GE Launches CARESCAPE – Sort Of

Posted by Tim Gee on May 28, 2007 in Company Profiles | 0 comments

A flurry of press releases over the weekend caught my eye, announcing that the FDA has given pre market approval to GE for their CARESCAPE Patient Data Module. Naturally curious, I started poking around. First things first; the CARESCAPE Patient Data Module is apparently a battery powered data capture device that is somehow attached to GE patient monitors that are connected to the patient as the patient moves through their hospital stay – presumably connected to a variety of patient monitors along the way. The module holds 24 hours of data (at least 3 days shy of U.S. hospitals ALOS – average length of stay). From the press release:

Marquette Medical introduced the modular Tram architecture 10 years ago, and this appears to be as much a refresh as a new module. An alternative approach would be to wirelessly acquire patient monitoring data and make it available to all clinicians over the network, rather than just the nurse at the bedside. Certainly there are use-models where wireless connectivity is not practical – like pre hospital monitoring – so local 24 hour trending and waveform review is a good thing.

Scrolling down the press release I came across this:

Hmmmm, I've never heard of a CARESCAPE portfolio, and a quick Google search found no mention of CARESCAPE prior to this press release on the Patient Data Module. In fact, there's not a single occurrence of the word “CARESCAPE” on GEHealthcare's website. The portfolio is apparently made up of GE's existing CIC central station, iPanel, enterprise networking (GE requires their own subnet), and the ability to view data on a variety of mobile devices. No mention of alarm notification – probably the most important mobile data application in patient monitoring. The end of the press release promises, “Additional information about the CARESCAPE portfolio and GE Healthcare’s
approach to patient monitoring can be viewed at www.gehealthcare.com” – good luck with that.

Now just about any product manager or market manager who's been in the medical device field for a few years can relate at least one product introduction horror story. Typically, product development schedules slide and run into revenue forecast expectations, resulting in some sort of product launch that becomes a “hail Mary” attempt to meet forecast. I'm not saying that's what happened here – I really don't know – but this is clearly not GE's best product launch. You can expect to see one or (probably) more “re-introductions” of CARESCAPE in the coming months.

There are no “re-dos” when it comes to product introductions. And re-introductions (individually or cumulatively) never provide the impact and results of launching a product right the first time. Pictured right is a TRAM module providing Masimo SpO2.

UPDATE: I have come accross this additional reference to CARESCAPE (below the photos of the Hospira GemStar pumps), in this May 2007 story on “flexible monitoirng” in Healthcare Purchasing News. Let me know if I've missed anything else…

UPDATE: Reader John Richards at UCSF provides the following information:

Thanks John! I too have heard that this is a re branding effort and that, with the exception of the Patient Data Module, nothing is new. I've also heard that GE has some interesting new things in the hopper for patient monitoring. Maybe we'll hear something official at AAMI.

Welch Allyn Launches Clinical Notification System

Posted by Tim Gee on May 24, 2007 in Company Profiles, Real Time Location Systems | 0 comments

At the AACN/NTI, Welch Allyn launched the alarm notification system that was shown for the first time at HIMSS in New Orleans. Alarm notification has been a persistent patient safety issue of such magnitude that the Joint Commission added it to their National Patient Safety Goals in 2003 and 2004.

Conventional alarm notification can be local, i.e., the alarm is annunciated at the device; alarms can be conveyed to a central station; and sometimes includes message panels, lights and annunciators distributed throughout the unit. Of course, all the flashing lights, alarms and blinking message panels contribut to alarm fatigue – a major factor in adverse events and failure to rescue.

The optimal solution for safe and effective alarm notification is to deliver the alarm directly to the responsible caregiver, where ever they are on the unit. The first vendor with this kind of alarm notification was Baxter with their Colleague “smart” pump – they use a Symbol PDA that receives alarms based on nurse to patient assignments. Welch Allyn is the first patient monitoring vendor with such a solution.

The AcuityLink clinical notification system provides alarm notification and escalation for life critical alarms, as well as near real time surveillance of moving waveforms from one to several patients. The system is designed to be safe and effective in a wireless environment where caregivers go in and out of wireless coverage and may leave the unit to transport a patient or take a break. The system has pre market approval via a 510(k) for alarm notification. In recognition that caregivers can't carry a PDA dedicated to each of the medical device vendors on their unit, AcuityLink does not preclude customers from loading and running third party software on the PDA. (In contrast, the Baxter PDA is “locked” and must be dedicated to running Baxter's application.)

Here's a link to an “editorially massaged” version of the press release, and an apparently unmodified press release. I looked for a copy of the press release and product information on the Welch Allyn sites (corporate and monitoring) and couldn't find a thing. Perhaps someone can send me a link once something is up.

