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Manufacturers Refuse To Allow Hospitals To Fix Ventilators That Are The Last Hope For Many COVID-19 Patients

from the right-to-repair-means-right-to-save-lives dept

The coronavirus pandemic has developed so quickly that the key people involved in dealing with it -- including medical staff, scientists, and governments -- are still struggling to find the resources to do so effectively. One key issue that has emerged is that there may not be enough ventilators to keep people with the most serious symptoms of COVID-19 alive. The fear is that doctors will have to make on-the-spot decisions about who has priority for the machines that are available -- tantamount to deciding who will live, and who will die. The prospect of that terrible burden being placed on medics' shoulders has led to a global scramble to obtain as many of these machines as possible so that there is a ventilator for everyone who needs one.

The urgency of the situation has led to some unprecedented solutions. For example, major car manufacturers are retooling their vehicle production lines to make ventilators. The US Health and Human Services Department has awarded a contract for $489 million to General Motors to make 30,000 ventilators. Meanwhile, Ford aims to supply 50,000 ventilators in 100 days. The Spanish car-maker Seat, part of Volkswagen, has built emergency ventilators out of windscreen wiper parts. Similarly, Tesla is seeking to re-purpose parts from its own cars to create ventilator systems.

Also noteworthy are a number of open source ventilator projects. The aim is to design models whose 3D plans can be shared freely so that much-needed devices can be built for a low cost around the world. As an article on Hackernoon looking at four projects that are furthest along points out, the complexity of the problem is underestimated by many hoping to contribute in this way. In particular, designing open source ventilators is the easy part: the hard part is rigorous testing and gaining approval from the relevant health authorities.

The obstacles to supplying new devices has led many to concentrate on a better utilization of the ventilators that hospitals already have. However, as an article on the Vice site explains, at a time when most companies are doing what they can to help address the coronavirus pandemic, some manufacturers think protecting copyright and proprietary designs is more important than saving thousands of lives. Specifically, it turns out the lack of a "right to repair" -- something covered extensively here on Techdirt -- is stopping hospitals from fixing the ventilators they own quickly, and forcing them to ship units back to the manufacturers:

Core to the fight against coronavirus, then, will be keeping the ventilators hospitals do have online. Many of them are not empowered to fix their own machines, however, due to the exact same issue that we've outlined before with John Deere tractors and other devices: medical devices, including ventilators, have gotten more complicated over the years. They are now controlled by microprocessors and software. That complexity hasn't made them inherently more difficult to repair, but manufacturers have artificially put "software locks" on them, meaning that only those who are authorized can make modifications.

Some ventilator manufacturers are going out of their way to make repair difficult. For example, they have tried to keep service manuals out of the hands of independent repair professionals. They have even taken legal action against independent databases of manuals. The site Frank's Hospital Workshop, which seeks to help people repair medical equipment, has been forced to remove some manuals, replacing them with the explanation: "Download prohibited... Support is not desired." The argument against allowing hospitals to employ independent technicians is the usual fear-mongering:

AdvaMed, the medical device manufacturer trade group that represents more than 400 companies (including Siemens, GE Healthcare, and Philips, which are among the largest), wrote a letter to lawmakers in Massachusetts claiming that right to repair legislation "could result in maintenance and repairs of medical devices being performed by untrained personnel, and that inappropriate replacement parts may be used."

In other words, manufacturers are insinuating that there's a risk that "untrained" personnel might do a bad job, and result in equipment that is dangerous for patients. The US government doesn't think that's true: a 2018 Federal Drug Administration report found that many third-party repairs "provide high quality, safe, and effective servicing of medical devices" (pdf). And even if it were true, the choice would then be between putting COVID-19 patients on a repaired, working ventilator that might have some risk, or not having access to one at all, and probably dying as a result. Do manufacturers seriously think people would prefer the latter?

Follow me @glynmoody on Twitter, Diaspora, or Mastodon.

Filed Under: covid-19, fixing, hospitals, right to repair, ventilators


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  • icon
    That One Guy (profile), 10 Apr 2020 @ 2:18am

    Let's see, might not work properly vs complely gone...

