IAHCSMM Chapter 5

CSTs must be familiar with regulations and standards because:

1. Compliance with regulations is mandatory and failure to comply can lead to serious legal consequences for the healthcare facility. 2. Many regulations and voluntary guidelines focus on workplace safety. 3. Awareness of regulations and standards can help with decisions regarding the acquisition and use of products in Central Service.

What are the characteristics of a Class III medical device?

1. These medical devices are the most stringently regulated devices. Examples: heart valves, infant radiant warmers, pacemakers, other implants 2. These medical devices require pre-market application and extensive testing demonstrating their safety and effectiveness before approval.

Beginning in 2000, medical facilities were required to report suspected medical device-related deaths within ___ working days to the FDA and the manufacturer.

10

What does the Failure to Abate OSHA violation rating mean?

A Failure to Abate violation is a failure to correct a prior violation and may result in penalties of up to $7,000 per day.

Define a voluntary standard.

A comparison benchmark that is strongly recommended by a governing agency or professional organization that provides recommendations and guidelines to provide better patient care.

Standard

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

What does the willful OSHA violation rating mean?

A willful violation is one that the employer intentionally and knowingly commits. These carry fines and penalties of $5,000 to $70,000 per incident.

Statue

A written and enforceable law enacted by a governing body

OSHA federal regulations apply to _____ states.

All.

ANSI

American National Standards Institute Promotes and facilitates voluntary consensus standards in America

510k

Application to the FDA to prove that a product is equivalent to a device already being marketed Required for class I-II, class III may require this or a PMA

APIC (Association for Professionals in Infection Control and Epidemiology) members work in conjunction with other agencies such as (the) _____ to adopt standards for infection/disease prevention.

CDC (Centers for Disease Control)

What class of FDA recall covers low risk products? There is little chance that using or being exposed to the product will cause health problems.

Class III (low risk)

The National Emissions Standards for Hazardous Air Pollutants (NESHAP) [part of the _____ _____ _____ Amendment] has established emissions standards for industrial ethylene oxide (ETO) used in sterilization facilities.

Clean Air Act

The Central Service Department that transports minimally cleaned items between facilities for processing are impacted by _____ regulations. [What agency?]

DOT

DOT

Department of Transportation Regulates transportation of hospital waste

What federal agency requires pre-market clearance of new medical devices?

FDA

All medical device recalls are mandatory. T / F

False

Unlike hospitals, Third Party Reprocessors do not need FDA clearance to reprocess SUDs. T / F

False

Minimally cleaned instruments that are transported to repair facilities must by shipped following EPA regulations. T / F

False [They must be shipped according to DOT regulations.]

A Class I FDA recall is on a device that poses low risk of injury or death. T / F

False ( Class I FDA recalls are HIGH RISK. There is a reasonable chance the product will cause serious health problems or death.)

EPA FIFRA requires manufacturers to obtain and EPA registration number for most chemical sterilants, disinfectants, and sanitizers. T / F

False (EPA FIFRA requires manufacturers to do this for ALL chemical sterilants, disinfectants, and sanitizers.

A medical device recall means that the device can no longer be used. T / F

False (It could mean that the product must only need to be repaired or checked.)

The DOT requires all products to meet strict labeling requirements. T / F

False (The EPA makes this requirement.)

There are five categories of FDA recalls. T / F

False (There are three categories of FDA recalls.)

ISO (International Standards Organization) is a globally based non-governmental standards organization. ISO (International Standards Organization) standards are mandatory for all members. T / F

False. ISO standards are voluntary.

OSHA is required to give a facility 24-hour notice before an inspection. T / F

False. Inspections can be announced or unannounced.

In 1996 the FDA released a document, "Re-labeling Reusable Medical Devices for Reprocessing in Health Care Facilities" to provide _____ for FDA reviewers who evaluate pre-market approval applications for medical devices.

Guidance

The Joint Commission is an independent, not-for-profit organization which conducts on-site surveys (inspections) of ____ .

Healthcare facilities.

Class II

Indicators, sterilization equipment, must submit a 510k before these can be sold

ISO

International Standards Organization Voluntary, International organization for creating international standards

Class III

Life-sustaining devices- need pre market approval (PMA)- heart valves, pacemakers, etc.

Class 1 devices

Low risk instruments: ultrasonic cleaners, handheld surgical instruments, these are subject to "general controls"

Regulation

Mandatory law issued by a governing body

FDA

Medical device classification, reporting, recalls, re-use of single use devices, labeling

An action taken when there is a problem with a medical device that violates FDA regulations is called a _____ .

Medical device recall

An organization's loss of Joint Commission Accreditation (due to results of a survey) may result in forfeiture of _____ and _____ reimbursement payments.

