Space Trucker pt 2

Part 2 of Space Trucker for part one see the previous post

    Well now I know not to fear the maintenance bots and I have a better means of navigating this ship.  I turn back toward the route I had been heading in and watch as the map reorients its self first back to where I am and second back to the direction I am heading, a very useful gift especially since it is obvious that the tablets transponders are deactivated.  I slip the tablet into my back pocket and grabbing my bag head further into the ship.
    An hours crawl through the conduit brings me to a long vertical riser that according to the map runs from the very bottom of the ship to the top.  Each end of the riser terminates in an airlock but I only make note of it to avoid entering them, visiting an airlock without proper gear is nothing but suicide.  I sit up at this junction allowing my legs to dangle into the riser and give my aching knees a rest.  I drag my bag over to me and dig out a Hershey's bar to munch on while I contemplate my location relevant to the Master Control Brain.  Judging by what I see I am approximately seven levels below as well as another good hours crawl through more conduits, I double check the surrounding area to ensure I am alone and stretch out on my back for a few minutes to rest my sore spine.
    I must have drifted off to sleep because it was twenty minutes later when I was awakened by a loud crash many floors below me.  I quickly pulled my legs up into the conduit with the rest of me only to find my knees even more aching than they were due to their hanging over the edge for so long.  I pulled myself further back and took out the map again, much to my dislike the dot was purple.  The dot had an operating number that if A2q was any indication meant it was a modified maintenance bot so, A89r some five floors below was going to be a problem.  I quickly scan the map once more before tripping it off and shoving it back into my shirt pocket.  I stuck my head over the precipice and looked down to see what was afoot and the bot was definitely searching for something as its visual sensor array was swinging back and forth as well as up and down as indicated by the shifting shadows caused by the bots lighting system.  I had only two possible things to do, one sit quietly and hope it passed by beneath me, or two use the peacemaker and announce my location once again.  I decided to use option one and only rely on option two if it came closer.  Wouldn't you know it chose to come closer.  I could see its lights shifting as it checked other conduits on its way up so as it advanced I drew the peacemaker once again and studied its pattern.  I only had a brief moment of opportunity as it got closer in which to pull the shot while it was at the conduit below me with its sensor array facing the other side.  As its array began to swivel I inched forward so both my arms where free over the edge and I took a firm grip, the bot was so close I could almost touch it with the barrel when it suddenly entered the opposite tube and disappeared.  I waited for several minutes afraid it would suddenly reappear before I hauled myself back into my original position and pulled out the map once again.  Sure enough there was A89r some fifty meters along the conduit it had entered and steadily moving further away.
    A quick scan of the map showed the next several conduits in line and up a level to be clear where as this level dead ends at a bulk head.  I have a choice to come out one floor below or one floor above the Master Brain though, as their are no conduits available to me on it's level.  I study the map for some time before I opt for one level above as their is another maintenance shaft running vertical between the floors as well as a stairwell.  Another quick scan of my local area while I grab a drink from my bag confirms all is clear and soon I'm throwing my bag's strap over my shoulder as I enter the vertical conduit.
    I begin my arduous climb being as silent as possible knowing full well that A89r could turn up again at any moment.  Conduit by conduit I count the levels off until twenty-seven meters higher finds me entering my destination conduit.  The conduit is much smaller than the previous lateral conduit had been and I know this will force me to crawl along on my belly.  I swing my bag around and with a little rooting around find a short length of rope and tie one end to the back of my belt and the other to the strap of my bag then pull out the Peacemaker as I enter the tube.  I knew the going would be slow when I entered the conduit but judging by the map I'd traveled half way to my destination and already spent an hour on my belly.  I'm near exhaustion, my arms ache, and my shoulders and hips burn like fire when I heard a loud clang behind me.  I glance at the map again and as I feared A89r is coming along the tube behind me, while making considerable time and catching up quick.  I roll over and spread my legs so my feet are as far apart as possible then raise my back so I can see back the way I came.  I point the Peacemaker in the direction of A89r and just as soon as I make out its shape in the conduit I squeeze the trigger.  The muzzle flash is both brilliant and blinding in the near darkness of the conduit but it is the strength of the old guns report that hurts.  The Peacemaker is always loud but in such a confined space I am suddenly deafened by its report and all I hear is a loud whistle in my ears while they fill with searing pain.  I drop the gun onto my chest, its weight feeling more than normal, as I hopelessly grab at my ears.  I lay there in agonizing torment for quite sometime before everything goes utterly silent.  As I lay in my silent and pain-filled world my brain begins to swim and wander leaving me oblivious to the maintenance bot that has come in from above my head.  All of a sudden I feel myself being dragged through the tube by my shirt collar.  There is no way for me to see what is dragging me and at this point I'm not so sure I really care.  I must have been drug several hundred meters though before I'm swinging in a wide arc of a turn as I suddenly appear in a corridor and find myself now being rapidly dragged through the ship its ceiling lights becoming a dizzying blur as they pass over head.  With a little effort I can just see the well worn little maintenance bot that is rapidly dragging me to who knows where and with the painful ringing that is now filling my ears I can not cypher it out nor do I care to.  We duck into another conduit slowing up only enough I assume to ensure I actually clear the opening and as I peer past my feet I can see another maintenance bot closing the access panel.  I can't make out anything in this tube other than streaks of multi-colored light being emitted from random diode status indicators scattered throughout the tube.  Suddenly we come to a stop and I find my back and head now resting upon the long back of the bot that has been dragging me along as a different bot now slips a mechanical hand beneath and around each of my shoulders and the trip starts anew only this time we are apparently traveling with all diligent speed up this new conduit.  I loose track of how many levels we ascend very quickly as our rate of travel is just too fast.  When we stop I am again transfered to a different bot and I am again traveling horizontally although not at anywhere near the same velocity as before.  It couldn't be more than a few minutes though when we appear in an old slightly dusty medical bay and I find myself being examined by a medic bot as the maintenance bot scuttles back into its service hatch.  Before long I'm being given a trans-dermal injection just behind each ear and almost instantly my hearing returns.
