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IAHCSMM CCSVP Vendor Education Program

Module 6

The Impact of Regulations and Standards on CS

Introduction

• Today’s CS department faces many challenges. Understanding some of the agencies and associations that impact the polices and protocols of the CS department can help enhance communication between you and the CS department.

• This module is designed to provide you with an overview of some of the agencies and associations that impact CS.

Instructions • Read Chapter 5, in the IAHCSMM

Central Service Technical Manual, Eighth Edition, 2016.

• Review this module.

• Complete the online quiz for Module Six.

Objectives

• Upon completion of this module, you will be able to:

– Define the difference between a standard and a regulation

– Identify the agencies and associations that impact CS, such as: FDA, CDC, DOT, EPA, OSHA, AAMI, ANSI, AORN, APIC, ISO, The Joint Commission, and SGNA.

Rules are EVERYWHERE in CS!

Where Do the “Rules” Come From?

Regulation

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

Standard

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

Types of Standards • 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 acre.

CS Technicians Must Be Familiar with Regulations and Standards Because:

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

• Many regulations and voluntary standards focus on workplace safety.

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

• Knowledge of regulatory requirements and state of the art professional practices enhances the professional growth of each CS technician.

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

CS 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)

FDA • Functions with the Public Health Service in

the US Department of Health and Human Services.

• Regulates: –Sterilants

–High Level Disinfectants

–The manufacture of all Medical Devices

–Requires pre-market clearance of new Medical Devices

Classification of Medical Devices

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

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

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

Class I Devices

• Low Risk Products such as:

– Ultrasonic Cleaners

– Most Hand-Held Surgical Instruments

Class II Devices

• Pose a potential risk. Subject to Performance Standards.

• Include:

– Sterilizers

– Biological Indicators

– Chemical Indicators

– Packaging

Class III Devices

• Most stringently regulated.

• Include:

– Heart Valves

– Infant Radiant Warmers

– Pacemakers

– Other Implants

Medical Device Reporting

• 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 within 10 working days. Serious injuries must also be reported.

Medwatch Program

• Provides for voluntary reporting of device-related problems.

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

Medical Device Recalls

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

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

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

Categories of FDA 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.

FDA Labeling Document

• “Labeling Reusable Medical Devices for Reprocessing in Healthcare Facilities”, 2015

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

FDA Labeling Document

Manufacturers are Responsible to:

• Provide sufficient instructions on how to prepare the device

for the next patient

• Provide documentation of testing that proves that the instructions are adequate and can be reasonably executed by users

FDA Labeling Document

Users are Responsible to:

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

• Ensure that the instructions are followed

Re-use of Single Use Medical Devices

• Single Use Devices (SUDs)

• Labeled as:

–Single Use

–One Time Use

Any Institution that Re-uses 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

FDA Enforcement Requirements for Reprocessing SUDs

• 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.

Hospital Re-use Options • 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.

Third Party Reprocessors

• Have received FDA Clearance to reprocess SUDs

• Must show evidence of quality and testing

SUD Considerations • 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

Other Federal Regulatory Agencies

• Centers for Disease Control (CDC)

• Department of Transportation (DOT)

• Environmental Protection Agency (EPA)

• Occupational Safety and Health Administration (OSHA)

CDC Centers for

Disease Control

CDC • 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

DOT

Department

of

Transportation BioHazard

DOT • 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 • CS Departments 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.

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.

EPA Environmental Protection Agency

EPA

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

The EPA is Responsible for:

• Minimizing greenhouse gasses

• Minimizing toxic emissions

• Regulating the re-use of Solid Wastes

• Controlling indoor air pollution

• Developing and enforcing pesticide regulations

EPA

• 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.

EPA – FIFRA 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

Clean Air Act Amendments

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

• Regulate Medical Waste Incinerators

OSHA

Occupational Safety and Health Administration

OSHA

• 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 Requires:

• “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’s Impact on CS

• Employee exposure to hazardous and/or toxic chemicals

• Employee exposure to Bloodborne Pathogens

• Protect employees from other potential hazards

OSHA may conduct…

…announced and unannounced inspections of any workplace.

OSHA Violation Ratings:

• Willful: A violation that the employer intentionally and knowingly commits. These carry fines and penalties of $5,000 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 $7,000.

OSHA Violation Ratings (continued):

• Repeat: A violation of any standard regulation or rule where, upon re-inspection, 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 $7,000 per day.

OSHA • 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.

State Agencies

• 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.

Centers for Medicare and Medicaid Services (CMS)

• Operates under the U.S. Department of Health and Human Services

• Surveys healthcare facilities to ascertain quality processes

• Failure results in nonpayment of Medicare and Medicaid funds

Professional Associations

Develop and promote voluntary standards that

set the foundations for good work practices.

AAMI

Association for the Advancement of Medical Instrumentation

AAMI • Voluntary Consensus Organization with a membership of

over 6,000 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.

ANSI

American National Standards Institute

ANSI • 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)

AORN Association of periOperative Nurses

AORN • Professional organization dedicated to

providing optimal care to the surgical patient

• Regulatory officials look for compliance with AORN Guidelines

APIC

Association for Professionals in Infection Control and Epidemiology

APIC • 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

ISO International Standards

Organization

The Joint Commission

• 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

The Joint Commission

• 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

NFPA National Fire Protection

Association

NFPA • International organization that works to

reduce the burden of fire and fire hazards around the world

USP-NF United States Pharmacopoeia –

National Formulary

United States Pharmacopoeia – National Formulary

• Creates and revises standards for the purity of medicines, drug substances and dietary supplements

• Sets standards for purified water

WHO World Health Organization

WHO

• An agency of the United Nations developed to promote the general health of people world wide

• The WHO is often at the forefront when infectious disease threatens anywhere in the world

SGNA Society of Gastroenterology

Nurses and Associates

SGNA

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

Many of the Decisions Made by CS Technicians are Based on Regulations

and Standards.

Regulations and Standards Quiz

To gain access to the Final Exam, you must first complete the Module 6 online quiz.