The end of life (EoL) or PC life cycle is an important topic in the medical device manufacturing world. A PC life cycle can be defined as a cycle that describes the usefulness of a desktop or laptop computer to an agency, from its initial acquisition through its ultimate disposal—a fitting definition. Cybernet’s entire line of medical computers have a 3-5 year life cycle that’s determined by evaluating several factors—longevity of all computer components, intent of each computer, average use time, environmental factors, software that’s to be used, and other reasons. Sometimes, however, medical computers go through revision changes that can signify an end of life, and the process from revision change back to full certification is highly involved! The revision process to certify a medical computer just to control a specific medical device can be a complicated thing, especially if the two devices don’t communicate well. Here are some ways that the end of life cycles affect medical device manufacturers and the processes that happen behind the scenes.
End of Life Cycles Means Customers Must Review Changes
End of Life for certain components in a system doesn’t mean just replacing said components; it takes time to review what changes were made, suggest implications for impact, and go through a process called design verification for both hardware and software. All settings, drivers, and applications need adjustment to fit the new drive images. The devices must be rigorously tested together, bugs must be addressed both on a software and hardware level, and then the results must be sent to the FDA to ensure an entirely seamless validation. All documentation (the device master record, drawings, etc.) that is associated with the hardware in question must be updated too. Verification and validation are two intense procedures—validation is defined per Wikipedia as the assurance that a product, service, or system meets the needs of the customer and other identified stakeholders. Verification is defined as the evaluation of whether or not a product, service, or system complies with a regulation, requirement, specification, or imposed condition. These are at the heart of design verification, just one component of the entire implementation from A to Z. That doesn’t even factor in signatures and approvals from medical device executives and FDA individuals. These processes are highly involved and can take anywhere from several weeks to several months for implementation depending on the severity of changes—even a small revision to a tiny component! It’s clear that these steps are under heavy scrutiny and take careful thought to move through. The goal is to ensure hospital satisfaction and patient safety in all these steps, which leads to…
End of Life Cycles Mean More Certifications Are Coming
FDA approvals alone are difficult to achieve since all of our medical computers must be rigorously tested with the medical devices in question. Any revisions or changes to a medical computer must be resubmitted for certification in order to work with medical devices again. Imagine the implications of having an untested medical computer on an x-ray machine! Even a pair of similar computers don’t have the same electromagnetic compatibility (or EMC), so switching computers on a medical device isn’t very simple. Introducing an untested medical computer to a medical device could cause it to malfunction, necessitating months and perhaps years of testing before certifications. That doesn’t even consider global certifications, as every locale where our medical grade computers may be used could have vastly different requirements. Different certifications can cost more time, resources, and money, sometimes in the range of hundreds of thousands of dollars.
What that Means for The Operator and Patient
The FDA categorizes medical devices into three classes of risk, the third class being the highest risk—pacemakers, for example. Patient and operator lives are at risk when working with class 3 medical devices, but those cannot be put to market without full verification and validation. The FDA requires full V&V for Cybernet’s medical computers to function with class 3 medical devices, a process that is ensured through rigorous testing, retesting, and approval. Patient and operator safety is in good hands when a medical computer’s end of life is in question—every computer out of our warehouse that interfaces with a medical device isn’t just some assemblage of parts that works with machines. They are fully-approved and certified medical computers designed from the ground up for patient and operator safety. Yes, it takes time and money for our customers to use these computers with their medical devices. That’s just proof that we are second to none in this amazing industry.