THIS WEEK'S ARTICLES
The Importance of Following Standards and Guidelines for Sterilization - Sponsored Content
Instrument Optimization Starts in Sterile Processing
Standardized practices ensure complete and properly cared-for tools reach ORs.
Reprocessing techs should identify and address broken, missing or incorrect instruments before sending sterilized sets to surgery, according to recent research.
The study, conducted at a 700-bed academic hospital and recently published in the journal BMJ Quality & Safety, observed 3,900 defects in trays of sterilized instruments over the course of a year in the facility's two sterile processing departments (SPDs). Missing instruments were the most common defect reported, occurring in nearly 18% of the incidents discovered, followed by broken instruments (11%) and wrong instruments (9%).
The defects impacted nearly 42,000 surgical cases. "These failures were precipitated by technological shortcomings, production pressures, tray composition, unstandardized instrument nomenclature and inadequate SPD staff training," state the authors.
The researchers believe these issues should be identified and corrected during the instrument set reassembly phase. They performed a work system analysis to develop an understanding of the nuances of surgical tray assembly, the range of challenges surrounding the process and the variables that could influence poor reprocessing results.
They say supporting patient safety and avoiding delays in the OR by minimizing tray defects requires a well-designed instrument tracking system, standardized nomenclature, coordination of reprocessing tasks among OR and SPD staff, and cross-training of staff members in both departments.
"This analysis can provide administrators, clinicians and staff with the ability to understand the relationship between system components, generate and prioritize interventions, and then predict benefits, side effects and barriers to implementation," states the study.
Say Goodbye to Blue Wrap
Rigid sterilization containers improve the reprocessing of total knee instrumentation.
Surgical facilities that are searching for ways to increase the overall efficiencies of total knee replacements should use rigid sterilization containers instead of blue wrap, according to a study that examined four aspects of the perioperative process: setup and takedown times of surgical trays in the OR; the amount of time trays spend in sterile processing; associated case cost in ORs and sterile processing departments; and the amount of waste produced during cases.
The results showed that the use of sealed containers reduced case turnover times by 57 minutes, could decrease waste disposal by more than 95% and also could produce annual savings in OR and sterile processing departments amounting to nearly $250,000.
Rigid containers contribute to increased efficiency in the total turnover times of instrument trays according to the study, which was published in the journal Surgical Technology International. For example, rigid containers allow trays to be put through sterilization cycles with faster dry times, a factor that can shave about 40 minutes off the entire process. "This could potentially create far-reaching opportunities for orthopedic surgeons who wish to perform procedures in outpatient surgery centers," says the study.
The faster case turnover times realized from using rigid containers could increase an OR's daily caseload and reduce the amount of instrument trays needed to perform cases. "This simple means of increasing efficiency could be used as a model for facilities wishing to streamline surgical trays and reduce costs," says the study.
Joint replacement procedures are on the rise — about 1.3 million total knees were performed in the U.S. last year — and many of them are now performed in HOPDs and ASCs. As a result, note the study's authors, efficient management approaches to meet increases in demand are becoming vitally important.
The Importance of Following Standards and Guidelines for Sterilization
Meeting guidelines for product identification and traceability, record-keeping and monitoring of chemical sterilization.
Standards provide healthcare providers with a set of requirements, specifications and guidelines established and agreed upon by industry experts as the gold standard of care. In the United States, the American National Standards Institute Inc. (ANSI) and the Association for the Advancement of Medical Instrument (AAMI) are recognized authorities and sources of consensus standards for the medical device industry.
For sterilization guidance, there are two primary ANSI/AAMI documents that provide what OR teams need to make good choices about their facility's sterilization processes. These include ANSI/AAMI ST79:20171 which is a comprehensive guide to steam sterilization and sterility assurance for facilities. NSI/AAMI ST58:2013/(R)20182 was developed by the AAMI and approved by the ANSI in 2013. It provides standards and recommended practices specifically for the use of low temperature chemical sterilization and high-level disinfection in a healthcare facility. Standard 58 (ST58) covers a broad range of topics including work area design considerations (Section 3), decontamination and preparation of instruments (Section 6), and using chemical sterilant safely and effectively (Section 7).
