Chapter 5 - Regulations & Standards

This nonprofit develops standards for industry, government and healthcare for all Canadian provinces.

Canadian Standards Association (CSA)

What's the regulatory agency responsible for minimizing greenhouse gases and toxic emissions, regulating the reuse of solid wastes, controlling indoor air pollution and developing and enforcing pesticide regulations?

The Environmental Protection Agency

True or False? Packaging materials, sterilizers and quality monitors such as biological indicators are not regulated by the FDA

False

In 2008, the CDC released a document entitled _______________ which outlines preferred methods for cleaning, disinfection and sterilization of patient care medical devices and for cleaning and disinfecting the healthcare environment.

Guideline for Disinfection & Sterilization in Healthcare Facilities

AORN's _______________ for _______________ _______________ has several sections on cleaning, disinfection, packaging, endoscope processing and sterilization

Guidelines for PeriOperative Practice

What's an FDA "Class 3" recall?

No risk. Use of the product is not likely to cause adverse health consequences but instead is in violation of FDA law. The manufacturer must notify customers. No press release issued.

Are CDC GUIDELINES considered regulatory?

No, but other agencies rely heavily on them for compliance

Are there national emission standards set for ETO sterilization?

No, though some states have imposed ETO emission limits

What federal agency that operates under the US department of labor protects workers from occupationally-caused illnesses and injuries?

Occupational Safety & Health Administration (OSHA)

What's the federal agency responsible for ensuring that foods, cosmetics, human and veterinary drugs, biological products, medical devices and electronic products that emit radiation, are safe for public use?

The Food and Drug Administration (FDA)

What is FIFRA?

Regulates pesticide safety and effectiveness & impacts all antimicrobial products such as disinfectants, sanitizers and ETO (Ethylene Oxide).

What are Technical Information Reports?

Reports developed by experts in the field that contain valuable information needed by the healthcare industry. TIR's have not been formally approved and may need further expert evaluation. TIR's also may be revised or rewritten at any time because they address a rapidly-evolving field or technology.

What organization enhances global competitiveness of US business and american quality of life by promoting voluntary consensual standards whilst ensuring their integrity?

The American National Standards Institute (ANSI)

What non-profit voluntary organization is comprised of healthcare tech professionals, with an interest in development, management and use of safe and effective medical technology?

The Association for the Advancement of Medical Instrumentation (AAMI)

What professional (but not regulatory) agency consists of peri-operative nurses and others who are dedicated to providing optimal care to the patient?

The Association of PeriOperative Registered Nurses (AORN)

The CDC's primary objective is what?

To prevent and control disease, injury and disability by responding to health emergencies.

True or False? The FDA regulate sterilants and high-level-disinfectants used to process critical and semi-critical devices

True

The Centers for Medicare & Medicaid (CMS) operates under what branch of government?

U.S. Department of Health & Human Services

This professional organization creates and revises standards for the PURITY of medicines, drug substances and dietary supplements

United States Pharmacopoeia - National Formulary (USP-NF)

When it comes to differing state, local or federal regulations concerning something, whose regulations do you follow?

Whichever regulations are the most stringent.

When it comes to safe medical device reprocessing, what is the users responsibility per the FDA?

1. Confirm that they have the facilities and equipment to execute the instruction 2. The verification of manufacturers instructions and ensuring the instructions are followed

When it comes to safe medical device reprocessing, what is the manufacturers responsibility per the FDA?

1. Ensure the claim of reuse with adequate labeling and ensuring the labeling has sufficient instructions on how to prepare the device for the next patient 2. Validation and documentation of tests, which show that the instructions are adequate and can be reasonably executed by the users

Why is it important for CS professionals to be familiar with regulations and voluntary standards?

1. Not following statutes and regulations could cause the healthcare facility to face legal consequences 2. Regulations and voluntary standards may include workplace safety issues, which protects CS professionals from infectious agents and toxic substances 3. Regulations and voluntary standards may include disinfection and sterilization practices which help in pre-purchase product evaluations 4. Adhering to statutes, regulations and voluntary standards ensures the highest quality of patient safety

All EPA approved products must contain these 6 items on its label:

1. Product ingredients 2. Directions for use 3. Precautions and warnings 4. Directions for storage and disposal 5. EPA registration # 6. Expiration date (if applicable)

What 2 EPA acts are relevant to Central Service?

1. The Federal Insecticide, Fungicide & Rodenticide Act (FIFRA) 2. The 1990 Clean Air Act Amendments

Which 3 OSHA regulations and standards have been passed into laws by Congress?

1. The Occupational Exposure to Blood-borne Pathogens Standard 2. Guidelines for the Use of Ethylene Oxide Sterilization 3. General Duty Clause of the Occupational Safety & Health Act

What 2 US DOT laws relate to healthcare?

1. The transporting of of minimally processed instrumentation for repair 2. The reprocessing and transportation of hazardous and radioactive items

What is Medicaid?

A federal and state run program that pays medical expenses for low-income individuals

What's a 510k application?

A packet of information that demonstrates that the new product is pretty much just like what's already on the market

What voluntary organization works along with the CDC and other agencies to adopt and develop standards for preventing HAI's in healthcare facilities?

Association for Professionals in Infection Control & Epidemiology (APIC)

What's the Clean Air Act of 1990?

Bans ozone depleting CFC's & HCFC's and established NESHAP (National Emission Standards for Hazardous Air Pollutants), which set emission standards for industrial ETO sterilization facilities

How often do deaths and serious injuries need to be reported to the FDA?

Bi-annually on January 1st and July 1st.

This organization is similar to AAMI, however all 33 European countries have adopted their standards exclusively. If a US company is selling products to the European market, they must follow this organizations standards and regulations.

