IAHCSMM CHAPTER 5

Which two acts does the EPA administrate?

1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 2. 1990 Clean Air Act Amendments

Standards (regulatory)

A comparison benchmark that is mandated by the governing agency and, if not complied with, may cause a facility to be in violation and liable for legal penalty.

Standards (voluntary)

A comparison benchmark that is strongly recommended by a governing agency or professional organization that provides recommendations and guidelines to provide better patient care.

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.

Medicaid

A federal and state assistance program that pays covered medical expenses for low-income persons.

Medicare

A federal medical insurance program that primarily serves those over 65 years of age, and younger disabled persons and dialysis patients.

Regulation

A mandatory law or rule that is used by a governing body.

Joint Commission

A private, independent not-for-profit organization that develops standards for health care facilities. (Conducts on-site surveys every three years)

Association of Operating Room Nurses (AORN)

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

1990 Clean Air Act Amendments

A regulatory program to protect the earth's ozone layer.

MedWatch Program

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 the Advancement of Medical Instrumentation (AAMI)

A voluntary consensus organization that develop new or existing Recommended Practices and Standards that address the use, care and processing of devices and systems.

Medical Device Recall

An action taken to address a problem with a medical device that violates FDA regulations.

World Health Organization (WHO)

An agency of the United Nations. Combats disease, especially key infectious diseases, and to promote the general health of the peoples of the world. (Monitors diseases like SARS, Malaria, and AIDS)

Greenhouse gases

Any gas such as carbon dioxide, methane, halogenated fluorocarbons, and ozone which contributes to potential climate change.

Class III Devices

Are the most stringently regulated devices, and include heart valves, pacemakers, and other life-sustaining devices.

Products recalled in 2006

Automated external defibrillators. Teething rings. Volumetric infusion pumps. Vascular grafts. Coronary Stents.

Environmental Protection Agency (EPA)

Create and enforce laws relating to cleaner water, air, and land.

The Association for Professionals in Infection Control and Epidemiology (APIC)

Dedicated to the prevention and control of infections and related outcomes. (Works with CDC)

American National Standards Institute (ANSI)

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.

Hemodialyzers

Equipment used to remove impurities and waste products from blood before returning it to the patient's body.

National Emission Standards for Hazardous Air Pollutants (NESHAP).

Established emissions standards for industrial ethylene oxide (ETO) sterilization facilities.

FDA (U.S. Food and Drug Administration)

Federal agency responsible for ensuring that foods, cosmetics, human and veterinary drugs, biological products, medical devices, and electronic products that emit radiation are safe and effective for public's use.

Department of Transportation (DOT)

Federal gov agency dedicated to ensuring a fast, safe, and efficient transportation system.

What can DOT do?

Inspect and cite organizations for statue violations.

International Standards Organization (ISO)

Is a non-governmental organization with a network of National Standards Institutes representing 156 countries.

Society of Gastroenterology Nurses and Associates (SGNA)

It collects information and establishes standards and guidelines relating to the processing of flexible endoscopes.

Class I Devices

Low risk devices such as most hand-held surgical Instruments and ultrasonic cleaners.

What does the FDA regulate?

Manufacture of all medical devices and requires the pre-market clearance of new medical devices. It also regulates sterilants and high level disinfectants.

What did the Clean Air Act Amendments establish?

National Emission Standards for Hazardous Air Pollutants (NESHAP).

Class II Devices

Pose potential risks great enough to warrant a higher level of regulation. Includes most types of sterilization equipment, and biological and chemical indicators.

Centers for Disease Control (CDC)

Promotes the health and quality of life by preventing and controlling disease, injury, and disability, and by responding to health emergencies.

Standards (AAMI)

Recommendations representing a consensus of AAMI members that provide guidelines to device manufacturers that address design, performance, labeling, and other factors applicable to the instruments they manufacture.

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

Regulates pesticide safety and effectiveness, and it impacts all anti-microbial products including disinfectants and sanitizers.

PMA (Pre-Market Approval)

Required for most class III devices. Must prove the device has a reasonable assurance of safety and effectiveness for its attended use based on valid scientific evidence.

The Safe Medical Devices Act of 1990

Requires healthcare facilities to become subject to user reporting requirements.

European Commission for Standardization (ECHN)

Sets the health care standards for Europe in much the same way that AAMI sets standards for the U.S.

SUD

Single-use device

United States Pharmacopoeia-National Formulary (USP-NF)

The USP creates and revises standards for medicines, dosages, forms, drug substances, and dietary supplements. These standards are published in the USP National Formulary (NF).

Medical Device Classification

The level of regulation placed on any device depends upon how the FDA has classified that device.

Class II: Less Serious Risk (FDA recall)

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

Class I: High Risk (FDA recall)

There is a reasonable chance the product will cause serious health problems or death. (The company must also issue a press release to notify the public)

Class III: Low Risk (FDA recall)

There is little chance that using or being exposed to the product will cause health problems.

Occupational Safety and Health Administration (OSHA)

To protect workers from occupational-caused illnesses and injuries.

Prions

Virus-like infectious agents that cause a variety of neuro degenerative diseases of humans and animals. Differ from viruses by containing neither DNA nor RNA, only protein. They are extremely resistant to inactivation by heat and disinfecting agents.

Recommended Practices and Standards (AAMI)

Voluntary guidelines representing a consensus of AAMI members that are intended for use by healthcare facilities to help ensure that medical instrumentation is safe for patient use.

When is a 510(k) submission required for Class I and II devices?

When a device is not listed as exempt from regulation.

OSHA violations are rated as:

Willful. Serious. Repeat. Abate.

National Fire Protection Association (NFPA)

Works to reduce the burden of fire and other hazards around the world.

Are voluntary standards issued by professional organizations?

Yes

Does all EPA approved products contain strict label information?

Yes

Is ANSI the sole U.S. representative to the International Standards Organization (ISO)?

Yes