Healthcare technology is transforming at a velocity that is catching many in the industry unprepared. As the use of computers in hospitals and other healthcare facilities has increased, computers have transitioned into a type of “medical device.” This is a testament to how critical computers are to healthcare workflows.
Medical Grade Computers (MGC) are designed and engineered to satisfy demanding, mission-critical goals to improve the quality and efficiency of healthcare environments. MGCs exceed the performance of Tier 1 desktop or mobile computers and meet standards such as UL60601-1 and EN60601-1 for medical safety approval, and IPX1 certification for dust and water drip-proof housing. From infection control to improved patient care, there are nearly endless opportunities to leverage computers specifically built for healthcare environments. The rise of Medical Grade Computers is poised to become a transformational force in healthcare.
The Rise of the Medical Grade Computer
The role of the computer in the healthcare environment has changed drastically. The healthcare industry’s shift toward full computerization is a key driving force behind the rise of the Medical Grade Computer. MGCs are not standard computers simply moved into a medical environment. MGCs are specifically designed for healthcare environments and healthcare workflows.
“Medical grade” is used to describe many products in the healthcare environment. However, there is no universal definition. In some cases, it means the product has met certain industry standards. It could also mean the product has been tested in a lab to measure its impact on patients’ safety and/or health. In regards to computers, the term “medical grade” may be supported by tests and certifications. Among other features, Medical Grade Computers could include 24/7 reliability, antimicrobial housing, fanless operation, and security protocols that can be customized for various healthcare workflows.
Each day, doctors, nurses, and other healthcare professionals experience life and death situations. Every instrument they use must support the mission-critical aspect of their workflows. The wide adoption of battery-operated mobile computers is a clear example of computers specifically designed for medical environments and workflows. Medical Grade Computers improve the standard of care as they enable doctors and nurses to manage treatment more effectively.
What does Medical Grade Mean?
When healthcare facilities purchase computers, they have different concerns than non-healthcare entities. A healthcare environment has to consider patient health/safety, infection control, the fact that these computers will likely be running 24/7, and liability. The Medical Grade Computer manufacturing process must conform to the strictest of standards.
The Computer is a Medical Instrument
Computers in a healthcare environment must be viewed as medical instruments. They are crucial to the delivery of care on all levels of the healthcare environment. Medical Grade Computers are mission-critical medical instruments responsible for life and death. They are a critical component of the modern healthcare workflow. The MGC is no less of a medical instrument than a scalpel. Medical Grade Computers and tablets incorporate built-in features ensuring patient and operator safety, optimized for the rigors of healthcare environments, and infection control. Medical grade is a key differentiator as not all computers are suitable for healthcare use. Medical computers must meet a complex slate of requirements for safety and performance. They must be optimized for healthcare environments and workflows. Medical Grade Computers need to be able to run 24/7 as healthcare never stops.
“Computers used in healthcare environments must be designed differently. They must be medical grade.”
Designed for Healthcare Environments
Medical Grade Computers must operate 24/7. Most tablets or PCs are not suitable for use in healthcare. Hospitals also run powerful medical applications continuously. They make use of database software, diagnostic tools, radiology imagery, and lab reports. Hospital IT departments are responsible for constant 24/7 uptime, so reliability is of utmost importance. Some MGCs are portable and use hot-swappable batteries to support doctors and staff on the move tending to patients.
For optimal healthcare workflow, operators must be able to control the device while wearing surgical gloves to support infection prevention protocols. To maintain an ergonomic, user-friendly interface, intuitive programming buttons should allow simple setting changes.
Compared to off-the-shelf displays, medical-grade LCDs offer superior performance. Medical touchscreen computers are designed for the continuous demand of the healthcare environment. The capacitive touch capability of Medical Grade Computers offers the following advantages:
- Touch works with gloves
- Outstanding sensitivity
- Multi-touch capability
- Excellent durability
- Liquids don’t impact performance
Medical Grade Computers can also incorporate Gorilla® Glass touchscreens. They are thicker than consumer-grade screens to withstand drops.
Medical Grade Computers are designed with all the demands of the healthcare environment in mind. If a typical computer, like something designed for the home, was used in a hospital, it would need much more maintenance in a shorter time. Instead, MGC manufacturers use higher-grade components when making parts for the computers. All these components are designed to last five or more years and are expected to provide over 50,000 hours of use before failure. Medical grade components are simply more reliable and require less maintenance than machines built by Tier-1 counterparts.
MGCs are designed and manufactured under ISO 13485, which is the most widely used medical device QMS (Quality Management System) standard. The international standard for medical device manufacturers is ISO 13485, which sets standards regarding both product quality and compliance with governmental regulations.
