Central Service Technical Manual Boxed Course: Central processing chapter 5 Regulations & Standards Flashcards


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1

Regulation

A mandatory law or rule that is issued by a governing body

2

Standard

A uniform method of defining basic parameters for processes, products, services and measurements

3

Standards (regulatory)

Mandated by the government, if not complied with may cause fines

4

Standards (voluntary)

A benchmark recommended, but not enforced by the governing body

5

Statute

A written or enforceable law enacted by a governing body

6

Compliance

Typically mandatory and can carry fines or lead to legal consequences if not followed

7

Food and Drug Administration (FDA)mission

A government agency responsible for foods, cosmetics, vet drugs, biological, medical products

8

FDA functions within

Public Health Services of the US Department of Health and Human Services

9

Class 1 Devices

Include low risk devices like hand-held surgical instruments, and ultrasonic cleaners

10

Class II Devices

Considered to pose a potential risk to warrant a higher regulation. Includes most types of sterilizers, biological and chemical indicators.

11

Class III

Includes heart valves, pace makers and other life sustaining devices

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Pre and post market requirements

Unless exempt a 501k submission is required for class I and II devices. Class III require a 501k or a PMA

13

Post Market device requirements

Requires registration and listing
Medical device reporting/tracking/corrections/removal
Quality system regulations
Labelling

14

Safe Medical Device Act

Created in 1990 requires health care facilities to become subject to user reporting requirements

15

Medical Device Reporting

Beginning in 2000, requires the medical field to report suspect medical devices-related deaths to the FDA within 10 working days

16

Med-Watch Program

A safety information and adverse event reporting system

17

Medical Device Recalls

To fix or check a product when it is defective or poses a risk to health

18

FDA Recall Class I

Highest risk - reasonable chance the product will cause serious health issues or death

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FDA Recall Class II

Less serious risk - There is a possibility the product will cause temporary or reversible health risks

20

FDA Recall Class II

Low risk - Little chance of being expose or hurt from this product

21

FDA Labeling Product

Created in 1996, to provide guidance for FDA reviewers who evaluate pre market approval applications for medical devices - reprocessing

22

FDA Labeling Product responsibilities

Manufacturer responsible for:
Supporting the claim of reuse with adequate labeling on how to reprocess the equipment
Documentation of tests

23

Re-Use of a single use medical device

Dates back to 1970 states
(a) the item can be cleaned and sterilized
(b) the quality of the item will not be effected
(c) device will remain safe

24

FDA Enforcement Requirements for Hospital Reprocessing for single use devices

Created in 2000 documents highlighting the reused of medical devices

25

Hemodialyzers

Equipment used to remove impurities from blood before returning it to the patients body

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Third party reprocessors

Regulated by the FDA decides on what SUDS will be reused

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Center for Disease Control (CDC)

Federal agency works to promote health and quality of life by preventing disease and injury

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Department of Transport (DOT)

Responsible for fast and efficient transport of instrumentation and hazardous/radioactive waste

29

Environmental Protection Agency (EPA)

Created to enforce the laws relating to cleaner water, air, and land.

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EPA products must contain

Product ingredients
Direction for use
Product precautions and warnings
Directions for storage and disposal
Registration number

31

Clean Air Act

Created in 1990 to protect the earths ozone layer

32

Occupational Safety and Health Administration (OSHA)

Creating in 1971 to protect workers from occupational illness and injuries
May intervene when no specific regulation covers a situation

33

Association for the Advancement of Medical Instrumentation (AAMI)

Founded in 1967, voluntary consensus organization to recommend practices and standards around the use, care, and processing medical devices

34

American National Standards Institute (ANSI)

Founded in 1918, primary mission is to enhance the global competitiveness of US businesses and the American quality of life

35

Association of Operating Room Nurses (AORN)

Professional organization consisting of pre op nurses

36

World Health Organization (WHO)

United Nations organization formed to improve health conditions