Hospira Acquires EndoTool
On Oct. 13, 2008 Hospira announced that it had acquired the EndoTool business from MD Scientific. (Press release) The EndoTool glucose management system is software used to determine optimal insulin dosages to help establish and maintain glycemic control. Target markets for the product include critical care and surgery, as well as lower acuity areas on hospitals. Hospitals are also considering use EndoTool in Labor and Delivery. The product was launched 18 months ago by MD Scientific, and seen increadible adoption (60 hospitals currently). The product won’t be “relaunched” under the Hospira brand. You can read the publicly available FDA 510k stuff here.
Software designed to support the application of clinical protocols has been in the works from various vendors. Patient monitoring examples include Philips Protocol Watch, soft-launched back in February 2007, and . These applications automate what are otherwise onerous manual calculations with data acquired from medical devices and integrated with data from other information systems. This is workflow automation of the most important kind, diagnosis and therapy delivery. These applications are typically regulated as Class II medical devices.
Last week I spoke with Philip Settimi, MD, vice president of global strategic marketing for Hospira. According to Settimi, “EndoTool replaces spreadsheets of physician preferences and worksheets full of manual calculations for managing patient glucose levels.” Such manual methods are obviously inefficient, but also susceptible to human error. This approach provides an effective tool to impose a controlled and centralized tool for managing tight glycemic control (TGC). Endo Tool comes with a specific protocol based on sophisticated algorithms to support glucose management. The key: taking all that complexity (the calcs) at the point of care and automating those 33 different non-linear equations.
Barcoding and Patient Context
One of the most important areas of connectivity, and one that frequently does not receive the attention it deserves, is establishing and maintaining patient context. Historically, connected devices identified data by location – tagging data with a bed or even port number – rather than the actual patient name or ID. Because patients are frequently moved during an episode of care – not to mention ambulatory – data that is only tagged with a location presents risks of misidentification. In an effort to improve positive patient identification, data is increasingly tagged with a patient identifier.
Besides patient safety, patient context also greatly impacts medical device workflow. (Medical device connectivity is workflow automation through the integration of medical devices and information systems.) How a vendor implements patient context can have a big impact on usability and customer acceptance.
Patient context requirements can vary, based on the type of medical device in question. What is not variable is the requirement to reliably establish and maintain context. Mobile applications (like smart pumps or patient monitoring) where the device may go in and out of network coverage while constantly in use present special challenges. This compares to a fixed or portable medical device, like a dialysis machine or diagnostic ultrasound, with an episodic use case during which neither the device or patient is moved. Another variable is whether the application is life-critical. Continuous patient monitoring and many alarms (e.g., smart pumps and ventilators) are life-critical applications with a higher threshold of requirements. This contrasts with connectivity for documentation like with point of care testing or spot vital signs capture. In all cases though, patient context must be safe and reliable. The above issues just help define how many hoops you have to jump through to be safe and reliable.
Pressure to Increase Hospital Patient Safety Reporting Grows
Washington state governor, Christine Gregoire, has proposed legislation mandating hospital reporting of all adverse events. From the Seattle Post Intelligencer:
[...] Gregoire said she expects full public access to hospitals’ track
records to be done without extra cost to the state treasury. She said
she will introduce legislation giving consumers information about
“adverse events,” such as infections or patient deaths, at each
hospital.”With full disclosure, the health care system can
learn from its mistakes and prevent new ones,” Gregoire said in a
policy paper released by her office.
Such reporting could motivate hospitals to undertake difficult cultural changes and invest in products that will improve patient safety. The best run hospitals, with the appropriate technologies, could better compete with hospitals in their markets if prospective patients knew hospitals’ adverse event track records.
I’ve mentioned before (here, here and here for 3 recent examples) how transparency pressures will shine a bright light on adverse events through increased reporting. This won’t be an easy transition, but the industry will be better for it. I mean we’re here to save lives, right?