Complex System Integration
Medical Grade Computers undergo compatibility and stability tests for 3rd party peripherals. Windows Embedded or Android operating systems ensure flexible deployment, enabling versatile yet safety-certified options for specific applications. Healthcare providers can select the best-suited system environment for their workflows; for example, Windows operating system may better integrate with software commonly used in hospital information systems (HIS), while the Android operating system is optimal for a wide selection of mobile apps. Support for a legacy RS232 port is a good feature for customers who need to utilize the system in Pre-Op, PACU, or OR, which may have legacy medical devices that are designed with RS232 ports.
One of the most important aspects of Medical Grade Computers is validation. Industry-leading partners such as Cerner and Epic each use their own term – Cerner calls it “Cerner-Validated” and Epic’s term is “Exceeds Epic’s Base Specifications” – to indicate that a computer model is “recommended” to be integrated into one of their healthcare solutions. The validation process is extensive to ensure compatibility with systems and software.
Certifications and Ratings
The purpose of certifications is to guarantee reliability and ensure that the medical device won’t cause harm. The IEC or International Electrotechnical Commission is the standards organization responsible for the UL60601-1 certification for electromagnetic compatibility and safety for medical devices. A Medical Grade Computer must be UL60601-1 certified. If a medical device meets the UL60601-1 standard, it meets the highest requirements available for safety and electromagnetic compatibility. It has been tested for hazards like fire, ignition from flammable anesthetics, electrical shock, mechanical impact, excessive electrical energy output, and radiation. This standard continues to evolve in order to protect patients from potential hazards.
UL-60601-1 certification is granted when a medical electrical device undergoes testing. For a device to be certified UL-60601-1, it costs about $30,000 and takes months. Tests must be completed by an independent lab. After a product receives certification, it can no longer be changed or must be recertified.
Isolated Power Systems
Standards such as NFPA 99 and CSA Z32 require isolated power systems in all areas deemed “wet procedure locations” in healthcare facilities. Medical Grade Computers are protected from electrical frequency leakage making them safe to be used in close proximity to patients and other medical devices. Some Medical Grade Computers have galvanically isolated serial, USB, and Ethernet interfaces. A shielded power system will not interfere with other sensitive medical equipment and meets the latest Standard 60601-1-2 4th Edition EMC.
MOPP and MOOP
Medical Grade Computers with UL60601-1 certification are required to have a medical certified power supply but do not require an isolation transformer. Medical Grade Computers must incorporate one or more Means of Protection (MOPs) to isolate patients and operators from the risks of electrocution. UL60601-1 3rd edition differentiates between the risks to patients and the risk to operators. Therefore, a MOP can be classified as Means of Patient Protection (MOPP) or a Means of Operator Protection (MOOP). To achieve 2 x MOPP qualification, the isolation test is particularly demanding at 4000 Vac, and the creepage distance of 8mm is twice that required for 1 x MOPP. Power supplies that meet 2 x MOPP standards provide the highest level of protection.
While computers can help to provide better healthcare workflow and safer patient care, computers can be one of the culprits of spreading infection. According to the CDC, every day, about one in 31 hospital patients has at least one healthcare-associated infection. Computer touch screens and various input devices can be contaminated with microorganisms when touched. Methicillin-resistant staphylococcus aureus (MRSA), E. coli, vancomycin-resistant enterococcus (VRE), and other gram-positive bacteria can survive months on computer equipment. For improved infection control, Medical Grade Computers are built with antimicrobial enclosures.
Each year about 2 million U.S. patients suffer from healthcare-associated infections, and nearly 90,000 are estimated to die. These infections can come from contact with other humans or objects – like computers. Antimicrobial technology has a key role in preventing the spread of infections through computers. The antimicrobial computer housing and screen prevents pathogens, such as MRSA, from propagating and supports lower patient infection rates.
Microbes live longer on plastics, so computer hardware is of special concern. While patients sign waivers before surgery and admission, hospitals and/or doctors can still be sued if someone acquires an infection. These lawsuits are expensive and damage the reputation of the hospital and doctor. Lawsuits aside, everyone is hoping to reduce the number of infections. Controlling infection is important, especially at hospitals and medical facilities.
Technology has been developed that can fight microbes and help to maintain a germ-free environment. Computers in areas of the hospital where patients or healthcare workers can come in contact with them, and potentially spread germs, need this antimicrobial technology. Some manufacturers apply antimicrobial powder-coating after the manufacturing process is complete, while others might have the antimicrobial properties baked into the resin during the manufacturing process. In addition, antimicrobial protection helps prevent the growth of stain and odor-causing bacteria. The sealed housing is smooth and easy to clean.
