This document discusses regulations and standards that impact central service departments. It provides information on the differences between regulations and voluntary/regulatory standards. It reviews regulations from the FDA regarding medical device classification and labeling. It also discusses the roles of the CDC, DOT, EPA, and OSHA and how their regulations impact central service. Professional organizations that develop standards affecting central service are also reviewed.

1. Regulations and Standards
Chapter 5

2. ∗  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:

3. ∗  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

5. ∗A Mandatory Law or Rule
that is issued by a
governing body.
Regulation:

6. ∗A uniform method of
defining basic parameters
for processes, products,
services, and measurements.
Standard:

7. ∗ 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

8. ∗ A written and enforceable law enacted by a
governing body.
∗ Voluntary Standards are sometimes incorporated
into Federal, State, or Local Statutes.
Statute

9. ∗ 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:

10. 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)

11. ∗ Functions with the Public Health Service in the US
Department of Health and Human Services.
∗ Regulates:
∗Sterilants
∗High Level Disinfectants
∗The manufacturer of all Medical Devices
Requires pre-market clearance of new Medical Devices.
FDA

12. 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

13. 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

14. 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

15. ∗ 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

16. Medwatch Program
∗ Provides for voluntary
reporting of device-related
problems.
∗ Provides a vehicle for
Healthcare Professionals to
notify the FDA of problems.

17. ∗ 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

18. ∗ 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:

19. ∗ “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

20. ∗ 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:

21. ∗ 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:

22. 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

23. ∗ 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.

24. ∗ 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

25. ∗ Have received FDA Clearance to reprocess SUDs.
∗ Must show evidence of quality and testing.
Third Party Reprocessors

26. ∗ 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

27. Other Federal Regulatory Agencies
∗ Centers for Disease Control (CDC)
∗ Department of Transportation
(DOT)
∗ Environmental Protection Agency
(EPA)
∗ Occupational Safety and Health
Administration (OSHA)

28. ∗ 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

29. ∗ 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

30. ∗ 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

31. 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

32. ∗ Established in 1970 to
enforce Federal laws
pertaining to Air and
Water Pollution and
other environmentally-
related statutes.
EPA
ENVIRONMENTAL PROTECTIVE AGENCY

33. ∗ 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:

34. ∗ 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.

35. ∗ 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

36. ∗ 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

37. ∗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

38. ∗ “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:

39. 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.

40. Announced and unannounced
inspections of any workplace
OSHA May Conduct…

41. ∗ 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:

42. ∗ 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:

43. ∗ 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

44. ∗ 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

45. Professional Associations
Develop and promote voluntary
standards that set the foundations
for good work practices

46. ∗ 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

47. ∗ 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

48. ∗ 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

49. ∗ 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

50. ∗ 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

51. 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.

52. ∗ 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

53. ∗ 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

54. ∗ 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

55. ∗ 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

56. ∗Sets healthcare standards for
Europe in much the same way
that AAMI sets standards in the
United States
ECHN:
European Commission for Standardization

57. ∗ 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

58. ∗ 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

59. USP-NF
APIC
AORN
NFPA
State Law
JCAHO
AAMI
OSHA
EPA
FDA
Central Service
Compliance is our Job!

60. 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