Regulations and Standards

Chapter 5

Tell the difference between regulations and voluntary and regulatory standards

Provide basic information about the U.S. Food and Drug Administration (FDA), and review its regulations applicable to:

Medical device classification Pre- and post-market requirements Medical device reporting requirements Medical device recalls FDA labeling document Re-use of single-use medical devices

Explain the roles and responsibilities of other federal governmental agencies that impact Central Service, and discuss important aspects of the regulations and standards they administer:

Centers for Disease Control (CDC) Department of Transportation (DOT) Environmental Protection Agency (EPA) Occupational Safety and Health Administration (OSHA)

Learning Objectives:

Discuss the assistance provided by professional associations that develop regulations and standards affecting Central Service:

Association for the Advancement of Medical Instrumentation (AAMI)

American National Standards Institute (ANSI) Association of Operating Room Nurses (AORN) Association for Professionals in Infection Central and

Epidemiology (APIC) International Standards Organization (ISO) The Joint Commission National Fire Protection Association (NFPA) United States Pharmacopoeia – National Formulary

(USP-UF) World Health Organization (WHO) Society of Gastroenterology Nurses and Associates

(SGNA)

Learning Objectives - continued

A Mandatory Law or Rule that is issued by a governing body.

Regulation:

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

Standard:

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

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.

Types of Standards

A written and enforceable law enacted by a governing body.

Voluntary Standards are sometimes incorporated into Federal, State, or Local Statutes.

Statute

Compliance with regulations is mandatory and failure to comply can lead to serious legal consequences for the healthcare facility.

Many regulations are voluntary guidelines focus on workplace safety.

Awareness of regulations and standards can help with decisions regarding the acquisition and use of products in Central Service.

Knowledge of regulatory requirements and state of the art professional practices enhances the professional growth of each Central Service Technician.

Careful compliance with Standards and Regulations protects the welfare of patients.

Central Service Technicians Must be Familiar with Regulations and

Standards because:

Federal Regulatory Agencies

Food and Drug Administration (FDA)

Centers for Disease Control (CDC)

Department of Transportation (DOT)

Environmental Protection Agency (EPA)

Occupational Safety and Health Administration (OSHA)

Functions with the Public Health Service in the US Department of Health and Human Services.

Regulates:SterilantsHigh Level DisinfectantsThe manufacturer of all Medical DevicesRequires pre-market clearance of new Medical Devices.

FDA

Classification of Medical Devices

Class I Devices - Subject to general controls, exempt from pre-market submission requirements.

Low Risk Products such as:

Ultrasonic Cleaners Most Hand-Held Surgical

Instruments

Class II Devices

Class II Devices – Considered to pose potential risks. Subject to special requirements and post market surveillance. Manufacturers required to submit pre-market notification (510K).

Pose a potential risk. Subject to Performance Standards. Include: Sterilizers Biological Indicators Chemical Indicators Packaging

Class III Devices

Class III Devices – Most Stringently regulated devices. Require pre-market application and extensive testing demonstrating their safety and effectiveness before approval.

Most stringently regulated.

Include: Heart Valves Infant Radiant Warmers Pacemakers Other Implants

Safe Medical Devices Act of 1990 Healthcare Facilities required to

report events to the FDA.

Beginning in 2000, medical facilities were required to report suspected medical device-related deaths with 10 working days. Serious injuries must also be reported.

Medical Device Reporting

Medwatch Program

Provides for voluntary reporting of device-related problems.

Provides a vehicle for Healthcare Professionals to notify the FDA of problems.

An action taken if there is a with a medical device that violates FDA regulations.

Can be enforced when a device is defective and/or poses a risk to health.

Can be voluntary when instituted by the manufacturer, distributor, or other interested party.

Medical Device Recalls

Class I – High Risk: There is a chance the product will cause serious health problems or death.

Class II – Less Serious Risk: There is a chance the product will cause temporary or reversible health problems. There is a remote chance the device will cause serious health problems.

Class III – Low Risk: There is little chance that using or being exposed to the product will cause health problems.

Categories of FDA Recalls:

“Re-labeling Reusable Medical Devices for Reprocessing in Healthcare Facilities”, 1996

The document requires manufacturers to comply with seven criteria, mostly involving reprocessing instructions, when they submit medical device applications to the FDA for evaluation.

FDA Labeling Document

Provide sufficient instructions on how to prepare the device for the next patient.

