Is the iPad a medical device?
Last Updated on September 3, 2016 by Joseph Gut – thasso
September 03, 2016 – This morning, I stumbled upon the headline of a posting on mobihealthnews, entitled “Study finds iPads and games as effective as sedatives to calm pre-op anxiety in children” and starting out with saying “The hypnotic trance kids enter when they’re staring at an iPad isn’t just for on-demand quiet time in restaurants or
cars. Turns out, the smart tablets are so effective at zoning out kids, they work just as well as sedatives to quell anxiety before surgery“. This posting caught my attention immediately for at least two reasons.
First, for parents like myself, it would be very reassuring if, before any surgery, in effect you would not have to calm your child with any kind of medication but instead let them play, on their mobile yet smart device. Secondly, the posting points in the direction that in fact iPads (most probably, for that matter, any smart mobile device of today or of the future) might actually be approvable as a medical device. So, what would then qualify as a medical device? The definition by the American Food & Drug Administration (FDA) for medical device says that a medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
When you read the posting below, then it becomes clear that in the cited study, iPad had just the effect to “affect a function of the body (control of anxiety level) and doing so without chemical action within or on the body”. Bingo. As of yet, I would not want to speculate about the changes in the market place and pricing scheme for both, devices and medications, if in fact mobile smart devices should one day in the future become approvable as medical devices.
In the meantime, we may rest with taking note of the study by a group of French doctors, led by Dr. Dominique Chassard of Hopital Mere Enfant, Hospices Civils de Lyon, presented a poster at the World Congress of Anesthesiologists in Hong Kong that compared the use midazolam, a conventional sedative, to that of iPads loaded with age-appropriate game apps on 112 children aged 4 to 10 years old during and after ambulatory surgery. The children were randomly divided into two groups, with each group receiving either the midazolam or iPad 20 minutes before anesthesia. Child anxiety was measured (using m-YPAS scoring, a standardized assessment tool), by two independent psychologists at four time points: arrival at the hospital, separation from parents, during anesthesia induction and post anesthesia care unit. A half an hour after the child received their last dose of anesthesia, they were transferred to the ambulatory surgery ward. Parents were also assessed for anxiety during the arrival, separation and in the post-surgery unit.
The researchers found anxiety levels to be similar in both groups. The team has not published a full paper yet, but the poster referenced a 2006 study showing similar outcomes when using mobile devices as a means of distraction before pediatric operations.
“Our study showed that child and parental anxiety before anaesthesia are equally blunted by midazolam or use of the iPad,” Chassard concluded in the poster.
What’s more, the parents prefer to trade drugs for the mobile interactive tool to the sedative, and nurses found the anesthesia induction quality was higher with the iPad group. “… the quality of induction of anesthesia, as well as parental satisfaction, were judged better in the iPad group,” wrote Chassard. “Use of iPads or other tablet devices is a non-pharmacologic tool which can reduce perioperative stress without any sedative effect in pediatric ambulatory surgery.”