Regulations and Standards in Sterile Processing: Understanding FDA, OSHA, and AAMI

This presentation explores the critical statutes, regulations, and standards that govern business operations within the Sterile Processing Department (SPD). Careful compliance with these rules is essential to ensure the highest level of patient safety and quality care while helping facilities avoid legal consequences and citations.

• Regulations vs. Standards: We explain the difference between a statute (a written law adopted by a legislative body), a regulation (rules issued by administrative agencies with the force of law), regulatory standards (comparison benchmarks mandated by a governing agency, noncompliance may lead to penalties), and voluntary standards (guidelines and best practices developed by industry or non-profit organizations).

• The U.S. Food and Drug Administration (FDA): Learn about the FDA’s role in regulating medical devices, high-level disinfectants, sterilants, and packaging materials. The FDA mandates pre-market clearance for new medical devices and uses a classification system for medical devices: Class I (low-risk, generally exempt from pre-market notification), Class II (warranting a higher level of regulation, requiring pre-market notification), and Class III (most stringently regulated, including life-sustaining devices).

• Manufacturer and User Responsibilities: FDA regulations require manufacturers to provide detailed Instructions for Use (IFUs) for proper device processing, which must cover disassembly, cleaning, disinfection, and sterilization. Users must confirm they have the equipment and facilities to execute these instructions and ensure the IFUs are followed.

• Reporting and Recalls: The presentation details medical device reporting requirements, including notifying the FDA and manufacturers of suspected device-related deaths or serious injuries. It also explains the three categories of FDA Medical Device Recalls: Class I (high risk, likely to cause serious health problems or death), Class II (less serious risk, possibility of temporary health problems), and Class III (low risk, not likely to cause adverse health consequences).

• Other Key Regulatory Agencies: Discover the roles of other organizations impacting SPD functions, including the Centers for Disease Control and Prevention (CDC) (for infection control guidelines), the Occupational Safety and Health Administration (OSHA) (for protecting workers from injuries and illnesses, including guidelines for bloodborne pathogens and EtO use), and the Centers for Medicare and Medicaid Services (CMS) (which administers HIPAA standards and whose failure to comply may result in loss of federal funds).

• Professional Associations and Standards: We look at organizations that develop critical standards, such as the Association for the Advancement of Medical Instrumentation (AAMI), which produces standards like ANSI/AAMI ST79 for steam sterilization, the Association of Perioperative Registered Nurses (AORN), and The Joint Commission (TJC), which evaluates healthcare organizations.
It is vital for all Sterile Processing professionals to "stay abreast of the organizations and standards that affect your responsibilities