Science & Technology

Improved safety standards for bionic devices

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Applied physicists at the University of Sydney are proposing new standards for measuring water leakage to bioengineering devices such as pacemakers, cochlear implants, and retinal replacements.

Researchers funded by an industry partnership through the Australian Research Council to carry out the study, the new moisture standards may give bioengineered implant wearers more confidence in the operation of life-changing devices. It states that there is. They also state that the improved moisture testing regime can be used in emerging renewable energy industries where new-generation solar cells require high levels of humidity control.

Bionic implants need to function properly in the moist environment of the human body. The potential for large leaks to the device can be easily detected during manufacturing, but small leaks can escape detection and require standard testing to ensure safety and prevent moisture failure.

Professor David McKenzie of the University of Sydney’s Department of Physics said: Accurate measurement Suppressing water penetration into medical devices is essential to ensure long-term performance. Accurate measurements require accurate industry standards for assessing leak risk. “

He said there are commercial systems for measuring relative humidity, but these are not sensitive enough for the most demanding applications of implantable biomedical devices. Using mass spectrometry technology to measure helium as a substitute for moisture leaks is the de facto industry standard test for serious small leaks that are difficult to pick up.

In fact, and most of the time Bionic device Is a good standard, but we believe that by improving compliance by a factor of 10, the industry can further guarantee the safety of biomedical implants, “says Professor Mackenzie.

“Helium leak detection tests are widely used in more sensitive leak locations, but direct measurement of gas or liquid leaks at similar sensitivities has proven to be difficult.” He said.

Professor Mackenzie and colleagues at the Australian Government’s National Institute of Measurements have shown how to develop a standard leak test and use it to verify the quality of encapsulation and the containment of medical devices.

They presented their work to the American Chemical Society Applied Materials & Interfaces..

Dr. Wenwenley, lead author of the National Institute of Measurements, said: “If the sensitivity is very high, it is important to measure the risk of water leakage directly, not the de facto measurement of helium.

“Water has a special ability to penetrate very small spaces, given its different behavior. For example, with carbon nanotubes, where water does not appear to touch the sides of small passages, water is very strange. It was recently discovered that it works in a way that is much wider than one millionth of human hair. “

Professor Mackenzie said: “Such a’nano leak’is very serious when it occurs in medical devices, especially medical devices with many feedthrough openings such as bionic eyes. “

The new standard moisture leak opens up new horizons by studying the behavior of water in stable polymeric materials. Using the new test, researchers directly compared water leaks and helium leaks in biomedical test structures. They found that in most cases, calibrated measurements of moisture leakage rates exceeded helium leakage rates, especially for very small and large leaks.

Given their discoveries water it can leak At up to 10 times the rate of helium leaks, they propose to strengthen compliance standards helium Biomedical equipment tests are 10x, or 1 digit.

“As we improve bionic technology, wearable implants become more common, so it’s important to give people that extra level of security,” said Professor Mackenzie.

Researchers develop better ways to detect groundwater leaks

For more information:
Wenwen Lei et al, Quantification of Moisture Permeation of Encapsulated Devices by Heavy Water Mass Spectrometry: Standard Moisture Leakage Using Poly (Ether-Ether-Ketone), ACS Applied Materials & Interfaces (2021). DOI: 10.1021 / acsami.0c23115

Quote: Https: // Improved safety standards for bionic devices acquired on March 29, 2021 (2021, March 29). Day)

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