Sterilization Practice Review: 10 Steps When Installing New Sterilizers or Changing BI Systems
Installing a new sterilizer or changing a biological indicator (BI) system can represent a significant advancement for a Sterile Processing Department (SPD). New technology may provide faster results, improved monitoring, better connectivity, increased processing capacity, and more efficient workflows.
But purchasing and installing the technology is only part of the process.
Before the new sterilizer or BI system becomes part of everyday operations, Sterile Processing leaders should ask an important question:
Did our sterilization practices change along with the technology?
A new sterilizer or biological monitoring system should not simply be installed, validated, and placed into service without reviewing the processes surrounding it.
Changes in sterilization equipment or biological monitoring can affect:
Sterilization cycle selection
Load configuration
Biological and chemical monitoring
Load release
Documentation and traceability
Recall procedures
Staff training and competency
Department policies and procedures
Manufacturer Instructions for Use (IFUs)
A comprehensive Sterilization Practice Review can help identify gaps before they become routine practices—or potential compliance and patient-safety concerns.
A Sterilizer Is Only One Part of the Sterilization Process
Effective sterilization depends on multiple components working together.
Sterilizer → Cycle → Load Configuration → Packaging → Medical Device → Monitoring System → Documentation → Load Release
Each component matters.
A sterilizer may be capable of running a particular cycle, but that does not automatically mean every medical device, rigid sterilization container, packaging system, biological indicator, or process challenge device used by the department is validated for that cycle.
This is why reviewing the entire sterilization process—not simply the sterilizer—is so important when implementing new technology.
1. Review Sterilizer and Cycle Selection
Begin by reviewing each sterilizer and every cycle enabled for clinical use.
Sterile Processing staff should understand not only how to select a cycle but why that cycle is appropriate for the load being processed.
Review the cycle type, exposure temperature, exposure time, drying time, load restrictions, cycle-specific limitations, and applicable manufacturer instructions.
Compare those requirements with the medical devices and packaging systems being processed.
One question can reveal a great deal about the process:
Can the department demonstrate why every item in the load is appropriate for the sterilization cycle being used?
Cycle selection should be supported by applicable IFUs—not simply department habit or the need for faster instrument turnaround.
2. Evaluate Sterilizer Load Configuration
The next step is to evaluate how sterilizer loads are actually being configured.
Observe routine production loads and compare staff practices with the sterilizer, rigid container, packaging, and medical-device IFUs.
Review the placement and orientation of:
Wrapped instrument sets
Rigid sterilization containers
Peel pouches
Basins and trays
Specialty devices
Also consider mixed loads, weight and density limitations, spacing, sterilant contact, and drying requirements.
This is especially important when replacing sterilizers. A new chamber, rack, loading cart, or sterilizer design may require different loading practices than the equipment it replaced.
Do not assume that an old loading practice is appropriate for new equipment.
3. Review Biological, Chemical, and Physical Monitoring
Changing biological indicator systems should trigger a review of the department's entire sterilization monitoring process.
Evaluate:
BI selection
Sterilization cycle compatibility
Process challenge device (PCD) use
BI/PCD placement
Monitoring frequency
Implant-load practices
Chemical indicators
Physical monitoring
BI incubation
Control requirements
Result interpretation
Documentation
Response to unexpected results
When transitioning to a new BI system, compare the old and new systems directly.
Differences in incubation time, PCD configuration, controls, documentation, connectivity, result interpretation, or failure-response procedures should be understood before the new system goes live.
Changing the BI may seem like a small change.
Operationally, it may affect much more.
4. Perform an IFU Alignment Review
One of the most important parts of a Sterilization Practice Review is verifying that the applicable Instructions for Use work together.
Consider developing an IFU compatibility matrix that connects four critical components:
Sterilizer → BI/PCD → Packaging System → Medical Device
For representative high-volume, specialty, complex, and high-risk instrument sets, verify that the selected sterilization cycle satisfies all applicable IFUs.
The fact that each individual product is being used according to an IFU does not necessarily mean the complete process is aligned.
For example:
The sterilizer may offer the cycle. The BI/PCD may monitor the cycle. The container may be validated for the cycle. But is the medical device validated for that same cycle?
Any conflict or unclear instruction should be identified, documented, and resolved before the process becomes routine.
5. Evaluate Load Release and Sterilization Documentation
Sterilization documentation should tell the complete story of the load.
Select several completed loads and attempt to reconstruct what happened from preparation through release.
Can you determine:
What was sterilized?
Which sterilizer was used?
Which cycle was selected?
Who processed and released the load?
What were the biological, chemical, and physical monitoring results?
Where were the processed items distributed?
Review cycle printouts or electronic records, load and lot numbers, BI and CI results, operator identification, load contents, implant documentation when applicable, release criteria, exceptions, and record retention.
