Guest Article: RFID Systems in Healthcare Institutions

Patient, medication, and equipment asset tracking are critical functions for any healthcare organization.  Yedidia Blonder of Vizbee RFID Solutions, a company providing RFID solutions for healthcare applications and other industries, provides an introduction to RFID technology and its benefits.

What healthcare executive wouldn’t want a system that:

  • Helps nurses locate necessary equipment in seconds?
  • Ensures that only the mother of a newborn or a nurse could remove that baby from the nursery?
  • Makes sure patients don’t wander into staff only areas?
  • Lists inventory of all the medications in a large medicine storage area in minutes?
  • Ensures even equipment distribution across wings and prevents theft?
  • Tracks disinfection patterns of employees?

Enter RFID.

RFID (radio frequency identification) is a technology in which radio waves emitted from electronic tags identify them uniquely. The tags are often used to pinpoint the location of the object, or person, to which the tag is attached. This is different than barcode technology, which is usually used to identify an object as belonging to a larger category without individual identification. Barcodes also need to be read one-by-one from very close proximity, whereas RFID readers can read many tags with a single pass of an RFID reader a few meters away.

How does RFID work?

First you need the tags. RFID tags can be split into two main categories: active tags and passive tags. The active tags are battery operated and transmit their data periodically to readers. Their reading distance varies between a few meters to hundreds. Passive tags are much smaller (sometimes like a paper sticker) and do not transmit their data until being interrogated by a reader in their proximity. The passive tags' reading distance can reach 2-3 meters. Passive tags are usually used for inventory purposes.

The readers consist of an RFID antenna connected to an RFID reader. They receive the data from the tags and then, in order to have a functioning system which will do all the above tasks, transmit the data to a software system which manages the received data.

When the system receives the data, it will both store it for immediate or later review by the healthcare staff, as well as act according to predefined rules set by the administrator. For example, in the case of preventing equipment theft, a rule could be set that if tags attached to pieces of expensive lab equipment go past the reader stationed near the exit to the lab, its signal will set off an alarm, alert important staff members, and lock the exits to that wing of the hospital.

How can RFID help a healthcare institution?

Keeping in mind the stunning figure of 15% of hospital equipment stolen annually as well as the damage that improper maintenance causes, RFID tracking can significantly diminish losses and increase efficient use of equipment. It can ensure that only the right person uses or moves any given piece of equipment, guarantee the correct quantities of a certain apparatus in a designated zone, enable the immediate and accurate location of any item, indicate which item is in use or available, and the list goes on.

RFID can also provide an accurate and comprehensive picture of the total amount of the organization’s inventory, including expiry dates and amount of usage, and provide real-time data on parameters such as temperature and moisture levels, providing alerts in the case of inappropriate conditions that could damage equipment and medications.

Add to this the capacity to track patient and staff movement and interactions with other people and objects - and your RFID healthcare system gives you your entire hospital at a glance, and alerts you to problems.

Implementing RFID systems.

RFID technology is also getting easier to customize. In the past, often RFID hardware would be programmed to work only with specific software. Recently, there have been advances in RFID technology enabling administrators to choose hardware and software independently according to the unique needs of each project. Parameterization tools built into the software can customize applications to specific projects while enabling the implementation of RFID projects in a very short time (days to weeks). You no longer have the time, expense and risk that come with developing software just for your project.

With RFID systems, managing healthcare institutions is getting easier, safer and more efficient.

UPDATE (9/8/2012) : Tim has written an excellent article on the subject:  RFID RTLS Update – Where to Start

Posted in Medical Devices, Technology | Tagged | 4 Comments

Open Source Medical Device Connectivity

In The Case for Open Source Healthcare IT John Zaleski uses the VistA open source software as a model for improving the medical device data gathering in order to produce a "more robust end product".  On the whole, I could not agree more. Achieving this in such a diverse and fragmented community would be a real challenge, but it may indeed be a worthwhile path to pursue.

There was one item I'd like to comment on:

The challenge is, of course, regarding regulatory management of open source frameworks. To a large degree open source software is anathema to the FDA regulatory process–and it relates to control and management of access.

OSS detested or loathed by the FDA? I don't think so. The open source framework itself would not be subject to regulatory control.  The FDA does not really care where any specific software component comes from.  Also, security and  access management are certainly important, but I'm not sure of their applicability at the device connectivity level.