Provide documentation of test that show that the instructions are adequate and can be reasonably executed by users.

FDA Labeling Document

Manufacturers are Responsible to:

Confirm that they have the facilities and equipment to execute the instructions.

Ensure that the instructions are followed.

FDA Labeling Document

Users are Responsible to:

Reuse of Single Use Medical Devices

Single Use Devices (SUDs)

Labeled as: Single Use One Time

Use

Any Institution that Reuses an SUD Should be able to demonstrate that:

The item can be adequately cleaned and sterilized

The quality of the device will not be adversely affected

The device will remain safe and effective for its intended use

All Hospitals and Third Party Reprocessors who reprocess SUDs are required to be in compliance with pre-market and post-market requirements outlined in “Enforcement Priorities for

Single-Use Devices Reprocessed by Third Parties and Hospitals”, FDA

2000.

FDA Enforcement Requirements for

Reprocessing SUDs.

Re-use options should be considered by a multidisciplinary task force that can evaluate the legal, ethical, and economic issues involved

If the hospital chooses to reprocess, they are subject to stringent FDA regulations and on-site surveys

Hospitals may choose to outsource that process to Third Party Reprocessors

Hospital Re-use Options

Have received FDA Clearance to reprocess SUDs.

Must show evidence of quality and testing.

Third Party Reprocessors

Preliminary Evaluation Evaluation of Reuse Alternative Initial Cost Analysis Risk Assessment Consideration of Reprocessing Protocols Examine Facility Requirements Develop Procedures Undertake Potential Cost Assessment Obtain Necessary Approval Conduct Clinical Study Undertake Actual Cost Assessment Implement SUD Reprocessing System

SUD Considerations

Other Federal Regulatory Agencies

Centers for Disease Control (CDC)

Department of Transportation (DOT)

Environmental Protection Agency (EPA)

Occupational Safety and Health Administration (OSHA)

Federal agency the collects and analyses data about infectious diseases.

Issues infection control guidelines.

Many CDC Guidelines and Recommendations are incorporated into healthcare facility policies and procedures and other agencies rely heavily on them.

CDC CENTERS FOR DISEASE

CONTROL

Federal Government agency that is dedicated to ensuring a fast, safe, and efficient transportation system

DOT regulates labeling and containment of Hazardous Waste, Biohazard items and minimally processed items for transport

Dot also regulates labeling and containment of radioactive materials for transport

DOT DEPARTMENT OF

TRANSPORTATION

Central Service Department that transport minimally cleaned items between facilities for processing are impacted by DOT regulations.

Minimally cleaned instruments that are transported to repair facilities must be shipped following DOT regulations.

DOT

State or Local DOT

State or Local DOT regulations may be more restrictive than Federal DOT regulations

When that happens, the most stringent regulations apply

Established in 1970 to enforce Federal laws pertaining to Air and Water Pollution and other environmentally-related statutes.

EPA ENVIRONMENTAL PROTECTIVE

AGENCY

Minimizing Greenhouse Gasses

Minimizing Toxic Emissions

Regulating the Re-use of Solid Wastes

Controlling indoor air pollution

Developing and enforcing pesticide regulations

The EPA is Responsible for:

Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) gave the EPA responsibility to regulate all products with antimicrobial claims, such as Sterilants, Disinfectants, and Sanitizers.

EPA All surface

disinfectants and sanitizers must be registered with the EPA.

All products must meet strict labeling requirements.

Manufacturers must obtain an EPA registration number for every chemical sterilant, disinfectant and sanitizer.

Each product’s label must contain:

Product Ingredients Directions for Use Product Precautions and Warnings Directions for Storage and Disposal The EPA Registration Number

EPA – FIFRA Requirements

National Emissions Standards for Hazardous Air Pollutants (NESHAP) set emissions standards for industrial Ethylene Oxide Sterilization Facilities.

Regulate Medical Waste Incinerators

Clean Air Act Amendments

Created in 1971 as a part of the U.S. Department of Labor

Its primary role is to protect workers from occupationally-caused illnesses and injuries.

OSHA Occupational Safety and Health

Administration

“That each employer furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing, or are likely to cause, death or serious physical harm to his employees.”

A Safe Workplace

OSHA Requires:

OSHA’s Impact on Central Service

Employee exposure to hazardous and/or toxic chemicals.

Employee exposure to Bloodborne Pathogens.

Protect employees from other potential hazards.