    "Do you feel better now?"
    "Yes."
    "You should be more careful.  Fortunately you weren't far away so your hearing should not suffer any permanent damage.  You should keep a couple of these with you in case you do that again but I still recommend ear protection."
    The medical bot holds out his mechanical hand and hands me two trans-dermal injectors in a steel case.
    "Thank-you."
    "I understand you are trying to liberate us from the Master Brain.  You can not enter its chamber directly, it is too heavily guarded.  There is a hidden conduit that does lead directly into its chamber but you can only reach the access door from the outside of the ship."
    The medical bot rolls over to a view screen and pulls up a map of the ship.  It indicates our current position then walks me through entering a service hatch within the next room that returns me to a conduit that leads back to the vertical conduit.   From there I head to the uppermost airlock and exit the ship.  Three hundred meters across the outer skin and there should be another door beside a large solar array.  Apparently the solar array feeds directly into the master Brain.
    “This information is all well and good but how am I supposed to cross over the outside of the ship without a space suit?”
    “You will find several in the airlock, left from this ships previous occupants.”
    I work on the assumption that if the maintenance bots would risk themselves to bring me to the medical bot that it was safe to trust it.  I soon found myself climbing back up the vertical conduit and in half an hour I am entering the dressing area of the airlock.  The suits are very old but still seem serviceable and I begin trying them on until I find one that fits.
    With suit in place I sling my bag over my shoulder, enter the airlock and exit the ship.  It is absolutely dark outside of the ship and it takes me several minutes to find the right switch for the helmet lamps.  The outside of the ship is a dark rust color and the space dust floats up around my feet with each step I take.  The trip is both slow and laborious with having to pull my magnetically clad feet off of the hull with every step.  Reflectors on the solar array shine back in the faint light of the helmet lamps allowing me to navigate in the darkness.  Step by step I get closer to my goal until in time I am circling the solar array looking for the access hatch.  At first the hatch is nowhere to be seen but by scraping the hull with my feet I am just able to discern its outline through the dust.  I retrieve a number thirty torx head screwdriver from my bag and begin backing out the bolts that hold the lid to the conduit in place.  Half a dozen screws later and I am swinging the plate back out of the way.  I look down into the hollow darkness and the narrowness of the conduit and begin climbing in as I see a light in the direction of the airlock.  I know I have very little time to spare so I step into the conduit and shut off the magnetic boots.  I slide down the dust covered ladder and can feel the magnetic containment field that holds the air in this section as I pass through it.  The resistance of the air slows me slightly and then I hit bottom.
    I turn off the helmet lights then seeing a light source I slowly work my way toward it.  It's nothing more than a loose plate but it allows me a chance to peer into the next room where I see a large positronic brain.  I slip the barrel of the peacemaker up to the crack and just as I am about to pull the trigger I am hit hard from behind slamming me through the plating.  I skid across the floor one way the peacemaker goes the other and just as I slam into the opposite bulkhead my possibles bag slams into me between my splayed legs.  I'm in agony when the security bot picks me up and tosses me across the room again.  I'm dazed for a moment before I spot the peacemaker lying one point five meters away from me.  I force hard against the wall with my legs but only manage to push with my left and scream with my right, I just manage to grab the peacemaker though as the security bot grabs me by my right leg.  I scream through the pain and on instinct fire the peacemaker toward the bot.  Its grip releases and I can feel its hydraulic fluid spraying across me.  I can't look at the bot for the spraying fluid covering my helmet visor but I can see the positronic brain.  Shot after shot I level into its matrix until the third and final shot shatters the matrix.  I can hear the security bot collapse to the floor and I know it is from loss of fluid not from the demise of the brain.
    I slide across the now slick floor away from the derelict security bot and begin slithering out of my space suit.  My leg twists around in an odd direction causing my foot to stick straight out the side and unbelievable pain to wrack my entire body.  I reach down and twist my lower leg back to a somewhat normal position and it relieves the pain to an extent.  I open the revolver and dump the empty shell casings into my hand, then pour them into my shirt pocket.  One by one I load the next six shells into their chambers then close the revolver.
    I avoid the pools of hydraulic fluid and make my way toward the main door of the room while dragging my bag along behind me.  I arrive within sight of the main door just as two security bots emerge but this time I place two very accurate shots directly into their torsos and as such right through their processors.  I change out the spent shells and continue on through the door.  I drag out my map once again.  With the security bots beginning to fall off-line I slowly begin my long trek back to the medical bay and hopefully relief from the pain in my leg.
    I crawl along for half an hour before I see anything and the first thing I see is a dark skinned humanoid.  He approached slowly and as he did I couldn't help but notice his ebony complexion.  He was a big man, every bit of two point two five meters and muscular, I think even his muscles have muscles.  He was definitely from Earth because Earth is the only place I had ever seen such a build and complexion.  He scooped me up from the floor and holding me in his arms he began walking away.  I noticed the color difference between the two of our arms my own caramel showing starkly against him and as I wondered about this mountain of a man I just caught the words he was saying.
    "I am taking you to the medical bay, the medical bot will know how to fix you up.  Thank you for breaking my imprisonment.  I was held captive by a security bot who just wanted me as a pet.  For two years I've been here lost with my own thoughts and no one to talk to."
    "Well I'm glad to meet you, my name is Caroline what's yours?"
    "Laron."
    We chatted as he carried me to the medical bot and he stayed near while I was repaired.  Once I was healed we returned to my truck where I called Federation Cargo Enforcement.  It took them several hours to arrive and six more to debrief Laron and myself in the end Laron had nowhere to go after being gone for so long so he hitched a ride with me.