    AdvaMed, the medical device manufacturer trade group that represents more than 400 companies (including Siemens, GE Healthcare, and Philips, which are among the largest), wrote a letter to lawmakers in Massachusetts claiming that right to repair legislation "could result in maintenance and repairs of medical devices being performed by untrained personnel, and that inappropriate replacement parts may be used."

    '... something that might result in the machines not working properly, causing harm or even death before they can be properly fixed. Much better that the machine only be repaired by certified technicians at the manufacturer's factory, a process which should only take a few measly days/weeks including shipping, a time period which I'm sure no-one would need the machine and die without it.'

    Even if they were right they'd still be wrong, given unless they are shipping out people to repair the devices at the hospitals the process of fixing them 'properly' is likely to remove them from the hospital entirely for a good while, during a period when days can literally be the difference between life and death. Given the choice between 'we can use this machine to keep you alive, but it might not work perfectly' or 'we had a machine that would have kept you alive, but we had to send it back for repairs' I'm pretty sure I know which the overwhelming majority of people affected would pick.

    reply to this | link to this | view in chronology ]

  • icon
    Stephen T. Stone (profile), 10 Apr 2020 @ 3:26am

    I’d do one of those little back-and-forth hypothetical dialogue thingies here, but even I don’t want to get into the mindset of someone who would rather let people die before they ever let the right to repair fall into the hands of the public.

    reply to this | link to this | view in chronology ]

    • icon
      That One Guy (profile), 10 Apr 2020 @ 10:35am

      Re:

      The irony of course is that their obsession with keeping 'right to repair' out of the law no matter what is instead providing a perfect example of why it most certainly should be part of the law, as it's difficult to think of a better example in favor of right to repair than 'people not being able to repair the stuff that they own might literally be the difference between life and death'.

      reply to this | link to this | view in chronology ]

  • identicon
    Anonymous Coward, 10 Apr 2020 @ 4:01am

    claiming that right to repair legislation "could result in maintenance and repairs of medical devices being performed by untrained personnel, and that inappropriate replacement parts may be used."

    Do they believe that hospitals would not be held responsible for shoddy repairs? Only those with the Intelligence of Trump supporter would believe that.

    reply to this | link to this | view in chronology ]

    • identicon
      Anonymous Coward, 10 Apr 2020 @ 7:21am

      Re:

      Hospitals were not in charge of maintaining the hundreds of ventilators the federal government was supposed to be keeping for emergencies, but instead they let the things fall into disrepair. Wonder where the money went that was supposed to be used for that purpose.

      reply to this | link to this | view in chronology ]

    • icon
      Cdaragorn (profile), 10 Apr 2020 @ 8:02am

      Re:

      When trying to save lives, holding someone responsible because something wasn't done perfectly is just as despicable as letting them die because you don't want to chance a shoddy repair.
      No, no one will be "held accountable" because trying to save a life and failing when there was no other way is freaking OK.

      reply to this | link to this | view in chronology ]

  • This comment has been flagged by the community. Click here to show it
    icon
    PackagingBee (profile), 10 Apr 2020 @ 4:39am

    It doesn't make any scence

    Well, during this pandemic situation it is very important for all of us to contribute to humanity. Not only Doctors but also all of us should be available for us to considers as a useful assist during this time. The shortage of ventilators medicines and even food, this must be the worst case around the world right now. As all business and industries also effected by this situation. IF you want to bring up with contribution plan to needy for your products, then you must pack them in vulnerable product boxes from https://packagingbee.co.uk/ to giveaway boxes.

    reply to this | link to this | view in chronology ]

  • identicon
    Anonymous Coward, 10 Apr 2020 @ 7:23am

    These people are criminally negligent and need to be held accountable.

