Sterile Processing Technical Manual - Chapter 6: Regulations and Standards *Need to review and/or update to HSPA 9th Edition.

What is the definition of "Medicaid"?

A federal and state assistance program that pays covered medical expenses for low-income individuals. It is run by state and local governments within federal guidelines.

What is definition of "Medicare"?

A federal medical insurance program that primarily serves those older than 65 years (regardless of income), people under 65 with certain disabilities, and people of all ages with end-stage renal disease.

What is the definition of "best practice"?

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

Under what circumstances can a recall of a medical device be initiated?

A recall can be initiated when a device is defective and/or poses a health risk.

What actions may be required as a result of a recall of a medical device? Does a recall always necessitate the cessation of use, or are there other potential measures?

A recall does not always mean the affected product can no longer be used. Instead, it could mean that the product must be checked or repaired.

What is the purpose of a medical device recall?

A recall is an action taken to address a problem with a medical device.

What is the definition of "standard"?

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

What is the primary function of the committees and workgroups within the Association for the Advancement of Medical Instrumentation (AAMI)?

AAMI committees and workgroups research and develop new standards and technical information reports (TIRs).

What are some of the key areas addressed by the published standards and technical information reports (TIRs) of the Association for the Advancement of Medical Instrumentation (AAMI)?

AAMI publishes many standards and TIRs, many of which address functions that affect the SPD, including cleaning, sterilization, packaging, and equipment testing.

What is the primary mission of the American National Standards Institute (ANSI)?

ANSI's primary mission is to "enhance the global competitiveness of U.S. business and the American quality of life by promoting and facilitating voluntary consensus standards.

Which document is considered to be the most widely used in the field of Sterile Processing (SP)?

ANSI/AAMI ST79:2017 with 2020 Amendments Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities is one of the most widely used documents in SP.

How are the standards published by the Association for the Advancement of Medical Instrumentation (AAMI) regarded in the realm of healthcare guidelines, despite AAMI being a voluntary organization?

Although AAMI is a voluntary organization, AAMI standards are considered a key resource for healthcare guidelines, as many of their documents have been approved by the American National Standards Institute (ANSI).

How do healthcare facilities and other regulatory agencies interact with the guidelines provided by the Centers for Disease Control and Prevention (CDC)?

Although CDC guidelines are not considered regulatory, other agencies rely heavily on them and review healthcare facilities for compliance.

What is the definition of the term "serious injury"?

An injury or illness that is life-threatening, resulting in permanent impairment of a bodily function or permanent damage to a body structure, or necessitates medical or surgical intervention to preclude permanent impairment of a body structure.

Which entity or organization is credited with developing the initial practical recommendations for isolation techniques and infection control guidelines?

CDC personnel developed the first practical recommendations for isolation techniques and guidelines for infection control.

Which government agency is involved in administering and enforcing the standards set forth by the Health Insurance Portability and Accountability Act (HIPAA)?

CMS is also one of the agencies that administers the standards of the Health Insurance Portability and Accountability Act (HIPAA).

Why is the Centers for Medicare and Medicaid Services (CMS) significant for Sterile Processing (SP) technicians?

CMS is important to SP technicians because the agency performs both announced and unannounced surveys of hospitals, long-term care facilities, ambulatory surgery centers, and laboratories.

What additional regulatory measures are typically imposed on Class II devices?

Class II devices are usually subjected to performance standards, postmarket surveillance studies, and specific guidelines or special labeling.

What level of risk is associated with Class II devices and what are some examples of Class II medical devices?

Devices considered to pose potential risks great enough to warrant a higher level of regulation. Class II devices include most types of sterilization equipment, BIs, and chemical indicators (CIs).

How was the Emergency Use Authorization (EUA) utilized during the COVID-19 pandemic in relation to the decontamination of certain single-use devices (SUDs)?

During the COVID-19 pandemic, EUA was implemented to decontaminate some SUDs, like N95 face masks, because they were a critical item used to prevent the spread of COVID-19 and were in short supply.

What is the purpose of the Emergency Use Authorization (EUA) granted by the FDA?

