Regulations and Standards Chapter 5
May 13, 2015
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