Resources
AAMI Association for Advanced Medical Instrumentation (AAMI)
AAMI is comprised of professionals in engineering, medicine, nursing, the medical device industry, and governments with the common goal of increasing the understanding of and beneficial use of medical instrumentation.
This site provides a search tool: Go to: "Resources" then to “Reuse of SUDs” at:
AdvaMed - Advanced Medical Technology Association
Protecting Patients and Limiting Risk: FDA and Manufacturers' Pro-Active Response.
AMDR Association of Medical Device Reprocessors
Trade-based association representing companies that are third party
reprocessors of medical devices
AMDR members perform an estimated 90 percent of the third party
reprocessing done in the United States.
The site includes links to the FDA and to bills in Congress. Links to members of Congress with template letters to send one's legislators are included.
AHRMM Association for Healthcare Resource and Materials Management
Consistent with their mission to provide cost-effective, quality healthcare, the Association for Healthcare Resource & Materials Management (AHRMM) supports the regulated reprocessing of selected medical devices originally labeled for “single use” by the original equipment manufacturer. This is their reprocessing advisory.
Download the AHRMM Reprocessing Advisory (.doc) (27 KB)
ADDM Association of Disposable Device Manufacturer
700 13th Street NW, Suite 1200, Washington, DC 20005-3960
Information is available by calling: 202.737.5600 Fax: 202.737.9329
AORN Association of Operating Room Nurses
AORN Guidance Statement: Reuse of Single-Use Devices – February 2001
This guidance statement describes AORN's thoughts on the reuse issue.
Download AORN’s Guidance statement on reuse (.pdf) (55 KB), or go to:
APIC Professionals in Infection Control and Epidemiology
APIC's position paper - Reuse of single-use devices (8/31/07) (.pdf) (35 KB)
DSMICA Division of Small Manufacturers, International and Consumer Assistance
This FDA Division provides technical and regulatory assistance to small manufacturers to help them comply with the FDA requirements for medical devices. Contact them through their Web site:
http://www.fda.gov/cdrh/devadvice/36f.html
ECRI - Medical Device Safety Reports
ECRI is a nonprofit health services research agency. Reports and advisories garnered by ECRI on device-associated problems are collated into a database.
This site provides abstracts on medical device reports and recommendation based on ECRI findings. Search by device types and/or types of risk at the Web site listed below.
FDA Food and Drug Administration
FDA Reuse home page: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/default.htm
Premier Group Purchasing Services
Nursing and Premier Safety Institute
Key decision parameters to consider when evaluating the decision to reprocess single-use devices.
Download the White paper - key decision parameters summary (.doc) (47 KB)