It’s becoming increasingly clear in the healthcare industry that the use of rugged tablets must have similar characteristics as other medical instrumentation used in medical care. In essence, it must be capable of acting with the same safeguards and functionality as any other medical device. Consequently, the features of an efficient and reliable medical grade tablet must be geared to the needs of the healthcare environment where it will be part of the instrument chain providing patient care.
Industrial Android tablets have become a staple in healthcare for things like medication alerts and tracking, Electronic Health Record (EHR) support, blood pressure monitoring, among others. While these uses have an ancillary relationship to patient outcomes, they do not provide direct medical function to healthcare providers or patients as a medical device. That is changing fast due to the evolution of purpose-built tablet designs that adhere to FDA, Medical Device Directive 60601, and ISO 13485 regulations.
For example, tablets that interface directly with medical devices to perform medical treatment procedures are required to be capable of adhering to stringent FDA regulations. Many medical devices now have the ability to connect to, communicate with, and operate other medical devices or systems, particularly treatment devices, which makes these connecting devices medical devices in the eyes of the FDA.
Devices that are already FDA approved or cleared are being updated to add digital features. New types of devices that already have these capabilities are being explored. Today’s devices are designed to work with complex software and provide interface ability with next generation medical devices to provide direct patient diagnosis and treatment.
This includes uses as direct interfaces via software for glucose meters, infusion pumps, and as critical displays of radiological images as just three examples. Adding application-specific capabilities, such as specifically calibrated displays, often customized secure wireless connections, and tethered medical instruments enable a medical grade tablet for safe and reliable medical treatment, such as monitoring and changing critical fluid intake and body functions or guided medical procedures.
The FDA regulates the software and the mobile devices as medical devices requiring adherence to specific FDA code of federal regulations (CFR). There are numerous differences between consumer and medical grade tablets that elevate the latter to the level of medical device according to the FDA.
Today, a custom rugged tablet may use software as well as specific interface functionality that elevate it to a medical device. Both of these aspects make the tablet subject to strict guidelines for software control including specifically timed software updates that are not usually possible with off-the-shelf tablets.
Because these devices are directly in the hands of medical specialists and in close proximity to patients, they must also provide a much higher level of safety and security. That includes things like electrical shock prevention, audible medical alarms, failsafe mechanisms and more depending on the uses. In summary, the tablet is designed to protect the patient and medical provider from harm in the case of failure. Off the shelf tablets may be designed to protect themselves from damage in the case of failure with less thought for protecting the user first.
Biocompatibility is also crucial as the enclosure materials must not cause medical issues like allergic reactions. They must also accommodate routine medical cleaning and disinfectant procedures with sterilization liquids to halt the spread of hospital acquired infections and much more.
It is not just the design and use compatibility of an industrial Android tablet that must meet these stringent regulatory standards. It is also the longevity, viability, and authenticity of the components used in these devices that must pass extreme scrutiny. The FDA certification process is long and arduous and it is critical for the tablet to have a long life availability and stable supply chain after going through this scrutiny.
In short, these devices must use components and assemblies that are tested for long life and flawless operation under critical and adverse conditions. It is equally important that they be capable of remaining viable and available for sourcing as medical technology and needs evolve. The supply chain must include protection from the use of counterfeit components which could induce safety and reliability issues.
The reality is that every use case for a rugged tablet is different, and that’s equally true in healthcare where there are myriad uses. Understanding the differences between the limitations of commercial grade tablets and a medical grade Android table in healthcare settings goes far beyond routine data access uses. The healthcare continuum is seeing the value in choosing an industrial Android tablet that is custom designed to meet the needs of the healthcare environment. Leveraging existing technologies customized for specific uses makes sense for better patient outcomes as well as efficiency, safety, security, performance, and the bottom line.
