Review of Regulations and Standards (copy)

OSHA

š Operates under the U.S. Department of Labor

š Primary focus is to protect workers from occupational injuries and illnesses

š General Duty Clause allows for OSHA to        step in when there is no specific regulation     that covers a situation.

š Regulates EtO in CS

š Occupational exposure to bloodborne pathogens

• PPE

• Proper transportation of souled items

• Needlestick exposure protocol

FDA

š Develops regulations for foods, cosmetics, medications, and medical devices

š The Safe Medical Devices Act for reporting faulty equipment

š Issues device recalls

š Wrote “Enforcement Priorities for Single-Use Devices (SUD) Reprocessed by Third Parties and Hospitals”

š Classifies medical devices based on how strict of regulations are placed on them

US FDA- the agency responsible for pre market requirements of medical devices, faulty devices reporting, & for classifying them

š CLASS I

Lowest level of regulations

š Chemicals

š Ultrasonic washers

š CLASS II

Moderate level of regulations

š Biological/Chemical Indicators

š Sterilization wrap

š CLASS III

Highest level of regulations

š Heart valves

š Pacemakers

DOT

š Writes laws for the transportation of minimally-processed instrumentation for repair or reprocessing

š Writes laws for the transportation of hazardous and radioactive wastes

š Inspects and cites for violations

When CS transports soiled instruments between facilities, DOT regulations for labeling & packaging must be followed

Ex : biohazard label & puncture proof container

EPA

š Regulates pesticides, and disinfectant and sterilant chemicals used in CS

š Environmental Protection Agency- and other toxic chemicals. ALL SPD DISINFECTANTS MUST BE EPA APPROVED

š Regulates indoor air pollution

š Clean Air Act – National Emission Standards for Hazardous Air Pollutants

š Ethylene Oxide

-because disinfectants are intended to kill pests-specifically, microorganisms including pathogens, on surfaces - they are considered pesticides & therfore must be registered by EPA

EPA established regulations that limited the amount of ETO that a facility can omit into the atmosphere, FIFRA Federal Insecticide, Fungicide & Rodencide Act for regulating pesticides with publis health uses. EPA regulates all anti microbial products including disinfectants, sanitizers, & ETO. Every disinfectant & sanitizer manufac has to obtain EPA registration number. EPA reviews the product and set regulations label wuth directions for use. Ingredient, warnings, expiration, etc

CDC

š Not regulatory

š Focuses on infection control

š This federal agency is not regulatory

š Many CDC guidelines are used by regulatory agencies and used at healthcare facilities

š In 2008 wrote the "Guideline for Disinfection and Sterilization in Healthcare Facilities"

TJC

š Private, nonprofit accrediting organization that develops standards for healthcare facilities

š Focuses on quality improvement practices for patient care

š Conducts on site surveys every 3 years

• arrive unannounced

• 3-5 day reviewing every aspect

• Failure to comply result in loss of government accreditation. Which in yurn loses your medicaid/medicare quickly

AAMI

š Group of healthcare technology professionals from many different fields that have ties to medical devices

š Research and test new standards for the care and processing of devices

š Wrote the “Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities”

Made up of manufacturers, scientists, health care personnel, committee members from FDA. The __ writes recommendations regarding sterilization practices and other instrument specific regulations. Addressed CS processes that include different types of sterilization, cleaning, packaging, indicators

WHO

š Agency of the United Nations that focuses on combating key infectious diseases such as AIDS, SARS, malaria, and CJD

š Many countries collaborate and share research to further international cooperation in improving health

š Writes the reprocessing recommendations for items contaminated with the Creutzfeldt-Jakob Disease (CJD) prions

AORN

•      Write “Guidelines for Perioperative Practice” each year

•      Recommendations apply to anything relating to surgery

SGNA

š Nonprofit organization dedicated to safe reprocessing of GI endoscopes

š Wrote the "Guideline for the Use of High Level Disinfectants and Sterilants for Reprocessing of Flexible Gastrointestinal Endoscopes“

š Wrote the "Standard of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes"

Statues

Written by LAW adopted legislative body that governs city, county, state or country. MUST BE FOLLOWED

Regulation

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

Regulatory Standards

Regulations are Enforced by government agencies

Voluntary Standards

Recommended practices researched by non-government agencies

Standard of practice list and describe practices of the profession. They represent the highest standard of care within the specialy & result from evidence-based practice. May include safety issues - protect against exposure from infectious agents & toxic substances. May incluse disinfection and sterilization practices. May be helpful prior to purchase of new equipment. Compliance leads to work safety & patient safety is at the highest level of quality care

Best practice

A method or technique that has been consistently shown superior results over other means

Regulatory Agencies

Facilities are LEGAALLY REQUIRED to comply to the regulations written by these agencies (OSHA, PDA, DOT, EPA, CDC)

Regulations & standards (both regulatory & voluntary are issued by federal state & local governments. Some voluntary standards are issued by professional organizations & are developed using best practice by guidelines

Occupational Safety and Health Association

OSHA

U.S. Food and Drug Association

FDA

U.S. Department of Transportation

DOT

U.S. Environmental Protection Agency

EPA

Center for Disease Control and Prevention (CDC) (technically not a regulatory agency by itself)

CDC

Professional Associations (write guidelines and recommendations)

TJC, AAMI, WHO, AORN, SGNA

Regulatory agencies

Occupational safety & health association

US Food and drug administration (FDA)

US Environmental Protection Agency (EPA)

Center for Disease Control & Prevention (CDC)

• technically NOT a regulatory agency by itself

Class one FDA classified recalls

This is the most serious of the recall classes, exclusive to dangerous products that could cause serious health problems of death

• manufacturer must notify customers & direct them to notify recipients. Manufacturer must also issue a press release to notify public

Class 2 Classifies Recall

Product might cause temporary or medically reversible health problems, but the likelihood of severe damage is remote

• manufacturer must notify customers & may/may not have customers informed. May/may not have a press release

Class 3 Classified for Recalls

These products are in violation of a law or regulation enforced by the FDA, but are unlikely to cause any adverse health problems

• Manufacturer must notify customers, no press release

Professionals associations

• Writes guidelines & recommendations

The joint commission (TJC)

World Health Organization

Association of perioperative registered nurses (AORN)

Association for the Advancement of Medical Instrumentation (AAMI)

Society of Gastroenterology Nurses and Associated (SGNA)