Medicare, Medicaid

Healthcare professionals can report medical device malfunctions, labeling inadequacies, and other problems through what FDA vehicle?

Medwatch Program

The program that provides for voluntary reporting of device-related problems is the _____ .

Medwatch Program

What is the voluntary reporting system that serves healthcare professionals and ensures public safety by reporting serious problems and adverse events suspected to be associated with the drugs and medical devices they prescribe, dispense, or use.

Medwatch Program

OSHA

Occupational Safety and Health Administration Protects workers from occupational- caused illness and injuries

AAMI uses technical advisory groups comprised of _____ , _____ , and _____ to develop Recommended Practices and Standards.

Practitioners. industry experts, manufacturers

FDA enforcement requirements for reprocessing SUDs state that all hospitals and third party reprocessors who reprocess SUDs are required to be in compliance with _____ and _____ requirements outlined in "Enforcement priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals." FDA 2000

Pre-market Post-market

PMA (as relating to medical devices)

Pre-market approval

In order to receive clearance to reprocess SUDs, Third Party reprocessors must show evidence of _____ and _____ .

Quality testing

Although AAMI is a voluntary organization, its _____ _____ and _____ are considered to be a major resource of health care guidelines, and noncompliance with theses standards is cited by regulatory organizations that inspect health care facilities.

Recommended Practices and Standards.

The Joint Commission's mission is to continuously improve the _____ and _____ of care provided to the public through the provision of health care accreditation and related services that support performance improvement in hospitals.

Safety, quality.

SUD

Single use device or one time use

SGNA

Society of Gastroenterology Nurses and Associates Creates standards for processing endoscopes

Standards are submitted to ANSI for _____ , from other organizations such as AAMI. ANSI does not develop American standards; it provides a neutral arena for interested parties to work toward agreement.

Standards

ANSI's (American National Standards Institute) mission is to "enhance the global competitiveness of U.S. business and the American quality of life by promoting and facilitating voluntary consensus _____ and ensuring their _____ .

Standards, integrity.

A written and enforceable law enacted by a governing body is a _____.

Statute

A Class II FDA recall is a less serious health risk. There is a possibility that the product will cause a _____ or _____ health problem; or, there is a remote chance the device will cause serious health problems.

Temporary reversible

The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) gave the EPA the responsibility to regulate all products with _____ claims, such as sterilants, disinfectants, and sanitizers.

antimicrobial

OSHA is part of the U.S. Department ___ _____ .

of Labor

T he primary purpose of OSHA is to _____ _____ from occupationally-caused illnesses and injuries.

protect workers

OSHA requires each employer furnish to each of his employees employment and a place of employment which are free from _____ _____ that are causing, or are likely to cause ____ , _____ or _____ _____ _____ to his employees.

recognized hazards harm, death or serious physical harm

AAMI (Association for the Advancement of Medical Instrumentation) is a ____ consensus organization with a membership of both individuals and organizations.

voluntary

State OSHA, DHS, DOT, and EPA may have regulations that are more stringent than the federal regulations. In this case, what set of regulations applies?

The most restrictive regulations always apply.

Medical device recalls can be enforced when a device is defective and/or poses a risk to health. T / F

True

Medical device recalls can be voluntary when instituted by the manufacturer, distributor, or other interested party. T / F

True

Standards groups such as AAMI submit standards which are granted ISO status based on the consensus of the entire membership. T / F

True

According to the FDA Labeling document the users are responsible for what two actions?

1. Confirming that they have the facilities and equipment to execute the product instructions. 2. Ensuring that the instructions are followed.

OSHA's impact on Central Service: It sets regulations concerning what three areas?

1. Employee exposure to hazardous and/or toxic chemicals. 2. Employee exposure to bloodborne pathogens. 3. Protect employees from other potential hazards.

Functions of the Centers for Disease Control (CDC):

1. Federal agency that collects and analyses data about infectious diseases. 2. Issues infection control guidelines. 3. Many CDC guidelines and recommendations are incorporated into healthcare facility policies and procedures and other agencies rely heavily on them.

Functions of the Department of Transportation (DOT)

1. Federal government agency that is dedicate4d to ensuring a fast, safe, and efficient transportation system. 2. DOT regulates labeling and containment of hazardous waste, biohazard items and minimally processed items for transport. 3. DOT also regulates labeling and containment of radioactive materials for transport.

Environmental Protection Agency (EPA) is responsible for:

1. Minimizing greenhouse gasses. 2. Minimizing toxic emissions. 3. Regulating the re-use of solid wastes. 4. Controlling indoor air pollution. 5. Developing and enforcing pesticide regulations.

