Reusable Medical Device Reprocessing & Cleaning Validation

Reusable Medical Devices require validation testing to confirm the procedures used to clean, disinfect, and/or sterilize a device between patients are effective. Medical devices in this category must have adequate labeling and directions for use (21 CFR Part 801) related to the Instructions for Use (IFU) and reprocessing. These studies apply worst-case challenge conditions and are required to ensure a reusable device is appropriately prepared in order to minimize infection risk to subsequent patients. 

 

Testing Capabilities

  • Instructions for Use consultation
  • Lifecycle conditioning
  • Cleaning validations
  • Disinfection validations
  • Sterilization with dry-time validations. 

 

Standards

  • AAMI
  • ANSI
  • ASTM
  • FDA
  • ICH
  • ISO
  • JP
  • USP

 

Testing Categories and Specifications

Test Name

Sample Needed

Turn-Around Time

Instructions for Use Consultation
Sample quantity varies per study
Approximate turnaround time is based upon study specific parameters.
Life Cycle Conditioning AAMI/ISO/IEC
Cleaning Validation ANSI/AAMI/ISO
Disinfection Validation ANSI/AAMI/ISO
Sterilization and Dry-Time Validation ANSI/AAMI/USP

 

Toxikon Expertise in Reusable Medical Device Reprocessing & Cleaning Validation

The diverse scientific capabilities within the department are leveraged appropriately to address each unique product requirement. With the emergence of complex devices, such as combination products, our team has become recognized by the industry as a valuable resource in developing early stage screening studies to final product verification and validation studies. Our experience and direct interaction with regulatory agencies have provided Toxikon a unique understanding of product development and regulatory needs.

 

Reusable Medical Device Reprocessing & Cleaning Validation
Reusable Medical Device Reprocessing, Cleaning Validation, Reusable Medical Devices, RMD, AAMI, ANSI, ASTM, FDA, ICH, ISO, JP, USP, Sterilization, Disinfection validations, Lifecycle conditioning, 21 CFR Part 801
Reusable Medical Devices require validation testing to confirm the procedures used to clean, disinfect, and/or sterilize a device between patients are effective. Contact Toxikon for Reusable Medical Device Reprocessing & Cleaning Validation processes.