The time spent testing and measuring a medical device is invaluable, and doing so ineffectively can undermine the quality and safety of your device.
Engineers must calibrate test equipment and ensure that it functions correctly, and they must follow specific steps to do so. Manufacturers must also follow specific regulations. It may seem quite a process, but the benefits are well worth the invested time and effort.
Testing a medical device is more than just a box to check off during production. It is a crucial step for several reasons, including those discussed below.
Safety of Patients
You wouldn’t want to use a pacemaker that glitches or an x-ray machine that delivers a lethal dose of radiation.
When it comes to medical devices, there is little room for mistakes. Engineers of medical devices must be certain that no surprises will arise because the consequences could be fatal.
The most important reason to effectively test and measure data on medical devices is to ensure the safety of the patients.
Regulations
Regulatory bodies, such as the FDA and ISO, must approve medical devices for use. Regulations for safety and quality that devices must be met so manufacturers can distribute a product.
Approval is non-negotiable. There are serious penalties for those who haven’t received approval, and those who continue to defy regulations may never see their device reach their intended clientele.
Audits
Audits are always possible, and devices that must comply with the FDA are audited at least every 12 months. Manufacturers who do not test their devices may face unforeseen difficulties.
For example, it would be nearly impossible to know that a device will malfunction after eight months of use if the engineers tested it only once or twice in the development process. Proper use of a test system assures that products will continue to function effectively even after audits occur.
Steps of Testing and Measuring Medical Devices
There are three classes of medical devices, associated with the device, health safety measurement controls, effectiveness of the device, and influence on the patient’s health. These include:
- Class 1: Low Risk (e.g. gloves and wheelchairs)
- Class 2: Medium Risk (e.g. pregnancy test kits and blood transfusion kits)
- Class 3: High Risk (e.g. suture needles and personal insulin injectors)
Portions of the test system may need to be adjusted, based on the class of the medical device under observation. The basic steps include:
- Quality Standards of Your Medical Device
- Document Information
- Set-Up
- Test and Measure
- Clinical Investigations on Medical Device
Best Practices
How can you run effective test and measurement procedures?
- Standardize your devices. Identical devices will all meet quality systems requirements, and you know that the tested device will react the same as those on the market.
- Use identical tools throughout the testing process. Keeping your tools the same will lower the cost of training employees and allow them to work on different steps rather than being confined to just one.
- Ensure that your outsourcing team and clients can communicate, if applicable.
- Test your samples continuously and repeatedly. Use test and measurement equipment to detect and report malfunctions and thus lower the risk to patients.
- Plot your test data 1,000 times every second. This will allow you to see when and how any failures occur.
Final Thoughts
Regulatory bodies play a huge role in developing and testing medical devices. However, manufacturers are responsible for ensuring the performance and safety of medical devices.
When testing a medical device, keep in mind that it could be the one thing that saves someone’s life. If you have the opportunity to make a difference that big, you can’t waste it.