Considerations (steps) for reuse of SUDs:

1. Preliminary evaluations. 2. Evaluation of reuse alternatives. 3. Initial cost analysis. 4. Risk Assessment. 5. Consideration of reprocessing protocols. 6. Examine facility requirements. 7. Develop procedures. 8. Undertake potential cost assessment. 9. Obtain any necessary approval. 10. Conduct clinical study. 11. Undertake actual cost assessment. 12. Implement reprocessing of single-use items.

EPA's FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act) requires manufacturers to label every chemical sterilant, disinfectant, and sanitizer with: _____ , _____ , _____ , _____ , and _____ .

1. Product Ingredients. 2. Directions for use. 3. Product precautions and warnings. 4. Directions for storage and disposal. 5. The EPA Registration Number.

According to the FDA Labeling document the manufacturer is responsible for what two actions?

1. Providing sufficient instructions on how to prepare the device for the next patient. 2. Providing the documentation of tests that show that the product's instructions are adequate and can be reasonably executed by users.

Any institution that reuses an SUD should be able to demonstrate: (3 things)

1. The item can be adequately cleaned and sterilized. 2. The quality of the device will not be adversely affected by reuse. 3. The device will remain safe and effective for its intended use.

FDA regulates:

1. The manufacture of all medical devices. 2. Sterilants 3. High level disinfectants

What are the characteristics of a Class II medical device?

1. The medical device can pose a potential risk. Examples: Sterilizers, biological indicators, chemical indicators, packaging 2. The medical device is subject to performance standards (and post market surveillance). 3. Manufactures required to submit pre-market notification (510K).

What are the characteristics of a Class I medical device?

1. The medical devices is considered a low risk product. Examples: ultrasonic cleaners and most hand-held surgical instruments. 2. The device is subject to "general controls". 3. The device is exempt from FDA pre-market submission requirements.

CSTs must be familiar with regulations and standards because:

4. Knowledge of regulatory requirements and state of the art professional practices enhances the professional growth of each CST. 5. Careful compliance with standards and regulations protects the welfare of the patient.

Define a regulatory standard.

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.

What does the repeat OSHA violation rating mean?

A repeat violation is any standard regulation or rule where, upon re-inspection, a substantially similar violation is found. These carry penalties of up to $70,000.

What does the serious OSHA violation rating mean?

A serious violation is one 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.

APIC

Association for Professionals in Infection Control and Epidemiology Voluntary organization dedicated to preventing infection

AAMI

Association for the Advancement of Medical Instrumentation Recommendations for the use, care and processing of devices and systems, voluntary organization but standards are cited by regulatory organizations

AORN

Association of Operating Room Nurses Organization dedicated to providing optimal care to the surgical patient- voluntary

All surface disinfectants and sanitizers must be registered with the _____ .

EPA

Strict labeling requirements for surface disinfectants and sanitizers are required by the _____ .

EPA

The Clean Air Act Amendments allow the _____ to regulate medical waste incinerators.

EPA

EPA

Environmental Protection Agency Responsible for minimizing greenhouse gases, toxic emissions, air pollutions

The EPA's FIFRA requirements include providing workers a safe environment. T / F

False. OSHA requires a safe environment for workers.

Regulatory officials look for compliance with AORN Recommended Practices and Guidelines, but do not comply with AORN standards. T / F

False. Regulatory officials look for compliance with both AORN Standards and AORN Recommended Practices and Guidelines.

Healthcare facilities are required to report events to the EPA involving a medical device according to the Safe Medical Devices Act of 1990. T/F

False. They must report it to the FDA

The NFPA (National Fire Protection Association) sets _____ _____ standards used for the buildings in which CSTs work.

Fire safety.

NFPA (National Fire Protection Association) is an international organizations that works to reduce the burden of _____ and other hazards.

Fire. Fire burden (risk of fire) of all disposable packaged items stored and used within the health care facility.

Medical facilities are required to report serious injuries involving a medical device to the ___ within 10 work days.

Manufacturer. If the manufacturer is unknown, the injury report goes to the FDA.

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

Manufacturers

APIC (Association for Professionals in Infection Control and Epidemiology) is a voluntary international organization whose members are dedicated to the _____ and _____ of infections and related outcomes.

Prevention, control

The Joint Comission

Private, not for profit,voluntary, develops standards for healthcare facilities and conducts on-site surveys

States may have State OSHA Offices in addition to the federal office. The state agencies may be more _____ (but never less stringent) that the federal regulations.

Stringent.

Standards for health care facilities are developed by The Joint Commission. These standards are used as a measurement of organizational quality. T/F

True

USP-NF (United States Pharmacopoeia--National Formulary) creates and revises standards for medicines, dosages, forms, drug substances and dietary supplements. T / F

True

Voluntary standards are sometimes incorporated into federal, state, or local statues. T / F

True

Surveys (inspections) from The Joint commission may be announced or unannounced. T / F

True.

Medwatch program

Voluntary reporting to the FDA