Cleaning reusable medical devices between uses is vital when it comes to stopping the spread of illness and infection. As such, having a qualified medical device cleaning validation company like HIGHPOWER to validate the manual or mechanical cleaning process ensures patient safety. HIGHPOWER’s test methodology for cleaning validation is based on methods outlined in AAMI TIR12, AAMI ST-98, and the FDA Guidance Document “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Reusable medical device cleaning standards require validation in order to assure proper and safe reprocessing of the devices by staff at health care facilities. A device which has not been cleaned properly prior to sterilization 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 validation testing program verifies that gross amounts of soil can be removed from the test device following the device’s recommended cleaning procedure. HIGHPOWER tests whether the cleaning process yields the required results under worst-case testing conditions.
The medical device cleaning validation testing objective is to verify the effectiveness of the manufacturer’s cleaning process as listed in the device’s instructions for use (IFU) and to validate that the cleaning process is reproducible. It’s important to know that every medical product has detailed and effective processes for cleaning. So, if no process has been documented for the device, HIGHPOWER staff will work directly with the client to develop and validate a cleaning process for their product so that the end users can confidently use the device for its intended purpose.
Cleaning analytes (protein, hemoglobin, TOC) that are utilized by HIGHPOWER during medical device cleaning validation studies have been accepted by the U.S. FDA and our bioburden test by the European Medical Device Directive. Our tests, methods, and protocols have seen a long line of success by many major entities in the medical industry.
We’re constantly adding new tests to meet our customer’s expectations. If you don’t see your required test listed, please contact us at clientservices@highpowervtls.com with your inquiry. We want to ensure that all our clients receive the support they need during product development.
Tests Available by Test Code:
| Test Code | Test Name |
|---|---|
| MAN-3LOG | Manual Cleaning Validation — 3 Log Reduction |
| MEC-3LOG | Mechanical Cleaning Validation — 3 Log Reduction |
| MAN-HEM | Manual Cleaning Validation — Hemoglobin Analyte |
| MAN-PRO | Manual Cleaning Validation — Protein Analyte |
| MAN-TOC | Manual Cleaning Validation — TOC Analyte |
| MEC-HEM | Mechanical Cleaning Validation — Hemoglobin Analyte |
| MEC-PRO | Mechanical Cleaning Validation — Protein Analyte |
| MEC-TOC | Mechanical Cleaning Validation — TOC Analyte |
| MAN-HEMO3 | Manual Cleaning Validation — Hemoglobin Analyte w/8 Repetitive Cycles |
| MAN-PRO3 | Manual Cleaning Validation — Protein Analyte w/8 Repetitive Cycles |
| MAN-TOC3 | Manual Cleaning Validation — TOC Analyte w/8 Repetitive Cycles |
| MEC-HEMO3 | Mechanical Cleaning Validation — Hemoglobin Analyte w/8 Repetitive Cycles |
| MEC-PRO3 | Mechanical Cleaning Validation — Protein Analyte w/8 Repetitive Cycles |
| MEC-TOC3 | Mechanical Cleaning Validation — TOC Analyte w/8 Repetitive Cycles |
| MAN-HEMO6 | Manual Cleaning Validation — Hemoglobin Analyte w/18 Repetitive Cycles |
| MAN-PRO6 | Manual Cleaning Validation — Protein Analyte w/18 Repetitive Cycles |
| MAN-TOC6 | Manual Cleaning Validation — TOC Analyte w/18 Repetitive Cycles |
| MEC-HEMO6 | Mechanical Cleaning Validation — Hemoglobin Analyte w/18 Repetitive Cycles |
| MEC-TOC6 | Mechanical Cleaning Validation — TOC Analyte w/18 Repetitive Cycles |
| MEC-PRO6 | Mechanical Cleaning Validation — Protein Analyte w/18 Repetitive Cycles |
| SIM-USE | Simulated Use Testing |
| IN-USE | In Use Testing |