Dealing with, heading off reprocessing breakdowns

No matter how skilled and talented you are or how well-organized and efficiently managed your sterile processing operation is you’re bound to hit a few speedbumps and roadblocks along the way.

So you have to plan for any reprocessing breakdowns, using either past experience or hypothetical predictions, to keep your procedures and staff on their toes.

Here’s what three experts suggest.

"Education is an extremely important part of any high-level disinfection process, and every facility needs to have a policy to ensure staff members are consistently and continually educated," said Carol K. Stevens, BSN, R.N., CGRN, clinical education consultant, Advanced Sterilization Products. "Even the most seasoned staff needs to be educated on new or changing technology and changes to instructions for use (IFU).

"We also recommend regular reviews of IFU and material safety data sheets to make sure the facility is aware of the most current instructions," Stevens continued. "It is a good idea to bring in your partners – the manufacturers of the endoscopes your facility uses, the manufacturer of your reprocessing technology, even the manufacturer of your detergents and biocides – to ensure all your practices and procedures are up to date.

"Of course, guidelines can also change," she added. "For instance, the Society of Gastroenterology Nurses and Associates (SGNA) guidelines are reviewed every three years. The facility also must keep up with FDA guidance and announcements."

Lenny Jordan, executive vice president for surgical devices, Integrated Medical Systems International Inc., suggested three primary areas of concern.

• Cross sterilization – Although there are a number of approved methods for sterilizing rigid endoscopes, using one method consistently will extend the life of your equipment. For example, if a scope is being sterilized with STERIS in the operating room for quicker turn time and then sterilized with STERRAD at the end of the day in the central service department, the interaction of chemicals from the two systems can lead to a reaction that damages the scope’s adhesives and can allow moisture to intrude. To avoid this problem, consistently use one approved sterilization method for each scope in your inventory.

• Improper use of enzymatic cleaner – It is crucial to follow all label directions for enzymatic and other cleaners, including dilution ratios, temperature of the enzymatic bath, and exposure time of the scope’s internal and external surfaces. Keep these instructions in a place where all affected personnel can easily locate them. Provide periodic education and review to ensure your team understands which products are approved for use on specific equipment.

• Buildup of anti-fog compound – When an endoscope moves from the cool OR environment into the warmth of the patient’s body, the rapid change in temperature can fog the lens, obscuring the doctor’s view. Anti-fog compounds can prevent this; however, if these compounds are not removed during the manual cleaning process they can be baked onto the lens during the sterilization process. When this occurs, it is virtually impossible for the doctor to see through the lens, and at this point, the only viable option is sending the scope in for repair. To avoid this problem, simply wipe the lens with alcohol prior to sterilization.

Gregg Agoston, M.B.A., associate director, Protection 1 Services, Karl Storz Endoscopy Inc., emphasized the following:

The most important aspect of sterilization is the preparation of the device for sterilization. As stated by others, the device cannot be sterilized unless it is first properly cleaned. Any bioburden left behind by improper cleaning, even if the instrument is processed through a sterilization cycle, can be pyrogenic and cause patient harm. Rigid and flexible endoscopes require special handling and cleaning to ensure successful sterilization. The manufacturer’s guidelines for both cleaning and sterilization must be followed.

Unfortunately, we have witnessed multiple occasions when sterilization was compromised due to instruments being contaminated. We also witnessed shortcuts being taken or processes skipped during the cleaning or sterilization cycle. In one case, we found flexible intubation scopes that were hung back on the intubation cart after cleaning — the sterilization processing was skipped. For flexible endoscopes, it is critical that the endoscope be checked for leaks prior to decontamination and prior to sterilization. For any rigid or flexible endoscope that has a lumen, it is very important to brush and flush the lumen, ensuring that that proper brush size is used to prevent damage to the working channel. Guidelines must also be followed regarding vent caps and a method of sterilization is used that has been validated for the particular endoscope.

It is also important to note that Advanced Sterilization Products (ASP) issued a statement regarding their stance on any device that has been repaired by a third party. "Independent repair organizations may be registered with the FDA as a business, be both ISO (ISO 9001: 2000) certified, and compliant with Good Manufacturing Processes (GMP) (21CFR82) for quality systems regulations on the operation of their services. However, they are not regulated by the FDA, and are not subject to the same audits and controls as OEMs. Moreover, third-party repair services may use parts and materials that differ from the original parts and materials that were used in the original STERRAD System validation.

Without knowledge of the consistency of the materials used or the final quality of each repair, ASP cannot guarantee the sterility or functionality of any medical devices altered by a third party and then sterilized in the STERRAD System. ASP recommends that all repairs, adjustments or alterations be performed only by the original manufacturer or an authorized repair facility using original parts and components to ensure both sterility and functionality after sterilizing with STERRAD Systems.