Medical device quality assurance is a complex, scientific process that is critical to modern medical product development and medicine.
Consider this your primer on the state of contemporary medical device quality assurance. Here, you can learn what it is, why it’s important, how it works, what kind of problems it can solve, and how you can get in touch with medical device QA professionals today.
What is Medical Device Quality Assurance?
Medical device quality assurance is the scientific process of making sure that a medical device product can perform its intended use effectively without breaking down or becoming contaminated in the process. All medical devices need to be thoroughly and scientifically tested before medical professionals can legally or safely use them in their practices.
Why is it important?
The most obvious reason medical device QA is important is also the most relevant: it can be a matter of life and death. If a medical device malfunctions or fails to perform during an important medical procedure such as surgery, the consequences for the patient could be life-threatening. This is exactly why the medical community imposes such strict standards and regulations on any manufacturers creating devices intended for medical use.
Another reason why medical device QA has become as important as it is today is because of how much can go wrong with today’s devices. Many modern medical devices are extremely complex and delicate instruments. Even the most minute of contaminations could drastically affect such an instrument’s performance.
These contaminants could also come from nearly anywhere – from the components used to create the actual device, to the treatments and coatings applied to different surfaces of the device, to the packaging materials used to store and transport them, or even from the environment in which they’re stored and used.
Consequently, professionals must perform a wide variety of different types of quality assurance tests on different medical devices. This has made medical device QA a highly varied and complicated analytical industry.
What are Medical Device Quality Assurance Procedures Used For?
Medical device QA is the process of using scientific analytical material testing to identify possible problems with medical devices and solve those problems.
QA professionals evaluate medical devices to determine whether or not they’re going to perform their jobs to a very high standard of quality. If their tests reveal that the device does not reach the required level of quality, they will conduct further tests to figure out why.
These professionals will then report their findings back to the medical device manufacturer, often along with informed recommendations on how to prevent the problems they discovered. For example, if medical device analysts discover that a certain contaminant is entering the medical device during the manufacturing process, they might suggest how that process could be altered to prevent contamination in the future.
A few of the most common applications for medical device quality assurance include:
- Quality control testing: confirming if a medical device will perform according to the necessary requirements for the necessary period of use.
- Cleanliness testing: confirming if medical devices are clean and free of any possible microcontaminants.
- Materials testing: evaluating how different materials may affect medical device performance, including whether they may introduce contamination or lead to product failure.
- Materials characterization: evaluating what materials were used to manufacture a medical device and how each of those materials may be affecting its intended performance.
- Failure analysis and troubleshooting: determining the reason why a medical device has failed and identifying the cause of failure, such as an electrical short or similar malfunction.
- Outgassing testing: testing how a medical device will respond to different intensities and durations of heat exposure to ensure it won’t emit volatile chemicals when used or stored.
How Does Medical Device Quality Assurance Work?
The quality assurance applications outlined above require several different types of scientific testing procedures. Depending on the device in question and what the manufacturer or user wants to test about it, professional quality assurance testers like the experts at Innovatech may utilize any of the following methods to find out what they need to know.
Ion Chromatography (IC)
Ion Chromatography can identify and find the source of ionic contaminants by separating the cations and anions out of a sample solution. In medical device QA it is primarily used on electronic devices, especially those intended for human implantation such as pacemakers. Using IC can help manufacturers remove ionic contaminants from these devices that might otherwise cause infection.
Fourier Transform Infrared Spectroscopy (FTIR)
Fourier Transform Infrared Spectroscopy is used to identify and characterize organic (and some inorganic) contaminants that may cause malfunction when they interact with a sensitive medical device. In medical device QA it is often the first step in a materials testing process because of how quickly it can identify a wide variety of substances. It can also be used to characterize any films left behind on the surface of medical devices.
Electron Spectroscopy for Chemical Analysis (ESCA)
Electron Spectroscopy for Chemical Analysis, also known as X-Ray Photoelectron Spectroscopy (XPS Analysis) is a surface analysis technique that provides information about the elemental and binding energy of a material’s surface and interfaces. In medical device QA it’s used to study the surface chemistry of insulating materials, evaluate passivation layers, and solve potential issues with how different metals or metals and resins used in the manufacturing process are interacting with each other.
Auger Electron Spectroscopy Testing & Analysis (AES)
Auger Electron Spectroscopy Testing & Analysis is a surface analysis technique that helps medical device manufacturers understand more about the surfaces and interfaces of their products. In medical device quality assurance, it’s used to analyze and identify possible contaminants and measure passivation layers on device’s stents, wires, titanium electrodes, and other components.
How Can I Get Professional Medical Device Quality Assurance?
If you need expert medical device quality assurance help, you can get in touch with the experts at Innovatech right away. We can identify the procedures you need and perform them in-house quickly and professionally.
Leave a Reply