Failure to receive accreditation from ________ can result in the loss of Medicare and Medicaid payments

Class ______ medical devices are identified as having some risk but not a great risk.

a non–government agency with a network of national standards institutes

responsible for pre and post market medical device requirements

a voluntary international organization dedicated to the prevention and control of infections and related outcomes

enforces laws relating to the transport of medical waste

furthers international cooperation in improving health conditions

protects workers from occupationally caused illnesses and injuries

organization which has established standards for the effective reprocessing of flexible endoscopes

one of the major resources for healthcare quidelines

creates and enforces laws relating to cleaner air, water and land

provides standards and evaluations for healthcare facilities. Evaluations are in the form of on–site surveys at least every three years.

develops nationally recognized standards, recommended practices and guidelines for the peri–operative setting

creates and revises standards for processing water for irrigation

Third party re-processors are regulated by the

Third party reprocessors are regulated by the FDA

Failure to receive accreditation from the ANSI can result in the loss of Medicare and Medicaid payments

A Class ______ medical device recall is a High Risk device recall

a law written by a legislative body

a comparison benchmark that is mandated by a regulatory agency

gases that absorb solar radiation

a federal medical insurance program which primarily serves those over 65 years of age

federal and state insurance program for low income individuals

reports developed by experts containing valuable information

3rd party reprocessors are required to have a

a high risk device

Responsible for the operation of Medicare, Medicaid and The State Children's Insurance Agency

agency which regulates the manufacturers of medical devices

comprehensive guide to steam sterilization...

AAMI is the ___________ for the Advancement of Medical Instrumentation

Who is responsible for validation of medical devices?

a Biological Indicator is a class ______ medical device

a facility must have a 510K in order to....

developed by experts, have not undergone formal approval and may be revised or withdrawn.