Quiz 5

Under current regulations, who is required to report suspected medical device-related deaths to the U.S. Food and Drug Administration?

Device manufacturer and Hospitals

Agency which may intervene in a matter of worker protection even if there are no specific regulations covering the situation.

Occupational Safety and Health Administration

Chemical indicators are classified as

FDA Class II medical devices

Heart valves and pacemakers are examples of

FDA Class II medical devices

True or False. It is optional to follow the Occupational Safety and Health Administration's regulations for wearing person protective equipment in Central Service decontamination area.

False

True or False. Reuse of single use medical devices is less regulated now than it was in the 1990's.

False.

True or False. The occupational safety and health administration is a voluntary association dedicated to infection control and prevention.

False.

Sometimes state or local regulations differ from Federal regulations and when that happens, the most stringent regulations apply. True or False.

True

True or False. Failure to receive accreditation from the join commission can result in the loss of medicare and medicaid payments.

True

True or False. Recommendations regarding sterilization practices are provided by the Association for the Advancement of Medical Instrumentation.

True

True or False. Third-party reprocessors are regulated by the U.S. Food and Drug Administration.

True

The society of Gastroenterology Nurses and Associates is a source for information about the proper processing of flexible endoscopes.

True.

True or False. Class III medical devices are identified as high risk.

True.

True or False. The U.S. Food and Drug Administration recalls may be either mandatory or voluntary.

True.

Medical device reporting is regulated by the

U.S. Food and Drug Administration

Standards and regulations help set levels of ____________ in our departments.

both quality and safety

The agency which imposes very strict labeling requirements on manufacturers of disinfectants used by Central Service departments.

environmental protection agency

Healthcare regulations and standards establish

minimal levels of quality and safety

The Department of Transportation enforces statutes relating to the

transportation of clean and soiled instruments between facilities

Regulations under the Clean Air Act are administered by

Environmental Protection Agency