Emergency Use Authorization (EUA) allows the FDA to help strengthen the nation's public health protection against chemical and biological threats, including infectious diseases, and other threats, by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies.

What requirement must disinfectant and sanitizer manufacturers fulfill in relation to their products?

Every disinfectant and sanitizer manufacturer must obtain an EPA registration number for every covered product.

How does the stringency of FDA recalls, specifically Class I recalls, compare to the stringency of medical device classifications, particularly Class I medical devices?

FDA recall Class I is the most stringent recall whereas the medical device Class I is the least stringent category.

How do FDA regulations serve to protect the safety of patients and healthcare workers, particularly Sterile Processing (SP) technicians, and what specific requirement does the agency impose on manufacturers?

FDA regulations help ensure medical devices are safe for patients and healthcare workers, including SP technicians; the agency requires the manufacturer to provide instructions for use (IFU) with the product.

What does the term "failure to abate" refer to in the context of Occupational Safety and Health Administration (OSHA) regulations?

Failure to abate refers to the failure to correct a prior violation, which may result in high financial penalties.

What are the potential consequences of failing to adhere to the standards set by the Centers for Medicare and Medicaid Services (CMS)?

Failure to follow CMS standards may result in the loss of all federal funding to a facility, including Medicare and Medicaid payments.

In the context of a Class II FDA recall, what is the typical practice regarding the issuance of a press release?

Generally, neither the FDA nor the manufacturer issues a press release.

Are standards typically considered legally binding, or can they be incorporated into law by governmental bodies?

Generally, standards are not law; however, they may be incorporated into law by governmental bodies.

What is the purpose of the Health Insurance Portability and Accountability Act (HIPAA)?

HIPAA is the act that established national standards to protect patients' medical records and other personal health information.

What does a Class I FDA recall signify in terms of the level of risk associated with a medical product?

High Risk - This means there is a reasonable chance the product will cause serious health problems or death.

What should user facilities do in cases where the manufacturer of a medical device is unknown?

If the manufacturer is unknown, the injury should be reported to the FDA.

In the case of a Class I FDA recall, what is the responsibility of the manufacturer regarding communication with customers?

In a Class I FDA Recall the manufacturer must notify customers and direct them to notify the product recipients.

What approach has the FDA adopted in recent years to gather information about potential problems related to medical devices?

In recent years, the FDA has used both voluntary and mandatory reporting programs to collect information about specific potential problems.

Who are the entities involved in the development of standards?

Industry, nonprofit organizations, trade associations, and others develop standards.

What are some specific areas within healthcare that involve laws related to transportation?

Laws relating to healthcare include those concerning the transportation of minimally processed instrumentation for repair or reprocessing and the transportation of hazardous and radioactive wastes.

What is the significance of a Class II FDA recall in terms of the level of risk associated with a medical product?

Less serious risk - This means there is a possibility that the product will cause a temporary or medically reversible adverse health problem, or there is a remote chance that the device will cause serious health problems.

What is the significance of a Class III FDA recall in relation to the risk level associated with a medical product?

Low Risk - This means the use of the product is not likely to cause adverse health consequences.

What level of risk is associated with Class I devices and what are some examples of Class I medical devices?

Low-risk devices, such as most handheld surgical instruments, hospital beds, and ultrasonic cleaners.

What is the requirement for manufacturers of new Class III devices?

Manufacturers of new Class III devices must obtain a premarket approval (PMA) from the FDA to demonstrate product safety and efficacy.

What is the source of authority for the regulations and standards enforced by the Occupational Safety and Health Administration (OSHA)?

Many of OSHA's regulations and standards are represented in laws passed by the U.S. Congress.

What are the reporting obligations imposed by medical device reporting regulations on user facilities and within what timeframe must these reports be submitted?

Medical device reporting regulations require user facilities (i.e., hospitals, ambulatory surgical facilities, nursing homes, and outpatient treatment facilities) to report suspected medical device-related deaths to the FDA and device manufacturers within 10 days of the event.

What are the potential consequences of non-compliance with the Occupational Safety and Health Administration's (OSHA) standard related to bloodborne pathogens?

