Rules issued by administrative agencies that have the force of law
Regulation
A uniform method of defining basic parameters for processes, products, services and measurements
Standard
What is not a law, but can be incorporated into law by governmental bodies.
Standards
Failure to comply with regulations may result in
Legal consequences in the healthcare facility
Regulations and standards may include what to protect SP techs from exposure to infectious agents and toxic substances.
Workplace safety issues
Regulation and standards may include what 2 practices
Disinfection and sterilization practices
Regulations and standards are issued by
Federal, state, and local governing agencies
What provides significant assistance to healthcare personnel because they are developed according to best practice?
Professional organizations
A method or technique that has consistently shown results superior to those achieved by other means.
Best practice
Who is responsible for ensuring that medical devices are safe and effective for patient care?
The U.S Food and Drug Administration (FDA)
Who regulates the manufacture of all medical devices?
The U.S Food and Drug Administration (FDA)
Who regulates sterilants, high-level disinfectants, packaging materials, sterilizers, and quality monitors such as biological indicators (BIs)?
The U.S Food and Drug Administration (FDA)
The level of regulation placed on any device depends on how
The FDA classifies that device
Low-risk devices (Ex: most handheld surgical instruments)
Hospital beds and ultrasonic cleaners
Class 1 devices
Subject to “general controls,” which include registration and device listing, medical device reporting, and quality system regulation and labeling.
Class 1 devices
Devices considered posing potential risks great enough to warrant a higher level of regulation.
Class 2 devices
Devices that includes most types of sterilization equipment, BIs and chemical indicators (CIs)
Class 2 devices
Devices that are usually subjected to performance standards, postmarket surveillance studies and specific guidelines or special labeling.
Class 2 devices
The most stringently regulated devices, including heart valves, pacemakers and other life-sustaining devices.
Class 3 devices
Manufacturers of new Class 3 devices must obtain a _________
from the FDA to demonstrate product safety and efficacy.
Premarket approval (PMA)
The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class 3 medical devices.
Premarket approval (PMA)
What should contain detailed instructions on how to properly process and use the product. This includes disassembly, cleaning, assembly, disinfection and sterilization instructions
Instructions for use (IFU)
Class 1 devices are
Class 2 devices pose
Class 3 devices are
Low-risk devices
Potential risk great enough to have higher level of regulation
The most regulated
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Chapter 528
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assisting with minor surgery19
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chapter 623
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chapter 28
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chapter 952
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Chapter 9 Vocab11
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Chapter 14 High Temperature Sterilization15
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Abbrev/ Surgical Proced./ Meaning17
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low temp. sterilization19
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8 Basic Requirements11
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communication16
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Chapter 1 Vocab13
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Study Chapter 115
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Study Chapter 2: Suffix29
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Chapter 205