European Committee for Standardization (CEN)

The FDA functions within what branch of the government?

Health & Human Services

What branch of the government is the Center for Disease Control & Prevention under?

Health & Human Services

What does HIPAA stand for and what does it do?

Health Insurance Portability and Accountability Act. It protects confidentiality of a patients medical information.

What's an FDA "Class 1" recall?

High risk recall. There's a chance the device may cause serious health problems or even death. The manufacturer MUST get in touch with its customers and in turn their customers MUST get in touch with device recipients. The notification will include: 1. The name of the device 2. Lot or serial # 3. Reason for the recall 4. Instructions to correct, avoid or minimize the problem The manufacturer MUST release a press release The FDA MAY release a press release

The level (and amount) of regulation placed on any device, by the FDA, depends on what?

How the FDA classifies the device

What are Medical Device Reporting requirements?

If a malfunctioning device leads to serious injury of a patient, the user must notify the manufacturer within 10 days of the event. If a malfunctioning device leads to the death of a patient, the user must notify the FDA within 10 days of the event. If a malfunctioning device leads to serious injury or death of a patient but the manufacturer is not known, the user must notify the FDA within 10 days of the event.

Do Single Use Devices require a 510k? If so, why or why not?

If reprocessing Single Use Devices is being done on-site, then yes they require a 510k. If reprocessing of SUD's is outsourced to a 3rd party, a 510k is not required.

What does "Pre-market approval" mean?

It's required for most class 3 devices new to the healthcare market. 1. The manufacturer must prove the device is safe and effective. 2. Sometimes clinical data is required to backup safety claims. 3. The manufacturing facility must be inspected. 4. The FDA may also choose to collect annual data on critical products after they're IN the market to ensure the devices are doing what's expected of them.

When soiled instruments are traveling between healthcare and repair facilities, DOT regulations for biohazard _______________ & _______________ MUST be followed!

Labeling & packaging

What might happen if a facility fails to follow CMS standards?

Loss of all federal funding

What are FDA "Class 1" devices?

Low risk devices that are subject to general controls. Most class 1 devices are exempt from a pre-market notification approval Examples: hand-held surgical devices and ultrasonic cleaners

What are IFU's?

Manufacturer's Intended For Use instructions are included with each device that outlines proper cleaning, assembly, disinfection and sterilization of the device

What is the medical program launched by the FDA designed for reporting device-related problems?

MedWatch

What is Medicare?

Medicare is a federal medical insurance program that primarily serves people over 65, regardless of income, people under 65 with certain disabilities or people of all ages with end stage renal disease.

What's an FDA "Class 2" recall?

Moderate risk. It's possible that the product will cause a temporary or medically reversible adverse health problem or there may be a very small chance that the device will cause serious injury. The manufacturer MUST get in touch with their customers and SOMETIMES have their customers get in touch with the device recipients. Generally, no press release is issued.

How are "serious injuries" defined?

Permanent incapacitation of a body part or expected permanent incapacitation of a body part without preemptive surgical intervention

What are FDA "Class 2" devices?

Poses greater risks to the patient. Manufacturers are REQUIRED to submit a pre-market notification for approval (510k) Examples: sterilization equipment and biological and chemical indicators

What document did AAMI release that's most widely used in Central Service?

ST79 Comprehensive guide to steam sterilization & sterility assurance in healthcare facilities.

What non-governmental organization has a network comprised of 163 countries that has no legal authority but has developed standards that some countries have adopted as law in their respective jurisdictions?

The International Standards Organization (ISO)

This private and independent non-profit organization develops standards for healthcare facilities and evaluates said facilities at least every 3 years. Their standards are voluntary but failure to comply could result in loss of millions of dollars in Medicare and Medicaid payments.

The Joint Commission (TJC)

This organization works to reduce the burden of fire and other hazards around the world by using a process to develop codes and standards that influence building safety in the US and in other countries.

The National Fire Protection Association (NFPA)

This nonprofit organization is dedicated to the safe and effective practice of gastroenterology and endoscopy nursing. They also collect information and establish standards and guidelines relating to the processing of flexible endoscopes.

The Society of Gastroenterology Nurses Association (SGNA)

What's the federal agency dedicated to ensuring a fast, safe and efficient transportation system?

The U.S. Department of Transportation

This organization combats disease, especially key infectious diseases and promotes general health worldwide. They also provide a central clearing house for research services and international standards. Agencies such as the CDC base their standards and research direction from this organization.

The World Health Organization (WHO)

Who does the FDA hold accountable for safe reprocessing of medical devices?

The manufacturer and the user

What are FDA "Class 3" devices?

The most stringently regulated devices. Manufacturers MUSt obtain pre-market approval to demonstrate product safety. Examples: Pacemakers & heart valves

A method or technique that has consistently shown results superior to those achieved by other means

best practice

The CDC developed the first practical recommendations for _______________ _______________ and guidelines for infection control.

isolation techniques

The FDA regulates the manufacture of all _______________ _______________ and requires _______________ _______________ of new medical devices

medical devices, pre-market clearance

What 4 operations is CMS responsible for?

medicare, medicaid and the state children's health insurance program, administering HIPAA standards

Rules issued by governmental administrative agencies that have the force of law.

regulations

Comparison benchmarks mandated by a governing agency. Noncompliance may lead to citations and legal penalties.

regulatory standards

Uniform methods of defining basic parameters for processes, products, services and measurements.

standards

Written laws adopted by a legislative body that governs a city, county, state or country.

statutes

Guidelines or recommendations for best practices to provide better patient care. Industry, non-profit, trade associations and others develop these.

voluntary standards