CRCST Chapter 5 Regulations and Standards

Regulatory Standards

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

Best Practice

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

International Standards Organization (ISO)

A non-government organization with a network of National Standards institutes representing 163 countries. ISO standards are voluntary and the organization has no legal enforcement authority.

FDA Med Watch Program

A safety information and adverse event reporting program designed for the voluntary report of serious problems involving device-related issues.

Standard

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

Association for Professionals in Infection Control and Epidemiology (APIC)

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

Statue

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

Class II Medical Devices

Are considered to pose potential risks great enough to warrant a higher level of regulation. Most of the sterilization and biologic and chemical indicators. Manufacturers are required to submit a premarket notification application 510(k) before they can sell these devices.

Class I Medical Devices

Are low-risk devices such as most hand-held surgical instruments and ultrasonic cleaners.

Class III Medical Devices

Are the most stringently regulated devices that include heart valves, pacemakers, and other life-sustaining devices. Manufacturers must obtain a premarket approval (PMA) from the FDA to demonstrate product safety and efficacy.

Environmental Protection Agency (EPA)

Clean Air Act is administered through this agency. They also impose very strict labeling requirements on manufacturers of disinfectants used by the CS department.

United States Pharmacopoeia (USP)

Creates and revises standards for processing water for irrigation.

Association of periOperative Registered Nurses (AORN)

Develops nationally recognized guidelines for the perioperative setting.

Department of Transportation (DOT)

Enforces laws relating to the transportation of medical waste.

World Health Organization (WHO)

Furthers international cooperation in improving health condition.

Voluntary Standards

Guidelines or recommendations for best practices to provide better patient care. Industry, nonprofit organizations, trade associations and others develop these.

minimal levels of quality and safety.

Healthcare regulations and standards provide:

National Fire Protection Association (NFPA)

International standards to reduce the burden of fire and other hazards.

Class I FDA Recall

Is a high-risk recall. There is a reasonable chance that the product will cause serious health problems or death.

Association for the Advancement of Medical Instrumentation (AAMI)

Is considered one of the major resources for healthcare guidelines.

Class II FDA Recall

Less serious risk recall. There is a possibility that the product will cause a temporary or medically reversible adverse health problem, or there is a remote chance that the device will cause serious health problems.

Class III FDA Recall

Low-risk recall. Use of a product is not likely to cause adverse health consequences.

Centers for Disease and Control (CDC)

Promotes health by preventing and controlling disease.

American National Standards Institute (ANSI)

Proposed standards are submitted from members such as the Association for the Advancement of Medical Instrumentation

Occupational Safety and Health Administration (OSHA)

Protects workers from occupationally-caused illnesses and injury.

The Joint Commission (TJC)

Provides standards and evaluation for healthcare facilities. These evaluations are in the form of onsite surveys at least every three years.

The Safe Medical Act of 1990

Requires healthcare facilities to report medical device malfunctions to the FDA.

Regulation

Rules issued by administrative agencies that have the force of law.

SUD

Single-Use Device Reprocessor acronym.

Occupational Safety and Health Administration (OSHA)

The agency that may intervene in a matter of worker protection even if there are no specific regulations covering the situation.

Society of Gastroenterology Nurses and Associates (SGNA)

This organization specializes in endoscopy issues and has established standards for the effective processing of flexible endoscopes.

U.S Food and Drug Administration (FDA)

Under current regulations, the device manufactuer and hospitals are required to report suspected medical device-related deaths to what organization?