By clicking “Accept All Cookies”, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. View our Privacy Policy for more information.
4 minutes

Ensuring Patient Safety: Leak Detection for Medical Devices

Published on
January 14, 2024

Medical devices play a vital role in modern healthcare, supporting diagnosis, treatment, and monitoring of various conditions. Their safety and efficacy are paramount, and leaks can compromise both. Medical device packaging testing is an essential practice that helps identify leaks and other defects, safeguarding patient well-being.

Why is Medical Device Packaging Testing Important?

  • Patient Safety: Leaks can cause malfunctions, device failures, or even harm patients. Leak detection minimizes these risks.
  • Regulatory Compliance: Leak testing is mandatory in many countries, ensuring medical devices meet industry standards and regulations.
  • Quality Assurance: Testing is crucial for identifying defects and maintaining quality.
  • Cost Savings: Early leak detection reduces reworks and recalls, saving money.
  • Brand Reputation: Leaks can harm patients and damage a manufacturer's reputation. Leak testing enhances trust in your devices.

The Benefits of Non-Destructive Testing

Medical device testing can be destructive or non-destructive. Non-destructive methods are preferred because they allow you to assess quality and integrity without damaging the device. This is advantageous for several reasons:

  • Safety: Devices remain usable after testing.
  • Cost-Effectiveness: No need to replace destroyed devices.
  • Efficiency: Faster testing process.
  • Accessibility: Wider range of devices can be tested.
  • Compliance: Meets regulatory requirements for non-destructive testing.

Oxipack Leak Testers for Medical Devices

We offer various non-destructive leak testers for different types of medical device packaging:

  • Stationary Leak Tester: Ideal for flexible packaging like catheter packaging or infusion bags. This tester uses the vacuum decay method (ASTM F2338) to detect leaks.
  • Stationary Leak Tester XS or M: Designed for rigid packaging like trays or other hard plastic containers. A custom-made insert ensures accurate testing using the vacuum decay method.
  • Vacuum Leak Tester: Used for vacuum-sealed pouches, bags, and containers. Different methods are employed depending on the specific packaging type.
  • The Rotator: This automated system can test up to 120 flexible packages per minute, ideal for high-volume production lines.

Medical device packaging testing is a critical step in ensuring patient safety, regulatory compliance, and product quality. Our non-destructive leak detection solutions protect patients, save costs, and build trust in your medical devices. Contact us today to discuss the best leak testing solution for your specific needs.

Share this post