Surgery

Five essential steps to understanding effective Equipment Sterilization

A national expert gives a handful of pointers on keeping clean and compliant.

Regina Boore, RN, BSN, MS CASC Newport Beach, Calif.

Sterile processing is one of the most critical functions in the comprehensive service of ophthalmic surgery. When we consider the devastating consequences of ophthalmic surgical site infections, it is clear sterile processing warrants scrupulous and relentless attention to detail. Addressing these five essentials in your sterile processing program will establish a solid foundation and keep you on the right track.

1. Base your program on evolving nationally recommended guidelines and standards.

The CMS Ambulatory Surgery Center Conditions for Coverage require an ongoing infection control program designed to prevent, control and investigate infections and communicable diseases. In addition, the infection control and prevention program must include documentation that the ASC has considered, selected and implemented nationally recognized infection control guidelines. Examples of nationally recognized guidelines include publications from the CDC, the Association for Professionals in Infection Control and Epidemiology (APIC), the Society for Healthcare Epidemiology of America (SHEA), and the Association of periOperative Registered Nurses (AORN).

By mandating adherence to nationally recognized infection control guidelines and standards, CMS effectively demands compliance with evolving standards of practice. For instance, AORN Standards and Recommended Practices (RPs) are updated and published annually. In recent years, AORN has revised their RP on home laundering of scrubs and flash sterilization, among other topics. CMS frequently references AORN in deficiency reports citing the gap in compliance between the facility practice and AORN RPs. It is essential to stay abreast of changing national standards and maintain specific references to support your facility practices.

2. Establish a process consistent with Standard Precautions.

Taking “universal precautions” is the practice of avoiding contact with patient bodily fluids through the use of Personal Protective Equipment (PPE). Body Substance Isolation (BSI) included additional precautions implemented when the patient (source) was known or suspected to have an infectious condition. In 1996 these concepts were replaced by a combination of the two, called “standard precautions.” With standard precautions, all bodily fluids and Other Potentially Infectious Materials (OPIM), are handled the same way, as if they were infectious. This consistent approach extends the greatest protection to Health Care Personnel (HCP) and minimizes the risk of infection transmission.

Inherent in implementing this concept is an appreciation for the fact that every patient is presumed infectious. Everything that contacts the patient must be considered contaminated and must be decontaminated before it can be sterilized.

Decontamination is a process of cleansing an object to remove contaminants such as micro-organisms. Because residual enzymatic cleaner has been associated with Toxic Anterior Segment Syndrome (TASS), some ASCs elect not to use it. However, mechanical cleaning (brushing, sonic), flushing, rinsing and inspection are essential components of the decontamination process before used (contaminated) instruments can be sterilized. A cursory decontamination process of wiping and flushing instruments on the sterile field in the OR prior to sterilization is unacceptable and inconsistent with the principles of sterilization and disinfection. Instruments must be removed from the OR, covered, and thoroughly decontaminated in soiled utility, prior to sterilization.

3. Establish a process consistent with manufacturer Directions for Use.

In 2009 CMS issued a memo to provide guidance for CMS surveyors regarding flash sterilization. They acknowledged sterilizer technology has an improved capacity for steam penetration, allowing for effective sterilization of “wrapped/contained” loads in short cycles. They deemed these shorter cycles acceptable as long as the following criteria are met:

■ The sterilizer has been cleared by the FDA to run short cycles.

■ Manufacturer Directions for Use (DFUs) for the items being sterilized, support shortened exposure time.

■ Items to be sterilized, are “wrapped/contained” in a manner approved for use in a short cycle.

■ Items must be thoroughly cleaned (decontaminated) prior to sterilization.

■ Adequate inventory of instrumentation must be made available.

Manufacturers provide specific instructions for consistency in instrument processing personnel and the process itself helps to ensure these facility standards for cleaning and disinfection, consistent with manufacturer DFUs, are implemented reliably.

4. Train your staff

All staff involved in sterile processing must be well trained to understand not only what to do, but why to do it. A thorough understanding of standard precautions, aseptic technique, decontamination and sterilization, infection control, OSHA bloodborne pathogen standard and manufacturer DFUs are essential for instrument processing personnel. Instrument processing is a function that attracts significant surveyor scrutiny and the personnel involved are frequently questioned on details of the process. They need to be well prepared to respond to these questions effectively and should have appropriate references and resources at their fingertips to support the facility practices in place. CMS requires ongoing specific training in infection control for your infection control coordinator. It is wise to consider including lead sterile processing personnel in this annual training to reinforce previous training and to stay abreast of changes and evolving standards.

5. Ongoing monitoring and oversight

Sterile processing must be validated to ongoing monitoring. Biological and chemical monitoring should be routinely conducted and recorded. The records should be maintained in such a way as to facilitate validation of sterilization parameters during an infection control investigation. Vacuum sterilizers must be tested using Daily Air Removal Test (DART) to assure proper function of the vacuum mechanism. Additionally, autoclaves must be maintained and tested to assure proper function through regular preventive maintenance. OP