Effect of Environmental Design on Reducing Nursing and Medication Errors
Are you at a hospital that is planning new construction or renovation? Are you a vendor with a product or service that’s used at the point of care in hospitals? You should check out the latest survey from The Center for Healthcare Design, the Effect of Environmental Design on Reducing Nursing Errors in Acute Care Settings. You can get your copy for $35.
With the U.S. market in the midst of a hospital building boom, the environment at the point of care is changing. Variable acuity units (aka, universal beds or rooms), distributed nursing units, and other big changes are being adopted now. These changes will impact market requirements for both medical devices and health care IT.
You have been warned.
The Value of Unique Device Identification
Is there a need to better track the use of medical devices? You bet. Besides tracking implantables for post market surveillance and recalls, tracking medical devices used at the point of care can reduce the risk of infections like methicillin-resistant Staphylococcus aureus (MSRA) through physical contact and cross contamination. There are no national hospital reporting requirements, and few state requirements for these infections. This story in the Baltimore Sun reports on a news study released by the CDC on MSRA infections:
“This is the first time that we’ve been able to measure the number of infections,” said the study’s lead author, Dr. R. Monina Klevens, an epidemiologist with the federal Centers for Disease Control and
Prevention. “We were surprised that the rates were so high. It’s a call to action.”
Industry consultant Brad Sokol developed a Medical Device Pedigree for tracking the use of devices and related patient outcomes last year. You can get the low down on Sokol’s pedigree from this presentation (pdf) on the FDA web site.
His theory predicted 13,000 to 26,000 thousand deaths from infection caused by contaminated medical devices and instruments. In the new study, “Of those infected with MRSA, almost 1,600 died, about 18 percent of the total. Extrapolating those figures to the entire U.S.
population, researchers said some 94,000 people might be infected, with 19,0000 deaths.” It would seem that Sokol was right on target.
The paucity of quality and outcomes reporting by providers is slowly changing as hospital and physician data is published by CMS and other federal agencies, state governments, hospitals themselves, and others. But we have a long way to go.
Much of the debate about Unique Device Identification (what the industry refers to as “UDI”) for medical devices is misdirected. There is too much talk about needing a unique identifier, as if the law did not already mandate one (see this, and here).
MDDI magazine ran a story that revealed the real UID agenda, From Information Silo to Bridge: The State of UDI. The real issue here is the need to track medical devices – especially implanted devices – to determine their performance. From the MDDI story:
When it comes to devices, comparisons with other products are inevitable. For example, the Advancing Patient Safety Coalition recently compared medical devices to peanut butter. Specifically, in a letter to congressional members dated June 18, 2007, the coalition stated, “We can simply and quickly identify each and every jar of peanut butter that might have salmonella and remove them from store shelves in hours, but we cannot do that reliably today with potentially life-threatening defective medical devices.” Similarly,
during a 2006 CDRH public meeting, Larry Kessler said that the medical device industry is “probably a decade or more behind the grocery industry” in terms of product tracking.
By equating medical devices with peanut butter, the authors imply it is the device vendor who is responsible for this sorry state of affairs. In fact, the guilty party is the equivalent of the grocery industry, health care providers.
There is no doubt that better tracking of medical devices would improve recalls, provide better post-market surveillance to better reveal safety issues, and reduce avoidable infections. But we don’t need some new fangled UID standard affixed to medical devices to do it. Here’s what’s really missing:
- A mandate that providers track, record, and report the use of all medical devices (and associated clinical outcomes data) without exception,
- A repository where data is aggregated across providers, devices and device vendors, and
- Someone to analyze this data and report it to the public, providers, patients, and vendors for appropriate responses and follow up actions.
This makes forcing device vendors to replace the currently mandated unique identification (you’ve probably heard of them, serial numbers) with a “new” and “improved” UID seem like the side show that it really is. Let’s assume that AdvaMed doesn’t muster the political leverage to forestall the UID, and in a few years some standards body promulgates a new UID standard. Okay, the easy part is done, now for the hard stuff.
- Who’s going to mandate that providers do all this tracking and reporting?
- Who pays for all the fancy new IT and labor required to track and report this data?
