Sterile Processing

Electronic tracking systems have been commonplace in just about every industry since the 1970s. Virtually every product sold in America has a barcode on it, linking it to a central database so that the product can be easily identified. That is how manufacturers can recall products, from contaminated peanut butter to toxic dog food from store shelves within hours, and trace E. coli-infected spinach to the field in which it was grown. Yet we have no such system for medical devices, including those that are implanted in patients to help keep them alive. Its hard to believe that our country can track the location of dog food better than we can a sophisticated medical device.

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).