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Time Capsule: Embrace FDA Oversight If You Want Clinical – not Clerical – Systems

December 16, 2011 Time Capsule 8 Comments

I wrote weekly editorials for a boutique industry newsletter for several years, anxious for both audience and income. I learned a lot about coming up with ideas for the weekly grind, trying to be simultaneously opinionated and entertaining in a few hundred words, and not sleeping much because I was working all the time. They’re fun to read as a look back at what was important then (and often still important now).

I wrote this piece in December 2006.

Embrace FDA Oversight If You Want Clinical — not Clerical — Systems
By Mr. HIStalk


Most hospital information systems are old. Faded pictures of the original system architects feature bushy-haired guys wearing plaid pants, wide ties, and leisure suits. Given their unfortunate fashion sense, it’s not surprising that their precognition of today’s healthcare environment didn’t include having physicians and other clinicians use their creations directly. The goals of information technology were simple: capture charges, batch-bill the heck out of Medicare and Medicaid, and maybe provide a simple order entry function just good enough to support those first two items.

Today’s so-called “clinical” systems mostly sit atop that antique and unsuitable foundation, outdated not because of old programming languages and hardware platforms, but because their original design mindset is now hopelessly obsolete. Clinical applications are really just green-screen type data entry forms that happen to accept clinical information. It’s the mainframe mentality at its worst – the all-knowing system that requires regular data feedings from subservient users who, despite their occupational disposition, are relegated to being keypunchers.

Eventually, some company will actually design a new inpatient clinical system from the ground up. We can fervently hope that when they do, they’ll start with a blank slate and not simply port outdated, monolithic thinking to a newer technology platform. With that innovation, though, will come the crossing of a huge chasm: that no-man’s land between “information systems” and FDA-approved medical devices.

Clinicians gripe that systems are user-unfriendly, do little to help them perform their jobs, and add minimal value to personal productivity or patient outcomes. They’re just accounting systems whose widgets are clinical. One reason: HIT vendors are terrified of FDA regulation. It’s easier to make sure systems are too dumb to require it than risk exposing sometimes bad software practices to government oversight.

Clinicians are overwhelmed by too much raw data whose presentation can’t be individualized, i.e. they insult bone marrow docs with low platelet warnings (if they have alerting capability at all, that is.) That picture that’s worth 1,000 words can’t be included because 1980s-era programmers didn’t see cheap multimedia and storage coming. Failure to rescue can’t be detected in crashing patients. Systems deliver data like an obedient mailroom clerk, adding equally unimpressive value. The average automobile, riding on even older design, has better data aggregation and presentation capabilities, replacing data lists with idiot lights, navigation capability, and easy-to-comprehend gauges.

It’s like Lucy working on that candy assembly line – reams of often irrelevant information are unceremoniously dumped faster and faster into the laps of physicians and nurses, who are expected to manually figure out what’s useful and then “process” it, often by entering even more on-screen information. Eventually, the administrivia buries someone who ought to be making patient care decisions instead of romancing a keyboard.

IT vendors have good reason to fear the FDA, which won’t be happy to hear about buggy code, poor testing practices, slow updates for known defects that have clinical implications, and head-scratching user interfaces that merited no more than an afterthought. Maybe that level of scrutiny would slow development and increase costs, but accepting possibly dangerous software as long as it’s fast to develop and cheap (both debatable) doesn’t seem like much of a bargain.

A smart clinical systems vendor would include FDA approval into their long-term plans and build killer applications around it, thereby scooping their competition by years. Redesign the first-generation systems, step boldly into the FDA-regulated space before the device vendors instead invade the IT space, and build systems that improve patient care, not just turn paper forms into on-screen forms.

Today’s software was designed around old constraints and its design shows it. Someone should get clinicians together (no programmers allowed) to design the systems of tomorrow, software whose effect on patient care is less interruptive and more assistive. Doing that right will require FDA approval. For that reason, the industry should welcome it.

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Currently there are "8 comments" on this Article:

  1. I think the FDA simply isn’t prepared, in it’s current form, to regulate clinical software.

    The notion that they improve design simply isn’t true.

    Blood bank serves as a great example to examine to figure out if your perspective is correct. I don’t think anyone would consider FDA regulation of Blood Banking as key event in the improvement of the usability and intuitiveness of Blood Bank software.