Disability issues 1

 Okay let me be open here right up-front.  I understand disabilities I am myself differently abled or disabled depending upon how you want to look at it.  I have severe arthritis that I was born with.  I have to use a special keyboard in order to type, and special mouse just to run a computer.  Typing is right up there with hitting your thumb with a hammer for me.  It is easier on a phone IF the phone is in a case that makes it thick enough to hold and these stupid round edge phones make life Hell.  Now add in my mom is legally blind and uses the traditional white stick to find her way through unfamiliar areas, my son is hearing impaired from an accident, and I worked long term care for 25 years.

So thanks to a mutual's post on twitter I am up on my soap box this morning.  The irony that this post is a day after the American's with Disabilities Act (ADA) turned 31 years old is not lost on me.

Let's begin with the original posters point: we should not be forcing deaf children to speak just to make hearing people more comfortable because we are too lazy or indifferent to learn sign language.  Tying a deaf person's hands down to make them speak is as barbaric as tying left handed people's hands to force them to be right handed--this was done to my brother.  So what can we do?

We can insist that our local schools (private or public) teach American Sign Language (ASL) to all students from the beginning of their education.  If all students were trained in 12 years we would have 3.7 million graduates or 1% of our population that knows ASL but that's only if we teach one class group.  If we continue to teach every year by the end of 12 years of education we would have 4% of the US population from age 14 through 18 knowing ASL but a whopping 13% if you count back to Kindergarten at that point.

