Study Looks at Cost of Adverse Events
Medicare pays hospitals $300 million a year to treat adverse events. Unfortunately for hospitals those payments cover less than a third of the additional treatment costs for patients after an adverse events.
and paying providers for high-quality care, Medicare pays hospitals a
substantial amount of money for adverse events that occur during
hospitalization, according to a new AHRQ study published in the
September/October issue of Health Affairs. The study found that
Medicare paid an additional $300 million per year, or 0.3 percent of annual
Medicare hospital spending, for five types of adverse events in hospitals in
2003. However, these extra payments covered less than one-third of the
additional costs that hospitals incurred in treating these adverse events. Under
Medicare's hospital payment system, hospitals are reimbursed a set amount for a
patient's condition or Diagnosis-Related Group (DRG), determined at admission.
The study by AHRQ's Chunliu Zhan, M.D., Ph.D., found the DRG changed only in a
small number of cases. For example, the DRG changed in only 1 percent of cases
where a patient had post-operative bloodstream infections and 10 percent for
patients who experienced post-operative bleeding. Even if the DRG doesn't
change, adverse events may result in additional costs, for example if the
patient needs to spend more time in the hospital.
You can read an abstract
of the study, “Medicare Payment for Selected Adverse Events: Building the
Business Case for Investing in Patient Safety” to get a feel for potential ROIs from patient safety improvements.
Why Some Vendors Really Like WiFi Dongles
I was talking with a clinical engineer the other day about the scourge of connectivity, the dongle. Also known as a wart or pustule, this is a wireless radio wrapped in a little box and stuck onto the back of a medical device. Now if you're wirelessly enabling legacy devices (either devices you already own, or devices currently sold by vendors) a dongle makes sense – it's certainly preferable to those serial cables that caregivers are always yanking out of the wall.
What caught my attention was the excuse that a number of vendors have given this biomed for using dongles in place of, you know, actually building the WiFi radio into the device. Much like with patching operating systems, the convenient excuse was our friends at the FDA. “We can't build the radio into the device because then the FDA would require that we file a new 510(k),” is what a number of vendors claimed. That is so wrong.
First, from a regulatory perspective, the requirements for filing a new 510(k) are based on changes to the device – in this case, wireless enablement. The impact of regulations is not dependent on whether the radio is attached on the outside, or integrated within the case. A substantially new medical device (as opposed to “re-skinning” an existing product) requires a new 510(k) anyway. Even the minor changes involved in re-skinning a device can trigger a new 510(k) if, like most vendors, there are already too many letters-to-file on the device. Any vendor who thinks they can take a device with a serial port and add WiFi connectivity without a 510(k) can expect some 483s (or worse) from their next FDA inspection.
The real reason some vendors want to use a dongle is captured by three little words, cost-of-goods (COGs). Most current medical devices are designed for worldwide markets, and outside the developed nations it's all about COGs. Since the vast majority of radios and radio chips are designed for general purpose computing platforms, they expect the host processor (in this case the medical device's CPU) to provide memory and processing for things like encryption, authentication, and quality of service. This additional processing overhead frequently means a more expensive processor must be used (which could also require changing the operating system), and the additional cost of more memory. As a result, even devices sold without the radio option cost more than a similar device that do not support radio capabilities. Sales and product managers can gnash their teeth and pull their hair all they want, but getting a program manager to increase his COGs – especially if you're “changing requirements” – can be darn near impossible.
So, what can you do, use a dongle like this one? Building two products (one with, and one without radio support) is too expensive. If you build in radio support, your ROW (rest of world) COGs are high, and if you use a serial-to-WiFi wart, your wireless solution is less competitive.
There are ways around this conundrum, but they are not easy either. If you're curious about some of those ways, give me a call.
You can expect the best connectivity features from the few vendors who really understand connectivity – everyone else will put off taking the plunge as long as they can, and when they do adopt, they will take the easy route – warts. A key competitive race (and one many vendors aren't looking forward to running) is developing a core competency in connectivity – good connectivity in products, along with the ability to properly sell (dealing with IT), install (especially systems and network integration), and support (good log files, remote access, IT-knowledgeable service techs).
Connectivity is a tall order, and the proliferation of warts on new or “upgraded” products indicates how far the industry has yet to progress. Pictured right is the DPAC serial-to-WiFi external dongle module.
Biotronik Releases New ICD and Home Monitoring System
Biotronik has released a snazzy new ICD (implantable cardioverter defibrillator) that is the first implant to send ECG data automatically when it detects a heart rhythm disorder. Other vendor's products typically transfer data at a predetermined period, like at night as the patient sleeps near a receiver/gateway device. Along with this advancement in implantable sensor communications, Biotronik uses the Cardio Messenger as a gateway. The Cardio Messenger is designed to be carried by the patient, and transmit data over GPRS (T-Mobile) to an online patient record that's managed by Biotronik in Germany. A phone line can also be attached to the Cardio Messenger's dock if cellular service is not available.
This more immediate form of communications has clinical benefits. Many arrhythmias are not felt by the patient – they don't know to press an event marker button.
fibrillation,” says Dr Leal of the Hospital Universitario de Valme in
Seville. “Automatic transfer of the ECG data opens up new possibilities
for the diagnosis of atrial fibrillation. We are immediately informed
on the disorder, and do not wait until the next routine check-up to
initiate the appropriate therapy,” Dr Leal further says. The RIONI
study, which involved 347 patients, showed that atrial fibrillation can
be correctly classified in dual chamber ICDs via IEGM Online in 100
percent of cases.
Combined with the ICD's improved communications abilities, Biotronik's online data management application provides cardiologist's with a better way to manage pacemaker patients.
follow up, as remote diagnosis enables physicians to be continuously
informed on their patients’ health status. In case of any rhythm
disorder in either the atrium or the ventricle, the integrated GPRS
technology automatically sends ECGs of both chambers to BIOTRONIK’s
service center. The physician’s monitor can display more than 30
seconds of IEGM [intracardiac ECG] Online. The intracardiac ECG reflects both the onset
time (period before the rhythm disorder) and the phase after
termination of the event, thus considerably improving the physician’s
diagnostic scope. Moreover, the cardiologist may analyze the ICD’s
programming at any time using the Internet.
Along with the online information system, the Lumax ICD's event driven communications may possibly reduce care delivery costs.
consult their physicians when it is really necessary – clinics and
hospitals can manage their human resources more efficiently. Every
consultation costs time and money, and is a burden for the patients as
it reduces their working or leisure time.
With the Internet-based Home Monitoring technology, BIOTRONIK [...] supports clinics and
physicians who intend to develop efficient disease management programs.
The cardiologists receive pertinent and precise data, and can implement
intelligent data management procedures. A simplified and comfortable
user-interface, multiple automatic triggers for event monitoring, and
an intelligent energy management that leaves the battery service life
practically unaffected by the device’s enhanced functionality, are
further assets of the Home Monitoring technology.
Continuous monitoring of patients with heart rhythm disorders has
already demonstrated its superiority in clinical practice. Each month,
more than 2,000 new patients benefit from the advantages of the Home
Monitoring technology. Some 250,000 people worldwide will receive an
ICD by the end of the year.
Pictured right is the Cardio Messenger taken when I had an opportunity to examine one in the wild.
