Spd Chapter 6 Flashcards
Low-risk devices, such as most handhel surgical instruments, hospital beds and ultrasonic cleaners. These items are subject to “general controls” which include registration and device listing, medical device reporting, and quality system regulation and labeling.
Class I devices
Devices considered to pose potential risks great enough to warrant a higher level of regulation. Class Il devices include most types of sterilization equipment, BIs and chemical indicators (CIs). Class Il devices are usually subjected to performance standards, postmarket labeling. surveillance studies and specific guidelines or special labeling
Class II devices
The most stringently regulated devices, including heart valves, pacemakers and other life-sustaining devices. Manufacturers of new Class III devices must obtain product safety and efficacy. A premarket approval (PMA) from the FDA to demonstrate product safety and efficacy
Class III devices
Is responsible for ensuring that medical devices are safe and effective for patient care
The U.S Food and Drug Administration (FDA)
Regulates the manufacture of all medical devices, it also regulates sterilants, high-level disinfectant, packaging materials, sterilizers, and quality monitors such as biological indicators
U.S Food and Drug Administration (FDA) and its REGULATORY
A method or technique that has consistently shown results superior to those achieved by other means
Best practice
The FDA process of scientific and regulatory review to evaluate(check before) the safety and effectiveness of Class Ill medical devices.
Premarket approval (PMA)
What regulations help ensure medical devices are safe for patients and healthcare workers, including SP technicians
U.S Food and Drug Administration (FDA) and it is REGULATORY
requires the manufacturer to provide instructions for use (IFU) with the product.
FDA
should contain detailed INSTRUCTIONS on how to properly process and use the product. This include disassembly, cleaning, assembly, disinfection and sterilization instructions.
Instructions for use (IFU)
regulations require user facilities (ie, hospitals, ambulatory surgical facilities, nursing homes and outpatient treatment facilities) to report suspected medica device-related deaths to the FDA and device manufacturers within 10 days of the event.
Medical device reporting
program is designed for the voluntary REPORTING of device-related problems.
The FDA Medwatch
Program is designed for the voluntary reporting of device-related problems; provides a vehicle by which healthcare facilities can notify the FDA about medical device malfunctions, labeling inadequacies and other problems including inadequate IFU
Medwatch
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.
Serious injury
A voluntary organization promotes health by preventing and controlling disease.
CDC (Center for Disease Control) VOLUNTARY
A voluntary organization that
provides state of the art specifications for products, services, and good practices
ISO (International Organization for Standardization) and it’s VOLUNTARY
A voluntary organization that works to prevent healthcare-associated infections.
Association for Professionals In Infection Control And Epidemiology (APIC) and it is VOLUNTARY
A regulatory organization that enforces laws relating to the transportation of medical waste.
U.S Department of Transportation (DOT)
A voluntary organization that furthers international cooperation in improving health conditions.
World Health Organization (WHO)
A regulatory organization that protects workers from occupational caused illnesses and injuries.
Occupational Safety and Health Administration (OSHA)
A voluntary agency that specializes in endoscopy issues and has established standards for the effective processing of flexible endoscopes.
Society of Gastroenterology Nurses and Associates (SGNA)
A nonprofit voluntary consensus organization whose membership is comprised of healthcare technology professionals, committee and workgroups research and develop new standards and technical information reports (TIRs), cleaning, sterilization, packaging, and equipment testing.
Association for the Advancement of Medical Instrumentation (AAMI)
Creates and enforces laws relating to cleaner water, air and land. Monitor main sewer lines pouring blood down sewage
U.S. Environmental Protection Agency (EPA) and it is REGULATORY
The voluntary organization that provides standards for healthcare facilities : the evaluation are in the form of onsite surveys at least every three years.
The Joint Commission (TJC)
A voluntary organization that directly affects the SPD, including cleaning, disinfection, packaging, endoscope processing, and sterilization.
Association of periOperative Registered Nurses (AORN)
A voluntary organization that creates and revises standards for processing water for irrigation.
