FAQ: What is the FDA’s role in the release of new Class II devices?

No. Sterilization monitoring products, defined by the FDA as Class II medical devices, are "cleared" for sale in the U.S., not "approved". (FDA "pproval" is required for Class III medical devices that are high risk or life supporting, such as pacemakers.) The FDA’s role is to assure that products sold in the U.S. are safe and effective when the manufacturer’s instructions are followed.

No. The FDA regulates sterilization monitoring products and the companies who make and sell them, but not the health care professionals who use them. Therefore, the FDA clearance process is limited to assuring safety and efficacy, and does not offer guidance on how sterilization monitoring products should be used. The specific use and frequency-of-use of sterilization monitoring products, such as biological and chemical indicators, are determined by health care professionals at each health care facility.

Health care professionals establish policies and procedures that describe the use and frequency-of-use for the sterilization monitoring products used at their facility. Written policies and procedures should be based on industry standards, guidelines, and recommended practices, such as those published by AAMI, AORN, and the CDC.

Electing to develop policies and procedures that deviate from standards or recommended practices should be approached with caution and include the evaluation of scientific data and involvement of stakeholders throughout the facility (e.g., infection control, risk management, surgeons, etc.).

A CE credited in-service entitled FDA, 510(k)s, and Standards: What they mean and how they affect you by Bryan Becker, 3M Regulatory Affairs, was recently published in Healthcare Purchasing News. Click on the link below to access the article.

http://www.hpnonline.com/ce/pdfs/0810cetest.pdf