September 1, 2004

Ms. Debbie Eckard
Product Manager
American Safety Razor Company
One Razor Blade Lane
Verona, VA 24482

Dear Ms. Eckard:

Thank you for your May 7, 2004 letter to the Occupational Safety and Health Administration's (OSHA's) Directorate of Enforcement Programs (DEP). Your letter addresses several issues which are restated 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(s) not delineated within your original correspondence.

Question 1: Do healthcare facilities need to use reengineered safety scalpels to be in compliance with the bloodborne pathogens regulations, or can they simply evaluate?

Reply 1: OSHA's bloodborne pathogens standard at 29 CFR 1910.1030(c)(1)(iv) requires employers to evaluate safer medical devices to eliminate or minimize employee exposure to blood or other potentially infectious materials (OPIM). Employers must solicit input from non-managerial employees in the selection process [29 CFR 1910.1030(c)(1)(v)]. Engineering controls, including safety scalpels, must be implemented where their use is feasible [29 CFR 1910.1030(d)(2)(i)].

Question 2: If not, under what circumstances may they choose not to employ safety scalpels?

Reply 2: OSHA recognizes that no one medical device is appropriate for use in all circumstances and that it is important to safeguard both patients and employees during medical and surgical procedures. If the use of a particular engineering control, in this case a safety scalpel, compromises patient safety, its use would not be considered feasible. The employer, therefore, must determine what engineering and work practice controls effectively minimize hazards without unduly interfering with medical procedures. The standard also recognizes that market availability is another limiting factor in implementing the use of engineering controls and must be considered in both your choice of an engineering control and our enforcement of their use [29 CFR 1910.1030(c)(1)(iv)(B)]. However, please be aware, where exposures have been determined and where engineering controls are commercially available and feasible, they must be used.

Additionally, the bloodborne pathogens standard requires that employers "document annually [their] consideration and implementation of appropriate commercially available and effective safer medical devices..." [29 CFR 1910.1030(c)(1)(iv)(B)]. OSHA compliance officers have issued citations to employers at facilities where the Exposure Control Plan (ECP) did not contain such documentation. It is required, therefore, that a site choosing not to employ safety scalpels, specifically address the non-use of a safety scalpel in its ECP.

Question 3: If surgeons don't "like the new safety scalpels as well as the traditional designs," but the surgeons don't demonstrate that the newer designs would result in a negative patient outcome, is it then permissible not to use the reengineered safety scalpel devices?

Reply 3: Please see Reply #2.

Question 4: Are there definitive guidelines regarding safety scalpels listed within any of the OSHA websites?

Reply 4: While OSHA's website does not have specific guidelines regarding safety scalpels, OSHA maintains a safety and health topics page dedicated to bloodborne pathogens and needlestick prevention located at http://www.osha.gov/SLTC/bloodbornepathogens/index.html.

Question 5: What is the cost of non-compliance? Is there a schedule?

Reply 5: Section 17 of the Occupational Safety and Health Act, 29 USC §666, outlines the prescribed civil penalties and factors for consideration in the assessment of each violation cited by the agency. A willful or repeated violation may result in a penalty of up to $70,000; there is a minimum penalty of $5,000 for willful violations. Serious violations (where there is a substantial probability of death or serious physical harm) require a penalty of up to $7,000. Other-than-serious violations may result in a penalty of up to $7,000. If an employer fails to abate a violation set forth in a citation which has become a final order, the employer may be assessed a penalty of up to $7,000 for each day during which the violation continues.

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 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,


Richard E. Fairfax, Director
Directorate of Enforcement Programs