Patient safety is a major priority in healthcare. Medical staff from providers, registered nurses, to various aides rely on many tools and equipment to keep patients alive and stable until they’re well enough to do it on their own. This is especially true in hospitals. People’s lives every day hang in the balance in emergency rooms (ER), intensive care units (ICU), and surgery theaters.
So it’s not surprising many of those tools and equipment are highly regulated by law. It makes sense. You would not want new hypodermic needles from the manufacturer swarming with highly infectious germs, would you? This is true with drugs used to treat patients from anything like headaches to anesthetics in prep for major surgery. It’s important for healthcare organizations to be ever vigilant in making sure all their tools and equipment have patient safety in mind.
This same logic applies to medical devices and computers. Medical devices, per the US Food and Drug Administration or FDA, are defined as: “An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory….” The above needles (and even their syringes) are considered medical devices. X-ray machines, heart monitors, IV pumps, and pulse oximeters are other examples.
Computers are not medical devices. However, they play a big role in modern healthcare. They rapidly made inroads into medical clinics, doctor’s offices, and – of course – hospitals since the first PCs showed in the Sixties in clinics. Displaying patient health status, automating drug delivery, and providing patient information through electronic medical records (EMR) are just a few of the many tasks performed by computers today.
It’s vital, then, that computers used in healthcare will not in any way affect the patient or interfere with the function of their medical devices. Computers are electronic devices with electricity coursing through them. They radiate radiation like waste heat. Thus you would not want electrical sparks from the PC to somehow travel through a nearby heart monitor and shut it off. Like, no one wants it to somehow ignite any possible flammable anesthetic gas in the air during surgery.
Medical clinics and hospitals have turned to medical grade computers and similar computing equipment to avoid such tragic possibilities. The term “medical grade” has a very specific meaning in the medical equipment industry. For something to be called medical grade (example: rugged medical grade tablet), it must meet the highest requirements available for safety (Safety 60601-1) and electromagnetic compatibility (EMC 60601-1-2) in medical settings.
Commonly known as 60601-1, both these requirements were first laid down and – kept up to date – by the International Electrotechnical Commission (EMC). Europe added additional requirements (EN60601-1) as well as other nations like the US and Canada ( UL60601-1, and cUL60601-1 respectively).
They go over in depth to make sure any proposed medical equipment will not interfere with a patient’s life-sustaining devices like the above monitors or anesthesia machines.
A major part of 60601-1 is testing. The equipment must be tested by an accredited lab. This is a long and expensive process. Only after passing such testing and receiving the certification can the equipment be called “medical grade.”
Computers certified as medical grade can be sold as such to healthcare organizations, which can trust them to work safely near their patients. They must keep vigilant, though. Sometimes they’ll come across equipment manufacturers hawking their computers to be “medical grade PCs,” “hospital grade computers,” or “healthcare grade machines.”
None of these are true medical grade. Many times the computers will have features like an antibacterial housing or IP65 rated sealed front bezels for easy cleaning and disinfection. They have not undergone testing at an accredited lab. To find out, just simply ask them to show their certifications.
Occasionally a company will state that their computers are “medical grade compliant” and may provide a certification for one of the two tests. A common one is the medical grade PC coupled with a standard (non-medical) medical grade power supply unit (PSU). Their product is still not not medical grade with the PSU possibly bringing risk to the patient, their medical devices, or both. Healthcare organizations prioritizing their patients’ safety should insist on both.
“Do no harm” is the well-known part of the Hippocratic oath sworn by medical students and is the aim of all providers. It’s a good goal which medical device and equipment manufacturers should take to heart as well. Medical computer makers can do so by taking the time and covering the expense to get their PCs’ 60601-1 certified and thus be truly medical grade.