Connectivity for Ventilators
John Zaleski over at MedicInfoTech has an interesting post on the design for a central surveillance system that supports ventilators from multiple vendors. Referred to as the Remote Mechanical Ventilation Manager, the system is a rather conventional affair similar to systems for patient monitoring. The system assumes RS232 interfaces on the ventilators.
Changes in hospitals over the past few years have heightened the market requirement for ventilator connectivity. Once limited to critical care areas, ventilated patients who don't require the 1:1 nurse to patient ratio of an ICU have increasingly been transferred to lower acuity on-service units or general care wards. Patients that were once found in highly concentrated locations are now all over the hospital, presenting challenges for respiratory techs and the busy nurses that provide their immediate care.
RTs typically have no visibility into the status of their ventilated patients, until they receive a page or are at the patient's bedside. This lack of data – real time performance, ventilator settings, alarms, and orders for therapy or care – creates an environment in which human error can flourish.
An increasing burden has also fallen on the staff nurse who must juggle the care and vigilance for 5 to 8 patients and keep track of a ventilated patient. The lack of alarm notification beyond local alarms on the device places a special burden on the unit to place ventilated patients where alarms can heard. Coordinating care with respiratory therapy and consulting pulmonologists represents additional complexity. Finally, documentation of ventilator settings, therapies and any resulting clinically significant alarms adds to RT and caregiver documentation responsibilities.
CMS' recent IPPS draft rules for 2008 include provisions for no longer reimbursing hospitals for preventable adverse events. On this list of 13 “hospital-acquired conditions” is ventilator acquired pneumonia (number 7 on the list). As hospitals realize that they will be at greater risk financially with ventilated patients, the need to automate care, surveillance, and alarm notification will increase dramatically.
All this unmet market need creates both opportunity and risk for ventilator vendors. The opportunity revolves around leveraging connectivity features to differentiate and offer unique capabilities. The risk is that competitors may field connectivity features first and lock you out of and increasing number of sales situations. Basic connectivity features fall into a few categories:
- Surveillance: the ability to remotely view ventilator settings, performance, alarms from locations like RT areas and nursing stations.
- Alarm notification: alarm annunciation communicated to the caregiver.
- Event review: the ability to look at past changes in patient condition and response to various therapies, alarms and other pertinent events.
- HL7 interface: used to export ventilator data to the patient chart and pull in patient demographics for patient identification.
- Remote access: a web server that provides clinicians the ability to view near real time patient data anywhere there is network connectivity, event across the Internet.
- Wireless: since RTs and caregivers are almost continuously mobile, you get extra points for wireless enablement of ventilators and the above connectivity features.
The ventilator market is one of the few medical device markets that has avoided “standardization” – where hospitals standardize on just one vendor's products. Proprietary end-to-end connectivity systems could drive hospitals to standardize, possibly squeezing out niche vendors. Note that John's paper shows an installation made up of both Puritan-Bennett and Siemens vents.
Pictured right are a few of the many ventilators found in Cardiopulmonary Corps' integration lab. Cardiopulmonary provides a vendor neutral RT information system called Bernoulli.
Patent Reform Shakes Up Device Vendors
Medical Devices Today reports that identical bills introduced in the House and Senate April 18 (HR 1908
and S 1145) could weaken the value of patents and jeopardize firms' access to venture capital. The reforms are backed by IT giants like Microsoft, Cisco Systems
and Intel. Sponsors say the legislation will prevent litigation abuses
and increase patent quality. There are three primary changes in the draft legislation.
Infringement Penalties
One key change to the patent system included in the legislation
would be to base penalties for infringement on the isolated value of
the patent in question instead of the value the patent may add to the
overall product, a guiding consideration under current practice. As a
result, awards would likely be smaller.
This so-called “apportionment” provision was included at the behest
of information technology firms that have had to pay damages that some
say are far greater than the worth of the minor patent involved.
However, in the medical device arena, “there is this iterative
process [where] one minor improvement can really mean the difference of
tremendous additional sales in the marketplace,” Leahy explained. “We
feel that the overall value should be captured.”
Another far-reaching provision in the bills would establish a
“post-grant opposition” system under which patents could be challenged
through the Patent and Trademark Office instead of in court. The idea
is to offer parties an alternative to high-cost litigation.
