In the realm of healthcare, the sterile processing field is governed by strict regulations and standards to ensure the delivery of quality patient care. For perioperative professionals, understanding these guidelines is crucial to prevent increased infection rates, inefficient workflows, and potential loss of accreditation and funding.

Regulations vs. Standards: What’s the Difference?

It’s essential to differentiate between regulations and standards. Regulations are legally mandated by state and federal laws, while standards are best practices developed by industry experts. Though standards may not have the force of law, they are critical for maintaining the health and efficiency of Sterile Processing Departments (SPD). Organizations such as the Joint Commission often reference these professional standards when evaluating a healthcare facility’s safety and operational effectiveness.

Key Regulatory and Professional Organizations in Sterile Processing

To fully comprehend your SPD’s needs for quality care, familiarize yourself with the following organizations:

The FDA

The Food and Drug Administration (FDA) plays a pivotal role in sterile processing by regulating medical instruments. Before the FDA’s involvement, sterilization practices varied widely, resulting in inconsistent quality. The FDA’s requirements for medical device manufacturers to release Instructions for Use (IFUs) and for chemical companies to provide Safety Data Sheets have standardized practices across the field. It’s vital for Sterile Processing Professionals to stay informed about the FDA’s system for medical instrument recalls, corrections, and removals.

AAMI

The Association for the Advancement of Medical Instrumentation (AAMI) is a cornerstone in setting cleanliness and sterilization standards. Working closely with accreditation bodies like the Joint Commission, AAMI helps establish benchmarks for proper instrument reprocessing. Adhering to AAMI ST108 is necessary to meet the Joint Commission’s expectations for instrument safety.

AORN

The Association of Peri-Operative Registered Nurses (AORN) creates standards for various OR roles, offering educational resources and professional guidelines for instrument reprocessing. SP professionals widely utilize their resources on instrument cleaning, reprocessing endoscopes, and sterilization, available through a subscription program.

SGNA

With the media highlighting Healthcare Associated Infections in endoscopic procedures, the Society of Gastroenterology Nurses and Associates (SGNA) has developed standards to address the complexities of cleaning and sterilizing endoscopes. SGNA provides essential documents on sterilants, disinfectants, and infection prevention standards for endoscopes.

Conclusion

Sterile processing, like all interdisciplinary OR partners, is governed by stringent standards to ensure top-tier patient care. The regulations and standards mentioned in this article represent a fraction of the guidelines needed to run an effective SPD. For more insights on achieving compliance with professional standards and guidelines, contact Chike Healthcare Partners’ consulting team to implement effective changes in your department today.