An Alarming Matter

Kelly Stephens, editor of 24×7 magazine, was kind enough to invite me to climb on the Soapbox and well, express myself.
Normally only my mother would be interested in something like this, but since the topic was point-of-care communications and alarm notification, I thought I’d share it with all of you. In my rant I lay out market requirements, the limitations of current solutions and describe my feverish fantasy for improved alarm notification.
Alarm notification (when it really counts) is all about life-threatening alarms (LTAs). The notification and management of LTAs is covered by the “indications for use†in a medical device’s 510k filing with the FDA. The methods or capabilities described in the 510k filing represent the primary means of alarm notification. Any method of alarm notification that is not covered by a device’s 510k filing is a secondary means of alarm notification. Nursing units must be organized, staffed, and managed based on the device’s primary alarm notification. Secondary alarm notification doesn’t count, and any hospital that runs its units based on secondary-alarm-notification capabilities is at risk.
Hospitals need real automation at the point-of-care (including alarm notification) upon which they can safely operate their nursing units and deliver quality care. This means one product that will support a wide range of phones, nurse call systems and medical devices (including integration with ADT, CPOE/OE/RR) – even within the same hospital. And it will require a solution with a 510k.
The vendor that provides this solution with a 510k is going to have a huge competitive advantage because they will have the only product on the market that offers all the benefits of point-of-care automation – the reduced operating costs along with improved patient safety. I wonder who it will be.
Read MoreExperts Look at Current Status of IT Adoption for Medical Products

The current issue of MX Magazine has a roundtable
discussion
to wrap up their series of articles on medical device connectivity. MX
editor-in-chief Steve Halasey was kind enough to include me in this
panel along with Lori Hack, Mark Leavitt and Tom McCausland (you can
see the full roster here).
seems to be a disconnect between companies that design and develop IT
systems, medical device manufacturers, and end-users. Is this problem
real or perceived? Do the differing views and goals of healthcare's
various stakeholders represent a problem in their own right?
Rod Piechowski:
It is a huge problem, and people are just beginning to grasp the nature
and size of the problem. Whenever we talk about who the stakeholders
are in healthcare relative to any particular issue, it is easy to come
up with a handful of them. But then healthcare people have a natural
tendency to segment themselves, and you start getting substakeholder
groups, each of which believes that it has a unique way of doing
things. That makes it far more complex when you try to integrate all of
this and find some method of implementing IT in such a way that
everybody benefits equally.
Tim Gee:
Medical device companies have always thought in terms of embedded
systems, and now they are faced with this whole new area of
general-purpose computing technology. They aren't fully aware of it
yet, and they haven't yet figured out how to interface with it. One of
my hospital clients had to send back about eight wireless
electrocardiogram (ECG) carts because the manufacturer did not build-in
the right kind of wireless local area network (LAN) security. Using
those devices would have compromised the hospital's entire wireless LAN
security scheme, so the hospital had to pass on them.
Lori Hack:
We certainly have heard stories to that effect as well. Taking a
systemwide perspective is really the key. From the level of the chief
financial officer throughout the whole system, it is critical that the
delivery system and the manufacturers understand that innovatively
solving the health delivery system's business problem may require fresh
thinking. They have to look at a device that typically was used in a
single department and think about its use across the system. That leads
to the issues of connectivity, performance, and integration, which have
never been considered either by the manufacturer or by the end-user.
I felt a bit like the contrarian of the group, especially when the topics of industry standards and pay-for-performance came up:
Gee:
For both medical device manufacturers and for hospitals, it comes down
to making wise investments in existing technology. There are many
opportunities for medical device companies to add value and
differentiate their products by adding connectivity today without
having to worry about reimbursement and all of these other longer-term
structural issues. There are a lot of opportunities for hospitals to
accrue benefits by investing in technologies that give them operating
advantages and increase patient safety and satisfaction—even if they
don't reduce full-time equivalents or other hard-dollar costs.
You could use point-of-care work flow automation as a model of what is
going on in the market. The caregiver and the patient are in the
middle, and they are surrounded by all of these different devices,
ranging from infusion pumps, patient monitors, and nurse-call systems
to order-entry systems, results-reporting systems, and the EHR. The
customer wants one solution, and obviously there is no single vendor
that supplies all of those products.
This
is not a situation that is going to be solved by top-down standards
being imposed on the industry. It will require a lot of business
development and alliances among vendors that are not necessarily direct
competitors, but that have never worked together before.
It was interesting hearing the different perspectives and get
a glimpse into the thinking behind the major industry stakeholders.
Read More