Pictured right is the AcuityLink PDA (really a HandHeld Products 7900) showing a snippet of ECG waveform that accompanies each alarm – this provides the caregiver an opportunity to determine if the alarm is a false positive (a frequent occurrence that results from patient movement) or an actual alarm. Shot at HIMSS 2007.

UPDATE: If you're interested in alarm notification, alarm fatigue and the future direction of medical device alarms, check out this article I wrote for Patient Safety & Quality Healthcare magazine, called Trends in Point-of-Care Alarm Notification.

Commenter Dave Hoglund mentions the Philips-Cisco-Emergin integration that provided alarm notification with a sample waveform on a Cisco wireless VoIP phone (using Emergin middleware) . This was shown a couple years ago at HIMSS in Dallas and made it's way into a Cisco brochure.

First off, alarm notification is unambiguously a “medical device” as defined by law and thus requires pre market approval by the FDA. Secondary alarm notification is a term of art created by vendors who sell alarm notification without pre market approval – the continued existence of this class of product is a consequence of the FDAs decision to look the other way if the alarm is simply a text alarm and does not include waveforms. I think the FDAs position is pretty smart – “secondary” alarm notification does provide some benefit, and the public's interest is probably not best served by yanking all those products from the market. At the same time, regulated alarm notification systems with proven safety and effectiveness (a consequence of pre market approval) better serves the public interest, so vendors are being pushed in that direction. To effect this push the FDA has been rapping knuckles when secondary alarm notification systems include waveforms. Alarm notification for many types of alarms are of limited utility without presenting a waveform with the alarm to filter out false/positive alarms; the market wants waveforms.

In the Philips-Cisco-Emergin example that Dave mentions, Philips was in the best position to 1) know that a 510(k) was required, and 2) to actually get pre market approval for the alarm notification feature. It certainly does not make sense for Cisco to get a 510(k) on their wireless VoIP phone as a medical device. As an event management middleware vendor targeting hospitals, a case could be made for Emergin to get a 510(k) – many events that occur at the point of care could theoretically fall under the legal definition of a medical device – but this is not necessary either.

There is a savvy product strategy in all of this somewhere – actually more than one.

Summer Conference Schedule

Posted by Tim Gee on May 23, 2007 in Standards & Regulatory | 0 comments

The summer is shaping up to be a busy one. Next month, I'll be presenting at the AAMI meeting in Boston on the topic of Point of Care Automation – with clinical engineering icon, Yadin David. There are a number of very interesting sessions scheduled on connectivity, systems integration and patient safety. This is always a great event, and I'm really looking forward to all the new research, best practices and products.

A week later I'll be back in Boston for the HCMDSS/MD PnP conference (that's High Confidence Medical Devices, Software and Systems/Medical Device Plug and Play). This event has pulled in a number of luminary figures keen on interoperability and error-resistant systems in health care – including Dr Robert Kolodner. Past meetings have been dominated by academics, providers (especially the big university teaching hospitals) and government – it will be interesting gage the level of vendor involvement. The current commercial availability of interoperability features is certainly not a result of insufficient science or technology, so a lack of vendor interest could be indicative of their relative interest in interoperability. Conference co-chair, Julian Goldman has promised me there will be some interesting announcements at the conference.

Then in July I'll be co-chairing a track at the fourth annual Healthcare Unbound conference, for the first time in San Francisco. Last year was my first involvement with this event, and I was impressed. This is probably the most focused annual event on remote patient monitoring and chronic disease management in existence – with a great mix of providers, vendors, academics, government and a few VCs sniffing around.

Fortunately there's nothing planned for August – too hot. And September I'll be taking off a couple weeks to go to the desert in Nevada. And all of this is in addition to client work – it's shaping up as a very busy summer.

Pictured right is the Ant radio for wireless sensors and personal area network applications, shot at last years Healthcare Unbound conference.

Feds to Stop Paying for Medical Errors

Posted by Tim Gee on May 23, 2007 in Patient Safety | 0 comments

Overall patient safety in hospitals is not improving. The latest HealthGrades report on patient safety in U.S. hospitals showed the PSI (AHRQ’s patient safety index) rate increased 8% between 2003 and 2005 (more here). The lack of significant progress with patient safety has caused some to ask why payors reimburse hospitals for the additional care necessary after a patient suffers a preventable adverse event. It seems payors are starting to ask themselves this very question – according to this Indianapolis Star story:

Late next year Medicare plans to stop paying hospitals for costs incurred from some of the most common and preventable medical errors suffered by patients.[...]

