Verifying the Life of Your Reusable Medical Devices
First to Last, Every Patient Deserves to Be Safe
SteriLogix can provide the robust science you need to verify the useful life of your device without overburdening your development process.
We Operate 24/5 Without Interruption
Clinical Reprocessing Cycles and Life Cycle Testing
Reusable medical devices must be reprocessed after each surgical use so that they are clean and sterile for the next procedure to ensure the safety of the end user.
The protocol for preparing the device for reuse, following the manufacturer’s IFU, and exposing the device to the same reprocessing conditions that it will see in a hospital or surgery center, is referred to as a Clinical Reprocessing Cycle (CRC).
Life cycle testing, sometimes referred to as durability testing, involves repeated application of these CRCs to simulate a lifetime of use. Successful completion of life cycle testing serves to validate the manufacturer’s reprocessing instructions for the device.
Our Process
Testing requirements for reusable medical devices have changed dramatically in recent years. Manufacturers must now determine the useful life of their reusable instruments and inform the user of this limit, based on testing data. Additionally, reusable instruments must be preconditioned prior to biosafety testing. Our focus on only high-cycle reprocessing allows you to collect this data on time and on budget.
Planning
Based on your instructions for use (IFU) and protocols, SteriLogix will create a customized document (or router) outlining the reprocessing steps we will utilize to achieve your testing goals.
Testing
The number of testing cycles will be set based on your study’s objectives. This will be used to validate the useful life of the device or precondition it for other post-exposure validation testing.
Documentation
Upon completion, you will receive a test certification or technical report documenting the reprocessing steps and number of reprocessing cycles.
Why Us?
Providing the Data You Need
SteriLogix delivers a complete package of steps and services. Utilizing our Clinical Reprocessing Cycles (CRC) testing provides a technical, nonbiased, certified validation so that you can be confident your materials and products are able to withstand the rigors of reprocessing.
Why Choose Our ISO Accredited Laboratory
Implant Direct
Our Values
Providing the Data You Need
Quality
An ISO accredited laboratory providing high quality clinical reprocessing validations.
Commitment
From proof of design to CAPA verification, we are committed to helping reduce your project timelines.
Experience
Over 50 combined years of experience in testing and evaluation of surgical implants and instruments.