Why should Medical Devices be tested

Medical Device Testing is a well established area of standards and scrutiny in order to ensure error free performance of these devices.

Medical Equipments make up for a very broad arena of products. It comprises many different testing instruments ranging from electrical safety to sophisticated diagnostic X-Ray meters. Medical Devices earlier have never been evaluated as rigorously as they are today. From a regulatory perspective, the ISO 10993 guidelines require assessment of the finished medical devices.

This requirement ensures the appropriate assessment of device biocompatibility, as there can be any number of factors that can alter the outcome of the device during use. Such factors can be chemical exposures, sterilization processes, various manual interactions, packaging, material degradation and other related factors. As the impact of these factors were better understood, the process of Medical Device Testing and data gained further significance.

All medical devices have a unique and thorough set of requirements for testing, which is enforced by many regulatory bodies that need to be fulfilled before the devices are released in the market. Medical Devices are also becoming smaller and more complex in design, mostly using advanced engineered plastics.

This makes the process of Medical Device Testing, their Validation and Verification even more important. Validation and Verification (V&V) is basically a device testing process — Validation ensures that the evidence the user needs and the intended use of the devices are met in actual medical conditions. This process usually involves tests, inspection and analysis. Verification typically confirms the objective evidence that specific requirements are met.

V&V covers all the phases of product development and many different techniques. It is very important to consider V&V in early design stage while developing the requirement specifications for the product. Clarity, conciseness, measurability, tolerances, accuracy and testability can all impact the final design and overall manufacturability. These are also the parameters that define the acceptance criteria for later V&V activities.

The shared goal of Medical Device Testing across the industry is to ensure that the devices are safe and effective for the intended users. For this several guidance documents have been updated and released in order to help improve device design and instructions to minimize errors and potential harm.

Conducting human factor studies play an integral role in Medical Device Testing and its operating instructions. Additionally, the application of these validation procedures help to save time, money and resources in the long run. Human Factors provide validity and value to medical device regulatory submissions. Results of evidence-based research help to better evaluate the safety, effectiveness and substantial equivalence in the medical devices that are prone to errors.

A human factor data is a valuable component in demonstrating safe and effective use of the medical devices and therefore should mandatorily be considered during product development, design and validation testing. Additionally, this data can be applied and evaluated for providing a more comprehensive premarket research.

Conclusion

Estimating the importance of quality and reliability of medical devices is very hard considering that the lives and well-being of the individuals are at stake. Testing and maintaining medical devices is as important as building life saving devices. Thus, having the right testing equipment is just as important as saving a life.

Michael works for Gallop Solutions, which is one of the North America’s largest Independent Software Testing companies operating since 2003 with offices in Philadelphia & California.