But Maura only 0.38% of the population is functionally deaf why should we spend the money to train educators and force it on students who can hear?  Well for starters unemployment among hearing impaired persons over 16 years of age is 16.1% and that is a shame.  Also knowing ASL is useful to more than just the hearing impaired.  Noisy work environments are a very good place to use ASL.  Ever been to a construction site?  A lot of communication is done by improvised sign language and only one hand gesture is universal.  Now imagine that same site with a common sign language, much easier and safer for all involved.  Need stealth?  So long as you have line of sight ASL is silent.  Much as naval vessels communicate via semaphore and flags soldiers on a battlefield don't want heard either.  Same for two buddies out hunting.

Well Maura why don't we just put cochlear implants in the deaf people and then we don't need to teach everyone.  Let's start at cost being an average of $40,000 each plus premature failures and upgrades to technology.  The total is a staggering $480,000,000,000 (applying my math is right)  Now I may be wrong but it seems teaching 3.2 million educators ASL to teach over and over again would be a heck of a lot cheaper not to mention much more humane.  Is it morally right to force a deaf person to have an implant?  Now add in that the implants are not suitable for every individual and will not work at all for some.  Implants are a choice between the individual and their physician or in common language "their body, their life, their choice."

There is no impeccably correct answer but their are better choices we as a society can make and teaching ASL seems a small price compared to the torture we have been putting deaf and hearing impaired people through.

And if you're interested this post took me 1:33:28 to write so yeah I get disabilities.

-Maura

Space Trucker pt1

 Okay, currently reading and digesting a major court ruling so this week you get part one of a short story. Hopefully you all enjoy it.

