Organizational Statements

Leading Healthcare Organizations Support Reprocessing

Many of the country's leading professional healthcare organizations' oversight or accrediting bodies support the reuse of single-use medical devices by FDA-regulated reprocessing companies. Their position statements follow:

AAOS - The American Academy of Orthopaedic Surgeons (AAOS) recognizes that all devices should be safe and efficacious. Manufacturers currently have the discretion to label devices for single-use without established criteria or oversight, even when the instrument may be safely utilized on a repetitive basis. Some orthopaedic devices may be efficiently cleaned and sterilized and provide the same assurances as a newly manufactured device. The AAOS supports the application of stringent criteria to assess the safety and effectiveness of reprocessed single-use devices.

ACC - "Reprocessing is safe. Reprocessing is a safe practice that hospitals and physicians have relied on for more than two decades. A significant body of peer-reviewed literature demonstrates that certain devices labeled as single-use can be safely and effectively reprocessed, including EP catheters used by cardiovascular specialists."

AHA - "With constrained health care resources and a heightened commitment to the environment, reprocessing makes sense. I need only reiterate the slogans we now teach our children - that's the three R's - reduce, reuse, and recycle. AHA members are committed to being better stewards of the environment by pledging to reduce, not increase waste. In 1998, the AHA and the Environmental Protection Agency initiated a joint-partnership to reduce hospitals' total waste volume by 50 percent by 2010. Responsible waste management and recent cost reduction initiatives support the long-standing practice that hospitals can safely sterilize, inspect, and repackage many devices for later use".

AHRMM - "Consistent with our 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 manufacturers...to contain costs, reduce waste, and promote quality patient care, AHRMM encourages hospitals to reprocess by outsourcing to third-party reprocessors."

AORN - The Association of periOperative Registered Nurses finalized its statement on reprocessing in a guidance document titled: AORN Guidance Statement: Reuse of Single-Use Devices. The document provides information to help perioperative nurses make informed decisions. In summary, reprocessing is an accepted practice when complying with FDA Quality System Regulations.

APIC - The Association for Professionals in Infection Control and Epidemiology published a Principles and Practice manual. Chapter 129, "Reuse of Single-Use Devices," outlines procedures for hospitals to follow when implementing a reuse/reprocessing program.

ASGE - American Society for Gastrointestinal Endoscopy, in 1999, wrote the following in a letter: "There is an extensive body of research demonstrating that many devices labeled as "single-use' can be reused after proper cleaning and restoration with no risk to patients. To discard these items is an unnecessary expenditure of health dollars. The only beneficiary of such disposal is the manufacturer of the items."

ASHCSP - "Regarding the reuse of single use devices (SUD), ASHCSP recognizes that hospitals and other healthcare providers are faced with financial limitations, which sometimes result in reuse. ASHCSP supports the reuse of single use devices provided the following criterion are implemented and sustained..."

CMS - Health Care Financing Administration in May 1999 stated, "It is our policy that devices that are approved for marketing by the FDA are considered safe and effective for purposes of Medicare coverage." "It is only for the HCFA to determine whether the device is reasonable and necessary for purposes of coverage."

ECRI -This non-profit health services research agency has studied reprocessing and concluded that "the practice may be accomplished safely and effectively, provided the specific devices are known to be suitable candidates for reuse."

FDA - Like the original devices manufacturers, the Food and Drug Administration oversees medical device reprocessing. In recent testimony to congress, the FDA concluded that "Reprocessed single use devices that meet FDA regulatory requirements are as safe and effective as new devices."

IAHCSMM - International Association of Healthcare Central Service Material Management has a "Position Statement: Reuse of Single-Use Medical Devices" published May 1999. Hospitals are discouraged from reprocessing in house and are given guidance for choosing a third party reprocessor.

JCAHO - Joint Commission on Accreditation of Healthcare Organizations, in 1995, removed the standard that prohibited reprocessing single-use devices. Hospitals need only to reflect the practice or use of a service in its policies and procedures.

NASPE - "NASPE adheres to the principle that reuse of electrophysiological catheters is a safe and cost effective practice provided that they are meticulously cleaned, sterilized, and inspected in accordance with accepted standards of practice as specified by the FDA."

SGNA - The Society of Gastroenterology Nurses and Associates, Inc. published a position statement (after FDA issued its enforcement priorities for SUD reprocessing in 2000) that maintains its position that critical medical devices originally manufactured and labeled for single-use should not be reused. The 2002 Administration of SGNA is currently reviewing their position.

For additional information, please call us at 1-888-856-4870 or email us at info@sterilmed.com.

Reprocessing

Conserve Your Healthcare Resources

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short executive briefing to show how medical facilities can save 40 to 50% on medical device purchases and reduce repair and equipment costs. Please contact us to learn more.

Reprocessing helps make healthcare more affordable

"The FDA believes that reprocessed SUDs are as safe and effective as a new device."- Dr. Daniel Schultz,
Director Center for Devices and Radiological Health, FDA