Announced and unannounced

inspections of any workplace

OSHA May Conduct…

Willful: A violation that the employer intentionally and knowingly commits. These carry fines and penalties of $5000 to $70,000.

Serious: A violation in which there is substantial probability that death or serious injury could result and the employer knew or should have known of the hazard. These violations carry fines up to $7000.

OSHA Violation Ratings:

Repeat: A violation of any standard regulation or rule where, upon reinspection, a substantially similar violation is found. These carry penalties of up to $70,000.

Failure to Abate: Failure to correct a prior violation may result in penalties of up to $7000 per day.

OSHA Violation Ratings continued:

Federal Regulations apply to ALL States.

States may have State OSHA Offices as well. Those agencies may be more stringent (but never less stringent) than the Federal regulations.

OSHA

State agencies such as DHS, DOT, EPA and OSHA may have regulations that are more stringent than Federal regulations

The most restrictive regulations always apply

State Agencies

Professional Associations

Develop and promote voluntary standards that set the foundations for

good work practices

Voluntary Concensus Organization with a membership of over 6000 individuals and 375 organizations

Uses Technical Advisory Groups comprised of practitioners, industry experts and manufacturers to develop Recommended Practices and Standards

Even though it is a voluntary organization, its Recommended Practices and Standards are used by regulatory organizations that inspect healthcare organizations

AAMI: Association for the

Advancement of Medical Instrumentation

Mission: “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.”

Standards are submitted to ANSI for approval, from other organizations such as AAMI (Association for the Advancement of Medical Instrumentation)

ANSI:American National Standard

Institute

Professional Organization dedicated to providing optimal care to the surgical patient

Regulatory officials look for compliance with AORN Standards, Recommended Practices and Guidelines

AORN:Association of Peri-Operative Nurses

Voluntary international organization dedicated to the prevention and control of infections and related outcomes

Works with the CDC and other related agencies to adopt standards for infection/disease prevention

APIC:Associations for Professionals in Infection Control & Epidemology

Globally based – non-governmental standards organization

Represents approximately 156 member countries

Standards groups such as AAMI submit standards which are granted ISO status based on the consensus of the membership

ISO:International Standards

Organization

The Joint Commission

(formerly) The Joint Commission’s Mission

“To continuously improve the safety and quality of care provided to the public through the provision of health care

accreditation and related services that support performance improvement in

hospitals.

Independent, Not-for-profit, Organization Sets Healthcare Quality Standards Is used as a measurement of organizational

quality Surveys approximately 15,000 healthcare

facilities in the United States Conduct on-site surveys (inspections) of

healthcare facilities Surveys may be announced or unannounced Loss of Joint Commission Accreditation may

result in forfeiture of Medicare and Medicaid reimbursement payments

The Joint Commission

International organization that works to reduce the burden of fire and other hazards.

Made up of representatives from nearly 100 nations and organizations.

Sets Fire Safety Standards.

NFPA:National Protection

Association

Creates and revises standards for medicines, dosages, forms, drug substances, and dietary supplements.

Sets standards for packaging, labeling, bacteriological purity, pH, and mineral content of purified water or water sterilized for irrigation.

USP-NF:United States Pharmacopia-National

Formulatory

An agency of the United Nations that was established in 1948 to further international cooperation in improving health conditions.

Its major task is to combat infectious disease and promote the general health of the peoples of the world.

Agencies such as the CDC may base their policies on WHO guidelines and research.

WHO:World Health Organization

Sets healthcare standards for Europe in much the same way that AAMI sets standards in the United States

ECHN: European Commission for

Standardization

A non-profit organization that collects information and establishes standards and guidelines relating to the processing of flexible endoscopes.

SGNA: Society of Gastroenterology Nurses and

Associates

Becoming familiar with the standards and regulations that impact their jobs.

Learning and correctly following procedures.

Calling attention to poor practices.

Keeping abreast of changes in standards and regulations.

Putting ourselves in the Patient’s place. What quality of care would you like to receive?

Central Service Technicians can insure compliance by

USP-NF

APIC

AORN

NFPA

State Law

JCAHO

AAMI

OSHA

EPA

FDA

Central Service

Compliance is our Job!

Web Sites

www.fda.gov www.cdc.gov www.dot.gov www.epa.gov www.osha.gov www.aami.org www.ansi.org www.aorn.org

www.apic.org www.iso.org www.jcaho.org www.nfpa.org www.usp.org/uspnf www.who.org www.sgna.org