September 12, 2002


Mr. George R. Salem
Akin, Gump, Strauss, Hauer, & Feld, LLP
Attorney at Law
Robert S. Strauss Building
1333 New Hampshire Avenue NW
Washington, D.C. 20036-1564

Dear Mr. Salem:

Thank you for your June 24, 2002 letter to the Occupational Safety and Health Administration (OSHA) regarding the applicability of needle destruction devices as engineering controls under the scope of OSHA's Bloodborne Pathogens Standard, 29 CFR 1910.1030. Needle destruction devices (NDDs), such as SharpX (BioMedical Disposal, Inc.), are medical devices designed to incinerate a contaminated needle attached to a syringe after withdrawal from a patient. Your letter addresses several issues, which are restated below, followed by OSHA's response.

Issue #1: OSHA inspectors continue to be advised that needle destruction devices (NDDs) are "not compliant" with the Bloodborne Pathogens Standard.

OSHA Response #1: 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 protection and needleless systems) that isolate or remove the bloodborne pathogens hazard from the workplace." A device that reduces the risk to employees by destroying contaminated needles is clearly a type of engineering control, and OSHA's field staff have been so advised.

To comply with the standard, an employer must use engineering and work practice controls that will "eliminate or minimize employee exposure" (Sec. 1910.1030(d)(2)(i)). OSHA's compliance directive explains that under this requirement "the employer must use engineering and work practice controls that eliminate occupational exposure or reduce it to the lowest feasible extent" (OSHA CPL 2-2.69 §XIII, D.2.). The employer's exposure control plan is to describe the method the employer will use to meet the regulatory requirement. The plan must be reviewed and updated at least annually to reflect changes in technology that will eliminate or reduce exposure (Sec.1910.1030(c)(1)(iv)).

An NDD may be included as a component of an employer's exposure control plan to the extent it assists the employer in minimizing exposures. Use of an NDD alone will not be sufficient to meet the standard's requirements, however it is appropriate where use of a different or an additional control will reduce exposure to a lower level. In this connection, we note that a Needle Destruction Device, like a sharps disposal container, is an engineering control for the point of disposal. Because an NDD is intended to eliminate the needle after use, it may be beneficial in reducing or eliminating exposure to downstream workers. On the other hand, an NDD provides no protection while an employee is using the needle or prior to placing the needle in the device. This is where much of the employee exposure occurs. For example, according to data from EPINet at the International Health Care Worker Safety Center at the University of Virginia (which you provided in your letter of May 23, 2002), most injuries from contaminated sharps occur during use (32%), between steps (13%), during other activity after use, before disposal (18%), and when putting the item into a disposal container (7%). Approximately 90% of the injuries documented occurred while using a needle without a safety feature.

In many situations, devices are available that will reduce exposures prior to the point of disposal. Where feasible, the most effective way of removing the hazard of a contaminated needle is to eliminate the needle altogether by converting to needleless systems. In other situations, the hazard can be reduced through using a sharp with engineered sharps injury protection (SESIP), which isolates the sharp from the healthcare worker as it is withdrawn from the patient. Congress recognized the value of needleless systems and SESIPs by enacting the Needlestick Safety and Prevention Act (NSPA), P.L. 106-430, 114 Stat. 1901, which amended the bloodborne pathogen standard to include and define these terms. Section 2(7) of NSPA provides that "…the use of safer medical devices, such as needleless systems and sharps with engineered sharps injury protection, when they are part of an overall bloodborne pathogens risk-reduction program, can be extremely effective in reducing accidental sharps injuries."

The distinction between NDDs, on the one hand, and SESIPs and needleless systems, on the other hand has been recognized by Federal OSHA, the State of California Department of Industrial Relations, and the Food and Drug Administration (FDA):

OSHA has stated previously, "the most effective way of removing the hazard of a contaminated needle is to eliminate the needle completely by converting to needleless systems. If this is not possible, removal of the hazard as soon as possible after contamination is required. This is best accomplished by using a sharp with engineered sharps injury protection (SESIP)" (Letter of Interpretation to Congressman LaTourette, June 27, 2001).

Further, Cal/OSHA, in its response to a petition submitted by BioMedical for its SharpX device (Cal/OSHA, Petition File No. 416, September 11, 2000), states, "other than possibly reducing needlestick injuries during disposal related to their use or failure, alternative disposal technologies [needle destruction devices] no more provide protection from contaminated needlestick injuries at ‘the point of use' than do traditional sharps boxes."

The FDA puts NDDs into the same family of protection as sharps containers. They "place sharps needle destruction devices in Class III because the technological characteristics of the sharps needle destruction devices raise new types of safety and effectiveness questions when compared to conventional sharps disposal containers. (Premarket Approval Applications (PMA) for Sharps Needle Destruction Devices; Final Guidance for Industry and FDA, March 2001)." The FDA also states that a label on an NDD may claim, "the device (NDD) serves as an alternative to or as an effective substitute for conventional sharps containers for disposal of contaminated sharps needles, if data demonstrate that the remaining needle nub is no longer a sharp."