Patent Challenges
The provision would allow persons to petition the patent office to
cancel a patent during the first 12 months after it is granted. Then a
“second window” would open for the rest of the patent's lifetime
whereby anyone at risk of “significant economic harm” could challenge
the patent's validity.
MDMA and other med-tech groups are particularly concerned about the
“second window” provision. While petitioning through this patent-office
avenue would preclude one's ability to make the same challenge in
court, device stakeholders are concerned that the open-ended timeframe
will lower the value of their patents by creating uncertainty about
their long-term stability.
Changes Regarding Patent Continuations
A third major provision in the bill grants the patent office
explicit rulemaking authority. Stakeholders believe this is a backdoor
way of finalizing the office's January 2006 proposal to limit the
number of continuations a firm can file on any one patent application.
Continuation applications allow firms over time to add new
knowledge, discoveries and innovations to the original “parent
application.” Such applications are commonplace for medical devices,
but the patent office's proposal would allow firms to file only one
continuation per parent application. The proposed change provoked
criticism from hundreds of stakeholders.
Continuation applications give firms the flexibility to modify
claims as their inventions develop, and Leahey explained they can
reduce the upfront cost of filing for patents by allowing firms with
limited resources to build their patent portfolios over time.
The legislation is quickly moving ahead; device vendors and others are scrambling.
Summary of IPPS Proposed Rule
You can find a pretty comprehensive report on the proposed reimbursement changes for 2008. The report was written by Larry Goldberg, senior advisor for health care
legislative and regulatory matters at Grant Thornton, LLC, an accounting, tax and business advisory firm.
[Hat tip: S-DRG Report]
Pay for Performance No Guarantee
Researchers led by the Duke Clinical Research Institute looked at whether paying hospitals extra for following specific treatment guidelines
would improve patient outcomes, and you know, reduce costs. “They found no evidence that financial incentives were associated with
improved outcomes, nor that hospitals had shifted their focus from
other areas in order to concentrate on the areas being evaluated for
possible increased payments.”
hospitals participating in a large Center for Medicare & Medicaid
Services (CMS) pilot project of pay for performance, found that paying
hospitals extra money for following specific guidelines led to better
patient care and outcomes. However, that study did not include a group
of hospitals not receiving incentives as a comparison. So the Duke team
compared the CMS data with that of a registry of 105,383 patients
treated for a heart attack at 500 hospitals involved in a national
quality improvement effort.
Did the Premier study fall victim to the Hawthorne effect? Researchers also made three important points about their study relative to the Premier study.
- “On one hand, the data showed that care is improving overall in the
United States, which is obviously good. However, we did not find that
pay for performance alone will be the sole means of improving care. In
fact, it all comes down to hard work by individual caregivers and
institutions.” [Imagine that.] - It appears that a voluntary effort to 'do good and improve care' [were] equally as powerful as the incentive for additional payment.
- Heart attack mortality declined significantly over time in
pay-for-performance and non-pay-for-performance hospitals over time
with better care processes.
Two things strike me. First, there is no silver bullet to improving patient safety and outcomes. Pay for performance is a novel incentive of some value, a carrot if you will, and CMS' proposal to stop reimbursing hospitals for the cost to treat patient's that the hospital itself has injured (initially, the 13 hospital-acquired conditions) adds a stick to the government's armamentarium to improve outcomes. A carrot and a stick together is always better than just one or the other.
I'm also struck by the admirable scientific bent physicians to apply to, well everything. According to one researcher, “…what we really need a robust research base to inform the design of
the program and clearly we need to continuously monitor performance to
ensure that we are achieving our clinical goals through these efforts.” To paraphrase, if your tool for studying change is the scientific method, then everything requires a randomized controlled double blind trial. What we need to apply to our persistent patient safety and outcomes problem is some engineering - specifically safety engineering. This is not rocket science, and has been done much more successfully in aerospace for decades.
Motion C5 In Action at HIMSS 2007
This clip was shot at HIMSS 2007 in New Orleans, with Joel French, VP and GM of the health care business group at Motion Computing. Joel was kind enough to take the new C5 tablet through its paces.
I've been fiddling around with video clips since, well HIMSS, and have finally worked out the kinks. More to come.
