Regulation
Rules issued by administrative agencies that have the force of law.
Standard
A uniform method of defining basic parameters for processes, products, services and measurements.
Best Practice
A method or technique that has consistently shown results superior to those achieved by other means.
Premarket Approval (PMA)
The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
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 the body structure.
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.
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.
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.
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.
FDA (Food and Drug Administration)
Regulates medical devices by risk:
Class I: Low risk (ultrasonics, hand-held surgical instruments)
Class II: Moderate risk (biological indicators, chemical indicators, sterilization wrap)
Class III: High risk requires premarket approval with safety evidence. (heart valve, pacemaker)
CDC (Centers for Disease Control and Prevention)
Sets guidelines for disease control and public health safety.
During COVID-19, CDC rapidly updated standards to control spread.
CMS (Centers for Medicare and Medicaid Services)
Works closely with the CDC on hospital infection rates.
Regulations affect hospital reimbursement for preventable infections.
Also governs accrediting bodies like Joint Commission.
OSHA (Occupational Safety and Health Administration)
Ensures workplace safety, including Sterile Processing.
Can inspect facilities and issue penalties for non-compliance.
EPA (Environmental Protection Agency)
Regulates emissions, waste disposal, and chemical use in healthcare.
Example: Strict regulations on ethylene oxide, a sterilizing agent used in hospitals.
Department of Transportation (DoT)
Regulates the safe transport of hazardous materials, including chemicals and medical waste.
Requires clear labeling and packaging to ensure first responders know what they are dealing with in case of accidents.
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.
Technical Information Reports (TIRs)
Reports developed by experts in the field that contain valuable information needed by the healthcare industry.
AAMI (Association for the Advancement of Medical Instrumentation)
Role: Sets industry standards for cleaning, decontaminating, sterilization, and disinfection.
Standards vs. TIRs:
Standards: Concepts/processes reviewed and approved by experts.
TIRs: Specific and technical reports with expert opinions.
ANSI (American National Standards Institute)
Mission: Enhance U.S. global competitiveness by promoting voluntary consensus standards.
Focus: National standards for businesses and quality of life.
ISO (International Organization for Standardization)
Role: Sets international standards to improve industry efficiency with products, services, and best practices.
Focus: Non-governmental, globally applicable standards.
APIC (Association for Professionals in Infection Control and Epidemiology)
Mission: Prevent hospital-acquired infections.
Focus: Works with agencies like the CDC to investigate, evaluate, and improve hospital care practices to reduce infection risk.
AORN (Association of Operating Room Nurses)
Role: Provides care guidelines for surgical patients.
Impact on Sterile Processing:
Environmental cleaning and attire standards that affect Sterile Processing.
Guidelines: Surface-level coverage of sterilization/cleaning in Sterile Processing, mainly focused on surgical environments.
ASHRAE (American Society of Heating, Refrigerating, and Air Conditioning Engineers)
Role: Establishes airflow, temperature, and humidity standards.
Focus: Ensures proper environmental controls in Sterile Processing areas (e.g., air exchanges, pressure).
