It’s likely you’ve read about the IEC 60601-1 medical certification here before, but previous topics haven’t detailed the specifics behind safety and why that matters for a hospital and its patients. If a computer isn’t 60601-1 certified, there are complicated hazards than what might appear on a surface level. Often times these computers will be next to patients undergoing surgery, and so one must think of the risks behind using electrical equipment next to a patient. There’s also a great risk to patients from computers in “the wild” with false 60601-1 certifications or computers that seem “good enough” for a medical environment but truly aren’t. Here’s why the certification matters and steps you can take to ensure your hospital or clinic has the proper hardware with the correct certifications.
Why the 60601-1 Certification Matters with Medical Computers
Electrical current is the main culprit that has potential in harming a patient under surgery. A rate of 50mA (milliAmps) per 250 milliseconds of electricity can actually stop a heart, so if your computer has electrical current leakage problems, let’s hope that it’s not next to a patient undergoing open-heart surgery. It’s a scary thought that a computer could malfunction next to a patient and cause harm, which is why medical device manufacturers go to great lengths to ensure their hardware is FDA-compliant. Some medical device manufacturers have tried to couple their devices with consumer-grade computers without certification by using isolation transformers to protect against the dangerous effects of current, but there’s still the process of verification and validation that can take several months to get the device FDA-approved. Certified medical computers are already approved by the FDA for near-patient use. Verification and validation are already built-in, and isolation transformers to protect the patient aren’t necessary.
Common Computing Trends in Hospitals
Unfortunately, it’s not every case where a hospital uses a medical computer; consumer-grade tier 1 computers are popular because of constant upgrades and cheaper prices. Some hospitals or clinics purchase tier 1 computers and hide them in the ceiling, then connect medical monitors to them. This still doesn’t guarantee total electrical safety. Hospitals that operate their hardware this way may be “audit safe,” but not likely patient safe. Plus, if a computer is hidden in a false ceiling and has a problem with overheating, that could expand the risk of a fire hazard that’s difficult to reach. In the short run it’s possible that a consumer-grade computer will save money, but the risk to patients and staff is far too high to gamble. It’s best to avoid the “workaround” trend of getting a consumer-grade PC and coupling it with a medical monitor—an all-in-one medical computer is still the prime option.
Ensuring Your Medical Computers Have True 60601-1 Certification
Some overseas organizations grant a 60601-1 “marketing label” to computers that aren’t valid—or even legal. With “bootleg” certifications abound it’s important to ensure your medical computer has the legitimate certifications in place. 60601-1 certification isn’t granted via just a label. Certification is a lengthy process and requires submitting a Risk Management File (RMF) to a testing lab. If you’re not certain that a product you’ve chosen for your hospital or medical device is certified (even though it may be labeled as so), you can verify the certification through the testing lab that granted the certification. When in doubt, ensure you’re protected so others are protected, too.
60601-1 certification has gotten more stringent with the 4th edition, a revision recently made in April of 2017 to increase thresholds on electro-static discharge and contact discharge which requires new design efforts. Cybernet is aware of these new adjustments. At Cybernet, all of our CyberMed computers are 60601-1 certified for near-patient use to protect the patient, the user, and the hardware. The 60601-1 certification ensures proper diagnosis, eliminates shock, protects the equipment, prevents interference, and ensures safety for all parties. For more information on 60601-1 certification you can contact us to find out how hospitals and medical device manufacturers are using Cybernet devices to ensure the highest quality of patient care possible.