CATEGORY: Compliance

Sep 25, 2024

4 Process Trends in GI and SPD & What You Need to Know

The one thing we can always count on working in reprocessing departments? Something is changing and evolving. Standards are amended, new studies are published, technical information reports (TIRs) transition to standards among many other changes and recommendations that keep our world in a state of constant development. There are several improvement recommendations that create a more robust process in sterile processing and endoscope reprocessing from decontamination to prep & pack. Efficiency and safety are at the crux of medical device reprocessing updates and expansions. However, these changes are not always easily implemented and take consideration when it comes to space, location and cost prioritization. Reprocessing steps are becoming more nuanced and regulated as we become more aware of gaps and the growing complexity of reusable medical devices. There are several updates in the industry now that require formal implementations and workflow evaluations. Extended soak times Extended soak times occur when flexible endoscopes cannot be reprocessed within the recommended 60-minute time period post procedure. However, this can also go for some surgical instruments whose manufacturer IFU’s have a soak time longer than the chemistries contact range. “When there is a delay and/or failure to perform point of use treatment, the endoscope should be processed using delayed processing protocols described in the device manufacturer’s IFU.” ANSI/AAMI ST91:2021 7.2.2 These extended soak times are necessary for appropriate and safe reprocessing but can lead to backlogged work and slower throughput times. These soak times may require a designated area to complete the steps so as not to disrupt other priorities. Visual Inspection: Borescopes & Cleaning Verification Test Channels and lumens commonly appear in SPD and endoscopy departments and increased visibility measures are required to full inspect and verify the instruments cleanliness before high-level disinfection (HLD) or sterilization. Cori Ofstead & Associates conducted a compelling research study that brought awareness and real-life application to the importance of visual inspection of channeled instruments. (Ofstead, et al, 2024) Following recommendations and IFUs doesn’t always guarantee a patient-ready product. Additionally, more detailed inspection such as borescope and cleaning verification highlights the quality of practices and outcomes, thereby shedding light on potential process gaps. Adding this measure of inspection to your workflow also brings up questions about location and feasibility. With this added step, keeping in mind the need to reduce cross- and even re-contamination plays a role in where and how this detailed inspection takes place. Borescopes are also incredibly delicate tools. Implementing them into workflows should consider spaces for storage, effective table space for coiling and staging instruments without smashing the borescope, and places for mounting IT and monitors. Cleaning verification provides a pass/fail indicator to our cleaning processes and can include test such as ATP, protein, carbohydrates and endotoxin among others. (ANSI/AAMI ST79 Annex D & ANSI/AAMI ST91 Annex F) Each test provides scientific bench markers to determine cleaning efficacy and is making it’s way into standardizing processing initiatives. Cleaning verification (borescope and marker testing) enhances department’s awareness and provides foundational benchmarks for appropriate and safe cleaning practices. Tray Configuration Tray configurations include a handful of checkboxes to maintain compliance. These include IFU compatibility between instruments and sterile barriers, IFU compatibility across instruments required in the set, and tray weight (ANSI/AAMI ST79 8.2 & 13.) The recommended maximum tray weight of 25lbs includes the combined weight of the instruments and sterile barrier. Some rigid container manufacturers also have validated weight limits included in their IFUs. Tray weights not only ensure standardized weights to reduce employee strain and injury but when tracked can also help verify to sterilization load weight compliance. “Instrument sets, including the sterile barrier system, should weight no more than 11 kg (25lb) (ANSI/AAMI ST77)” ANSI/AAMI ST79:2017 8.2(j Consideration should also be given to the load requirements specified by the manufacturer (e.g., number of devices, load weight) ANSI/AAMI ST79:2017 13.9.1 Electronic Record Keeping Digital record keeping continues to expand as technology and software capabilities increase. ANSI/AAMI ST79 13.3 both provide recommendations on what information needs to be maintained and traceable through each phase of reprocessing. Record keeping, especially at automated reprocessing machines, may require space for monitors, scanners and incubators to consolidate the process. Electrical power is also a serious consideration. Departments may be inadequately equipped to handle additional electrical requirements. Power cords or delicate IT accessories also need protection from regular damage. The process critical parameters (time and temperature) provided on the recording chart, printer, or tape should be reviewed, signed, and dated by the operator to indicate an acceptable cycle. For each sterilization cycle, the following information should be recorded: a) the load number; b) the specific contents of the lot or load, including quantity, department, and a specific description of the items (e.g., towel packs, type/name of instrument sets); c) the exposure time and temperature, if not provided on the sterilizer recording chart; d) operator identification; e) the results of biological testing, if applicable; f) the results of Bowie-Dick testing, if applicable; g) the response of the CI placed in the PCD, if applicable; and h) any reports of inconclusive or nonresponsive CIs found later in the processed devices (see also 13.5.2.2) ANSI/AAMIST79:2017 13.3.3 Prioritizing process implementation and placement not only equips the department to maintain compliance but also formalizes their processes and organization to ensure steps are not overlooked. Steps like optimized inspection and tray weight management among others contribute to overall patient safety and quality product throughput. References: Ofstead, et al, (2024) Beyond Endoscopes: Pilot Study of survival instrument Lumen Inspection https://array.aami.org/doi/10.2345/0899-8205-58.1.25 ANSI/AAMI ST91:2021 ANSI/AAMI ST79: 2017

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