Tag Archives: medical device manufacturers

Medical Device End of Life Cycle

3 Reasons Why End of Life Matters for Medical Equipment Manufacturers

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.

 

For Medical Device Manufacturers, Compliance Can Hinge on your Technology Partner

There are constant revisions to compliance in the medical field; Wikipedia cites that the FDA recently released several regulations to medical devices and how they handle sensitive patient data. Cleanliness, compatibility, safety, and cyber-security standards are ever-changing. It can be maddening to stay aware of all regulations to FDA compliance, which is why medical device manufacturers should be wise in selecting who they pair with when it comes to technology. The wrong machinery in the hospital can cost time, money, or worse—lives. That’s why it’s crucial to find the proper hardware to support medical devices—such as medical grade computers that meet or exceed the required standards. Here’s a rundown of the standards in question most pertinent to Cybernet.

International Electrotechnical Commission Standard 60601-1

The 60601-1 standard is set by the IEC to enforce safety rules when it comes to electrical equipment around patients. There’s always a question of what comes in contact with a patient and what said apparatus might do—consider radiation effects of an X-ray machine on a patient. Effects concerning safety, health, and other factors, not just of patients but for medical professionals too. These standards protect against fire, radiation, mechanical impact, electrical shock, and excessive electrical energy output.

All medical grade monitors from Cybernet meet this standard, and every hardware development cycle includes the certifications within the deployment timeline. The result is a more cost effective product for clients at the sacrifice of an internal long-term development cycle—three to five years. Project certification approval for some manufacturers can take several months, but at high costs to the client. We literally take the time and effort to have our medical PCs independently certified so it costs the client less. Once a given line of products is approved, clients can purchase computers to fit their project needs without waiting for approval.

Ingress Protection Ratings and Why they Matter

For medical device manufacturers, the choice should be clear; partner with a company that produces tech that can protect itself. Ingress protection is another compliance standard that should be met in the medical space when medical device manufacturers are looking for proper technology. There are two factors to IP—foreign objects and water, numerically denoted. The first digit suggests tools, body parts, dust, etc. Every medical computer that Cybernet manufactures is rated a 6 on the front bezel, which is dust resistant. Dust is a huge impairment for any kind of electronic component and a potential health hazard for patients.

The second digit addresses water. Lower numbers address moisture and condensation, while higher numbers address streams of water and even immersion. Cybernet’s medical devices are usually rated at a 5 for water ingress, meaning the front bezel of our machines are protected against projected water. We even have a video demonstration of how resilient they are against splash damage. These standards are a must-have for the medical space.

The FDA Regulation Cycle and Compliance with Medical Device Manufacturers

All devices made by medical device manufacturers are subject for review by the FDA’s Center for Devices and Radiological Health. Devices that do not pass the FDA’s standards can become extreme health hazards for patients—imagine what a malfunctioning pacemaker could do! If a device falls outside of FDA regulations, the process to have the device approved or cleared by the FDA must begin again. The same mentality must be held when questioning what kind of medical monitoring system hospitals need to utilize. Cybernet’s advantage is that all products within a project are kept the exact same—that means if a medical tablet wears down or malfunctions within it’s expected lifespan, the replacement device is already approved for use and goes into real-world application without fuss over more regulations. That ensures patient care is still the primary focus without squabble over technology or time wasted.

Medical device manufacturers are at the whim of the FDA, but regulations and compliance standards shouldn’t stop there. The whole solution lies in pairing medical devices with EMR computers that are ready to be deployed when the need arises. Our medical grade monitors meet the ever-changing compliance rules and regulations set by the FDA, the IEC, and other governing bodies.