Reprocessing Validations for Single-Use and Reusable Medical Devices

Why Companies Choose NAMSA

100K +

Medical Device Tests Run Annually

13

DABT Toxicologists on Staff

1967

Year NAMSA Started Testing Medical Devices

125+

Validation Projects Performed Annually

Deep Expertise in Medical Device Testing

Effectively reprocessing single-use and reusable medical devices is a vital component of preventing patient infections and ensuring patient safety. It is the manufacturer – not the care provider – that is responsible for providing complete and comprehensive written instructions for the reprocessing of their device(s). This requires the scientific validation of the cleaning, disinfection, and/or sterilization reprocessing methods used for their device, to ensure it can be used/reused in the way it is intended.

How We Conduct Reprocessing Method Validations on Single-Use and Reusable Devices

Reprocessing validations are intended to determine the efficacy of specific reprocessing procedures (e.g., cleaning, disinfection, and sterilization). Our team of experts can help define what reprocessing validations are required and readily available to the user (e.g., manual vs. automated methods, cleaning and disinfecting agents, and sterilization mode–such as steam, EO, Hydrogen Peroxide, etc.). Validations are executed using client-approved protocols designed to meet regulatory requirements for sample size, validation cycle parameters, challenge sites, and acceptance criteria.  All testing is conducted according to NAMSA’s Internal Quality System and Standard Operating Procedures (SOPs) which are based on Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) regulations.

NAMSA Offers a Full Range of Services to Support Reprocessing:

  • Manual and automated cleaning validations
  • Chemical and thermal disinfection validations
  • Sterilization validations
  • Rinsing validations
  • EO residual testing
  • Protein, Total Organic Carbon (TOC) and hemoglobin analyte (marker) testing
  • Consultation and regulatory support

Cleaning Process Validations

The first step in reprocessing any clinically used reusable device is cleaning.  Cleaning is performed to remove contaminants (human secretions), substances (lubricants and processing fluids) and procedure chemicals to ensure any further processing such as disinfection and sterilization can be performed effectively.  NAMSA supports manual and automated reusable cleaning validations for non-critical, semi-critical and critical devices, which may include:

  • Simulated use cycling
  • Extraction test method validations
  • Manual and automated cleaning
  • Visual inspection
  • Quantitative marker analysis using validated assays for protein, total organic carbon (TOC) and hemoglobin markers
  • Rinsing validations

Cleaning validations for single use devices are performed to ensure medical devices in their delivered state are clean and pose no risk to the patient.  Cleaning is performed to remove manufacturing contaminants from the device.  Cleaning validations for single use devices may include:

  • Visual inspection
  • Bioburden testing
  • LAL testing (bacterial endotoxins)
  • Organic contaminant analysis
  • Inorganic contaminants analysis
  • Particulate analysis
  • Cytotoxicity testing

Disinfection Process Validations

Disinfection is a process that kills pathogenic and other microorganisms by physical or chemical means. It may be used as an interim reprocessing step for reusable devices, following cleaning and prior to sterilization, to render the device safe for handling by processing personnel. Disinfection may also be used as the terminal process used to render single-use and reusable devices ready for patient use. NAMSA is supports all levels of disinfection validations for single-use and reusable devices which may include:

  • Test organism recovery validations
  • Neutralization validations
  • Chemical or thermal disinfection (Ao)
  • Log 10 reduction analysis
  • Rinsing validations

Sterilization Process Validations

Single-use and reusable medical devices, that are intended to be used sterile, require a validated sterilization process that attains a  specified sterility assurance level (SAL).  The devices may require sterilization by the user in a home or hospital setting or the devices may be sterilized in an industrial setting, prior to receipt by the user.

Sterilizing agents commonly used in hospital settings, for the sterilization of devices intended for first use or reuse, include moist heat (steam), ethylene oxide (EO) gas, hydrogen peroxide gas plasma and liquid chemicals.  NAMSA supports the following testing on site for sterilization performed in hospital settings:

  • Gravity air displacement and prevacuum air removal steam sterilization
  • Chemical sterilization
  • EO residual analysis
  • Rinsing validations

NAMSA supports industrial sterilization validations including Ethylene Oxide (EO) sterilization and gamma radiation (gamma, electron beam, and X-rays). NAMSA works directly with your sterilizer to prepare validation protocols and reports while our labs support the following testing:

  • Sterility Testing
  • Biological Indicator Tests of Sterility
  • Bioburden Testing
  • Population Verifications
  • Bacteriostasis/Fungistasis
  • Extraction Recovery Validations
  • Neutralization Validations
  • EO Residuals

Subject Matter Expert and Compliance Consulting Support

NAMSA experts have the experience and knowledge to guide device manufacturers from the device design phase through reprocessing validation support, including identifying design constraints that may negatively impact cleaning, disinfection and/or sterilization, developing or refining Instructions for Use (IFU) and preparing reprocessing validation protocols and summary reports.

Validation protocols not only outline test methods and acceptance criteria recognized by regulatory agencies but also include rationales supporting sample size, method validations (e.g., marker or challenge organism recovery), sample conditioning, soil/ test organism selection and reprocessing parameters.  We can help you:

  • Define the minimum reprocessing required for a medical device based on intended use
  • Develop or refine your IFU to meet regulatory requirements
  • Design a robust cleaning process for complex devices
  • Reprocessing Validation Protocols and Reports for Hospital and In-Home Settings
  • Industrial sterilization protocols and reports (EO and radiation)
  • Life-cycle studies
  • Master product and product family assessments
  • Process and product adoption assessments

No Shortcuts = No Surprises

NAMSA follows all applicable standards and guidance documents including FDA reprocessing guidance, ISO 17664 series, AAMI TIR 12, AAMI ST98, ANSI/AAMI ST58, ANSI/AAMI ST79, ISO 11135, AAMI ST77, ISO 17665

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Meet Our Sterilization and Validation Experts

Meet the scientists and testing specialists ready to put their expertise to work for you.

Meet Our Full Team
  • Ed Arscott, BS

    Principal Strategy Consultant, Microbiology
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  • Staci L. DeMoss, BS

    Principal Validation Scientist
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  • Marie-Eve Cluzel-Valentin

    Principal Biological Safety and Validation Scientist
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  • Shelley L. Green, BS

    Senior Validation Scientist
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  • Julie S. Tuinstra

    Validation Scientist
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