    Fat chance huh

    reply to this | link to this | view in chronology ]

  • identicon
    Anonymous Coward, 10 Apr 2020 @ 8:08am

    designing open source ventilators is the easy part

    Designing an automatic air pump is easy, designing a ventilator is much harder.

    reply to this | link to this | view in chronology ]

  • identicon
    Anonymous Coward, 10 Apr 2020 @ 8:10am

    Like most things related to the virus, the ventilator shortage is way overblown. Cuomo asked for 30,000 ventilators just for New York, any guess how many were actually needed? 20,000? 10,000? nope. Peak usage was actually a bit over 5,000. (https://covid19.healthdata.org/united-states-of-america/new-york)

    Get the facts before you panic.

    reply to this | link to this | view in chronology ]

    • icon
      Stephen T. Stone (profile), 10 Apr 2020 @ 8:15am

      ’tis far better to overreact and overprepare and save lives than to underreact and underprepare and watch people die.

      reply to this | link to this | view in chronology ]

    • icon
      Chris-Mouse (profile), 10 Apr 2020 @ 8:47am

      Re:

      How about we check some of your 'facts' To start with, the number of new cases reported is still in the hundreds per day. We don't know that the peak need is only 5000 units, because we certainly can't say we're past the peak.

      Second, at the time Cuomo asked for the ventilators, the number of cases was climbing rapidly. He asked for enough ventilators to meet the worst case projections that were being made at that time. Doing anything else would mean being prepared to let people die if the projection was off.

      Third, nobody was 'panicking'. They were prepared to waste money to be ready for a worst case situation, rather than preparing to waste lives by assuming an optimistic projection. Contrast that with the federal response that seems to be much more concerned about the amount of money the 1% is losing that the lives that the 99% are losing.

      reply to this | link to this | view in chronology ]

      • identicon
        Anonymous Coward, 10 Apr 2020 @ 10:09am

        Re: Re:

        adding on to the list:

        forth, many covid deaths occur at home and go unreported ... apparently there was a lack of resources to attempt saving them.
        I read it may be a large number.

        reply to this | link to this | view in chronology ]

      • identicon
        Anonymous Coward, 10 Apr 2020 @ 1:17pm

        Re: Re:

        I quoted a source, didn't notice one in your reply. Facts matter.

        reply to this | link to this | view in chronology ]

        • identicon
          ROGS, 12 Apr 2020 @ 9:14am

          Re: Re: Re:Bravo!

          Absolutely, There is a pretty core group of in-house trolls and spergs here who consistently, and constantly throw [citation need] at anyone and everyone. Stone, Hull, SDM, Toom, etc.

          And your point is valid, as is the fact that they only argue only with hyperbole and pseudo-reason, devoid of ANY engagement with facts.

          reply to this | link to this | view in chronology ]

    • icon
      PaulT (profile), 10 Apr 2020 @ 9:01am

      Re:

      So.. you're saying that government should order the bare minimum in the fact of a crisis, and wait until people start dying from lack of inventory before they place their larger order?

      "Get the facts before you panic."

      Even if your facts are correct, hundreds if not thousands of people would have died waiting for the ventilators had they become necessary under your scheme. I'd rather have too many prepped meals in my freezer than realise I've run out on the day the supermarkets close for a week.

      reply to this | link to this | view in chronology ]

      • identicon
        ROGS, 12 Apr 2020 @ 11:18am

        Re: Re:PaulT, Techdirt prepper

        PaulT the Techdirt troll is a fucking prepper, by definition. A genuine boogaloo.

        Let me cite that:

        I'd rather have too many prepped meals in my freezer than realise I've run out

        prepper
        [ˈprepər]
        NOUN
        NORTH AMERICAN

        a person who believes a catastrophic disaster or emergency is likely to occur in the future and makes active preparations for it, typically by stockpiling food, ammunition, and other supplies.

        Who knew that these derailing gatekeepers here at TD are fucking three percent boogaloos.

        TD so prepper.

        Masnick, these are your bro's, right?

        reply to this | link to this | view in chronology ]

        • identicon
          teka, 14 Apr 2020 @ 10:10am

          Re: Re: Re:PaulT, Techdirt prepper

          The amount of paranoia and fear you seem to live in, constantly, is tragic.

