July 13, 2012

Mr. Mark W. Bode, CEO
JoeyMedical / The Utopia Group LLC
6279 Tri-Ridge Blvd., Suite 207
Loveland, OH 45140

Dear Mr. Bode:

Thank you for meeting with the Occupational Safety and Health Administration's (OSHA) Office of Health Enforcement (OHE) on March 2, 2012. We appreciated having you demonstrate the Joey Medical umbilical cord clamp and cutter, a device which you described was designed to reduce the potential for blood splashes and sprays during umbilical cord transection. You expressed your concerns about potential occupational exposure to bloodborne pathogens during the transection of the umbilical cord in hospital delivery rooms. You also mentioned potential underreporting by healthcare providers that may have resulted in an underestimation of the true incidence of occupational exposures resulting horn blood splashes during transection of the umbilical cord. This letter is in response to your request for a written clarification on the applicability of OSHA's Bloodborne Pathogens standard, 29 CFR 1910.1030, to this source of occupational exposure.

Employers having employees with "occupational exposure," as defined by the standard, must comply with OSHA's Bloodborne Pathogens standard. The standard defines "occupational exposure" as "...reasonably anticipated skin,eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee's duties." [29 CFR 1910.1030(b)]. It is well-established that procedures followed in labor and delivery are reasonably anticipated to result in such contact with blood or other potentially infectious materials.

The standard requires employers to make a determination of potential exposure, including the specific tasks, which may result in occupational exposure. [29 CFR 19 10.1030(c)(2)]. The standard further requires using engineering and work practice controls as primary methods of protecting employees. [29 CFR 1910.1030(d)(2)(i)]. Engineering controls include safer medical devices. [29 CFR 1910.1030(b)].

As we mentioned during our meeting, OSHA may not and does not endorse or approve particular products. Nonetheless, the JoeyMedical umbilical cord clamp and cutter device appears to meet the criteria for safer medical devices for employer consideration and use. The employer is responsible for ensuring compliance with the Bloodborne Pathogens standard, including soliciting input from non-managerial employees responsible for direct patient care in the selection of appropriate safety devices [29 CFR 1910.1030(c)(l)(v)] and ensuring that employees are trained on the proper use of new devices and work practices necessary to prevent occupational exposure incidents [29 CFR 1910.1030(g)(2)(vii)(F)].

Thank you for your interest in occupational safety and health. We hope this provides the clarification you were seeking. 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,



Thomas Galassi, Director
Directorate of Enforcement Programs