Non-compliance with this standard, such as not following the guidelines for transportation of contaminated instruments or not complying with the personal protective equipment (PPE) requirements, carries heavy fines.

What is the consequence of non-payment for the duration of a patient's hospital stay due to a healthcare-associated infection (HAI) according to the Centers for Medicare and Medicaid Services (CMS)?

Non-payment for the amount of time the patient is in the hospital due to a healthcare-associated infection (HAI) means fewer operating funds for the facility.

What type of inspections are conducted by personnel from the Occupational Safety and Health Administration (OSHA) at facilities?

OSHA personnel conduct announced and unannounced facility inspections.

When Occupational Safety and Health Administration (OSHA) representatives enter a facility for a specific purpose, what authority do they possess regarding their ability to investigate violations?

OSHA representatives may enter a facility for a specific reason; however, once inside the facility, they have the right and obligation to investigate any violation they may find in any department.

Who has the authority to initiate recalls of medical devices, and what are the two possible ways in which a recall can be initiated?

Recalls can be instituted voluntarily by the manufacturer, distributor, or other interested party, or they can be mandated by the FDA.

Who issues regulations and standards that govern various sectors?

Regulations and standards are issued by federal, state, and local governing agencies.

In what ways do regulations and standards influence healthcare professionals?

Regulations and standards impact every healthcare professional, including those working in the Sterile Processing department (SPD).

What is the definition of "Technical Information Reports (TIRs)"?

Reports developed by experts in the field that contain valuable information needed by the healthcare industry.

What is the definition of "regulation"?

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

What is the responsibility of sterile processing (SP) technicians in relation to the chemical labels of products they handle?

SP technicians must always read and consistently follow the information provided on all chemical labels.

What is the role of the U.S. Environmental Protection Agency (EPA) in relation to disinfectants used in the Sterile Processing Department (SPD) and other areas involved in instrument reprocessing?

Since the EPA regulates disinfectants, all disinfectants used in the SPD and other instrument reprocessing areas must be EPA-approved.

What is the relationship between the standards and regulations set by state agencies and their federal counterparts?

Standards and regulations of state agencies may be more restrictive than, but cannot be less restrictive than, those of their federal counterparts.

How do professional organizations contribute to the healthcare sector in terms of standards development?

Standards are also issued by professional organizations and provide significant assistance to healthcare personnel because they are developed according to best practice.

In situations where there are both federal regulations and state or local regulations pertaining to a specific matter, what principle governs the application of these regulations?

State or local regulations may be more restrictive than federal regulations. In all cases, regulations with the most stringent provisions apply.

What is the nature and composition of the Association for the Advancement of Medical Instrumentation (AAMI)?

The Association for the Advancement of Medical Instrumentation (AAMI) is a nonprofit voluntary consensus organization whose membership is comprised of healthcare technology professionals.

What is the primary mission of the Centers for Disease Control and Prevention (CDC)?

The Centers for Disease Control and Prevention (CDC) is a federal agency that works to promote health and quality of life by preventing and controlling disease, injury, and disability and by responding to health emergencies.

What is the primary responsibility of the Centers for Medicare and Medicaid Services (CMS)?

The Centers for Medicare and Medicaid Services (CMS) is responsible for the operation of Medicare, Medicaid, and the State Children's Health Insurance Program.

What role does the U.S. Department of Transportation (DOT) play in ensuring compliance with statutes and regulations related to transportation?

The DOT inspects and cites organizations for statute violations.

Which organization or regulatory body is responsible for setting and enforcing emission standards specifically related to ethylene oxide (EO) sterilization?

The EPA regulates emission standards for ethylene oxide (EO) sterilization.

Once the FDA determines that the public health emergency or shortage has concluded, is the EUA revoked or no longer in effect?

The EUA is only authorized during a designated time period. Once the FDA has deemed that the emergency or shortage has ended, the EUA is removed.

What is the purpose of the FDA MedWatch program?

The FDA MedWatch program is designed for the voluntary reporting of device-related problems.

Apart from medical devices, which additional items or substances does the U.S. Food and Drug Administration (FDA) regulate?

