I've noted a recent flurry of search engine queries on “fda approved wireless
alarms.” The same topic was raised by a reader in a recent
email. So, given the subject's topical interest I thought I'd ramble a
bit.

First the short answer: the only FDA approved wireless alarm available
today is from Baxter with their Colleague CX smart pump. They have a
PDA that is included in their 510k as a means for primary alarm
notification. This means the wireless alarm notification capability was
validated and verified in accordance with the FDA's QSR (Quality System
regulation).

Now for the long answer. Patient care must be delivered in a way that
is consistent with the “intended use” of all medical devices (IV pumps,
patient monitors, vents, etc.) that are used in delivering care. This
means that staffing levels along with nursing unit policies and
procedures must be based on medical device capabilities that are
regulated and approved by the FDA. The “intended use” is a part of both
a products “directions for use” (DFU) and a part of the devices 510k
submission. Capabilities listed in the 510k are primary - this is the belt (my analogy will become clear in a minute).

Numerous products abound that “supplement” a device's primary capabilities - these secondary capabilities
are suspenders (more of my analogy). Any hospital that staffs or
delivers care based on secondary capabilities is exposed to
considerable risk because they are not using FDA regulated devices
consistent with their intended use and DFU. In the fashion world of FDA
regulated medical devices, primary alarm notification is the belt and
secondary alarm notification are the suspenders. From a risk management
point of view, hospitals can just wear belts or wear belts and
suspenders, but they cannot wear suspenders without a belt.

Pressures on operating costs, initiatives to improve patient safety and
staff productivity - even the trend to private rooms - all create
incentives to automate the point-of-care where devices connected to
patients generate alarms and caregivers must respond. The first major
dust up in this area was a few years ago with Data Critical. They came
up with a pager system that would generate a page upon an alarm
condition, sending the caregiver the patient, their room, the type
of alarm and even a snippet of waveform (so they could rule out common
false-positive alarms). Initially patient monitoring vendors offering
the Data Critical solution were “positioning” it as good as primary
alarm notification. Sadly, paging systems are open loop - there is
nothing that ensures
that a message was received and acted upon, and a number of sentinel
events ensued. Now monitoring vendors are much more
aggressive in making primary vs. secondary distinctions. Unregulated
vendors (wireless communications, software, data acquisition, and the
like) are not so proactive in making this distinction - the FDA can't
come in and close them down.

A clinical engineer from a major medical center sent me the following just last week:

It looks like he may be right.


There's a lot more on primary vs. secondary alarm notification here and here.
Also, try the term “alarm notification” in the Google search box on the
right hand of the page for many more entries - be sure to click the
“This site” button.