OSHA recognizes that needleless systems and SESIPs are not available for all situations. Moreover, there is a wide variety of devices available, and the device that most effectively reduces exposure can vary with the procedure. Employers must use their judgment in selecting appropriate engineering controls, and under NSPA, must consult with affected nonmanagerial employees [NSPA Sec. 3(4)(B); 29 CFR 1910.1030(c)(1)(v)]. In selecting controls that will eliminate or minimize exposure to its employees, an employer of course must take into account the full range of exposure, including exposure prior to the point of disposal.

The legislative history of NSPA, to which you have referred, is fully consistent with this position. The Joint Statement of Legislative Intent on Substitute to H.R. 5178 states:

To the extent that specific types of devices, such as catheter securement devices or needle destruction devices can reduce the risk of needlestick injuries, such devices could be appropriate components of an employer's comprehensive exposure control plan. Nevertheless, it is impossible for this legislation to recommend any one type of engineering control (106 Cong. Rec. p. H8676 (2000)).

This language does not say that the use of NDDs is always or generally sufficient to bring employers into full compliance with the standard. It only says that to the extent that they reduce the risk of needlestick injuries, they can be appropriate components of an exposure control plan. In this regard, the selection and use of NDDs may be most appropriate for clinical procedures where SESIPS or needleless systems are either not feasible or not commercially available (for example, certain procedures in geriatrics, pediatrics, and orthopaedics). Where NDDs are used, they should be used in accordance with manufacturer's instructions. For example, the SharpX is not meant to be used in potentially explosive environments, or where flammable gases or liquids are stored or used, such as operating rooms and emergency rooms.

Finally, your letter asserts that some SESIPs are ineffective. You refer to an article describing a citation issued by the State of California. There are many types of SESIPs and needleless systems that are commercially available. The standard requires employers to implement the use of SESIPs that do not compromise worker or patient safety or the outcome of the medical procedure. To meet the definition of a SESIP in the standard, a device must have a "built-in safety feature or mechanism that effectively reduces the risk of an exposure incident." See 1910.1030(b) (emphasis supplied). If a device that causes needlesticks to occur or blood to be emitted has been chosen, the device may not have been an appropriate selection. As noted, the standard requires the employer to use engineering and work practice controls that will eliminate or minimize exposure, and to review the availability of controls at least annually as part of its exposure control plan review. Thus, the California citation alleged that the employer's device did not meet the definition of a SESIP because it did not provide effective protection, and the article describing the citation states that there are many better, safer products on the market (May 23 letter, Tab 8).

Issue #2: NDDs must submit product clearance to the FDA at a "level three" approval, which requires clinical data conclusively demonstrating the product's safety and effectiveness. "Level Three" approvals require the most stringent level of testing, and all instructions, marketing materials and labeling must be approved by the FDA. Assuming that OSHA has been given the authority to institute a "hierarchy" of engineering controls, that "hierarchy" should be based on the classification system established by the FDA, the federal agency tasked with determining a medical device's efficacy.

OSHA Response #2: The FDA, in a 1994 memorandum to manufacturers and initial distributors of sharps containers and destroyers used by health care professionals, stated that "if the type of sharps device submitted in (the) 510(k) submission is found to be not substantially equivalent (NSE) to a predicated device, your device will automatically be classified in Class III, in accordance with the requirements of section 513(f) of the Act, thereby requiring the submission of an application for premarket approval (PMA)." In short, FDA "Level Three" approval is required because NDDs are newer devices that are not substantially equivalent to a device manufactured before 1976. Level Three approval does not imply that needle destruction devices afford greater protection against bloodborne pathogens than other engineering controls, such as needleless systems or SESIPs.

Furthermore, the FDA 510(k) Submission Application allows the label for a medical device with sharps injury prevention features to state that it meets the OSHA bloodborne pathogens standard only if permitted by OSHA.

Issue #3: OSHA is only permitting Becton Dickinson to explain the use of its engineering controls; BioMed and other NDD manufacturers formally request the same opportunity.

OSHA Response #3: As we stated in our May 2002 meeting with you, we welcome BioMed or any other medical device manufacturer to educate our staff on the use of its products. We have never restricted a manufacturer of a safety product from doing so. We welcome the opportunity for our staff to meet with device manufacturers and have had the pleasure of meeting with several companies that offer several different types of medical devices, personal protective equipment, training materials, and the like.

Issue #4: OSHA is apparently advising employers that OSHA is in the process of compiling a "report" concerning NDDs.

OSHA Response #4: OSHA is not compiling a report on NDDs or any other engineering control.

In conclusion, OSHA continues to categorize NDDs, and conventional sharps containers, as engineering controls for the disposal of contaminated needles. NDDs are currently designed to be used only with standard syringes that present the risk of exposure during use and prior to disposal. The use of an NDD alone, therefore, will not be sufficient to meet the standard's requirements where a different or an additional control, such as a needleless system or a SESIP appropriate for the procedure, is commercially available and feasible and will reduce exposure to a lower level.

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 apprized of such developments, you can consult OSHA's website at http://www.osha.gov. If you have any further questions, please feel free to contact the Office of Health Enforcement at (202) 693-2190.

Sincerely,



John L. Henshaw