IP (or “Ingress Protection”) ratings are defined in international standard EN 60529. The IP rating is used to define levels of sealing effectiveness of Medical Grade Computer enclosures against intrusion from dirt, germs, bacteria, moisture, etc. The IP ratings specify the extent to which a computer can be exposed to environmental influences without being damaged or resulting in a safety hazard.
The IP rating is the letters “IP” and two digits with an optional letter. The code indicates the level of protection that is provided against dust, solid objects, and water in hardware. For example, if a computer had an IP code of IP65, the 6 would indicate that the enclosure offers complete protection against dust. The 5 tells you that the enclosure is protected against water sprayed at a rate of 12.5 liters/minute from 3 meters away. IP65-rated devices can be scrubbed and cleaned with disinfectants.
The fans that typically operate in computers can blow dust and other particles around an otherwise sterile environment. Therefore, a fanless computer is a must for operating rooms or other healthcare environments like the ICU and ED. This will reduce possible infections and increase patient safety.
Fans also generate noise and vibration, which could interfere with both the patient and the healthcare professional. The fanless heat dissipation system adopted for Medical Grade Computers is noiseless during operation. The completely sealed design minimizes invasion of dust, risk of bacterial growth, and the spread of pathogenic germs.
Hygienic System Design
Medical Grade Computers are manufactured with either a plastic or aluminum housing. Some Medical Grade Computers feature a completely closed aluminum housing, but not all MGCs have this feature. Medical Grade Computers are able to withstand highly effective disinfectants, including bleach, and they can handle multiple cleanings. MGCs are designed with a fully enclosed gap-free housing – without joints or cracks, resistant to dirt and dust.
Medical Grade Security
Security is a concern with all computers, but healthcare information is particularly sensitive. In fact, patient medical records are highly coveted on the black market – even more so than credit card information. Medical Grade Computers can be customized with RFID scanners and other security measures like biometric access. This protects patient records and keeps them safe unless accessed by an authorized individual. There are also encryption keys that prevent the information from being read without them.
Intel SoC technology includes a range of security features, rooted in the hardware. For example, to strengthen encryption algorithms, Intel® Secure Key generates high-quality keys for cryptographic protocols. The Execute Disable Bit (EDB) technology reduces a Medical Grade Computer’s vulnerability to viruses and malicious-code attacks. EDB prevents harmful software from executing and propagating on the healthcare provider’s server or network.
Modern Medical Grade Computers ship with UEFI technology. UEFI is a low-level software that starts when you boot the computer. UEFI supports “Secure Boot” technology to check the operating system to make sure no malware has been detected from the moment the computer is powered on until the anti-malware application initializes.
For healthcare providers, HIPAA compliance is a must. Medical Grade Computers must be able to maintain HIPAA compliance. End-to-end encryption protects the data in transit from data breaches and man-in-the-middle attacks. HIPAA compliant medical computers enable the support of full disk encryption for data at rest and integration of end-to-end encryption solutions for data in transit.
A computer privacy filter is a necessary accessory of healthcare institutions regulated by HIPAA. A Medical Grade Computer privacy filter is designed to protect display data from prying eyes. Privacy filters limit the viewing radius of the screen to front view.
One of the most attractive benefits of medical cart computers are hot-swappable batteries. The hot-swappable feature allows operators to exchange batteries without powering down the computer. Each unit is equipped with multiple batteries, usually three, providing up to 17-hours of runtime without interruption (runtimes may vary with configuration and usage). The cart never has to be moved to another location for charging – the batteries are replaced with fresh batteries to continue operation.
Medical Grade Computers also feature flexible support for broad-spectrum connectivity options in the healthcare environment. Healthcare settings require versatility as a single organization may utilize a range of technologies such as radio frequency (RF) or near field communication (NFC). RFID-based data capture can be used to verify patient identity and proper medication
using correlating patient wristbands. Greater flexibility is achieved with support for a range of wireless local area network protocols (WLAN), including IEEE 801.11 a/b/g/n/ac. Bluetooth 4.0 and WiFi give Medical Grade Computers the latest in wireless connectivity.
The lives of people are in the hands of healthcare providers. It is impossible to provide the best possible care without the deployment of computers. But that doesn’t mean that any computer should be deployed in healthcare. The rigors, risks, and regulations of healthcare environments demand Medical Grade Computers. Engineered for the healthcare environment, Medical Grade Computers are designed to improve healthcare workflows.