The FDA cares about intended use, efficacy, and safety of medical devices. All FDA regulated software is subject to the same design controls (§820.30) -- design, risk analysis, verification, validation, etc. I.e. any company that included these open source software components would ultimately be responsible for proving these processes are followed.

Shahid N Shah's OSCon 2011 Talk: The implications of open source technologies in safety critical medical device platforms does a good job of detailing these points (Will the FDA accept open source in safety-critical system? Yes!) as well as presenting an OSS connectivity software architecture.

Posted in EMR, FDA, Interoperability, Medical Devices | Tagged | 6 Comments

Turning the Mind Into a Joystick

More "mind reading" hyperbole in today's New York Times Magazine: The Cyborg in Us All.

I've talked about EEG-related technology many times in the past. Here are some quotes from the article:

This creates a pulse in his brain that travels through the wires into a computer. Thus, a thought becomes a software command.

We’re close to being able to reconstruct the actual music heard in the brain and play it.

... a “telepathy helmet” that would allow soldiers to beam thoughts to one another.

The NeuralPhone was meant to demonstrate that one day we might mind-control the contact lists on our phones.

The general public has two reactions when the lay press publishes this kind of stuff:

  1. I always knew this would come true. I.e. perpetuation of scientific fantasies.
  2. This is really scary stuff. I don't want anybody reading my mind -- or worse, controlling it.
If you know anything about the underlying techniques and algorithms you also know that "mind reading" and useful brain-controlled interfaces are a long way off.  Because the article fails to provide any sort of time-frame perspective, why won't someone think these capabilities exist now.
The real problem I have with these kinds of articles is that this is important work that could potentially improve the quality of life for many disabled individuals.  Hyping it up to be something it's not doesn't help anyone.
One more quote:

“This is freaky.” And it was.

Huh? ... I think the NYT needs to improve their editorial oversight.

 

Posted in EEG, HCI, Technology | Tagged , | 5 Comments

Microsoft BUILD Conference

Wow -- talk about drinking from a fire hose. BUILD Conference news and opinions are everywhere.

Fun stuff. It's going to take a while to digest all of this.

Posted in .NET, Microsoft | 1 Comment

Third Annual Medical Device Connectivity Conference

This year’s Medical Device Connectivity Conference is less than a month away. It's being held Sept. 8-9, 2010 in Boston.


In addition to the post-conference workshops, there is also a special preconference event: an open house at the Medical Device Plug and Play Interoperability program’s lab. September 7, from 4pm to 6pm attendees can tour the lab, interact with various demonstrations and chat with program staff.

Tim has put together another great conference.

Posted in FDA, Interoperability, Medical Devices | Tagged , | Leave a comment

Standards & Interoperability (S&I) Framework

There's a new standards organization in town: Standards & Interoperability (S&I) Framework.

The objective of the S&I framework is to create a robust, repeatable process based on federal best practices that will enable ONC to execute on initiatives that will help improve interoperability and adoption of standards and health information technology.

The question is where is this new effort going to squeeze itself into the bigger picture of Healthcare Un-Interoperability?

It's been close to four years and nothing has really changed.

A lot of effort was put into HITSP, but "the S&I Framework is not envisioned to be the “sequel” to HITSP, but a new evolution in standards harmonization."  Your have to wonder how YASC (Yet Another Standards Committee) initiated by the government is going to add clarity to an already confused standards landscape -- again.

Technically, you have to love a standard that fully embraces acronyms:

  • Computational Independent Model (MDA-CIM)
  • Platform Independent Model (PIM)
  • Platform Specific Model (PSM)
  • Information Exchange Package Documentation (IEPD)
  • National Information Exchange Model (NIEM)
  • NIEM Health IEPD

Together, the CIM, PIM and PSM will be compiled to generate the NIEM Health IEPD.

Posted in EMR, Interoperability | Tagged , | Leave a comment

Google Health: R.I.P.

The announcement that Google Health was being discontinued shouldn't be a surprise.  In March the Wall Street Journal reported that once Larry Page took over the CEO role at Google he would be looking to cut projects:

Some managers believe Mr. Page will eliminate or downgrade projects he doesn't believe are worthwhile, freeing up employees to work on more important initiatives, these people said. One project expected to get less support is Google Health, which lets people store medical records and other health data on Google's servers, said people familiar with the matter.