Advanced Sterilization Products (ASP) can help meet AAMI quality control recommendations specifically for ST58 (Section 9) for cycle documentation and record-keeping through the company's built-in scanner and touch-screen interface that facilitate input of BI (biological indicator), sterilizer and load information, which reduces the need for manual record-keeping.
Together, STERRAD® Systems and STERRAD VELOCITY® fill this need which is discussed in ST58 (Section 9). This covers product identification and traceability, documentation and record-keeping, monitoring of chemical sterilization, product testing, product recalls and quality process improvement.
Another important guideline section, ST58 (Section 9), focuses on using biological indicators and process challenge devices. The AAMI recommendation states "health care personnel should use the BIs and PCDs recommended by the manufacturer of the selected gaseous chemical sterilization system and cleared by the FDA for use with that sterilization system or BIs and PCDs cleared by the FDA as substantially equivalent."2
Here, ASP can also help meet this guideline as the manufacturer of STERRAD® Systems, and only recommends the use of the STERRAD VELOCITY® System with its sterilizers. STERRAD ELOCITY® BI/PCDs were developed by ASP using exclusive proprietary data and technology which results in accurate results and minimizes false positives.
Finally, ST58 (Section 9) also focuses on the frequency of the use of biological indicators and process challenge devices. The AAMI Recommendation states, "A PCD with the appropriate BI should also be used at least daily, but preferably in every sterilization cycle."2 The condition of the sterilizer equipment, the expertise of the sterilizer operator and other factors determining the success or failure of a sterilization cycle could vary from one cycle to another.
ASP can help meet this guideline with STERRAD VELOCITY® BI/PCD, the only all-in-one Process Challenge Device for STERRAD® Systems that meets AAMI recommended guidelines. This means that when you run a STERRAD VELOCITY® BI/PCD in a sterilization cycle, the load is automatically challenged to a level equal to or greater than your most difficult device to sterilize.
Additionally, ST58 (Section 9) discusses the qualification test procedure with BIs. The recommendation includes these guidelines:
a) Before being exposed to the sterilization cycle, the PCD should be labeled with appropriate sterilizer lot and load information.
b) The PCD should be positioned in the load or chamber according to the sterilizer manufacturer's written IFU, and a normal cycle should be run.
c) Upon completion of the sterilization cycle, the manufacturer's written IFU for removing the PCD from the load or chamber and the BI from the PCD should be followed. The BI should be identified and then incubated according to the IFU of the BI manufacturer.
d) Each day that test BIs are run, at least one BI that is from the same lot and that has not been exposed to the sterilant should be incubated as a control to verify the pre-sterilization viability of the test spores, the ability of the media to promote growth of the test spores, and the proper incubation temperature. Test and control lot numbers should be recorded. Upon completion of the incubation period, the test and control results should be read and recorded. If the control BI from a lot fails to grow, it should be assumed that the test BIs from that lot are not viable or that improper incubation occurred. Therefore, the results from the test BIs should be considered invalid and the test should be repeated.
ASP can help meet this guideline with the STERRAD VELOCITY® System, which guides users through compliant biological indicator (BI) processing and automatically creates audit-ready records and can store up to 22,000 complete records including the information recommended by AAMI.
Note: Sophia Czechowicz, PhD, is ASP's Associate Director, R&D — Technical Business Solutions and she leads ASP's Technical Business Solutions R&D team in support of the development, implementation and use of ASP products and technologies for reprocessing medical devices. She authored this article on guidelines for sterilization (see: https://www.asp.com/media/sophia-czechowicz-phd).
For more information, visit www.asp.com.
1. American National Standard/Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities.
2. American National Standard/Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST58:2013/(R)2018 Chemical sterilization and high-level disinfection in health care facilities.
