Many people use medical devices every day. Some are routine devices to help us manage issues like glucose monitors or blood pressure cuffs. Others are needed in an emergency to keep a person alive such as oxygen machines and defibrillators. Whatever device you use must be trusted to operate effectively every time you pick it up.
When a person’s life is on the line, the quality of the product is everything. If the machine gets turned on and the battery fails or a wire shorts out, it could be bad for the person waiting on medical attention. That is why medical device manufacturers need a test and measurement system.
What Is Medical Device Testing?
Testing a medical device means demonstrating that it is safe to use, will perform as designed, and will be reliable. Since medical devices are necessary to the life of the people who use them, this testing begins at the design phase and goes through many iterations before the final product is shipped.
Testing can include ensuring the final product operates as designed. If you have a pacemaker keeping your heartbeat regulated, you want to find out early enough that it has stopped working. Manufacturers test for those issues.
If you have a device implanted in your body, you would not want to discover the plastic they used to build it had a toxic chemical. That is why manufacturers do a chemical analysis on all products before manufacturing them.
In the design phase, engineers look at how the device is shaped, where the controls are, and the human factor. They make a mock-up and hold it. They try to manipulate it and see how easily they can use it. Functionality, dimensional checks, and even package design are accounted for in testing.
Why Devices Should Be Tested
Manufacturers of any product have to be able to stand behind the things they sell. They can only make claims about its effectiveness by certified testing. That is especially true with something as vital as medical equipment.
Regulations
The FDA and ISO put their stamp of approval on a lot of devices. They certify the testing is complete and that the manufacturer follows all of their testing procedures. Testing equipment is calibrated regularly by certified professionals.
Devices that do not follow the guidelines set by these regulatory bodies will be heavily penalized. Manufacturers who try to get around the issue will likely never see the device on the market. It could be detrimental to their entire company.
Auditing
The FDA conducts an audit of most facilities every 12 months. That ensures all devices are tested per the standard put out by that company. They also check the calibration logs on the machines used to build and test them.
Suppose a company had testing records for a product, but the machine used to test them was not calibrated in over a year. The quality of that device would be questioned. Using the test system properly will ensure that all the products coming off the line are equally effective as the ones in front of it.
Patient Safety
The biggest reason to do regular testing on medical devices as they are manufactured is the safety of the people using them. An oxygen pump that stops working after several hours of use could risk a patient’s life. Most medical device manufacturers are in the business of making these kinds of products. They do not want a reputation for not taking patient safety seriously.
Medical Device Test Classes
Manufacturers are responsible for the test and measures of their medical devices. They test the device design, the controls and ease of use, effectivity, and what influence it has on a patient’s life. Determining the type of test needed depends on the risk level of each product.
Low Risk
Class 1 devices like gloves and wheelchairs are considered low risk. The FDA says these devices are not used in sustaining life. There is not much potential for injury in using them. Most approved medical devices available on the market are low risk. They have few regulations they must adhere to.
Gloves are personal protective equipment (PPE). They are used to protect someone from coming into content with pathogens. They are not a piece of life-saving equipment with dire consequences if they fail. The same goes for wheelchairs and other support items like walkers and canes. They help a person move, are designed simply, and their importance is not life or death.
Medium Risk
Class 2 devices are medium risk. They are slightly more complicated than low-risk products and require stricter controls to test them. That will give the proper assurance that they are effective and safe. Some necessary regulations for these devices are special labeling, registering patients, and post-market surveillance.
Devices that fall in the medium-risk category are pregnancy tests, powered wheelchairs, x-ray machines, and ultrasound equipment.
High Risk
The most stringent controls are placed on devices that fall under class 3. These are considered high-risk devices and usually include things used to make life-saving efforts or items implanted in the body. Examples might be insulin injectors, pacemakers, balloon catheters, and breast implants. These devices usually require clinical trials and premarket approval before they go on the market. Only about 10 percent of medical devices fall into this category.
What Medical Devices Are Tested For
Several levels of testing are completed depending on the risk factor of the device. Some of these begin in the design phase. But testing continues until the final product is packaged and ready for shipment.
Documentation Information
Every device or product made in the medical field must have the certification that all the documents meet all requirements. That means checking to be sure the documents that describe the components and instructions meet all of the ISO requirements. Companies also have to be sure they have everything they need to submit the device for regulatory approval. Otherwise, company standards were not followed as they should be.
Chemical Impurities
There have been lawsuits over implantable devices years after they were on the market and used to treat patients. These implants were found to have had a chemical impurity in the material they were made from that eventually made the patient sick.
One of the things that devices are tested for is elemental impurities that could have an unknown effect on the human body. This protects the patients from a potential illness later that could be debilitating or fatal. It also protects the company from being liable in those cases years down the road.
Setup
The setup of the device is tested throughout the manufacturing process. Personnel will repeatedly set up the device for use with various components to ensure it can be assembled quickly and easily. Some devices are moved routinely by nurses and doctors and need to be able to be brought up and functioning.
Test and Measure
Finally, the final product is tested for failure at the end of the manufacturing process. Samples should be taken frequently, and every conceivable situation tested for. When a healthcare worker or caregiver needs to use a device to save a life, they do not want to find out the device does not work.
Practicing Test and Measurement Procedures
To run a test and measurement system effectively, you must be proactive in your approach. Know your company’s procedures for all of the big-ticket items you make. Look at the most produced items and learn their requirements as best as you can. Once you know what is expected of you, testing and measurement will become easier.
Keep Devices Calibrated
Use the same equipment to do as much testing as you can. Keep those devices calibrated to ensure you get the same results as someone in another facility.
Use the Same Tools
If your company creates a lot of the same family of products, test as much of it with the same set of tools as possible. That will lower the risk of a tool problem being the reason a test failed. If more than one person is conducting tests, work on separate portions of the test instead of different parts so that you can continue using the same tool.
Continuous Sampling
The more samples you select for testing, the better your results will be. If a client orders thousands, they should not be getting the product tested only as many times as a client that ordered a hundred. It will make it much more likely to find malfunctions and protect patients.
Conclusion
Groups like the FDA and ISO are tasked with the standards companies use to create their testing procedures. However, it is the manufacturer’s responsibility to follow those standards to ensure the quality of their product. As a person tasked with those tests, your job responsibilities could ultimately approve a medical device later used to save a life. Your diligence is a big responsibility and should not be taken lightly.
SystemLink Software can help you manage your test and measurement system workflows. Contact us today and let us help you save time and achieve better outcomes.