The federal Centers for Medicare and Medicaid Services, which operates Medicare, is taking public comment on the proposal through June. The changes are scheduled to take effect in October 2008.

Medical mistakes are deadly and expensive. Infections acquired in hospitals account for about 90,000 deaths and $4.5 billion in extra spending each year, according to the U.S. Centers for Disease Control and Prevention.

Presently there are no financial penalties for hospitals when preventable misadventures occur. The hospital simply recodes the diagnosis and receives reimbursement for the additional length of stay and treatment required to treat the adverse event. It is true that hospitals have an incentive to avoid preventable adverse events; reduced length of stay can translate into higher utilization, increasing revenue. Unfortunately, most hospital administrators are more focused on cost reduction than revenue growth, and (if recent reports on patient safety “improvements” are to be believed) the stick – reduced reimbursement – will probably offer an incentive than the carrot.

The idea of not paying for mistakes probably started back in 2002 when the National Quality Forum sought to standardize adverse event reporting with their report, Serious Reportable Events in Healthcare (Word document). This report included their list of 27 things that should never happen. CMS is starting with a subset of the list. Here are the 13 “never should happen” adverse events that CMS is considering for no reimbursement:

1. Catheter-associated urinary tract infections
2. Bed sores
3. Objects left in after surgery
4. Air embolism, or bubbles, in bloodstream from injection
5. Patients given incompatible blood type
6. Bloodstream staph infection
7. Ventilator-associated pneumonia
8. Vascular-catheter-associated infection
9. Clostridium difficile-associated disease (gastrointestinal infections)
10. Drug-resistant staph infection
11. Surgical site infections
12. Wrong surgery
13. Falls

Starting to withold payment for adverse events will impact the health care industry as much as DRGs and capitation did years ago. Many “old school” hospital administration management techniques will fall from favor because doing things like increasing nurse to patient ratios have been repeatedly shown to result in more adverse events. This change will also eliminate the need to regulate nurse to patient ratios, like they have in California and a few other states – hospitals that operate at unsafe ratios this will go out of business (as they should).

Every hospital wants to make improvements that are easy and cost next to nothing. One of the frustrations of being a consultant is doing the needs assessment, the cost justification, and the implementation plan only to hear that, “that’s really too much trouble – we don’t want to do it.” Of course it’s even worse if you’re employed by the hospital (or vendor) as part of a LEAN team or innovation workgroup.

I’ll be watching for the fall out from this new trend – if you come across something, be sure to let me know! Pictured right is an example of an engineering feasibility project with great patient safety potential – interoperability between a Baxter infusion pump and Philips patient monitor. This was shot at the 2005 AACN/NTI meeting – interoperability of this type has yet to make it to the market in a commercially released product.

UPDATE: Here’s the CMS notice titled, “Proposed Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2008 Rates” that was published in the Federal Register on May 3, 2007. Do an Edit-Find (or Cntrl-F) and use the phrase “hospital-acquired conditions” to find the part that pertains to the 13 adverse events that CMS will not reimburse starting in 2008.

UPDATE: Welcome WEDI listserv! Should providers be reimbursed for preventable adverse events? How soon will commercial payers follow suit? Will this change provider behavior and improve safety? Hit the comments link and share your opinion.

[Hat tip: FierceHealthIT]

UPDATE: Read a subsequent post on this topic here.

Medical Device Connectivity and PACS

Posted by Tim Gee on May 23, 2007 in Uncategorized | 0 comments

Mike Gray continues to evangelize DICOM Archives (his latest here and here-registration required) – which I think has interesting parallels with medical devices at the point of care.

Imaging modalities are obviously the medical devices, similar to patient monitors, point of care diagnostics, pumps, vents, etc. at the point of care. The Picture Archiving and Communications System is equivalent to the servers that many of these medical devices communicate, storing data for surveillance, alarm notification and retrospective analysis. The medical device data stored on some device servers are of little value beyond the immediate future (like full disclosure waveform data), while other data has greater long term value (like the CQI data collected by “smart” pumps).

As the servers connected to medical devices proliferate, hospitals will increasingly face the prospect of migrating data from one vendor's server to another. I would imagine some vendors will refuse to offer any migration assistance – what's in it for them? In the radiology world, many migrations are handled by third parties. Here Mike describes the latest evolution in the PACS world:

Mike uses the term “tag morphing” to describe this translation between proprietary data formats contained in otherwise DICOM compliant records. Imagine tag morphing between smart pump servers for migration. Even more radical, imagine a tag morphing server that simply talks to multiple vendor's medical devices just like a PACS.

Hmmm.