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

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

Medical device disinfection validation is used to verify the manufacturer’s description of the disinfection steps and demonstrate the effectiveness of the microbicidal process. Disinfection validation studies should focus on “worst case” scenarios to demonstrate that end users can reliably disinfect devices if instructions are followed.

STEMart now offers disinfection validation services for reusable medical devices to ensure customers’ products meet FDA disinfection validation and patient safety requirements. Validation processes conform to 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 customer products meet FDA requirements for disinfection validation and patient safety. These validation processes conform to 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 uses physical or chemical methods to…