Killing Patients Wholesale

Empty patient bed image

As a writer you are faced with many dilemmas. The most paralytic of these is “where to start a story?” Pen names have existed for ages, so as long as you never put a picture of yourself on your work, few will know it is you. A metropolis sized sewer main puts fresh crap on Amazon at a rate beyond the capacity of even the world’s largest sewer system providing stark proof that nobody cares if it is good enough, yet, many a would be gifted writer gets paralyzed by the question “Where do I start?”

It isn’t that you don’t have a story to tell, you wouldn’t have the question if you didn’t have a story. It isn’t the fact nothing seems important in the story because you feel compelled to write it. No, the reason is the back story. The back story provides the flavor and gives substance to the meat but “the market” expects the first paragraph to launch the story with either sex or violence, preferably both.

This tale is one of those where the back story must come first.

Over the past 30 or so years I’ve been a traveling IT consultant. During the past decade I’ve moved on from large scale “Enterprise” applications to embedded touch screen devices using Qt and custom embedded Linux builds. For the first time in my life my resume can have links back to actual products, some of which are medical devices.

When you work on a medical device for a real company you go on a mountain of FDA mandated “training.” This training is meant to enlighten you so you don’t violate any of the rules and regulations of that world. It is also meant to inform you that you very well could go to prison for such violations. You will most definitely have the honor of your product/device/service appearing in those late night television commercials if there is even a single “adverse outcome.” Oh yes, the training is also meant to inform you on all of the different things which qualify as an “adverse outcome.”

MicroSD image
16Gig MicroSD “card”

It is quite a mix of people working on any given medical device. Some of them have little knowledge about the actual world they exist in, but vast knowledge of the tiny area they work in. I do mean tiny too. Some of these people work purely in hexadecimal values which get written/burned into a single chip to make it useful. Most of you have seen MicroSD “cards” by now. They are in cell phones, cameras and even Garmin navigation systems. There are dozens, if not hundreds, of “chips” in there make it appear like a great big disk drive, perform read/write operations as well as load leveling. I share this information so the non-technical reader understands what I mean by “tiny.” It isn’t a slam.

Given the odd mix of people and skills it should not surprise anyone to learn you occasionally get the cranky old man who cusses and hollers a lot wanting things done their way. I encountered one of these on a project and I still keep in touch with him. Since I’m tired of using Fred and we need a name here we will call him Bill. No, this story isn’t about Bill, but you need to know he exists to fully appreciate it. (That backstory thing again.) Besides, Bill also reminds you of those things which come in the mail which you have to pay. At least subconsciously it does. Fred just doesn’t have that effect. Neither does Ethyl and those are the other two names I love to use.

Now that you know all of this about me, it should come as little surprise a pimp (they like to be called “consulting firms” but they whore us out and take a margin so we call them pimps) arranged an interview with a venture funded startup working on some new medical device for post-op patients. (Yes, those last two words are really important.)

I gave the pimp a list of questions to ask the client before they were to present me because I wanted the answers before I would allow myself to be presented. Like the vast majority of pimps in today’s market they didn’t bother and both presented then scheduled the interview. I should have turned it down right there. As a result I will never work with this pimp again. Yes, I’ll name them, Cyber Coders.

Remember what I said about FDA mandated training? It is so much, some of it actually sticks with you long after you have left the FDA regulated world. The CTO calls me at the scheduled time and I shock him by asking my questions first. Here was the most important one:

ME: “The recruiter mentioned there could be some Windows involved in this project but I don’t see it listed on the job req.”

CTO: “We have not yet decided if it will be on Windows 10 or Linux.”

ME: “Well you do know that Microsoft has end of lifed Windows Mobile and I’ve been getting calls from companies running regular Windows Embedded saying their OS has been end of lifed too. Aren’t you worried about choosing a dead platform?”

CTO: “Not embedded. It will be standard desktop.”

Every fiber of my being wanted to slam the phone down. Sadly, in today’s cell phone universe, you cannot slam a phone down and have the person at the other end of the phone hear the slam. I sat there stupified. Quite honestly I was unable to answer the few questions I let him get through because of the shock.

On my last medical device we had to jump through oceans of hoops to both ensure and prove no network activity could possibly hang or interrupt any function of the device. We had to roll our own custom Linux kernel taking lots of “standard” stuff out to both secure the device and achieve this goal.

Oh come on, you’ve all seen it. You click on a dead link or your network connection wigs out and you get that spinning cursor in the center of your screen. While you can usually move the mouse around you cannot rotate to a different screen or application. This type of hang typically means your application isn’t getting service or processor time. What if you have a drug pump which is metering by start time and fluid pressure? What if it is pumping something like morphine or chemo chemicals? Instead of the fraction of a second zzzt the patient gets a network timeout dose (somewhere between 5-20 seconds depending on driver and settings) before the pump shuts off?

Here is something I didn’t know until I worked on a medical device. Each time you put a blood pressure cuff on there is a tiny statistical chance you could throw a clot which could go to your brain, heart or some other part of your body having catastrophic consequences. Don’t worry, for a one and done, not exceeding a max pressure safety limit, it is about the same statistical probability as a nuclear detonation setting off a chain reaction burning out our planet’s atmosphere. (Yes, that is a reality too. One of the many reasons nuclear tests moved below ground before being banned in most countries.)

They say every multi-state lottery ticket purchased has the same chance of winning. Many also say buying additional tickets doesn’t increase your odds. While someone may make such math work, if you have the funds to play every possible combination in a drawing, you have now increased your odds from insignificant to 100%. Sadly, as someone who tried that found out when they had to split the prize, lottery ticket sales aren’t unique. Every person on the planet could play the exact same 6 numbers turning you into a massive loser.

Why is that important? As sizes of nuclear warheads increased, so did the number of lottery tickets they were holding for the “burn it all” grand prize. There is also an FDA/medical minimum amount of time an automated blood pressure monitor has to wait for the next testing interval. Um, for those of you fortunate enough to never had anyone in the hospital with an automatic pressure monitor, this is where you are sitting there chatting or just being with them and you hear the pump start up and see a new pressure reading being taken and some time later it does it again. As it was explained to me that minimum wait time exists for several valid medical reasons, one of which is that sampling faster than said rate dramatically increases the chances of throwing a clot. (Remember, throwing clot bad.)

So, imagine a full desktop OS on some post-op medical device which is supposed to be helping keep you alive. A full desktop where someone could play solitaire, check their FaceBook page, download a virus infected “free” game or any other number of things. Imagine that, can you?

Suffice it to say I ended the interview early and I got in touch with my “inner Bill” when I did.

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