When sterilizers, BI readers/incubators, and instrument tracking systems exchange information electronically, those interfaces should also be evaluated.
Electronic documentation is valuable only when the information is complete, accurate, and retrievable when needed.
6. Test the Response to a Positive BI or Sterilization Failure
Every Sterile Processing Department should have a procedure for responding to a positive BI or other evidence of a sterilization process failure.
But having a policy and being able to execute that policy are two different things.
Review the department's process for:
Immediate notification
Removing equipment from service when indicated
Investigating the failure
Repeat testing
Identifying potentially affected loads
Quarantining products
Initiating a recall
Documenting actions
Notifying appropriate departments and leadership
Returning the sterilizer to service
Consider conducting a mock positive-BI exercise.
Provide staff with a hypothetical positive BI and ask them to walk through the response.
Who gets called first? What happens to the sterilizer? Which loads are affected? Where are those items now?
The exercise can expose gaps that are difficult to identify by reviewing a policy alone.
7. Test Sterilization Recall Traceability
Recall readiness should be tested before an actual sterilization failure occurs.
Select a previously processed sterilizer load and simulate a recall.
Then ask:
If this load failed today, could we identify and retrieve every affected item?
Determine how quickly staff can identify the load contents, where the devices were distributed, and what actions would be required to retrieve them.
Document how long the exercise takes and where traceability breaks down.
A recall procedure needs to work during an actual event—not simply exist in a policy manual.
8. Verify Sterile Processing Staff Competency
Vendor education is important when installing new sterilizers or biological monitoring systems.
But vendor training is not the same as competency.
Staff should demonstrate their ability to correctly perform:
Sterilization cycle selection
Sterilizer operation
Load configuration
BI/PCD use
Chemical and physical monitoring
Documentation
Load release
Response to failed monitoring
Recall procedures
IFU retrieval and interpretation
Competency should include demonstration, observation, and evaluation, rather than simply obtaining a signature confirming attendance at an in-service.
The objective is not to prove that an employee received training.
The objective is to demonstrate that the employee can correctly and consistently perform the process.
9. Update Sterilization Policies and Procedures
One of the easiest problems to overlook during an equipment change is the documentation written around the equipment being replaced.
The sterilizer may be new.
The BI system may be new.
But what about the policies?
Legacy cycle terminology, screenshots, BI instructions, load-release criteria, forms, testing procedures, competencies, and recall processes may remain embedded in departmental documentation.
This can create a significant disconnect:
The department may be operating new technology under old procedures.
When sterilization technology changes, review the department's:
Policies and procedures
Competencies
Forms
Job aids
Training materials
Electronic documentation
Monitoring instructions
Recall procedures
The written process should reflect the process employees are expected to perform.
10. Conduct a Post-Implementation Sterilization Review
Implementation day should not be the end of the process.
Schedule a follow-up Sterilization Practice Review after the equipment or BI system has been operating under normal workload conditions.
Evaluate actual production data and staff practices, including:
Sterilization records
BI results
Aborted cycles
Wet loads
Documentation errors
Cycle-selection patterns
Equipment alarms
Staff workarounds
Equipment downtime
Questions raised by technicians
There can be a significant difference between how a process works during implementation and how it functions several weeks later under normal production pressure.
Go-live tells you whether the equipment works. Post-implementation review helps determine whether the process works.
New Sterilization Technology Deserves a Fresh Look at the Entire Process
A new sterilizer or biological monitoring system can represent a substantial investment for a healthcare organization.
Protecting that investment requires more than successful installation.
The department should evaluate whether its cycles, loading practices, monitoring, documentation, competencies, policies, recall procedures, and manufacturer IFUs are aligned with the new technology.
That is the purpose of a Sterilization Practice Review.
The question should not simply be:
“Was the new sterilizer installed correctly?”
A better question is:
“Is the entire sterilization process working correctly?”
Sterilization Practice Reviews from Evolved Sterile Processing Consulting
Evolved Sterile Processing Consulting (ESP) helps hospitals, ambulatory surgery centers, and other healthcare organizations evaluate sterilization practices from equipment implementation through everyday operations.
An ESP Sterilization Practice Review can evaluate:
Sterilizer and cycle selection
Load configuration
Biological, chemical, and physical monitoring
BI/PCD practices
Sterilizer, BI, packaging, and medical-device IFU alignment
Load release and documentation
Recall readiness and traceability
Staff education and competency
Policies and procedures
Post-implementation practices
The goal is to identify process gaps, IFU conflicts, documentation concerns, competency opportunities, and operational risks before they become larger problems.
Installing new equipment is an important milestone.
Making sure the entire process works together is what comes next.
Install the technology. Validate the practice. Protect the patient.
Evolved Sterile Processing Consulting
Current Experience. Practical Solutions. Lasting Results.
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