          That said, stocking some basic home goods and food for any kind of disruption is only reasonable for anyone who lives where it ever snows or storms or shakes or hurricanes or, or, or- etc, so on. so, everyone.

          reply to this | link to this | view in chronology ]

    • identicon
      Anonymous Coward, 10 Apr 2020 @ 10:12am

      Re:

      Don't panic

      reply to this | link to this | view in chronology ]

  • identicon
    Anonymous Coward, 10 Apr 2020 @ 9:59am

    Any chance of tgese selfish assholes being criminally charged if someone does die because a ventilator could have been repaired and available, but wasn't? Something drastic like Murder 2 wmsou ds good! Mind you, if this whole debacle had never been ruled in in the first place and what you bought, you owned was what it always was and always should be rather than changed, thanks to certain judges stupidity (and probable financial 'encouragement'), these deaths and similar situations would never occur!

    reply to this | link to this | view in chronology ]

  • icon
    ECA (profile), 10 Apr 2020 @ 12:03pm

    Fixed.

    My house.
    My car
    A ton of computers of the years.
    Washers,
    Dryers
    Hot water heaters(and still no one can figure why the Dump on them is 1", and not big enough to Put your hand inside to CLEAN THEM)
    Bikes..
    And a few other things over time.

    How many people have seen the REPAIR time to get something Done? And remember, they only hire a few people to do this, around a LARGE area. Cable sucks in many places as you wait 2 weeks to get someone.
    HOW much do you think a hospital pays for EMERGENCY REPAIRS??
    Can you say STUPID?
    And how many of us, have opened Most any Home appliance to find a circuit board inside, insted of Mechanical Timing units, and Switches THAT CAN BE REPLACED..

    That computer in your CAR.. How much is it? $200-1000? for $50 MAX PARTS AND PROGRAMMING..
    This is the world of virtual parts and hardware.
    Inside your dashboard, IT USED to be a few light bulbs to replace.. NOW it is a Giant board, with LED's.. and if the LED dies..you replace the WHOLE THING..
    I love modular..AND even some Laptops are going back to that idea.

    reply to this | link to this | view in chronology ]

  • This comment has been flagged by the community. Click here to show it
    identicon
    ROGS, 10 Apr 2020 @ 12:30pm

    resources?

    STFU, anti-China guy.

    I have over 300 thousand ventilators available right now, with technical manuals written in the Kings English, all FDA approved.

    But the problem is political sourcing,the crisis PR people running the chicken little narrative, and then, who actually has these life-saving supplies, v. the PR mouthpieces who run narratives of shortages, aka, who can/will buy what, from whom without the various tribes trying to get a cut.

    You know where to find me (researchorganizedgangstalking.wordpress.com), but really, all of the writing that you will do between now and COVID-20 through 1012 won't solve the sourcing problem.

    I have that capacity to send ventillators to NYC, and elsewhere right now, but few/none of you pundits call.

    Stick with words on the internet; they seem to pay real, world changing dividends,and seldom save lives.

    Money/mouth, and all that.

    reply to this | link to this | view in chronology ]

    • identicon
      Eponymous Drawcard, 10 Apr 2020 @ 3:04pm

      Re: resources?

      Well, here are the people to contact (h/t Wikipedia). I'm sure they could use all 300 000 ventilators that actually exist.

      AL Kay Ivey (R)
      AK Mike Dunleavy (R)
      AZ Doug Ducey (R)
      AR Asa Hutchinson (R)
      CA Gavin Newsom (D)
      CO Jared Polis (D)
      CT Ned Lamont (D)
      DE John C. Carney Jr. (D)
      FL Ron DeSantis (R)
      GA Brian Kemp (R)
      HI David Ige (D)
      ID Brad Little (R)

