Figure shows a hand with a purple glove on sanitizing a surface
Device must be able to be sanitized
| Requirement | Specification | |
5 | Device must be sanitizable. | Use EPA approved disinfectants (Regulation No. 34810-37-5813)Isopropyl alcohol (70– 90%) |
| Justification | Non-critical medical device is expected to come into contact with patients’ urine.1 | FDA recommends thorough cleaning and low level disinfection 2 with EPA-registered disinfectants. |
Verification: Swab test for cleaning validation.
Example of EPA disinfectants:
- EPA-registered disinfectants: Clorox-Plant Based Disinfecting Wipes (Regulation No. 34810-37-5813).
- Ethyl or isopropyl alcohol (70– 90%).
References:
[1] GUIDANCE, D. Draft Guidance for Industry and FDA Staff Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.
[2] Rutala, W. A., & Weber, D. J. (2008). Guideline for disinfection and sterilization in healthcare facilities, 2008