Reusable Medical Device Testing

Reusable Medical Device Testing

Protheragen-ING Lab understands that reusable medical devices play a critical role in providing quality healthcare while ensuring patient safety. We specialize in providing comprehensive reusable medical device testing services to help medical device manufacturers and healthcare organizations ensure the reliability, effectiveness, and safety of their reusable devices.

Our experienced team of experts conducts thorough testing and validation procedures utilizing state-of-the-art equipment and following industry best practices. We work closely with medical device manufacturers and healthcare organizations to ensure compliance with regulatory requirements while maintaining the highest standards of quality and safety.

Fig.1 Reusable Medical Device Testing

The importance of reusable device testing

Reusable medical devices, such as surgical instruments, endoscopes, and anesthesia equipment, offer a cost-effective and environmentally friendly alternative to disposable devices. However, the complexity of these devices, coupled with the potential for biofilm formation and residual contamination, presents unique challenges in ensuring their safety and effectiveness.

Any malfunction or failure of a reusable medical device can have serious consequences. Testing and validation of these devices is critical to identify potential risks, ensure proper functioning, and minimize the potential for healthcare-associated infections. This is where our reusable medical device testing services come in.

How can Protheragen-ING Lab help you?

Our comprehensive reusable medical device testing consists of a series of critical tests to evaluate the safety, effectiveness, and performance of reusable medical devices. We take into account the unique characteristics and intended use of reusable medical devices and develop a test program specifically for your reusable medical device.

Items Details
Sterilization Validation This evaluates the ability of the sterilization process to eliminate or inactivate microorganisms on the surface of the device.
Cleaning Validation This test evaluates the effectiveness of the cleaning process in removing organic and inorganic residues from the surface of the device.
Sterilization and Drying Validation This test ensures that the sterilization process is effective in eliminating all live microorganisms and validates the drying process to prevent moisture-related problems.
Functional Testing This test evaluates the equipment to meet specified performance requirements after repeated reprocessing.
Life Cycle Testing It involves performing a simulated use cycle on the equipment to assess its safety, durability, reliability, and performance over its expected lifetime.
Human Factors Testing Testing: It evaluates the usability and user interface of the device to identify any potential usage errors and improve the user experience.
Biocompatibility Testing This test evaluates the interaction of the device with biological systems to ensure safe patient use.

Protheragen-ING Lab stays up-to-date with the latest regulations and standards to ensure that your testing procedures comply with the requirements set by the relevant organizations. Below is a list of the standards we test against including:

  • ISO 15883
  • ISO 11607
  • ISO 17664-1
  • AAMI ST77
  • AAMI ST79
  • AAMI ST98
  • AAMI TIR12
  • ASTM F3208
  • EN 285

Fig.2 Benefits of reusable medical device testing

Benefits of reusable medical device testing

  • Enhanced Patient Safety - Testing helps identify potential risks and ensures that the device is not contaminated, reducing the risk of healthcare-associated infections and adverse events.
  • Regulatory Compliance - Testing ensures that the device meets regulatory requirements and standards set by organizations such as ISO, ASTM, EN, and other relevant agencies.
  • Quality Assurance - By conducting rigorous testing, manufacturers and healthcare organizations can ensure the quality and reliability of their reusable devices, thereby enhancing their reputation and trust among healthcare providers and patients.
  • Cost Savings - Properly validated reusable devices help reduce the need for frequent device replacement, resulting in significant cost savings over time.

Let us be your partner in achieving the highest standards of quality and safety in reusable medical devices. Contact us today to discuss your specific testing needs.