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Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
March 2013
Are mobile devices and the iPad a threat to patient safety?
< 1 min reading time

As originally asked by Jim Bloedau.

Which tablet device is you organization most likely to adopt: Microsoft Surface, iPad Mini or the leading answer being NEITHER thus far? This poll and others that show at least 62% of physician adopting the iPad and half of them reporting it at the point of care forget about IP 65 and IEC 60601 which deal with infection control and electrical safety of equipment used in the clinical setting. Shouldn’t, What about the patient’s safety? be the more appropriate question? Do you think that this a more immediate discussion than how the FCC will regulate medical apps on mobile tech?


Kurt Periolat
Sales at Sales at Anixter
With a Projected Capacitive touch screen you can actually use it through glass. They work very well with gloves.

John Minarovich
Field Account Executive – West Coast at D-Link
Emilia, there are touch technologies that enable touch screen functionality through a zip lock bag or with latex gloves.

Myra Donnelley
Vice President of Resource Development at Eniware, LLC
Jim – There is a new room temperature gas sterilization technology that can sterilize endoscopes and may be able to sterilize tablets (but certainly not between patients). Contact the folks at Noxilizer to see what the opportunities are: [http://www.noxilizer.com/|leo://plh/http%3A*3*3www%2Enoxilizer%2Ecom*3/c2Gf?_t=tracking_disc] . Good luck!

Perry Mykleby
Customer Activation, Engagement & Retention
The bigger risk is probably HIPAA violation. Fines are huge. There are some good HIPAA-compliant services out there now, including a really good free one.

Re: the physical risk, a number of organizations now equip their sales forces with iPads (not to mention smartphones), and these routinely go into patient care areas without question (although maybe it should be questioned.) Some facilities have “no-transmit” zones in patient care areas, but most I’ve seen aren’t picky….yet.

Kurt Periolat
Sales at Sales at Anixter
IP65 has to do with how the bezel is sealed, not directly with infectious disease control (it will make the device much easier to keep clean however). As Gabriel pointed out, the EN/UL 60601 certification covers not only shock directly from the device but also weather or not in will interfere with other devices the patient may be hooked up to. If a facility is looking to protect itself from legal exposure they should be looking at 60601 rated devices where they will be coming into contact with patients. Data security is another issue with mobile devices, particularly iOS and Android devices. If you are looking for a IP 65 rated tablet that is EN/UL 60601 certified, runs Windows has the same for factor as the iPad we have the solution.

Ken Kasper
Kenneth C. Kasper, Ph.D., RAC
Good question Jim. Electronically communicated medical data is at risk. Do hardware suppliers and software suppliers operate with a common standard for compatibility of devices for medical use? Doubtful. All sorts of equipment in the hospital and clinical laboratory depend on electronic hardware, connectors, firmware, software, wireless, not wireless, and operating system software and special application software. Drug dosing software, automatic data reporting software, diagnosing algorithms, data entry crosschecking software, automatic updates for software versions, etc. Are mobile devices dedicated for medical use, or are they mixed with personal use? If mixed with personal use, can information be tracked by other parties? Aside from standards for validation, risk analysis and electrical safety, I would feel more confident if new designs for medical use were developed within a common technical framework, so that users could rely on the potential for interconnectedness of the devices.

John Minarovich
Field Account Executive – West Coast at D-Link
There is a clear opportunity to develop a device that is standards compliant, more affordable and presents less of an attractant to theft. Apple has seen a rapid adoption of iPads, but they are expensive and have limited flexibility. Android offers a less expensive and more flexible option, but is just as prone to theft. And do you really want your staff spending time engaged in Angry Birds or Cut the Rope? A proprietary device with managed security and the ability to administer the content seems a better option.

Jerry Robinson
Consulting Designer: mHealth, IoT, Embedded Products, Wireless Commun, Consumer, and Disruptive Innovation Tech.
What is the balance of beneficial versus the exponential downsides?

How good is good enough?

Apple is a relatively controlling ecosystem for mHealth…Android and the host of devices is much more complex and devious…

It’s a good topic…

Jim Bloedau BSMT, RRT, CPHIMS
Founder Information Advantage Group
Thanks Gabriel, great IEC info. My primary concern was with the tablets that physicians are buying and going from patient to patient without some form of infection control. My understanding is that the more popular oner (iPad) is not IP65 cleared and offers lots of nooks and crannies for infectious agents to hide. Any other thoughts out there about patient safety and tablets…other than security?

Gabriel Barbat
Sr. Electrical Engineer at Integer Holding Corp.
I understand that IEC 60601-1 essentially recommends non-medical electronic devices to be 1.5 m away from the patient. As this is not usually the case, at least the patient should never touch the device, because it could deliver high currents to the patient, e.g. in case of a single fault. Also, the physician should know that the device must not be plugged to the wall if it is within the patient environment in order to reduce the risk of shock. Anyway, the standard usually tries to cover worst case scenarios, in which the patient is in a debilitating condition. So, if the patient is in good overall health condition and he/she is not connected to other device, some requirements may be excessive, and usual certifications, as CE marking, are enough. This was just a quick analysis. I didn’t try to cover all the aspects.

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Posted by Joe Hage
Asked on March 27, 2013 10:16 am
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