5.1 Regulations & Standards Intro

Question 1

Statue

Answer 1

A written law adopted by a legislative body that governs a city, county, state, or country.

Question 2

Regulation

Answer 2

Rules issues by administrative agencies that have the force of law

Question 3

Standard

Answer 3

A uniform method of defining basic parameters for processes, products, services, and measurements. Might not be a law but might be required for accreditation.

Question 4

Regulatory Standards

Answer 4

REQUIRED. A comparison benchmark that is mandated by a governing agency. Noncompliance with regulatory standards may lead to citations and legal penalties.

Question 5

Voluntary Standards

Answer 5

VOLUNTARY (aka Strongly Recommended). Guidelines or recommendations for best practices to provide better patient care. Industry, nonprofit organizations, trade associations and others develop these. Might be required for accreditation/by different facilities/included in state statues.

Question 6

Best Practice

Answer 6

A method or technique that has consistently shown results superior to those achieved by other means.

Question 7

Standards vs Regulatory Standards

Answer 7

Standards may be regulatory OR voluntary. Regulatory Standards are requirements set by government agencies that may yield legal penalties if not followed.

Question 8

Class I Devices

Answer 8

Low Risk - hand-held surgical devices, ultrasonic cleaners, etc. Subject to “general controls” like registration, device listing, medical device reporting, quality system regulation and labeling. Do not require 501(k) premarket notification application

Question 9

Class II Devices

Answer 9

Potential Risk - Most sterilization equipment, biological and chemical indicators. Subject to performance standards, post-market surveillance studies, and specific guidelines and labeling. Do require 501(k) premarket notification application.

Question 10

Class III Devices

Answer 10

High Risk - most stringently regulated like heart valves, pacemakers, and other life sustaining devices. Must obtain premarket approval (PMA) from FDA

Question 11

501(k) application

Answer 11

comprehensive package of information demonstrating new product is “substantially equivalent” to medical devices already on the market.

Question 12

PMA - premarket approval

Answer 12

Proof a device new to the healthcare market is safe and effective for intended use, based on valid scientific evidence, often including clinical data

Question 13

Medical Device Reporting

Answer 13

As of 2000, must report suspected medical device deaths within 10 days, may also report serious injuries.