Reprocessing Associations & Standards Organizations

The following links provide access to organizations and resources involved with reprocessing, including those that set forth standards to which MEDISISS closely adheres:

Food and Drug Administration (FDA)
This link can be used to identify all requirements that a 3rd party reprocessor must meet in order to return product to its customers

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/registration.cfm
This link can be used to verify a company’s registration with the FDA

21CFR 820—FDA Quality System Regulation

MEDISISS uses applicable FDA recognized standards set forth by the following standards organizations:

• IEC-International Electrotechnical Commission
• ISO-International Organization for Standardization
• AAMI-Association for the Advancement of Medical Instrumentation
• AORN-Association of periOperative Registered Nurses
• ANSI-American National Standards Institute
• USP-United States Pharmacopeial Convention, Inc.
• ASTM-International Standards Worldwide

Additional Reprocessing-related Resources:

• Statement of Daniel Schultz, M.D., Director CDRH, Before the Committee on Government Reform
• Association of Medical Device Reprocessors (AMDR)
• GAO Report 2008
• Association for Professionals in Infection Control (APIC)
• The International Association of Healthcare Central Service Material Management (IAHCSMM)
• Position Statements