STERIS requires only one of each device being submitted for testing; however, accommodations can be made to meet specific internal quality requirements.
STERIS can provide guidance based on device type and specific modality for which the device is being tested.
We can test in all STERIS low temperature modalities and this can be further discussed in the preparation of the protocol. For critical devices,
V-PRO® Low Temperature Sterilizers and/or SYSTEM 1E® Liquid Chemical Sterilant Processing System should be considered. For semi-critical devices, Revital-Ox® RESERT® High Level Disinfectant, ADVANTAGE PLUS™ Automated Endoscope Reprocessor, DSD EDGE™ Dual Basin AER, and SYSTEM 1® endo Liquid Chemical Sterilant Processing System should be considered. Semi-critical devices should also be considered for sterilization per FDA guidance (see Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, FDA, March 17, 2015).
This is your decision, but STERIS would recommend per FDA guidance and ISO standards.
Each STERIS modality includes in its labeling a list of compatible materials. This list can be referenced for material compatibility and the information is located on this website in the Technical Data Monograph for each modality. However, if your organization requires additional compatibility data, STERIS may be able to perform this testing.
Yes, when your functional evaluations are completed for the tested devices and we receive your Manufacturer Evaluation Forms, STERIS will generate a report.
Devices should be shipped to:
Michele Ehrman (required, or package will be refused for security purposes)
STERIS
5960 Heisley Road
Mentor, OH 44060
Yes. Is the product sold in the US or expected to be?
Yes:
What is the Premarket Submission or PMA number?
What is the FDA product code?
What is the FDA regulation?
What is the FDA Establishment Registration Number?
In addition, the shipping container should be properly labeled identifying the manufacturer, product name and a reference to "Research & Investigating. Not for Sale in the USA." This reference should also be present on shipping documents.
The Medical Device Manufacturer is responsible for evaluating the device functionality. When the devices are returned to you, you will be asked to fill out the Manufacturer Evaluation Form indicating whether the device is or is not compatible with the modalities tested.
Yes, all devices will be returned to you after testing is complete.
This depends on a number of factors, including how many cycles you are requesting, the number of devices being sent in for testing, etc. Once all the information is received, STERIS can give you a general idea of how long the study will take.
A copy of the Instructions for Use (electronic preferred).
Inoculation sites for microbial efficacy testing, typically 1-3 clinically relevant sites (per FDA guidance and ISO standards). A pictorial representation is preferred.
These studies are performed at the expense of STERIS.
