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.

Validating the efficacy of SOPs and IFUs for reusable medical devices.

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
  • Instructions for Use Consultation
  • Life Cycle Conditioning AAMI/ISO/IEC
  • Cleaning Validation ANSI/AAMI/ISO
  • Disinfection Validation ANSI/AAMI/ISO
  • Sterilization and Dry-Time Validation ANSI/AAMI/USP

Sample Needed

Sample quantity varies per study

Turn-Around Time

Approximate turnaround time is based upon study specific parameters.

Toxikon’s Expertise in Reusable Medical Device Reprocessing & Cleaning Validation

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. The diverse scientific capabilities within the department are leveraged appropriately to address each unique product requirement. Our experience and direct interaction with regulatory agencies have provided Toxikon a unique understanding of product development and regulatory needs.