IAHCSMM CRCST EXAM CORRECT 100%(GRADED A+)

Statute - ANSWER A written law adopted by a legislative body that governs a city, county, state or country Regulation - ANSWER Rules issues by administrative agencies that have the force of law Standard - ANSWER A uniform method of defining basic parameters for processes, products, services, and measurements Regulatory Standards - ANSWER A comparison benchmark that is mandated by a governing agency. Noncompliance with regulatory standards may lead to citations and legal penalties Voluntary Standards - ANSWER Guidelines or recommendations for best practices to provide better patient care. Industry, nonprofit organizations, trade associations and others develop these. Best practice - ANSWER A method or technique that has consistently shown results superior to those achieved by other means. Class I Medical Devices - ANSWER low risk devices such as hand-held surgical instruments and ultrasonic cleaners; subject to "general controls" but most exempt from pre-market notification approval (501k) Class II Medical Devices - ANSWER considered to pose potential risks great enough to warrant higher regulation; includes most types of sterilization equipment and biological and chemical indicators; 501k required before manufacturers can sell these products Class III Medical Devices - ANSWER Are the most stringently regulated devices that include heart valves, pacemakers, and other life-sustaining devices. Manufacturers must obtain a premarket approval (PMA) from the FDA to demonstrate product safety and efficacy. The Safe Medical Devices Act of 1990 - ANSWER requires facilities to report medical device malfunctions to the FDA! User facilities are required to report suspected medical device-related deaths to the FDA and the device manufacturer within 10 days of the event MedWatch - ANSWER FDA system to receive information about adverse events or product problems Class I Medical Device RECALL by the FDA - ANSWER HIGH RISK Class II Medical Device RECALL by FDA - ANSWER Less Serious Risk Class III Medical Device RECALL by FDA - ANSWER Low Risk FDA (Food and Drug Administration) - ANSWER is the federal agency responsible for ensuring that foods, cosmetics, human and veterinary drugs, biological products, medical devices, and electronic products that emit radiation are SAFE AND EFFECTIVE for public use. FDA functions with the Public Health Service of the US Department of Health and Human Services. They REGULATE THE MANUFACTURING of all medical devices and REQUIRE PREMARKET APPROVAL of new devices. They also regulate the sterilants