- What entity(s) will assume responsibility for maintaining this repository of medical device usage – and outcomes?
- Who will enforce the implementation and conformance of this reporting by providers – and what penalties will be incurred for non-compliance?
- Who’s going to manage the recall communications and follow up?
- Who’s going to assess post market surveillance data and issue recalls? (That’s pretty easy, the FDA would clearly handle this – but they’ll need more money.)
- What about patient privacy, who will be responsible for maintaining it, and will patients be able to opt out?
The scope of the UID system that’s required to achieve the benefits many have attributed to this “great leap forward” becomes more clear. In fact, you could implement all the tracking and gain the very same patient safety improvements using the industries current UID, vendor serial numbers.
I should also note that vendors are currently required to maintain device history records that would benefit greatly from data held by providers (patient data for implants, near miss events, outcomes data) that is currently unreported. A simple mandate requiring providers to report this data to device vendors, and an open source software project driven by a foundation or university is a more direct and efficient solution.
All this really doesn’t have much to do with a fancy new identification number, does it?
Pictured right are some blood transfusion ID labels from the UK Blood Transfusion & Tissue Transplantation Services web site. The tracking of blood products might serve as a benchmark for UDI efforts.
UPDATE: From iHealthBeat, “Sen. Edward Kennedy (D-Mass.) on Thursday sent a letter to HHS Secretary Mike Leavitt urging the agency to finalize rules to implement the Patient Safety and Quality Improvement Act of 2005, Health Data Management reports.”
And this from FierceHealthcare:
Over the past week or so, the mainstream news media have crackled with the news of staph infections (including MRSA) found in community schools. Prompted by this, Rep. Tim Murphy (R-PA) has filed a bill tha would require all hospitals in the U.S. to report infection rates t HHS. Under the terms of the bill, HHS would make such information available publicly on its website.Such a measure would trump existing infection tracking underway in the states. Right now ninetee states require infection reporting, but not all make the information public. (Murphy’s home state of Pennsylvania does make hospital-acquired infection reports available at www.phc4.org.)
Thoughts on RFID in Hospitals
Yesterday I noted that the Biomed Listserv has moved to new digs. In addition to a new hosting service, there is a message limit of 450 words – sadly, only enough for one or two points for me. I learned about this limit when my message bounced, so I’ve posted it here.
James asked about RFID in hospitals: who’s got it, what they’re doing with it, recommended vendors, and problems people have had. The following are my two cents.
Besides infant abduction systems (which tend to rely on monitored choke points rather than positioning throughout the unit), there are only about 200 hospitals that have deployed active RFID in the US. Of that 200, most are pilot deployments – limited to specific areas or departments. There’s currently about 10 to 20 house-wide RFID installations. This is not the rush to adoption that many (especially some of the vendors) expected.
There’s been a bit of a shake up among RFID vendors over the past year, and some very interesting new vendors have come to market. One of these vendors, RadarFind, introduced their system at the last AAMI conference in Boston. (You can read a bit about them here.) All in all, the vendor situation is unsettled.
Things to keep in mind:
- Different applications require different levels of performance, especially positioning accuracy. Positioning accuracy varies considerably among the different RFID technologies on the market. A thorough needs assessment to identify positioning applications and requirements for each application is the first step to selecting the right vendor.
- The details around knowing where someone or something is at a given point of time vary with different applications. If you’re looking for that Newport vent that just got recalled, knowing the general vicinity is fine. If you’re trying to improve utilization in your operating rooms, location data is just the beginning – you need an application that uses location data to optimize a much bigger set of processes. Thus, the workflow to which your positioning data would be applied is also an important requirement to gather.
My view of current RFID offerings is that the technology has not matured to the point where you can treat RFID as a generic multipurpose piece of infrastructure that can be leveraged by most any application that uses positioning data.
Let me know if you’d like help with an analysis of vendors, needs assessment, or planning/vendor selection.
Pictured right is the back of an Awarepoint positioning receiver – they plug into 110 volt wall outlets.