    Government isn’t innovative. Government collects tax dollars and then hands out tax dollars to friends and old college classmates. That’s what it’s good at.

    Every once in a while someone who gets some of that money actually does something innovative with it (DARPA research projects and some NIH projects, etc.). But, for the most part, the money evaporates and the government doesn’t end up with much to show for it other than one more year with a bearable unemployment rate and another trillion dollars of debt accruing to someone.

  2. That the FDA isn’t capable of regulating the safety of clinical software is laughable. They already do.

    The medical device industry has made HUGE improvements in its consideration of safety and human factors since the FDA stepped in.

    The market will have to demand other aspects of human factors beyond safety, however. At some point, health systems will tire of spending hundreds of millions of dollars for systems that reduce productivity.

  3. Ever watch a nurse deal with 14 kinds of infusion pumps? Sort of cryptic, aren’t they? Look at the kinds of errors the ISMP deals with – most no FDA products and packaging.

    We’ll never be able to run the double blind test on this one, but I think if you study it you’ll realize that although the FDA does some good things and helps our society in many ways, creating more usable products and improving design simply isn’t one of them.

  4. “Ever watch a nurse deal with 14 kinds of infusion pumps?”

    Yes – and it’s a nightmare.

    Kind of like a physician dealing with multiple EHR systems (or modules), each with different interfaces. Or if you had to figure out if a car’s accelerator and brake were in the same or different place in each car.

    Is this a shortcoming of the FDA’s current approach? Absolutely. Are there people at the FDA who understand this? Absolutely. Is there the political will to address it / save the lives that would result from addressing it? Unfortunately not.

    With EHRs the industry hasn’t even admitted that there’s a problem with usability (quite the opposite, publicly at least).

    Probably for a lot of the reasons that Mr. Histalk outline in, oh, 2006. Of course, so much “innovation” has swept through the world of EHRs that everything is better now, right?

    A case study for an industry policing itself?

  5. Look, if life was as simple as a GO and STOP option, then the FDA would be your guys. As a matter of face, that little circle with a vertical line through it is sort of the Techno GO and STOP option.

    But, life isn’t that simple. At least not mine.

    There has ALWAYS been a problem with USABILITY and there ALWAYS WILL be. It’s the nature of a science that continually advances.

    Just like healthcare.

    Maybe you’d have the government hire and manage all doctors and nurses in this country. That might fix it.

  6. A number of clinical applications, particularly in spaces like the ICU and surgery, are already classed as medical devices (class II). The FDA has stated that EMR’s are, according to the new MDDS regs, medical devices that should comply with FDA-510K regs, BUT the FDA has chosen not to enforce that at this time. Imagine that . . . the FDA selectively allowing EMR’s to roam free of their oversight while at the same time increasingly putting smaller best of breed vendors under the microscope of their audits – sounds like politics to me.

    So for those best of breed, clinical apps that are already using FDA-510K quality processes in their product development cycle, this creates an uneven playing field in favor of the EMR’s who are increasing their functionality in the clinical space, but not having to comply with the extra 30% work required to document and test using FDA quality practices.

    In my opinion, any product used in patient care that stores and displays patient data SHOULD comply with FDA-510K, but it won’t happen anytime soon. The politicians and cabinet secretary who drove home meaningful use won’t burden the EMR’s with FDA regs.

  7. “There has ALWAYS been a problem with USABILITY and there ALWAYS WILL be. It’s the nature of a science that continually advances.”

    Of course…but doesn that mean that everything is equally un-useable? Should pilots in airplanes continue to use Wright-brothers-era controls because science has advanced since then?!?

    Because of the FDA (regulation) and their work with industry, the risk of USE ERRORS from medical devices is much lower than before their involvement. Many fewer BADLY DESIGNED medical devices reach the market than before. And for this we should thank the FDA. Because industry sure as shirt wasn’t going to do it on their own.

    You brought up the bigger issue of groups of devices (EHRs) working together / having consistent user interfaces (data interfaces are another issue). Today they don’t. And this is another opportunity for industry to voluntarily fix itself. But it won’t. And the FDA will NEED to step in eventually.

    The government hiring and managing all doctors and nurses in the country is, of course, a far spell down the slippery slope from a regulatory agency ensuring that dangerous medical devices must be fixed before they’re permitted in the marketplace…

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