American National ANSI/AAMI EC13:2002 Standard Cardiac monitors. heart rate meters, and alarms AAMI Association for the Advancement of Medical Instrumentation The Obiectives and Uses of AAMl Standards and Recommended Practices It is most important that the objectives and potential uses of an AAMI Each AAMI standard or recommended practice reflects the product standard or recommended practice are clearly understood collective expertise of a committee of health care professionals and The objectives of AAMI's technical development program derive industrial representatives, whose work has been reviewed nationally from AAMI's overall mission: the advancement of medical (and sometimes internationally). As such. the consensus recommendations embodied in a standard or recommended practice instrumentation. Essential to such advancement are (1) a continued increase in the safe and effective application of current technologies are intended to respond to clinical needs and, ultimately, to help to patient care, and (2) the encouragement of new technologies. It is ensure patient safety. A standard or recommended practice is limited, AAMI's view that standards and recommended practices can however, in the sense that it responds generally to perceived risks and contributesignificantlyto advancement medical conditions that may not always be relevant to specific situations. A the of instrumentation, provided that they are drafted with attention to these standard or recommended practice is an important reference in objectives and provided that arbitrary and restrictive uses are avoided. responsible decision-making, but it should never replace responsible decisionmaking A voluntary standard for a medical device recommends to the Despite periodic review and revision (at least once every five manufacturer the information that should be provided with or on the product, basic safety and performance criteria that should be con- years), a standard or recommended practice is necessarily a static document applied to a dynamic technology. Therefore, a standards sidered in qualifying the device for clinical use, and the measurement techniques that can be used to determine whether the device conforms user must carefully review the reasons why the document was initially developed and the specific rationale for each of its with the safety and performance criteria and/or to compare the per- provisions. This review will reveal whether the document remains formance characteristics of different products. Some standards em phasize the information that should be provided with the device, relevant to the specific needs of the user. Particular care should be taken in applying a product standard to including performance characteristics, instructions for use, warnings existing devices and equipment, and in applying a recommended and precautions, and other data considered important in ensuring the safe and effective use of the device in the clinical environment. practice to current procedures and practices. While observed or Recommending the disclosure of performance characteristics often potential risks with existing equipment typically form the basis for the safety and performance criteria defined in a standard, professional necessitates the development of specialized test methods to facilitate uniformity in reporting; reaching consensus on these tests can judgment must be used in applying these criteria to existing equip- ment. No single source of information will serve to identify a represent a considerable part of committee work. When a drafting particular product as "unsafe". A voluntary standard can be used as committee determines that clinical concerns warrant the establishment of minimum safety and performance criteria, referee tests must be one resource, but the ultimate decision as to product safety and provided and the reasons for establishing the criteria must be efficacy must take into account the specifics of its utilization and, of cost-benefit considera