There have been a number of retrospectives written today already, most concerned with the future of PHRs. For example:

It just goes to show you that being a pioneer does not guarantee long-term success. Microsoft HealthVault has done a much better job with device integration than Google Health did. There are many other factors that will determine the viability of PHRs in general though.  Adoption by the general population and a revenue model to support growth are just a few.

UPDATE (6/25/11): Mr. HIStalk's take is the lead in Monday Morning Update 6/27/11. Two quotable statements:

Why did Google Health fail? Simple and obvious: consumer demand for personal health records is close to zero, which has always been the case and probably always will be.

Probably true.

Google predictably did what its know-it-all technology company predecessors have done over the years: dipped an arrogant and half-assed toe into the health IT waters; roused a loud rabble of shrieking fanboy bloggers and reporters...

OK, but how do you really feel?

Seriously though, I think Google's foray in the Healthcare space was no different then how they approach any other market: "If we build it, they will come."  If they don't come, we pull the plug. Google has a graveyard full of products that suffered the same fate.

UPDATE (6/26/11): Some more:

UPDATE (7/1/11):

Posted in Google, PHR | Tagged | 2 Comments

ZDNet Healthcare: Gone forever?

Wow! It took me 7 months to realize that I had not seen an update from the ZDNet Healthcare blog. The reason is that Dana Blankenhorn was fired around the end of November 2010.  Apparently it was his Free and Open Source (FOSS)  blogging that lead to his demise at ZDNet. Also see the comments section in this article.

I commented on his Healthcare blog several times and even took issue with him in Access to Medical Data: Are PC Standards and PHRs (You) the Answer?

It looks like ZDNet has not found a replacement for dedicated Healthcare coverage. This means I can remove 'ZDNet Healthcare Blog RSS' from my reader feed.

Posted in General | Tagged , | 1 Comment

Final Plea to Launch: Healthcare IT Q&A

Closer to Launch: Healthcare IT Q&A didn't get close to doing the job. Even after 8 months the commitment level is still at only 60%:

It doesn't look like Area51 has a time limit on how long a proposal can languish in the Commitment phase, but we're going to need a lot more support to get to Beta. So go over and sign up today!

Posted in General | Tagged , , | Leave a comment

Discomfort with Computerized Medical Devices

Here are some thoughts regarding the article: I feel a little uncomfortable about computerized medical devices, and here's why.

  • Just about all medical devices are computerized these days. Most will not harm or kill you if their software fails (Class I & II), but that's no excuse for writing crappy code.
  • As pointed out, the mission critical nature of mass transit systems (airplanes, subways, etc.) affords those industries a much higher level of scrutiny then cars or medical devices ever will. But that's still no excuse for writing crappy code.

Even through drugs and airplanes need advance approval from authorities before being brought to the market, medical devices and software do not, at least in the United States.

  • This statement is not correct. All medical devices, including diagnostic and therapeutic software-only products, require FDA clearance to be sold in the US market (see the Class I & II link above).  There are many exemptions, but a 510k pre-market approval is generally a minimum requirement. After you receive approval the FDA can pull your device off the market (the dreaded “recall”) at any time due to complaints or unsatisfactory audit results.
  • The FDA QSR Subpart C (§ 820.30) looks a lot like DO-178B as quality system design controls go, but I'm sure the aviation standard enforcement is far more rigorous (well, at least I hope it is). It's true, there are no coding standards for medical device software.  Good companies set their own development standards and practices -- some even use static analysis! It's all the other companies that don't bother to do anything that you have to worry about.

I'm certain that static analysis technology has improved vastly in the four years since some of the articles below were written.  The challenge is that the complexity of medical device software and the systems they run on has also increased tremendously during that time. In particular, the explosion of high bandwidth wireless networks along with advances in handheld computing power and graphics capability (think iPhone/iPad, of course) is fundamentally changing the way medical devices will be developed and delivered to the market in the future.

Static analysis will remain a valuable tool for identifying critical software defects, but new methods will have to be developed for rooting out risks in the new network-connected, multi-touch world.

It's sad to say, but you should probably be more than "a little uncomfortable."

Other static analysis articles:

A Few Billion Lines of Code Later: Using Static Analysis to Find Bugs in the Real World
More Software Forensics and Why Analogies Suck
Medical Device Software Forensics
Pascal's 3 part static analysis series that starts here:
Guest Article: Static Analysis in Medical Device Software (Part 1) — The Traps of C

Posted in FDA, Medical Devices, Software Quality | Tagged | 1 Comment