Proper instrument processing should be a simple matter of following the device manufacturers' written instructions each and every time — no exceptions, no cutting corners. But in reality, it's not so easy. You and your processing teams struggle to keep up with evolving industry guidelines and an increasingly complex array of instruments and devices you've never dealt with before. Here's how to overcome 4 instrument processing challenges you're likely to face today.
1. Loaners and specialty items. As more surgical procedures move to the outpatient setting, surgery centers, both freestanding and hospital-based, are working with more loaners and specialty items to accommodate their increasingly diverse caseloads. It's an exciting time for surgeons, who love to get their hands on the latest devices. But at the same time, sterile processing personnel are struggling to keep up with the often widely divergent manufacturers' instructions for cleaning and sterilizing these specialty items, implants and loaner sets. Some can only be processed a limited number of times before they have to be discarded, while others come with complicated, multi-step cleaning specifications. For example, 1 manufacturer provides these time-consuming and labor-intensive processing instructions: 30 minutes of enzyme soaking; 2 minutes of manual cleaning, followed by rinsing; 30 minutes of sonic cleaning; 2 minutes of manual cleaning, followed by mechanical cleaning. That's a far cry from how your staff are used to processing basic instruments. It sounds simple, but the best way to ensure your staff aren't putting specialty items through the same cycles they use for basic instruments is to have the manufacturers' written instructions for processing every device at your facility readily available at all times. These instructions must tell you how to:
- Decontaminate and clean an instrument, including the type of detergent (enzymatic, for example) and the pH (if applicable).
- Sterilize an instrument, including any assembling and disassembling instructions. Sterilization instructions must specify the cycle type (gravity or dynamic air removal), exposure time and temperature.
Place copies of each manufacturers' instructions in 2 separate binders, which you can organize alphabetically or by specialty. Place 1 binder in the decontamination room to provide a reference for cleaning procedures and 1 binder in the packaging/sterilization room for assembly and sterilization specifications.
2. The right equipment. This is a big issue, particularly in smaller facilities that started out single-specialty but have since decided to expand their services. I recently visited a GI center that had planned to add podiatry to its case mix. While on a tour of the facility, I asked about the contents of a tray that the staff identified as podiatry instruments. But when I opened it up, I discovered it was an implant tray filled with screws and plates that required a special sterilization cycle very different from the one used to process instruments. That discovery led the facility leaders to realize their existing sterilization equipment wasn't sufficient to comply with the manufacturer's guidelines for cleaning and sterilizing the specialty items the surgeons would be using in the new podiatry cases. They wouldn't be able to do those procedures unless the facility purchased another sterilizer to accommodate them. When you're planning to add a new specialty or case that requires instrumentation or implants you haven't processed at your facility before, don't assume anything. Check the manufacturers' instructions for all the new items before you make a purchase or a commitment to the surgeon who wants to host those cases. If your sterilizer can't be set to the required cycle, you'll either have to purchase a new sterilizer or send those items to a local hospital for sterilization.
Create a Processing Paper Trail |
When an infection outbreak occurs, no one is going to care what your policies are — they're going to want proof that those policies were enforced. In addition to having clearly written instructions for cleaning and sterilizing surgical devices, you must also be sure to document every aspect of your processing procedures and keep those records on file for a period of time as recommended by your legal counsel. Some of the important records you must keep include (but are not limited to):
— Nancy Chobin, RN, AAS, ACSP, CSPDM |
3. Ophthalmic instruments. In 2007, the American Society of Cataract and Refractive Surgery published a new set of guidelines for cleaning and sterilizing intraocular surgical instruments for the prevention and reduction of toxic anterior segment syndrome (TASS). These guidelines have been incorporated into AAMI's Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities. But the proper processing of instruments for ophthalmology continues to be an issue in surgical facilities.
Some facilities are reluctant to use enzymatic detergents as recommended — and some facilities use no detergent at all. Unfortunately, some instrument manufacturers are making compliance with ASCRS guidelines more difficult by recommending that their instruments be cleaned with sterile water, which is not really cleaning at all. This inconsistency is causing a great deal of confusion among processing staff, who aren't always sure when they're supposed to clean instruments and what agents to use.
Don't rely on manufacturers' guidelines alone. Consult the ASCRS guidelines, which can be obtained from ASCRS or found in the AAMI ST-79 Annex 2008, and correlate them to manufacturer specifications in order to develop firm policies and procedures for processing the ophthalmic instruments and devices used at your facility. If a manufacturer recommends cleaning with sterile water, request documentation showing that cleaning with water alone won't interfere with effective sterilization. Be sure to include these basic rules of thumb when developing your own policies for processing eye instruments:
- Discard detergent after you've used it on 1 set of instruments.
- Clean eye instruments separately from other types of instruments.
- Dedicate cleaning implements to eye instruments, which you should clean and disinfect after each use. Be sure to discard single-use implements after each use.
Steam Sterilization Update |
The Joint Commission says it will refocus its survey efforts on all of the critical processes included in steam sterilization. Surveyors will, among other activities:
SOURCE: The Joint Commission Online, June 2009 |
4. Oversight. You don't want to wait for an outbreak to occur before you discover staff aren't processing instruments correctly. You should routinely monitor for staff compliance with all manufacturers' recommendations. Of course, ASC and hospital administrators tend to wear many hats and don't have a lot of extra time to devote to overseeing instrument cleaning and sterilization. Still, with the government planning to step up its oversight of infection prevention practices at ambulatory surgery facilities, it behooves you to get a head start by making yourself more aware of what really happens when instruments are sent to be processed. For starters, you should:
- Open up trays and examine how they were assembled.
- Review sterilization logs to determine if items requiring special cycles were actually run on those cycles.
- Perform cleaning effectiveness testing on flexible scopes weekly. Identify deficiencies and document corrective action taken.
- Ensure that specialty items are run separately from other items, since the other device manufacturers didn't validate that their devices could be processed on the extended cycles. This practice has the added benefit of extending tray and set turnaround times.
While it's important for you to be involved in overseeing instrument processing policies and compliance, you should appoint highly skilled team members who can be trusted to know the guidelines in and out and make sure they are followed at all times. At least 1 person in your facility should be certified in sterile processing. The Certification Board for Sterile Processing & Distribution (www.sterileprocessing.org) offers a Certified Ambulatory Surgery Sterile Processing Technician certification and a Certified Flexible GI Endoscope Reprocessor certification. The exams to qualify for these certifications concentrate on the knowledge and skills required for competent performance in both practice settings.