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.

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