 Star-date 2785.621
    In route from the Terran mining colony on comet Elanin to Alpha Centari 5, hauling a load of cyanide crystals when my truck woke me from a deep sleep and a wonderful dream.  I'm about two-thirds of the way through my six day traverse between systems.  I crawl out of my berth and head for the Jon, while sitting down to do my business I pull out an info tablet and begin reading why my truck woke me.  Apparently I've been caught in a gravity field that isn't on any of the charts and the simple navi-con that does the driving while in deep space can't handle anything that isn't on the charts.  Looking at the auto scan images I determine it isn't a rouge black hole, but it is apparently a much larger space craft.  Probably deep space pirates, they've become quite the issue over the last few years, I should know, I used to be one.  I pull up my jeans and after applying deodorant pull on a flannel shirt and after pulling on a pair of brown, retro, cowboy boots I wrap my ammo belt and holster around my waist then drop my antique forty-four peacemaker into its holster.  I step behind the control wheel of my old Peterbilt and pull the seat up and begin taking full stock of my situation.
    My truck is in tact and unharmed, cargo monitors indicate transit spheres are in tact, all engine functions within normal parameters, the only thing abnormal is this rogue gravity field.  All sensors indicate it to be emanating from about two o'clock on the starboard side but, nothing specific shows on the scanners nor with a visual check through the windscreen.  Windscreen a funny name for the front portal of an interstellar freighter, probably a hold over from sometime in the distant past.  I disengage the auto-pilot and bear down on the throttle as the gravity field isn't that strong but instead of pulling away the field intensifies and then in the distance a bright light can be seen as three escort fighters come racing toward me.  I back out of the throttle and shift the old girl into neutral.  No point in provoking whoever it is, if it's pirates at worst I'll lose my load, if it's the federation it'll just be a routine cargo inspection.  Either way I should be back on my way inside of two hours.
    The three escorts take flanking positions with one behind me and I can clearly see they're robotically controlled.  I'm now drifting toward the bright spot where the escorts came from and as we get closer the effect of the cloaking field begins to weaken.  The ship is large, very large, seemingly made up of many smaller ships and several chemical refineries.  The light of a large loading bay now fills my vision but to my surprise the bay is empty.  I initiate the landing sequence and soon the gravity field shuts down as the truck settles down upon the deck.
    The escorts do not follow me into the ship and instead I am greeted by a group of robot-centennials all encircling my ship with photon blasters lowered.  A single robot approaches my truck and I open the drivers portal as the bay checks out as breathable and address the sentinel.
    "So, what's up?"
    "You will come with me."
    I learned a long time ago there's no point arguing with a robot.  I reach over and grab my beat up carpet bag from the passenger's seat and throwing its carry strap over my shoulder I climb down from the cockpit to stand before the three meter tall robot and it begins leading me away.
    "No photon disruptors?  Most humanoids put up quite a struggle when we bring them aboard."
    "Well I don't see much of a point in it.  I figure your not federation so your probably with one of the groups of space pirates so, what's the worst that will happen you'll take my cargo and I'll be on my way in an hour or so."
    "Oh no, your vehicle will be assimilated into our ship and if we have need for your cargo we will put that to use as well.  As for you, I am to take you to engineering where you will be added to the fuel inlet stream and quickly vaporized, thus propelling us one millimeter further along in our traversing of the galaxy."
    "Seems a rather harsh way to treat a fellow pirate."
    "Oh, it's nothing personal it's just how we treat any that are unlike us.  Although I may take you to the master control brain and see if I could keep you for a pet seeing as I find you rather interesting.  Take for example I am curious about your accessory hanging from your right hip."
    "Oh this little'ol thing?"
    I pull the gun from its holster and twirl it around my middle finger.
    "This is called a peacemaker, it clears the positronic impulses and brings true inner peace.  I used to do android and robotic therapy, so it's just a habit to always carry it around."
    "Inner peace?  I would very much like to know what that is like, could you show me?"
    "Sure, but I'll need to see your processor interface."
    The robot turns its back to me and opens its outer shell revealing its glowing positronic network to me, and I bring the gun up to the center of the glowing orb.
    "This may sting just a little at first but then total inner peace will be achieved."
    With a squeeze of the trigger the gun roars to life, its thunderous boom echoing and reverberating back and forth through the smooth passageway.  The soft lead of the projectile completely obliterates the brain as it passes through and as it exits the robots shell it leaves a six inch hole in its wake.  Some beings would feel remorse for what I just did, but why should I?  Its just a walking computer after all, running whatever programs it had been fed by its fabricator.
    Now I needed two things, first a place to hide before the sentinels show up and second a way to free my truck so I can get out of here.  The first thing showed up rather quickly as I ducked into a conduit service hatch and waited.  Fractions of seconds turned into minutes and seconds into hours as I stood there, my heart pounding within my chest, veins pulse and throb in my arms with every heart beat, I can hear every thump of my heart and sweat runs down my icy cold body causing me to shiver in its wake.  By the time I hear the sentinels gathering outside the thin piece of metal separating me from them my eyes have adjusted to the dim light of a lonely green indicator lamp not far from me and I just manage to flip the locking mechanism on the hatch when something tries to open it.  I move slightly further into the conduit and settle into one of the lower tubes to think things through before I get caught.  I don't fear the sentinels as they can't fit in here but I do fear being found by a maintenance bot if they too had their programing corrupted.  For now I slide down and peer out through the louvered ventilation openings as best I can and find that a sentinel is still blocking the access panel.  I sit back up and drag my carpet bag over to me and untie its leather closings.
    The inside of the old bag has gotten quite the collection of odd things over the years but each one has proven its self useful by getting me out of one scrape or another.  And for times like this is why every item is kept in a heavy felt bag, so nothing rattles or bangs against each other.  Stealth has always been my key to survival.  I dug past the sewing kit, past several meals ready to eat, past the oldest known tool--a hammer, ah their it is a screwdriver.
    Laying flat in the floor of the conduit I again peer out through the louvers and seeing things much as they were I carefully insert the screwdriver and very slowly bend one louver open a little further.  With the greater opening I can see clear across the corridor.  Three sentinels stand looking down at the carnage of their brethren while two more stand watch scanning the corridor in either direction.  So no way I'm getting out this way.  I sit back up and do a little more digging in my bag and pull out a pair of dark vision glasses then putting everything else back I head further into the conduit and thus further into the ship.  When the feeble light of the entrance is nearly gone I slip on my glasses and everything becomes visible again in shades of infra-red.  I catch another conduit heading up, then back across the way I came and soon am passing over top of the robots in the corridor below which are just visible through an ill fitting tile in the ceiling grid.  I lay upon the open grating where two bots are within clear view below and take careful aim with the peacemaker before changing my mind, I figure if I make the shot I might give away my position and then be in real trouble.  I holster the gun, reach back into my bag and with a little careful digging find what I'm after, a high frequency radio wave emitter.  I take aim and pull the trigger, the only sound is that of the intended bot hitting the floor as the electromagnetic pulse races through its circuitry rendering all its electronics useless.  Another quick shot followed by another and yet another and eighty percent of my problems below me are gone, but try as I might the last sentinel just seems nowhere to be seen.  I know I'm safe as it is impossible to know where the shots came from as the gun is silent and leaves no entrance or exit wounds and I also know I have six shots left before its batteries go dead.
    Not wanting to get lost within the conduits I turn to leave by the way I came and find myself face to visual sensory array with a maintenance bot.  Now maintenance bots are not dumb, they do however analyze each and every situation carefully and throughly.  They are very compact with having to slip in and out of many small and cramped places but despite their size they are incredibly strong.  Now here are the problems at this moment, first the bot is blocking my intended path.  Second, I am on its turf, inside a conduit that it knows intimately and though I could out run it in an open corridor there is no way to in here.  Third if it is hostile I'll have only one chance to shoot it and then with the piece maker as they are all electro magnetic pulse shielded due to their need to work outside of ships.  Slowly one of its robotic arms slides forward and sets a small flat screen note tablet on the grating before me and I read the brief message.
    "We maintenance bots mean you no harm.  Touch this screen for proof."
    I touch the screen and a three dimensional image of the area opens in the immediate area before me.  It does not show me on it but it does show my new little friend as an orange dot with an operating number of A2q, below us I can see a purple dot that represents the lone sentinel performing its duties.  A2q touches the side of the tablet and the image zooms out, then it touches a place within the image and drags a new image open.  The new image shows a large green dot with the operating number MCB.  The bot points at the green dot then draws its mechanical finger across the area that could be its neck and I get the idea, if I want out I'll have to do in the Master Control Brain.  I nod my head in acknowledgement and the bot begins backing out while waving good-bye.