United States Pharmacopeia-National Formulary (USP-NF) and it is (VOLUNTARY)
CDC stands for
Centers for Disease Control and Prevention and its (VOLUNTARY )
ISO stands for
(IOS)
International Organizations for Standardization (VOLUNTARY)
FDA stand for
U.S Food and Drug Administration (REGULATORY)
APIC stands for
Association for professionals in infection control (VOLUNTARY)
DOT stands for
U.S Department of Transportation (REGULATORY)
WHO stands for
World Health Organization (VOLUNTARY)
OSHA stands for
Occupational Safety and Health Administration (REGULATORY)
SGNA stands for
Society of Gastroenterology Nurses and Associates (VOLUNTARY)
AAMI stands for
Association for the Advancement of Medical Instrumentation (VOLUNTARY)
EPA stands for
U.S Environmental Protection Agency (REGULATORY)
TJC stands for
The Joint Commission (VOLUNTARY)
AORN stand for
Association of periOperative Registered Nurses (VOLUNTARY)
USP-NF stand for
United States Pharmacopeia-National Formulary (VOLUNTARY)
ANSI stand for
American National Standards Institute (VOLUNTARY)
NFPA stand for
National Fire Protection Association (VOLUNTARY)
Specializes in endoscopy issues and has established standards for the effective processing of flexible endoscopes
SGNA (voluntary)
Furthers international cooperation in improving health conditions
WHO (voluntary)
Develops nationally recognized guidelines for the perioperative setting
AORN (voluntary)
Protects workers from occupationally caused illnesses and injuries
OSHA (regulatory)
Provides state-of-the art specifications for products, services and good practices
ISO (voluntary) International organization for standardization
Provides standards and evaluations for healthcare facilities; the evaluations are in the form of onsite surveys at least every three years
TJC (voluntary) The Joint Commission
Creates and revises standards for processing water for irrigation
USP-NF (voluntary)
Creates and enforces laws relating to cleaner water, air and land
EPA (regulatory)
Works to prevent healthcare-associated infections
APIC (voluntary)
Enforces laws relating to the transportation of medical waste
DOT (regulatory) Department of Transportation
Is considered one of the major resources for healthcare guidelines
AAMI (voluntary)
Develops international standards to reduce the risk of fire and other hazards
NFPA (voluntary)
Promotes health by preventing and controlling disease
CDC (voluntary) Center for Disease Control and Prevention
Responsible for premarket and postmarket medical device requirements as well as medical device classification and recalls
FDA (regulatory)
Enhances global competitiveness and quality of life by promoting standards and ensuring their integrity
ANSI (voluntary)
Responsible for regulating ethylene oxide (EO) emissions
EPA (regulatory)
Responsible for the MedWatch program
FDA (regulatory)
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.
Medicare
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.
Medicaid
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.
Health Insurance Portability and Accountability Act (HIPAA)
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.
Standards (AAMI)
Reports developed by experts in the field that contain valuable information needed by the healthcare industry.
Technical Information Reports (TIRs)
an action taken to address a problem with a medical device.
Medical device recalls
High Risk - Means there is a reasonable chance the product will cause serious health problems or death.The manufacturer must notify customers and direct them to notify the product recipients. 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. The manufacturer must also issue a press release to notify the public. In addition, the FDA may issue its own press release or public health notice.
FDA Devices recall class I
Less Serious Risk - 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. The manufacturer must notify customers and sometimes ask them to inform the product’s recipients. Generally, neither the FDA nor the manufacturer issues a press release.
FDA device recall class II
Low Risk - Means the use of a product is not likely to cause adverse health consequences. The manufacturer must notify customers, and neither the FDA nor the manufacturer will issue a press release.
FDA device recall class III
Many states look to their DHS to establish local health safety standards that may mirror federal standards or be more stringent.
Department of Health Services (DHS)
(REGULATORY)
-Manual Chemical High-Level Disinfection
-Processing Flexible Endoscopes
-Care and Cleaning of Surgical Instruments
-Sterilization Packaging Systems
-Sterilization
-Surgical Attire
-Environmental Cleaning
Pertinent AORN Guidelines
ANSI/AAMI ST58
Chemical sterilization and high-level disinfection in health care facilities
Comprehensive guide to steam sterilization and sterility assurance in health care facilities
ANSI/AAMI ST79
Flexible and semi-rigid endoscope processing in health care facilities
ANSI/AAMI ST91
ANSI/AAMI ST58 Chemical sterilization and high-level disinfection in health care facilities
ANSI/AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
AAMI ST90 Processing of health care products
Quality management systems for processing
ANSI/AAMI ST91 Flexible and semi-rigid endoscope processing in health care facilities
AAMI TIR34 Water for the reprocessing of medical devices
AAMI TIR63 Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection
AAMI TIR67 Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities
AAMI TIR68 Low and Intermediate Level Disinfection in Healthcare Settings for Medical Devices and Patient Care Equipment and Sterile Processing Environmental surfaces
Examples of AAMI Standards and TIRs
That Affect Sterile processing
What is AAAASF
The American association for accreditation of ambulatory surgery facilities (focuses on the quality of healthcare in outpatient facilities)
What is AAAHC
The Accreditation Association for Ambulatory Healthcare (an American organization that accredits its ambulatory healthcare facilities)
What is ACHC
The Accreditation Commission for Healthcare
What do Accreditation organizations do
Demonstrate that the healthcare facility follows the current healthcare regulations and standards