Ramping Up Reprocessing
This ASC's blueprint keeps instruments flowing when case volumes increase.
When Knoxville (Tenn.) Orthopaedic Surgery Center expanded its footprint to accommodate the launch of a comprehensive total joints program, every inch of the extra square footage was used to build two new ORs. Although no additional space was allocated for the sterile processing department, the reprocessing staff nevertheless handled a 50% increase in instrument volume without a hitch. Here are the secrets to the center's success:
No batching. Surgical technicians deliver case carts full of soiled instruments to the decontamination area at the end of each case, instead of waiting until several carts are ready to be transported. "Batching case carts seems to make sense at first blush — techs make fewer trips to the sterile processing department — but the sporadic arrival of instruments leaves reprocessing techs alternating between dealing with downtime and scrambling to keep up," says Jennifer Parrott, RN, the facility's OR clinical manager and sterile processing department manager. "A lineup of carts leads to backups and delays while reprocessing techs prioritize the multiple instruments sets for reprocessing."
Consolidated trays. When the center audited its instrument trays, it found tools that were rarely or never used. Working with their surgeons, instrument sets in partial joint replacement trays were standardized with identical components. The sets for total joint procedures, however, still needed to be configured based on the preferences of individual surgeons.
Staggered shift starts. The center transitioned the sterile processing department to three shifts, with a tech starting at 4 a.m., 9 a.m. and 1 p.m. "Reprocessing techs should never sit idle, so schedule their workdays to coincide with the ebb and flow of instruments through the department," says Ms. Parrott. "The techs meet briefly at shift changes to discuss potential issues — such as a higher-than-usual number of knee cases, trays with missing instruments or problems with the reprocessing equipment — and the incoming tech writes down what needs to be done to address them."
Repair services. The facility hired a company that comes once a month in a large truck equipped with a mobile instrument lab in which the company's reps sharpen instruments, remove burrs, tighten screws and replace damaged instruments. They take tools apart and thoroughly clean them. "The regular servicing extends the life of the instruments, which is a money-saver, and reduces the headache of having to deal with frustrated surgeons when damaged instruments wind up in ORs," says Ms. Parrott.
"It's nearly impossible to grasp the enormity and intricacy of sterile processing operations," says Ms. Parrott. "Yet with the right equipment and staff and effective communication, we continued to run smoothly even when our volume increased and our room to work did not. These concepts are replicable in facilities of all sizes and specialties."
FDA Recommends Using Endoscopes With Disposable Tips
The new devices improve access for cleaning and protect patients from harm
The FDA wants healthcare facilities to use duodenoscopes with disposable caps or distal ends to address the ongoing challenges involved in flexible endoscope reprocessing. Using scopes with disposable caps and ends facilitates improved cleaning and reduces risk of cross-contamination, it says.
Because endoscopic retrograde cholangiopancreatography (ERCP) procedures performed with duodenoscopes are often lifesaving procedures and meet a critical healthcare need, the FDA says doing everything possible to minimize patient-to-patient infection transmissions is of paramount concern.
Using scopes with disposable components doesn't eliminate the need for proper endoscope reprocessing. The plastic or rubber endcaps on fixed duodenoscopes are permanently glued to the metal edges around the distal end. This limits access to the crevices at the distal end needed to effectively clean them. Scopes with disposable ends and caps would help to solve this issue.
"We recognize that an immediate transition away from conventional duodenoscopes to the newer, innovative models will take time due to cost and market availability," the FDA writes. "We encourage healthcare facilities purchasing new duodenoscopes to begin developing a transition plan and work to replace their conventional duodenoscopes with newer models."
The newer devices are not without risk, however. The FDA notes three manufacturers have submitted a total of 10 Medical Device Reports about caps or ends falling off during ERCP. Three of the 10 reports involved models currently marketed in the U.S. Based on these incidents, the FDA reminds healthcare professionals to follow manufacturers' instructions for assembly of the caps and distal ends.