Sterile Processing

A new whitepaper is available to assist medical device manufacturers with understanding recent changes to the Food and Drug Administration (FDA)'s thinking regarding endotoxin testing.

The Occupational Safety and Health Administration (OSHA) says that more U.S. workers are injured in the healthcare industry than any other. This sector has one of the highest rates of work-related injuries and illnesses, and in 2010, it reported 653,900 injury and illness cases. Also for that year, the latest year for which data are available, OSHA says the incidence rate for work-related nonfatal injuries and illnesses in healthcare was 139.9; by comparison, the incidence rate for nonfatal injury and illnesses in all private industry was 107.7. That's a lot of injuries and illness despite the fact that the General Duty Clause of the legislation that created OSHA requires employers to provide workers with a safe workplace that does not have any known hazards that cause or are likely to cause death or serious injury.

The intent of this article is to answer some questions regarding which government agency or department regulates different classes of antimicrobials (disinfectants, sterilants), as well what is required to develop a 510(k) submission package for Food and Drug Administration (FDA) review, comment and ultimate clearance related to new high-level disinfectants (HLDs) and automated endoscope reprocessor (AERs).