The FDA also regulates sterilants, high-level disinfectants, packaging materials, sterilizers, and quality monitors such as biological indicators (BIs).

What specific concerns have been expressed by the FDA regarding the potential transmission of infectious diseases?

The FDA has expressed concern about the potential for the transmission of infectious diseases caused by improperly reprocessed medical devices.

Who does the FDA hold responsible for ensuring the safe and effective reprocessing of medical devices?

The FDA holds both the manufacturer and user responsible for safe and effective reprocessing of medical devices.

In the event of a Class I FDA recall, what action can the FDA take to inform the public?

The FDA may issue its own press release or public health notice.

What is the role of the FDA in relation to mandated recalls of medical devices?

The FDA monitors all mandated recalls to ensure the actions taken by the manufacturer are adequate to protect the public.

What is the definition of the term "premarket approval (PMA)"?

The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

Which organization is responsible for regulating the manufacturing of medical devices?

The FDA regulates the manufacture of all medical devices.

What is the purpose of the FDA document titled "Labeling Reusable Medical Devices for Reprocessing in Healthcare Facilities"?

The FDA released a document, "Labeling Reusable Medical Devices for Reprocessing in Healthcare Facilities", which requires manufacturers to comply with certain criteria - mostly involving reprocessing instructions - when they submit medical device applications to the FDA for evaluation.

What are the requirements set by the FDA for individuals or entities involved in the reprocessing of single-use devices (SUDs)?

The FDA requires anyone who processes single-use devices (SUDs) to obtain and comply with FDA 510(k) directives to reprocess SUDs.

What obligation does the General Duty Clause of the Occupational Safety and Health Act impose on employers?

The General Duty Clause of the Occupational Safety and Health Act requires that each employer provide each employee with a place of employment that is free from recognized hazards that are causing or are likely to cause death or serious physical harm to employees.

What is the definition of "Health Insurance Portability and Accountability Act (HIPAA)"?

The HIPAA Privacy Rule provides federal protections for individually identifiable health information held by covered entities and their business associates and gives patients an array of rights with respect to that information.

What specific information should be included in the instructions for use (IFU) of medical devices, as mandated by the FDA?

The IFU should contain detailed instructions on how to properly process and use the product. This includes disassembly, cleaning, assembly, disinfection, and sterilization instructions.

What types of problems or issues can healthcare facilities report to the FDA through the MedWatch program in relation to medical devices?

The MedWatch program provides a vehicle by which healthcare facilities can notify the FDA about medical device malfunctions, labeling inadequacies, and other problems including inadequate IFU.

What is the primary objective and responsibility of the Occupational Safety and Health Administration (OSHA)?

The Occupational Safety and Health Administration's (OSHA) primary role and responsibility is to protect workers from occupationally caused illnesses and injuries.

What is the primary objective of the U.S. Department of Transportation (DOT)?

The U.S. Department of Transportation (DOT) is a federal government agency dedicated to ensuring a fast, safe, and efficient transportation system.

What are the key responsibilities of the U.S. Environmental Protection Agency (EPA)?

The U.S. Environmental Protection Agency (EPA) is 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 chemical regulations.

What role does the U.S. Food and Drug Administration (FDA) play in relation to medical devices and patient care?

The U.S. Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective for patient care.

What is the definition of "MedWatch"?

The U.S. Food and Drug Administration's safety information and adverse event reporting system that serves healthcare professionals and the public by reporting serious problems suspected to be associated with the drugs and medical devices they prescribe, dispense, or use.

What factor determines the level of regulation imposed on a medical device?

The level of regulation placed on any device depends upon how the FDA classifies that device.

What is the role of the manufacturer in a Class I FDA recall when it comes to informing the public?

The manufacturer must also issue a press release to notify the public.

What actions are required of the manufacturer during a Class II FDA recall in terms of communication with customers?

The manufacturer must notify customers and sometimes ask them to inform the product's recipients.

In the case of a Class III FDA recall, what are the requirements for the manufacturer regarding communication with customers?

The manufacturer must notify customers, and neither the FDA nor the manufacturer will issue a press release.

What is the classification of devices that undergo the highest level of regulation and what are some examples of such devices?