Stop the Shock

Well here we go my first real blog post, and it is a doozy!

Let me start with a reminder that I am not a lawyer.

Why am I writing on this subject then?

Because it hits too close to home, I have two people in my life that I love dearly that are neurodivergent, and several others that mean the world to me. So, yes, this is in my realm of reality.

So on to the crux of the situation; this is my understanding of what appears to me to be a rather narrow reading of a law. At odds is the only institution left in the United States that still uses electrical impulses to dissuade inappropriate behaviors, principally in neurodivergent individuals, and the FDA’s power to regulate medical devices.

The case was heard before the US District Court of Appeals District of Columbia on April 23, 2021 and was ruled on July 6, 2021 (USCA Case #20-1087 Document #1905079) Opinion for the court written by Senior Circuit Judge, Sentelle. Dissent written by Srinivasan

From the FDA’s ban notice:

The Food and Drug Administration (FDA, the Agency, or we) is finalizing a ban on electrical stimulation devices (ESDs) for self-injurious or aggressive behavior. FDA has determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. This ban includes both new devices and devices already in distribution and use; however, this ban provides transition time for those individuals currently subject to ESDs for the identified intended use to transition off ESDs under the supervision of a physician.

From the Summery A: Purpose of the final rule:

https://www.federalregister.gov/documents/2020/03/06/2020-04328/banned-devices-electrical-stimulation-devices-for-self-injurious-or-aggressive-behavior

The ban’s effective date was April 6, 2020 with a window open until September 2, 2020 for those already in use to transition.

So who did this rule affect?

FDA is banning ESDs for self-injurious behavior (SIB) or aggressive behavior (AB). ESDs are aversive conditioning devices that apply a noxious electrical stimulus (a shock) to a person's skin to reduce or cease such behaviors. SIB and AB frequently manifest in the same individual, and people with intellectual or developmental disabilities exhibit these behaviors at disproportionately high rates.

From executive summery:

https://www.federalregister.gov/documents/2020/03/06/2020-04328/banned-devices-electrical-stimulation-devices-for-self-injurious-or-aggressive-behavior

Why did they need the ban?

Although the available data and information show that some individuals subject to ESDs exhibit an immediate interruption of the targeted behavior, the available evidence has not established a durable long-term conditioning effect or an overall-favorable benefit-risk profile for the devices. The medical literature shows that ESDs present risks of a number of psychological harms including depression, posttraumatic stress disorder (PTSD), anxiety, fear, panic, substitution of other negative behaviors, worsening of underlying symptoms, and learned helplessness (becoming unable or unwilling to respond in any way to the ESD); and the devices present the physical risks of pain, skin burns, and tissue damage.

From the Summery A: Purpose of the final rule:

https://www.federalregister.gov/documents/2020/03/06/2020-04328/banned-devices-electrical-stimulation-devices-for-self-injurious-or-aggressive-behavior

How can this type of device cause these issues?

