Best practices for sterilization of surgical instruments, medical devices

Reprocessing and sterilization guidelines follow evidence-based principles of classification, processing, inspection and storage of surgical and medical equipment.

During a June webinar hosted by Becker's Hospital Review and sponsored by Advanced Sterilization Products (ASP), sterilization expert Nancy Fellows, RN, MSN, senior clinical education consultant for ASP, reviewed current methods for sterilization of surgical instruments and medical device reprocessing. She shared best practices and reviewed specific uses, advantages and disadvantages of several cleaning and sterilization technologies.

Five key insights:
1. Patients deserve quality care using instruments and devices that have been properly sterilized. Equipment that is properly reprocessed presents a lower risk of surgical site infections and transmission of diseases. Reprocessing standards should be the same across care settings and should not be dependent on staff or inventory availability.

2. Organizations must understand and adopt best practices aligned with reprocessing. "There are several areas where best practices are aligned with reprocessing medical and surgical instrumentation: at the point of use, following manufacturers' written instructions for use, decontamination and cleaning, drying, inspecting, assembling or disassembling, packaging and reviewing process monitors, documentation and storage," Ms. Fellows said.

3. When choosing a method for reprocessing reusable instruments, it is important to determine if the instrument is critical or semi-critical. The Spaulding Classification, adopted in the 1950s, classifies instruments as "critical" or "semi-critical." Critical instrumentation enters the sterile tissue or vascular system and must be sterile because microbial contamination could transmit disease. Semi-critical instrumentation comes in contact with mucous membranes or nonintact skin. "The Spaulding Classification has proved an exceptional multi-decade standard for device reprocessing," Ms. Fellows said. "However, as of late it has come under scrutiny because of drug-resistant organisms" and other factors. As a result, "The thought or trend is to elevate one's practice to sterilization," in contrast to less-effective cleaning options.

4. Healthcare organizations need defined policies and standards of care for methods of decontamination. These policies and procedures should use recommended guidelines and be easily accessible for reference.

5. There are multiple factors to consider when choosing a sterilization modality. Ms. Fellows described steam sterilization and Immediate Use Steam Sterilization (IUSS), referred to as "flash sterilization." She also discussed several low-temperature sterilization technologies including:

• Ethylene oxide "ETO gas" sterilization
• Peracetic acid sterilizing
• Hydrogen peroxide gas plasma
• Vaporized hydrogen peroxide
• Ozone

Each option has advantages and disadvantages, including sterilization effectiveness, FDA clearance, cycle time, temperature, safety and cost.

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