To meet customer demands and an ever-changing FDA climate, HIGHPOWER has expanded our device cleaning program. We now have three (3) full size mechanical washer disinfectors and a state of the art “Sonic Irrigator.” HIGHPOWER also continues to add additional markers to meet the FDA’s new device cleaning requirements.
HIGHPOWER’s test methodology is based on methods outlined in AAMI TIR30. Cleaning instructions for reusable medical devices require validation in order to assure proper and safe reprocessing of the devices by health care facilities. A device which has not been cleaned properly may inhibit the ability of the sterilization process to achieve the proper sterility assurance level.
Device cleaning procedures must be able to remove gross amounts of soil from the device in order for it to be determined clean and safe for further processing. HIGHPOWER’s device cleaning program verifies that gross amounts of soil can be removed from the test device following the recommended cleaning procedure.
The test objective is to verify the effectiveness of the manufacturers cleaning process as listed in the devices instructions for use (IFU) and to validate that the cleaning process is reproducible. If no process has been documented, HIGHPOWER’s staff will work to develop and validate a cleaning process for the device.
Cleaning markers (protein, hemoglobin, TOC etc.) that are utilized by HIGHPOWER during studies are accepted by the U.S. FDA and our bioburden test by the European Medical Device Directive.
Let HIGHPOWER validate your reusable devices cleaning label claims, whether manual, mechanical or both. With 25 years’ experience, our dedicated staff will use proven cleaning protocols to help get your product to market faster and with less FDA red tape.
- Manual TIR 12-3 Log Reduction (Bioburden)
- Mechanical TIR 12-3 Log Reduction (Bioburden)
- Manual TIR 30 – Protein
- Mechanical TIR 30 – Protein
- Manual TIR 30 – TOC
- Mechanical TIR 30 – TOC
- Manual TIR 30 – – Hemoglobin
- Mechanical TIR 30 – Hemoglobin
- Mechanical Washer Repetitive Cleaning
- Manual Wash Repetitive Cleaning
If you don’t see your required cleaning test listed, please contact us at firstname.lastname@example.org with your inquiry.