Grand Rounds
I will be hosting the next Grand Rounds (number 41). Please send your submissions to tim@medicalconnectivity.com by 5pm Monday the Fourth of July. Thanks!
User Errors and Medical Devices
Tom Quinn has lead a recent discussion on the Biomed Listserv about the FDA and medical device safety. In his reading of the FDA's CDRH Annual Report for 2004,
the FDA attributes user error as the key factor in most complaints and
adverse events. (Tom, I hope I haven't put words in your mouth. Correct
me if I'm wrong.)
Having participated in adverse event investigations from the vendor
side, frequently the product performed as specified and the resulting
event was put down to “user error”.
These errors are all over the board. In one case that made the national
press recently, a hospital bought a telemetry system with no arrhythmia
analysis software, contributing to a number of patient deaths. I've
seen examples of failure to rescue due to the way alarms were
configured (alarm priorities and levels set in such a way that created
alarm fatigue and masking of alarms resulting in sentinel events).
There have also been more egregious situations where alarms were turned
off or ignored.
The obvious problem revolves around product design and end user
training. Clearly design influences usability, training requirements
and
susceptibility to user error. Design impact on the actual use of a
product is qualitative and hard to judge. I think there's an untapped
need for some professional organization or non profit to look into
usability factors, best practices, and vendor performance in this area
(ECRI?).
Part of the problem is that many medical devices have moved beyond
standalone boxes to become systems with networks, servers, client
applications, and interfaces to other systems that impact patient care.
This ever expanding notion of a “medical device” adds considerable
variability regarding installation, deployment, configuration, and use.
It is market requirements that drive the development of flexible and
highly configurable systems, to both meet a broad range of end user
workflows and to broaden the market appeal for vendor's products.
Vendors make recommendations on system configuration upon installation.
Sometimes customers ignore the vendor's advice, and sometimes things
like patient acuity, case mix or staff experience change over time
rendering initial configurations inadequate.
Finally we come to that actions (or inactions) of users. Like any tool,
a medical device can be used well or poorly. Some errors are honest
mistakes and others are truly negligent. I'm not sure
the FDA is the place to make those judgments and mete out punishment.
Negligence is already punished through criminal and civil means.
Rather than consider this a regulatory oversight problem, the industry
has taken a “safety improvement” approach. Hospital accreditation and
numerous patient safety initiatives are focused on proper policy and
procedures, training and data gathering to close the loop on problems
that occur in patient care. There's also been a lot said about creating
an environment for safety improvement that encourages problem reporting
and the open consideration of ways to improve patient safety. The
industry is trying to avoid a witch hunt mentality where caregivers are
afraid to raise problems and safety issues.
It's almost as if today's more pervasive and connected devices
disappear into the overall diagnostic and patient care process,
rendering user error as much a function of workflow and how care is delivered as it
is product design.
Delphi Medical Systems Acquires Caretools
Dephi Medical Systems seems to be making all the right moves, as they take their licensing deal with Caretools up a notch to outright acquisition.
the only provider of easy-to-use handheld devices that can monitor and
provide 2-way communication with a variety of medical devices,” said
Christophe Sevrain, Delphi Medical Systems managing director.
The software will soon be enhanced to provide short- and long-range
digital communication between the care provider and I.V. pumps, vital
signs monitors, respiratory devices, and dialysis equipment, all of
which are supplied by Delphi Medical. Medical devices made by other
companies can also be connected to the software. These medical devices
are used in alternate sites such as long-term care facilities, nursing
homes, doctors' offices, specialized clinics, and ambulatory care
vehicles.
The feature set they're building is needed across the health care
continuum, from home to hospital. If they can develop products that
delivers the above promise, at a price that their stated target markets
can afford, that will be a remarkable achievement. I know a few larger
established medical device vendors that wish they were working on half
of what Delphi's doing. I can't imagine Delphi not considering the much
larger hospital market for their suite of products.
Delphi has a corporate history as an OEM vendor, supplying core
technologies that go into larger products. But, rather than developing
traditional OEM modules like SpO2, NIBP, ECG
front ends, etc., they're pulling together what looks like the first
products to span the patient monitor-ventilator-IV pump market
segments. This
combo of therapeutic and surveillance devices could be very powerful.
The challenge is finding the right distribution strategy. Their stated
target market segments work well with an indirect distribution
strategy. However, hospitals are mostly a direct sales market. If they
can find a partner with a strong direct sales channel into hospitals
who's able to sell Delphi's complete medical device portfolio including
the connectivity to support caregivers at the point of care — wow,
talk about a paradigm shift.
Hospital Uses Software to Turn Networked PCs Into Virtual Paging System
Jane Phillips Medical Center (JPMC) is using AT&T Natural Voices from Wizzard Software
to announce codes and other overhead pages. JPMC was experiencing
inadequate paging coverage because some areas of the hospital cannot
hear overhead pages. They even experienced a total paging system
failure. Their solution was to annunciate pages through PCs connected
to the hospital's network.
Natural Voices to enable it with a highly intelligible,
natural-sounding voice. To send a message throughout the hospital, an
operator chooses the appropriate code color from a visual selection and
types the location of the alert. The message can be as simple as “Code
Blue Room 671″, or more complex like “First Responders – Front entrance
of the medical ark center.” The message is broadcast across the network
and a listening module in each client computer grabs the information,
brings up a color-coded window on the screen, and speaks the message in
a clear, natural-sounding voice. All hospital employees within earshot
of a computer will hear the message.
Newark Beth Israel Medical Center Implements Galvanon's MediKiosk
Making the transition from a kiosk vendor to a “patient experience company,” Galvanon has announced the implementation of their kiosks by Newark Beth Israel. Patients use the kiosks to identify patients during the check-in process, gather necessary forms
and signatures and collect co-payments and outstanding balances.
Center has experienced significant administrative and financial
benefits, and will continue to see increased staff productivity and
reduced paper and printing costs. Patient check in time has also been
reduced by 25% for first-time patients, and by 75% for subsequent
visits.
Newark Beth Israel Medical Center also uses SCI systems (formerly
scheduling.com), a Galvanon strategic business partner, for enterprise
scheduling and pre-registration. This partnership provides added value
for patients, including the ability to pre-register online prior to
their visit to the hospital. All demographic, history and insurance
information is then stored in the system for future appointments,
eliminating the need to complete paperwork at every visit and thus
improving patient satisfaction.