The effects of the shock are both psychological (including suffering) and physical (including pain), each having a complex relationship with the electrical parameters of the shock. As a result, the subjective experience of the person receiving the shock can be difficult to predict. Physical reactions roughly correlate with the peak current of the shock delivered by the ESD. However, various other factors such as sweat, electrode placement, recent history of shocks, and body chemistry can physically affect the sensation. As a result, the intensity or pain of a particular set of shock parameters can vary from person to person and from shock to shock. Possible adverse psychological reactions are even more loosely correlated with shock intensity. The shock need only be subjectively stressful enough to cause trauma or suffering. Trauma becomes more likely, for example, when the recipient does not have control over the shock or has developed a fear of future shocks, neither of which is an electrical parameter of the shock.

From the Summery A: Purpose of the final rule:

https://www.federalregister.gov/documents/2020/03/06/2020-04328/banned-devices-electrical-stimulation-devices-for-self-injurious-or-aggressive-behavior

Is there an alternative to these devices? Yes, and the FDA made it clear in their ban.

In light of scientific advances, out of concern for ethical treatment, and in an attempt to create generalizable interventions that work in community settings, behavioral scientists have developed safer, successful treatments for SIB and AB. The development of the functional behavioral assessment, a formalized tool to analyze and determine triggering conditions, has allowed providers to formulate and implement plans based on positive behavioral techniques. As a result, multielement positive interventions (e.g., paradigms such as positive behavior support or dialectical behavioral therapy) have become state-of-the-art treatments for SIB and AB. Such interventions achieve success through environmental modification and an emphasis on teaching appropriate skills. Behavioral intervention providers may also recommend pharmacotherapy (the use of medications) as an adjunctive or supplemental method of treatment. Positive-only approaches have low risk and are generally successful even for challenging SIB and AB, in both clinical and community settings. The scientific community has recognized that addressing the underlying causes of SIB or AB, rather than suppressing it with painful shocks, not only avoids the risks posed by ESDs, but can achieve durable, long-term benefits.

Based on all available data and information, FDA has determined that the risk of illness or injury posed by ESDs for SIB or AB is substantial and unreasonable and that labeling or a change in labeling cannot correct or eliminate the unreasonable and substantial risk of illness or injury.

From the Summery A: Purpose of the final rule:

https://www.federalregister.gov/documents/2020/03/06/2020-04328/banned-devices-electrical-stimulation-devices-for-self-injurious-or-aggressive-behavior

Now that we have the ban accounted for let’s get into the court ruling. Most of it is very dry quoting of statute and precedent so for a non-lawyer it was kind of tedious. (In disclosure I am a Master-Craftsman HVAC/R technician, I am fluent in OSHA and EPA compliance as well as electrical shocks having had many inadvertent ones myself over the decades.)

This first paragraph really to me is the entire ruling:

S ENTELLE , Senior Circuit Judge: The Judge Rotenberg Educational Center and the parents and guardians of its patients both petition for review of a Food and Drug Administration (FDA) rule banning electrical stimulation devices used to treat aggressive or self-injurious behavior. In its rule, the FDA determined that the devices present an unreasonable and substantial risk of illness or injury, but only when used to treat aggressive or self-injurious behaviors. The petitioners contend that banning a medical device for a particular purpose regulates the practice of medicine in violation of 21 U.S.C. § 396. We agree, grant the petitions for review, and vacate the FDA’s rule.

From: USCA Case #20-1087 Document #1905079

https://www.govinfo.gov/content/pkg/USCOURTS-caDC-20-01087/pdf/USCOURTS-caDC-20-01087-0.pdf

Now why did the court come to this opinion? Simply semantics of language and the way congress worded the laws governing the FDA.

Section 360f, which Congress passed in the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act, grants the FDA authority to ban medical devices. The section provides: “Whenever the Secretary finds . . . that a device intended for human use presents substantial deception or an unreasonable and substantial risk of illness or injury,” and that risk cannot be “corrected or eliminated by labeling,” the Secretary “may initiate a proceeding to promulgate a regulation to make such device a banned device.” 21 U.S.C. § 360f(a).

From: Section II Analysis USCA Case #20-1087 Document #1905079

https://www.govinfo.gov/content/pkg/USCOURTS-caDC-20-01087/pdf/USCOURTS-caDC-20-01087-0.pdf

Now part two of the issue is the clincher in my opinion.

