Defining Passive in Safety-Engineered Medical Devices: A National Overview

Occupational exposure to sharps contaminated with bloodborne pathogens continues to be an occupational health and safety concern among workers providing patient care. Sharps injuries have been substantially reduced in acute-care settings through increased awareness, thorough training, and technological advancement of safety engineered needles on syringes, blood collection devices, IV insertion sets and lancets. Within these families of devices, there have been multiple generations of safety designs that require the user to actively slide a sheath, flip a clip, advance a plunger, or add an extra aggressive push. Today, there are very few safety-engineered medical devices that require no active step to make a device safer during use, after use and prior to disposal. This brief report is an analysis of current national guidance for passivity in safety engineered medical devices.

Federal Compliance and Guidance

Since the promulgation of the Occupational Safety and Health Administration (OSHA)’s Bloodborne Pathogens Standard requiring the use of safety-engineered medical devices there have been enforcement and guidance documents from federal agencies including OSHA, the Centers for Disease Control and Prevention (CDC) and the National Institute for Occupational Safety and Health (NIOSH); as well as national, state, academic and private entities, including Training for Development of Innovative Control Technology Project (TDICT), University of Virginia International Healthcare Worker Safety Center, Massachusetts Department of Public Health, Premier Safety Institute and others. Device manufacturers, themselves, have published great pieces of information, forged ahead leaps and bounds on safer engineering design, and offered thousands of hours of training and assistance.