not new, especially if there are indications from the analysis of the sharps injury log that currently used products may not be sufficiently effective?

Response 3: There is no requirement under (c)(1)(iv) to reconsider already considered medical devices. Please keep in mind that it is common for facilities to observe a slight initial increase in injuries after the selection and implementation of a new device. Additional training is often needed when staff attempts to become familiar with a newly selected device. Any analysis of the sharps injury log should take these factors into consideration in arriving at a conclusion about the effectiveness of a newer device. However, if an analysis of the sharps injury log identifies a particular selected engineering device as the root cause of injuries (i.e., as opposed to work practices, employee training, or other issues), then the employer may choose to include one or more of the previously evaluated devices in the annual re-evaluation to determine if a better selection can be made.

Question 4: Employers are required to solicit input from non-managerial employees responsible for direct patient care. Is a simple open request for input adequate, even if none is received or does this require a serious study of user observations, opinions and testing of currently used and alternative devices?

Response 4: A simple open request for input is adequate. The employer must solicit employee input in a manner appropriate to the circumstances in the workplace. Methods for soliciting employee input may include joint labor-management safety committees; involvement in informal problem-solving groups; participation in safety meetings and audits, employee surveys, worksite inspections, or exposure incident investigations; using a suggestion box or other effective methods for obtaining written employee comments; and participation in the evaluation of devices through pilot testing. The opportunities for employee input shall be effectively communicated to employees [CPL 02-02-069, XIII.C.6]. The failure of employees to provide input is not in itself a violation of the standard. No studies are required under this provision.

Question 5: Does the maintenance of the sharps injury log relieve a hospital of the requirement to report sharps injuries under the FDA's Medical Device Reporting requirements, and in accordance with the Food and Drug Administration's (FDA's) Needlesticks: Medical Device Reporting Guidance for User Facilities, Manufacturers, and Importers?

Response 5: No, the requirement under OSHA's bloodborne pathogens standard, 29 CFR 1910.1030(h)(5)(i), does not exempt healthcare employers from having to report deaths and serious injuries related to medical devices to the FDA. The FDA's Medical Device Reporting (MDR) regulation, 21 CFR Part 803, is a separate and independent set of requirements under which facilities using medical devices must report such information to the FDA and/or the device manufacturers. The FDA has specific forms that must be completed and submitted for incidental and annual reporting. You may wish to contact the FDA directly for specific guidance on the information that must be included on the MDR forms.

Thank you for your interest in occupational safety and health. We hope you find this information helpful. 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 www.osha.gov. If you have any further questions, please feel free to contact the Office of Health Enforcement at 202-693-2190.

Sincerely,



Richard E. Fairfax, Director
Directorate of Enforcement Programs