Press Release

STEMart, a US-based provider of comprehensive services for all phases of medical device development, is pleased to announce that it offers Disinfection Validation Services for reusable medical devices. These services are designed to ensure that products meet FDA requirements for disinfection validation and patient safety.

Cleaning validation services must be performed on reusable instruments, trays, surgical kits, and similar items that have been used in patient care. Therefore, manufacturers of reusable medical devices must provide reprocessing instructions describing cleaning, disinfection and sterilization and prove that these procedures are effective.

Medical Device Disinfection Validation is used to verify the manufacturer's description of the disinfection steps to demonstrate the effectiveness of the microbicidal process. Disinfection validation studies should focus on "worst case" scenarios to show that end users can reliably disinfect devices when instructions are followed.

STEMart now offers Disinfection Validation Services for reusable medical devices to ensure customer products meet FDA's disinfection validation requirements and patient safety. The validation processes are in compliance with AAMI TIR12, ANSI/AAMI ST58, ISO 15883 series, ISO 17664, and FDA guidance documents. In addition to helping customers validate specific processes, STEMart also provides guidance on protocols for designing and manufacturing reusable devices.

STEMart now offers Disinfection Validation Services for reusable medical devices to ensure that customer products meet FDA requirements for disinfection validation and patient safety. These validation processes comply with AAMI TIR12, ANSI/AAMI ST58, ISO 15883 series, ISO 17664 and FDA guidance documents. In addition to helping customers validate specific processes, STEMart also provides guidance on protocols for designing and manufacturing reusable devices.

Disinfection employs physical or chemical methods to kill microorganisms, usually accomplished through chemical disinfectants or thermal disinfection. Validation of chemical disinfection is performed in a variety of ways to support high, intermediate and low level disinfection, depending on the required disinfection leverage. The level of disinfection is determined by the category of the device (critical, semi-critical, or non-critical). These validations require that the device be inoculated with bacteria and then immersed in a liquid chemical disinfectant solution. Finally, any remaining bacteria are extracted from the device and grown on plates in a manner similar to a bioburden test.

The other type of disinfection, thermal disinfection, utilizes hot water from 60°C to 95°C (140°F to 203°F). The level of thermal disinfection depends on the contact time and temperature.

If you are looking for professional disinfection validation services for your reusable medical devices, or would like to know more about STEMart's medical device development service, please visit https://www.ste-mart.com/.

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