The Ripple Effect: Re-Defining the Medical Device
With state-of-the-art medical devices already making waves
around the world, it may seem primitive to raise the matter of
medical device definition. Yet, innovation has brought uncertainty
to whether a product should be defined as a medical device. As a
result, regulators do not have clear jurisdiction to control. One
apparent example is the mobile medical app. Many medical-related
apps have erred on the side of fitness, well-being and health
management claims to stay well clear of the regulations. However,
with big data presenting opportunities to analyse physiological
parameters and wearable hardware exhibiting diagnostics
capabilities, medical apps are starting to behave and generate data
like medical devices; but, just shy of becoming one by way of
non-clinical claims. The non-clinical claim is becoming hard to
swallow for "wellness" apps that can measure breathing rate and
blood pressure, or lifestyle management apps for chronic disease
sufferers. What are these data used for then, if not to monitor or
predict abnormal clinical functions? For the fun of looking at
one's own health data for want of something better to do? Or the
novelty of finally being to see one's own heartbeat?
A medical mobile app is not a medical device unless proven or
claimed otherwise.Shaking Up the Status Quo
This situation has inevitably sent the medical device definition
into a spiral. The US FDA has attempted to hold it sacred by
specifying which medical apps would be regulated or excluded based
on their intended use. There is also a long list of apps for which,
the applicability of regulations will be discretionary. To add more
fuel to the fire of uncertainty, no ground rule has been provided
as to how this discretion will be exercised. TheUK MHRAtried to do
the same but showing much more fidelity to the existing definition
that they removed the discretionary list and relegated certain apps
under borderline medical devices (even more problematic - can an
app only be partly regulated?). Nevertheless, what is borderline
now will later require firmer delineation. But first, let us look
at the current medical device definition provided by theIMDRF:
Watch the online lecture on medical device definition and
download definitions from different regulatory authorities in the
United States, European Union, United Kingdom, Australia and
Canada.A medical device means any instrument, apparatus, implement,
machine, appliance, implant, reagent for in vitro use, software,
material or other similar or related article, intended by the
manufacturer to be used, alone or in combination, for human beings,
for one or more of the specific medical purpose(s) of:
diagnosis, prevention, monitoring, treatment or alleviation of
disease,
diagnosis, monitoring, treatment, alleviation of or compensation
for an injury,
investigation, replacement, modification, or support of the
anatomy or of a physiological process,
supporting or sustaining life,
control of conception,
disinfection of medical devices,
providing information by means of in vitro examination of
specimens derived from the human body;
and does not achieve its primary intended action by
pharmacological, immunological or metabolic means, in or on the
human body, but which may be assisted in its intended function by
such means.
To Be or Not to Be a Medical Device? What is the Likelihood?
The literal medical device definition has no mention of whether
a device's intended use should be in a clinical or non-clinical
context (although a clinical context is understood in spirit). In
this respect, there should be no doubt that medical mobile apps
could fall under this definition. Right? Well, it's not that
simple. The difference between a medical app and a medical device
is, the latter is an app first that is not universally designed for
a medical purpose. Its ability to drive a medical application is
incidental to its technological capability. On the other hand, a
medical device is designed from the outset for a specific medical
purpose. In other words, a medical mobile app is not a medical
device unless proven or claimed otherwise.
See the INFOGRAPHIC - When a Medical App Becomes a Medical
Device.So, how can one be sure if a medical mobile app is a medical
device or not? The first step is to see if a medical app meets the
criteria of the existing medical device definition. If the app sits
on the borderline or does not exactly satisfy the definition, the
IMDRF has suggested further tests for medical device
characterisation, where an app:
1. Exerts significant influence in healthcare
decision-making
2. Includes aspects that influences patient safety
3. Drives or informs clinical management
The more influence an app has on healthcare decision-making,
clinical management and risk to a patient, the more likely for it
to be a regulated medical device. The greater the influence, the
greater the risk categorisation for this app.
The Ripple Effect - A Risk-Based Definition
Clearly, in keeping to the current medical device definition,
only medical apps with a definite medical or clinical intended use
would be regulated. However, the forebearingborders of this
definition is beginning to ripple and pervade into matters of use,
reliance and impact. This ripple is expected to hit more and more
mobile medical apps venturing into the clinical space and gather
them under regulatory purview. The further the app is from the
definition epicentre (i.e. for treatment or diagnosis), the lesser
its risk categorisation. What could happen next is the possible
review or revamp of medical device classification rules. Of course,
applying these changes and starting to regulate medical mobile apps
should not fly in the face of innovation. There is already a
growing number of "medical-grade" apps plus hardware devices
approved by the US FDA. Whilst it is understandable that
regulations should not stifle innovation, it would be equally
unfavourable if we are forced to make sudden regulatory waves in
the aftermath of a major adverse event.
Nealda Yusof is a medical technology writer and founder of
Semoegy.com. Click here to contact the author.For more news, follow
us onTwitter and Google+.
Original article:
http://medtechupdates.semoegy.com/2015/05/re-defining-the-medical-device-the-ripple-effect/