The most stringently regulated devices include heart valves, pacemakers, and other life-sustaining devices.

What are the factors that determine the need for inspections by the Occupational Safety and Health Administration (OSHA)?

The need for inspections is based on complaints through OSHA's Whistleblower Protection Program, the rate of workplace accidents, high-hazard targets, referrals, and follow-ups from previous visits.

What specific information is required to be included in the notification issued during a Class I FDA recall?

The notification must include the name of the device being recalled, the lot or serial numbers, the reason for the recall, and instructions to correct, avoid, or minimize the problem.

What specific regulatory controls are applied to Class I devices by the FDA?

These items are subject to "general controls", which include registration and device listing, medical device reporting, and quality system regulation and labeling.

What is the scope of the Occupational Safety and Health Administration's (OSHA) guideline called "The Occupational Exposure to Bloodborne Pathogens Standard"?

This comprehensive OSHA guideline (The Occupational Exposure to Bloodborne Pathogens Standard) outlines employee safety in all areas of the facility as they relate to potential exposure from blood-borne pathogens.

What are the specific requirements that a facility must fulfill to obtain FDA 510(k) approval for the reprocessing of single-use devices (SUDs)?

To obtain approval with FDA 510(k) directives to reprocess SUDs, the facility must prove it can properly clean and sterilize the product to the original manufacturer's standards each time the product is reprocessed. The facility must also show that it is able to test the product to prove the standards have been met in all reprocessing areas, including decontamination, disinfection, and sterilization.

What are the reporting requirements for user facilities when it comes to medical device-related serious injuries?

User facilities must report medical device-related serious injuries only to the manufacturer within 10 days of the event.

What specific responsibilities fall upon the users in terms of the reprocessing of medical devices?

Users are responsible for confirming they have the facilities and equipment to execute the instructions and ensuring the instructions are followed.

What is the definition of "Standards (AAMI)"?

Voluntary guidelines representing a consensus of AAMI members that are intended for use by healthcare facilities and manufacturers to help ensure that medical instrumentation is safe for patient use.

What are the potential consequences when regulations and standards are not adhered to?

When regulations and standards are not followed, the results can vary from legal consequences to poor patient outcomes.

What are the specific requirements outlined by the U.S. Department of Transportation (DOT) regarding the transportation of soiled instrumentation?

When soiled instrumentation is transported between healthcare and repair facilities, DOT regulations for labeling and packaging must be followed. These requirements include proper biohazard labeling and containment.

What are some of the penalties imposed by the Occupational Safety and Health Administration (OSHA)?

• An employer who "willfully or repeatedly violates the requirements of section five of this Act" or rules promulgated under section six of this Act may be assessed a penalty "of not more than $70,000 for each violation, but not less than $5,000 for each willful violation". • An employer who received a citation for a serious violation under section five of this Act or rules promulgated under section five shall be assessed a "penalty up to $7,000 for each such violation". • An employer who received a citation for violating section five or six and is not one of "a serious nature" may be assessed a penalty of up to $7,000 for each violation.

What are some examples of the specific infections or events for which the Centers for Medicare and Medicaid Services (CMS) ceased reimbursing hospitals in 2008?

• Foreign object retained after surgery • Surgical site infection

What specific information is required to be included in all products that have received approval from the U.S. Environmental Protection Agency (EPA)?

• Product ingredients • Directions for use • Product precautions and warnings • Directions for storage and disposal • EPA registration number • Expiration date (if applicable)

For what reasons must Sterile Processing (SP) technicians be familiar with applicable regulations and standards?

• Regulations must be followed and failure to comply with them may result in legal consequences to the healthcare facility. • Regulations and standards may include workplace safety issues, which may help to protect SP technicians from exposure to infectious agents and toxic substances. • Regulations and standards may include disinfection and sterilization practices. • With careful compliance with regulations and standards, patient safety is at its highest level of quality care.

What specific responsibilities does the FDA place on the manufacturer?

• Supporting the claim of reuse with adequate labeling and complete reprocessing instructions • The validation and documentation of tests, which show that the instructions are adequate and can be reasonably executed by users.