IAHCSMM 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.

510 K Application

A comprehensive package of information designed to demonstrate that the new product is substantially equivalent to one or more medical devices already being marketed.

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 counties; they give state-of-the-art specifications for products, services and good practice, helping to make the industry more efficient and effective.

The Society of Gastroenterology Nurses and Associates (SGNA)

A nonprofit organization of nurses and associates dedicated to the safe and effective practice of gastroenterology and endoscopy nursing; they collect information and establish standards and guidelines relating to the processing of flexible endoscopes.

The Association for the Advancement of Medical Instrumentation (AAMI)

A nonprofit voluntary consensus organization whose membership is comprised of healthcare technology professionals, many of whom sit on one or more technical committees and working groups. These committees and workgroups research and develop new standards and Technical Information Reports (TIRs) that address use, care and processing of devices and systems, or revise existing standards and TIR.

The Joint Commission (TJC)

A private, independent, nonprofit organization that develops standards for healthcare facilities; they evaluate healthcare organizations and programs in the U.S. by conducting on-site surveys at least every three years.

Association of periOperative Registered Nurses (AORN)

A professional organization consisting of perioperative nurses and others who are dedicated to providing optimal care to the surgical patient.

MedWatch

A safety information and adverse event reporting system that serves healthcare professionals and the public by reporting serious problems suspected to be associated with the drugs and medical devices they prescribe, dispense, or use.

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 whose members work to prevent HAIs in the healthcare facilities; they work in conjunction with the CDC, to adopt standards for infection/disease prevention.

Statute

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

Medical Device Recall

An action taken to address a problem with a medical device; Consists of 3 categories: Class I High Risk, Class II Less Serious Risk, & Class III Low Risk.

World Health Organization (WHO)

An agency of the United Nations that was established to further international cooperation in improving health conditions; its major task is to combat disease, especially key infectious diseases, and to promote the general health of people worldwide; they coordinate international efforts to monitor outbreaks of infectious diseases.

The National Fire Protection Agency (NFPA)

An international organization that works to reduce the burden of fire and other hazards around the world.

Greenhouse Gases

Any of the gases that absorb solar radiation are responsible for the greenhouse effect, including carbon dioxide, methane, ozone and fluorocarbons.

Users

Are responsible for confirming they have the facilities and equipment to execute the instructions & the verification of manufacturer's instructions and ensuring the instructions are followed.

ANSI/AAMI ST79

Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities.

The United States Pharmacopoeia-National Formulary (USP-NF)

Create and revises standards for the purity of medicines, drug substances and dietary supplements. Standards are set for packaging, labeling, bacteriological purity, pH and mineral content.

The Clean Air Act Amendments

Created a regulatory program to achieve air quality goals.

U.S. Environmental Protection Agency (EPA)

Created by congress; for the purpose of protecting human health and the environment by writing and enforcing regulations based on laws passed by congress; also responsible for minimizing greenhouse gases and toxic emissions.

Guideline for Disinfection and Sterilization in Healthcare Facilities

Document by the CDC; It presents evidence-based recommendations on the preferred methods for cleaning, disinfection, and sterilization of patient care medical devices, and for cleaning and disinfecting the healthcare environment.

Department of Health Services (DHS)

Establish local health safety standards that may mirror federal standards or be more stringent.

National Emission Standards for Hazardous Air Pollutants (NESHAP)

Established by the Clean Air Air Amendments; these regulations established emission standards for industrial EtO sterilization facilities.

Voluntary Standards

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

Manufacturer

Is responsible for supporting the claim of reuse with adequate labeling and ensuring the labeling has sufficient instructions on how to prepare the device for the next patient & the validation ad documentation of tests, which show that the instructions are adequate, and can be reasonably executed by users.

Occupational Safety and Health Administration (OSHA)

Operates under the U.S. Department of Labor; Its primary role and responsibility is to protect workers from occupationally-caused illnesses and injuries.

Label Information for EPA approved products

Product ingredients, directions for use, product precautions and warnings, directions for storage and disposal, EPA registration number, and expiration date (if applicable).

Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)

Regulates pesticide safety and effectiveness, and it impacts all antimicrobial products, including disinfects, sanitizers and ethylene oxide (EtO).

The U.S. Food and Drug Administration (FDA)

Regulates the manufacture of all medical devices; it also regulates the sterilants and high-level disinfectants used to process critical and semi-critical devices. They also regulate packaging materials, sterilizers, and quality monitors.

Technical Information Reports (TIRs)

Reports developed by experts in the field that contain valuable information needed by the healthcare industry.

Safe Medical Devices Act of 1990

Requires healthcare facilities to report medical device malfunctions to the FDA, within 10 days of the event.

Regulation

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

Two acts that are important for Central Service Technicians

The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), and the 1990 Clean Air Act Amendments.

Medical Device Classification

The level of regulation placed on any device; which depends on how it is classified by the FDA.

Class III Low Risk Recalls

The use of a product is not likely to cause adverse health consequences.

American National Standards Institute's (ANSI's)

Their primary mission is to enhance the global competitiveness of U.S. business and the American quality of life by promoting and facilitating voluntary consensus standards and ensuring their integrity.

Class II Less Serious Risk Recalls

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 I High Risk Recalls

There is a reasonable chance the product will cause serious health problems or death.

Class II Devices

These are devices considered to pose potential risks great enough to warrant a higher level of regulation. These devices include most types of sterilization equipment, and biological and chemical indicators. Manufacturers are required to submit a premarket notification application before they can sell these products.

Class III Devices

These are the most stringently regulated devices and include most heart valves, pacemakers, and other life-sustaining devices. Manufacturers of new devices, in this class, must obtain a premarket approval from the FDA to demonstrate product safety and efficacy.

Class I Devices

These include low-risk devices, such as most hand-held surgical instruments and ultrasonic cleaners. Most of these devices are exempt from a premarket notification approval.

The Centers for Disease Control and Prevention

They work to prevent health and quality of life by preventing and controlling disease, injury, and disability, and by responding to health emergencies. The developed the first practical recommendations for isolation techniques and guidelines for infection control.