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ANSI Medical Device Standards Board Coordinates U.S. role Nationally and Internationally

AAMI Medical Device Standards Purchaser Survey Reveals Value

New York, Feb 04, 2003

Although medical devices are highly regulated, “voluntary standards still have an important role to play in the areas of patient and operator safety, as well as contributing to mutual recognition agreements between national regulatory bodies,” asserts Theresa Zuraski, chair of the Executive Committee of the ANSI Medical Device Standards Board (MDSB) and Association for the Advancement of Medical Instrumentation (AAMI) vice president of standards. “Because of the safety and regulatory implications of voluntary standards for medical devices, the highest priority of the ANSI Medical Device Standards Board,” in Zuraski's opinion, “is coordination of effort and lack of duplication at either the national or international level.”

The MDSB is a coordination and information-exchange committee that addresses issues related to national standards development efforts as well as U.S. involvement in the international and regional standards efforts in the technical area of medical devices. The scope of the MDSB includes, but is not limited to, devices used in or related to cardiovascular surgery, neurosurgery, ophthalmology, orthopaedics, dentistry, anesthesiology, thoracic surgery, respiratory function, biological analysis; also in-vitro diagnostic products and other devices connected with medical or biological treatment, monitoring or diagnosis, but excluding those medical devices falling within the scope of other existing ANSI Standards Boards.

The importance of medical standards was underscored recently by an AAMI survey to purchasers of the organization’s standards. Survey results indicated that these documents provide strong value, are highly effective in achieving their intended uses, and play an increasingly important role in the medical technology industry.

Of those surveyed, 97% said they purchase AAMI standards because of AAMI's credibility and reputation. Seventy-seven percent cited quality as a reason for buying AAMI standards, and 76% said formal recognition of the standards by the FDA or other regulatory bodies was a key reason for their purchases. Most purchasers of AAMI standards use them to comply with FDA regulations or Joint Commission A Health O requirements, maintain user or operator safety, and to provide a frame of reference for dealing with national and international markets and regulatory requirements.

AAMI currently publishes about 130 national standards, recommended practices, and technical information reports (TIR) covering areas such as sterilization, electromedical equipment, biological evaluation of medical devices, and other biomedical equipment. AAMI standards and recommended practices represent a national consensus and many have been approved by the American National Standards Institute (ANSI) as American National Standards. AAMI also administers a number of international technical committees of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), as well as U.S. Technical Advisory Groups (TAGs).

AAMI recently completed a major upgrade to its web site (www.aami.org) so that standards can be purchased electronically in PDF format for immediate download. AAMI standards are also available for purchase through ANSI’s Electronic Standards Store (ESS). An independent research firm completed the survey; results can be found on the AAMI web site at www.aami.org/pressroom/survey.html.

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