The United States Food & Drug Administration so greatly understands the importance of BYOD (and more specifically wireless technology) that the organization stepped in to provide additional guidance with an updated official document entitled, “Guidance for Industry and Food and Drug Administration Staff; Radio Frequency Wireless Technology in Medical Devices.”
While not an official list of industry standards that must be adhered to, the updated document does disclose a number of recommendations that can help to guide the safe, effective operation of hospital wireless networks and the devices that may utilize the wireless access these networks provide.
When it comes to BYOD in Healthcare facilities, the FDA certainly wouldn’t have much oversight as to the wireless devices that the hospital staff decide to place in their pockets or purses. However, since the manufacturers of devices the staff use to administer health care also are finding creative ways of “cutting the cord”, healthcare facilities will benefit from the technical aspects of what the FDA has recommended.
Manufacturers of mobile devices and those that specialize in wireless medical devices at healthcare facilities should consider how those new devices will function in the environments where they are intended to be utilized. Healthcare facilities present complex challenges when it comes to RF design, based on the other pieces of equipment operating in that environment. That makes BYOD in Healthcare a further challenge and great concern for facility administrators.
According to the FDA document, here are some things you may want to look out for:
- Poorly characterized or poorly utilized wireless systems (e.g., wireless networks)
- Lost, corrupted, or time-delayed transmissions, and degradations in wireless transmissions including when caused by competing wireless signals or electromagnetic interference (EMI) to the medical device or its wireless transmissions
- Lack or compromise of wireless security
- Potential misuse of a wireless medical device because of lack of or inadequate instructions for use.
Those are real issues that could open an organization to the dreaded “litigation” word when attempting to implement a BYOD solution for employees and guests to utilize. Again, think about all the current solutions that incorporate RF wireless technology:
- Wireless Medical Telemetry Service (WMTS)
- Medical Device Radiocommunication Service (MedRadio)
- Cellular communication chipsets
- RF identification (RFID) products
Certainly, these are not things you find in your home or office, therefore extra care (and security) has to be taken when trying to assure for the safe operation of wireless products that the consumer carries into the healthcare environment as part of a BYOD program.
The FDA proposal also takes care to make the distinction between what it calls “mobile platforms,” or commercial off-the-shelf computing platforms, like smartphones and tablets, and “mobile medical applications” which they define to be software programs tailored to run on one of those mobile platforms.
According to the FDA's guidance, not all health-related programs running on an iPad, iPhone or BlackBerry qualify as mobile medical apps—so my co-worker who uses the app on her iPhone to count calories or log her exercise time and distances would not qualify (sorry, Julie!)
That distinction is reserved for apps that are “used as an accessory to a regulated medical device” or that “transform a mobile platform into a regulated medical device.” So, a bedside monitor that transmits a wireless signal to the attending nurse’s iPad but requires an app to be downloaded for visibility of that data, would fall into that category.
Another consideration the FDA is including in their document is wireless coexistence. Given the current radio frequency spectrum available (though Forbes magazine recently refuted the reported shortage) wireless technologies may compete for access to the same spectrum. As a result, coexistence issues may pose risks that could result in medical device signal loss or other additional unwanted interference.The FDA clearly defines that when a mobile app's intended use is for diagnosing, preventing, treating or curing a disease or condition, the app is a device. Another factor the FDA will be taking into consideration is the level of risk to a person's health associated with the use of the mobile medical app. So, if you could speed up or slow down someone’s vitals by simply logging into that particular application from a BYOD smartphone, that is something the FDA would obviously discourage.
Some of the older devices that might face scrutiny as part of a BYOD in Healthcare implementation are the first generation of wireless devices that run on 2.4ghz. Other consumer goods that cause interference on that channel would be things like microwave ovens, an older wireless home phone and even baby monitors.
The FDA doesn’t “just” approve new medicines for the human body. The department also has an ongoing commitment to regulate any aspects of the science used to develop new tools, standards, and approaches to assess the safety, quality, and performance of all FDA-regulated products. So in this case, they are providing documented guidance to technological advancements like BYOD in Healthcare.
As with many other industries such as enterprise, retail, and education, BYOD will continue its proliferation in healthcare and at an accelerating rate. So if your hospital hasn’t yet considered BYOD, you might want to start. If you need help on where to start with your BYOD implementation we are here to help. We are experts on mobility in hospitals and can help you through any and every stage of the process for bringing BYOD to your hospital wireless network from the planning to the deployment and support we have you covered. Just contact us here for any questions or for a free consultation. Our goal is to be a resource to you!