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assessing the use of cleaning verification indicators, implement- ing good quality control practices, performing risk assessment and periodically testing the entire reprocessing procedure with microbial testing of patient-ready endoscopes. The open question in the guideline discussion is if flexible endoscopes should be classified as critical devices and terminal sterilization mandated. AORN 2016 Guideline for reprocessing flexible endoscopes states: Package and sterilize endoscopes that enter sterile tissues or the vascular system. The Spaulding system classifies items as critical, semi-critical, or noncritical. Items such as flexible endoscopes that come in contact with nonintact skin or mucous membranes are semi- critical and should be processed by sterilization or, at a minimum, by high-level disinfection.18

Clinical challenges Minimally invasive surgical techniques (MIS) represent a sig- nificant advancement in medical technology in the 20th 21st


centuries. The most common types of MIS procedures are performed through a very small incision using rigid endoscopes that are commonly terminally sterilized with steam sterilization. MIS procedures are also increasingly performed with flexible endoscopes that enter the body through existing orifices (e.g., mouth to esophagus or lungs, urinary tract to bladder or kidneys, rectum to large intestine, mouth to duodenum and other upper GI structures). MIS procedures can greatly benefit the patient with lower risk of infection, faster recovery and overall less cost to the healthcare system. 20

A more recent technological evolution of MIS

includes the use of robotics with flexible endoscopes which con- ceivably could present additional challenges for reprocessing.21 While the endoscopes themselves have evolved to perform complex procedures, the reprocessing standard of care has not evolved significantly. Even though flexible endoscopes are used in these critical MIS procedures, the standard of care in the gastro- enterology community for reprocessing these devices continues to be high-level disinfection.20 The Spaulding classification scheme is a widely referenced basis for determining how a medical device should be reprocessed based on how the device is used on the patient and the subsequent risk of infection to the patient.1

Most references citing Spaulding include

examples of various types of devices that fit into the three catego- ries: Critical, Semi-critical and Non-critical devices. Typically, the semi-critical category lists flexible endoscopes but if that endoscope is used in a procedure that enters the patient sterile body cavity or tissue or has contact with the vascular system or blood stream, that endoscope then becomes a critical device requiring terminal sterilization according to Spaulding.23

It is not the name of the

Figure 1 — Linear log kill kinetics of terminal sterilization process and depiction of ‘safety factor’ in an overkill process.


endoscope that determines the risk to the patient, but rather how that endoscope is used that dictates the risk to the patient. FDA recommends sterilization for all critical and semi-critical devices. If a semi-critical device cannot be sterilized, it should be at a minimum high-level disinfected.22

Additional requirements for successful reprocessing Effective cleaning procedures: It is critical to reduce the amount of clinical soil on flexible en- doscopes so that the subsequent lethal processes of high-level disinfection or sterilization can be effective. Precleaning should be performed according to IFUs and guidelines and full manual cleaning initiated within one hour of the procedure.

Inspection for damage: Careful inspection using lighted magnification is needed to assess damage to the endoscopes. Damage can impact the functionality of the endoscope and can also increase the risk of biofilm formation.8, 23

Satisfactory leak testing:

Performed prior to manual cleaning, leak testing ensures the endo- scope is not damaged so that fluids cannot invade the portions of the endoscope that are not designed for fluid contact. The appropri- ate procedure is described in the endoscope manufacturer’s IFU.

Effective drying:

Complete drying is required for effective sterilization and effective storage of a high level disinfected endoscope. Current data shows that a 10-minute forced air drying can be effective.24, 25

Compatible packaging for sterilized endoscopes: A terminally sterilized endoscope provides a sterile barrier and retains a sterile state until used or compromised. Some types of sterilization processes may require specific packaging compatible with that system.

Effective sterilization or disinfection process A compatible method that has been validated by the endoscope manufacturer and has demonstrated both efficacy and materials compatibility should be used.

Sterilization and high-level disinfection comparison According to ANSI/AAMI ST58: 2013 — Chemical Sterilization and high-level disinfection in healthcare facilities — Annex A, physical sterilization processes (including steam and chemical sterilization processes) are defined based on how effective they are at killing microorganisms, including bacterial spores.26


are the standard as spores have the greatest resistance to the le- thality of the process. The effectiveness of the chemical sterilant or high-level disinfectant is determined by how effective it is at killing spores under the defined conditions or parameters of the process. The methods used to validate or prove it works for steam and gaseous chemical sterilization processes are different than the methods used to validate liquid, high-level disinfection. High-level disinfection provides microbial kill under defined conditions but does not kill all spores. Terminal sterilization is a linear process. This means the process is predictable in how it delivers the lethality and can provide a prob- ability calculation of surviving microorganisms, also known as a sterility assurance level (SAL). The survival kinetics (or profile) for steam, dry heat, and for chemical sterilization with etheylene oxide

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Self-Study Test Answers: 1. B, 2. A, 3. A, 4. A, 5. B, 6. A, 7. A, 8. B, 9. B, 10. A

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