Reusable Device Testing

What are reusable medical devices? 

Medical devices and equipment are widely used in clinical practice for surgical, therapeutic, diagnostic, supportive, and life-sustaining functions. 

They can be single-use or reusable depending on their design and intended use. 

Reusable medical devices are essential tools in healthcare settings, but their reuse requires precise cleaning and often microbicidal processes to prevent the spread of infection. 

These products can include complex, critical medical devices that come into contact with sterile areas of the body to simple, non-critical devices or equipment that only contact intact skin or have no patient contact and are operated by healthcare practitioners.

Regardless of the product’s complexity, criticality, or designation as single-use or reusable, it is important to ensure they are safe for both patient and health care practitioners by routinely processing them according to defined instructions for use (IFU).  

What is reusable medical device processing? 

Reusable medical device processing (previously known as reprocessing) can include cleaning, disinfection, or sterilization depending on the risks associated with the use of the device. 

The medical device or medical equipment manufacturer is required to provide specific and validated instructions to the end users to ensure processing between patient uses can be safely and effectively conducted in compliance with national and international standards. 

Examples of reusable medical devices include, but are not limited to:

• Instruments used for:
  • Orthopedic procedures
  • Dental procedures
  • Laparoscopic procedures
  • Cardiac procedures
  • ENT procedures
  • OB-GYN procedures
• Ultrasound probes
• Electrical and fiberoptic cables
• Medical equipment:
  • Screens and monitors
  • Light sources o Infusion pumps
  • Pulse-ox and glucose sensors 

What are the reusable device testing standards?

Below are examples of standards and ISO references that are followed during reusable device testing. 

STERIS complies with the following industry standards and guidance for reusable device testing:

• ISO 17664-1
• ISO 17664-2
• ANSI/AAMI ST98
• AAMI TIR12
• FDA guidance document: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff 

Why STERIS Applied Sterilization Technologies? 

STERIS AST supports manufacturers in the design, development, and validation testing of reusable medical devices, single-use devices (SUDs), and medical equipment along with developing the processing instructions presented in the product’s IFU. 

Our reusable device testing services include:

• Research and development (R&D) engineering
  • Product or material evaluation, or process evaluation
• Pilot evaluation
  • Evaluation of the proposed recommended cleaning, disinfection, and/or sterilization processes prior to validation
• Validation of recommended processing instructions
  • Cleaning processes
    • Manual
    • Automated
    • Manual and/or automated with sonication
• Disinfection processes (low-level, intermediate-level, and high-level)
  • Interim thermal disinfection
  • Terminal thermal or chemical disinfection
• Sterilization processes
  • Moist heat (steam)
  • Vaporous hydrogen peroxide (VHP® or VH2O2)
  • Dry heat
• Consultation and support
  • Device design for healthcare processing
  • Human factors considerations in healthcare processing
  • Healthcare processing expertise
  • Instructions for use development
  • Troubleshooting
  • Regulatory support
  • Risk analysis 

Recommended Resources: 

TechTalk: Reusable Medical Device Testing | Video | STERIS AST 

reuseable-device-testing.pdf

Reprocessing: The Top 7 Considerations in Reusable Device Design | TechTip | STERIS AST

Reusable Medical Device Cleaning Validation: Soiling Considerations | TechTip | STERIS AST