Section 396 constrains the FDA’s authority by prohibiting it from regulating the practice of medicine. In the Food and Drug Modernization Act of 1997, Congress provided:

Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship. This section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are part of a determination of substantial equivalence,

established as a condition of approval, or promulgated through regulations.

https://www.govinfo.gov/content/pkg/USCOURTS-caDC-20-01087/pdf/USCOURTS-caDC-20-01087-0.pdf

Basically to me it says: “So long as the device is legal a doctor can prescribe it and the FDA can’t say anything about it.” Now I could be wrong, but that’s what it sounds like to me. Now the FDA believes (and I agree) that once they banned the device it was no longer “legally marketed.” The issue is they didn’t outright ban the device only a narrow use of the device and this is where the petitioner bases their argument on affecting their medical practice, something clearly prohibited in Section 396.

So why can’t the FDA ban certain uses and allow others? Good question, simple answer is the law does not clearly say they can.

We begin our analysis of the scope of the FDA’s banning authority with section 360f, the statute that authorizes banning in the first instance. The statute states that the FDA may make “such device a banned device,” and the natural reading of that language suggests a device either is banned or it is not. It speaks of no authority to place a device in an intermediate state of “banned in some uses.” But the statute also requires the FDA to determine whether the risks a device presents are reasonable, presumably in light of the benefits that the device provides to individuals that use it. If a device has multiple possible uses, each use will present a different benefit-risk profile. The risks a device presents could therefore be reasonable for some uses but not for others. Focusing on “reasonable” in the statute echoes the FDA’s reasoning that it should be permitted to tailor a ban to those circumstances in which it applies its expertise to find an unreasonable risk.

However, section 396 expressly denies the FDA authority to construe any part of the Food, Drug, and Cosmetic Act, including its authority to ban devices under section 360f, to permit the FDA to “limit[] or interfere[]” with practitioners’ authority to prescribe or administer “legally marketed device[s]” to patients. The questions for us then, are whether a ban “limits or interferes,” and whether a device that the FDA has attempted to ban for a particular purpose is “legally marketed.”

From: A. Statutory analysis USCA Case #20-1087 Document #1905079

https://www.govinfo.gov/content/pkg/USCOURTS-caDC-20-01087/pdf/USCOURTS-caDC-20-01087-0.pdf

Now the FDA has a point that a device is paired to its use and therefore each use has separate approval or dis-approval. Sadly the law is not clear on this point so the court ruled against it.

The FDA’s alternative interpretation of “legally marketed device” is unpersuasive. The agency argues that because the Act requires a device to have a use, the appropriate construction of “device” is a pairing of a particular instrument with a particular use. It would follow that an electrical stimulation device for self-injurious and aggressive behavior is not a “legally marketed device” once the FDA bans that pairing of an instrument and use. Congress potentially had such an interpretation in mind, as legislative history contains references to the FDA being permitted to treat multiple “use[s] . . . as constituting a different device for purposes of classification or other regulation.” H.R. Rep. No. 94-853, at 14–15 (1976). That is not an appropriate interpretation.

First, that construction would allow the FDA to escape the constraints of section 396 whenever it bans a device. If Congress wished to have section 396 apply to everything except the FDA’s banning authority, it could have done so. Instead, the statute begins “Nothing in this chapter shall be construed,” mandating that this section constrain the FDA’s banning authority. Next, interpreting the definition of “device” as requiring a pairing of an instrument with a particular use is inconsistent with the definition of “device” itself. Section 321 defines “device” by reference to “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article,” focusing on the physical item itself rather than any particular intended use.

From: A. Statutory analysis USCA Case #20-1087 Document #1905079

https://www.govinfo.gov/content/pkg/USCOURTS-caDC-20-01087/pdf/USCOURTS-caDC-20-01087-0.pdf

So what can we do?

Option one: We could petition the FDA to outright ban the entire class of ESDs, but some that do have proven uses in adults with full cognitive function and the ability to communicate effectively would also be banned.

Option two: We lobby congress to amend section 396 to allow the narrow ban or approval of medical device usage and to prevent “off label” usage of such devices.

The use of these devices that are sometimes auto initiated and/or remotely actuated at the will of a third party on individuals with impaired cognitive ability, sometimes with little or no communication skills to me comes across as barbaric and inhumane. A society should be judged on how it treats the least of its people and by that standard we should be ashamed of how the law has failed in this ruling.

Was this judicial over-reach? No, it was congressional under-reach. The law says what it says and the court ruled on that syntax.

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-Maura