Decontamination
documenting each processing step in standard work. This includes how the work is to be completed, what tools are required, how long it should take, and expectations for moving the product to the next processing step. Enabling process success is all about creating and complying with standard work. Every reprocessing leader should walk each step of the process and ask what the standard work is and how compliance is monitored and ensured. Don’t assume people know and remember what to do. Even if staff are trained correctly, their actions will drift over time and require continuous follow-up and observations to ensure compliance. Process includes all the standard
reprocessing steps: cleaning and disinfection, inspection, assembly, packaging, sterilisation, sterile storage, case carts, flexible scopes, and any other activity performed by staff. Whenever possible, leverage technology such as guided workflows to ensure compliance and remove reliance on human memory. The second focus area is operations management. If reprocessing operations focus on how instruments are processed, operations management focuses on how operations are managed and controlled. This enabler assists in ensuring key management activities are documented, standardised, routinely performed and reported on. While each reprocessing department may have unique custom activities and responsibilities, the core management practices typically include: l Standard work and checklists l Daily production management l Vendor instrument management l Performance metrics l Instrument inventory management and optimisation
l Instrument and device repair and maintenance
l CSSD and Perioperative collaboration
Creating the best processes and operations management routines leads to ensuring staff compliance and the next enabler.
Compliance
Compliance is doing what you’re supposed to be doing even when no one is watching. Compliance brings capacity, people, and process together to ensure best practices and clinical outcomes are met. Compliance is a broad term that includes
following standard work instructions, performing tasks as trained, completing leadership routines, documenting and following a quality management system, and being aware of and adopting regulatory requirements.
Enabling compliance is critical to ensuring everything works as planned. Reprocessing departments with high compliance exhibit positive cultures, excellent product quality, low defect rates, satisfied Customers, and documentation that supports operational activities. Compliance is more than ticking a box. It is culture, attitude, and awareness. The ‘Compliance Enabler’ ensures the department implements and follows a quality management system based on the ISO 13485 requirements. This includes standard work, management responsibilities, training records, complaint records, corrective and preventive action programme (CAPA), traceability, and system audits. Compliance also includes government and industry-based regulatory standards and internal audits. Additionally, accreditation agency audits and certification programmes are included in this enabler. Compliance can be improved through the use of the next enabler – Technology.
Technology Technology, and specifically AI, seems to dominate everyday discussions. While AI can and will provide value to reprocessing departments, technology is much more than AI. Reprocessing technology includes equipment automation, process automation, data automation and analytics, track and trace systems, and AI applications. Enabling equipment automation is less
obvious because it’s already common throughout reprocessing. Automatic loading
and unloading of washers and sterilisers, automatic dosing equipment, and automated robotic-assisted surgery washer cycles are a few examples. Equipment automation provides consistent reliable process control and outcomes, while reducing labour requirements. For example, the robotic-assisted surgery washer cycles have shown to save 142 minutes from the manual method.1 Process automation includes the use
of autonomous mobile robots (AMRs) and other robotics that automate the movement of products. The use of AMRs is still new to the reprocessing industry in general, but a recent study showed that an AMR loading and unloading washers saved 21.2km of staff walking, as well as manual handling washer racks 658 times in one week.2 Data automation is transforming how
reprocessing manages and improves operational performance. AI agents have the ability to transform data into actionable insights that drive value. Automating data analytics is closely tied to the use of track and trace instrument tracking systems that collect operational data through scanning trays with a barcode reader. Converting this scanning data into actionable insights is where AI and data automation come into play. Organisations that effectively leverage data automation may gain significant advantages in operational performance, decision making, and resource optimisation.
Data mining for instrument tray
rationalisation and optimisation, benchmarking performance, and tracking high and low
October 2026 I
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