      IL J. B. Pritzker (D)
      IN Eric Holcomb (R)
      IA Kim Reynolds (R)
      KS Laura Kelly (D)
      KY Andy Beshear (D)
      LA John Bel Edwards (D)
      ME Janet T. Mills (D)
      MD Larry Hogan (R)
      MA Charlie Baker (R)
      MI Gretchen Whitmer (D)
      MN Tim Walz (D)
      MS Tate Reeves (R)

      MO Mike Parson (R)
      MT Steve Bullock (D)
      NE Pete Ricketts (R)
      NV Steve Sisolak (D)
      NH Chris Sununu (R)
      NJ Phil Murphy (D)
      NM Michelle Lujan Grisham (D)
      NY Andrew Cuomo (D)
      NC Roy Cooper (D)
      ND Doug Burgum (R)
      OH Mike DeWine (R)
      OK Kevin Stitt (R)

      OR Kate Brown (D)
      PA Tom Wolf (D)
      RI Gina Raimondo (D)
      SC Henry McMaster (R)
      SD Kristi Noem (R)
      TN Bill Lee (R)
      TX Greg Abbott (R)
      UT Gary Herbert (R)
      VT Phil Scott (R)
      VA Ralph Northam (D)
      WA Jay Inslee (D)
      WV Jim Justice (R)

      WI Tony Evers (D)
      WY Mark Gordon (R)
      DC Bowser (D) (Mayor)

      Territories:
      AS Lolo Matalasi Moliga (D)
      GU Lou Leon Guerrero (D)
      MP Ralph Torres (R)
      PR Wanda Vázquez Garced (R)
      VI Albert Bryan (D)

      Bill de Blasio (D) New York City, NY Eric Garcetti (D) Los Angeles, CA Lori Lightfoot (D) Chicago, IL Sylvester Turner (D) Houston, TX Kate Gallego (D) Phoenix, AZ Jim Kenney (D) Philadelphia, PA Ron Nirenberg (I) San Antonio, TX Kevin Faulconer (R) San Diego, CA Eric Johnson (D) Dallas, TX Sam Liccardo (D) San Jose, CA Steve Adler (D) Austin, TX Lenny Curry (R) Jacksonville, FL London Breed (D) San Francisco, CA Andrew Ginther (D) Columbus, OH Betsy Price (R) Fort Worth, TX Joe Hogsett (D) Indianapolis, IN Vi Lyles (D) Charlotte, NC Jenny Durkan (D) Seattle, WA Michael Hancock (D) Denver, CO Muriel Bowser (D) Washington, DC Marty Walsh (D) Boston, MA Dee Margo (R) El Paso, TX Mike Duggan (D) Detroit, MI John Cooper (D) Nashville, TN Jim Strickland (D) Memphis, TN Ted Wheeler (D) Portland, OR David Holt (R) Oklahoma City, OK Carolyn Goodman (I) Las Vegas, NV Greg Fischer (D) Louisville, KY Jack Young (D) Baltimore, MD Tom Barrett (D) Milwaukee, WI Tim Keller (D) Albuquerque, NM Regina Romero (D) Tucson, AZ Lee Brand (R) Fresno, CA Darrell Steinberg (D) Sacramento, CA John Giles (R) Mesa, AZ Quinton Lucas (D) Kansas City, MO Keisha Lance Bottoms (D) Atlanta, GA Robert Garcia (D) Long Beach, CA Jean Stothert (R) Omaha, NE Mary-Ann Baldwin (D) Raleigh, NC John Suthers (R) Colorado Springs, CO Francis X. Suarez (R) Miami, FL Bobby Dyer (R) Virginia Beach, VA Libby Schaaf (D) Oakland, CA Jacob Frey (D) Minneapolis, MN G. T. Bynum (R) Tulsa, OK Jeff Williams (R) Arlington, TX LaToya Cantrell (D) New Orleans, LA Brandon Whipple (D) Wichita, KS

      reply to this | link to this | view in chronology ]

      • This comment has been flagged by the community. Click here to show it
        identicon
        ROGS, 11 Apr 2020 @ 8:54am

        Re: Re: resources?

        Thanks for that, but we have been going that route, and this does not get past most offices, even if submitted as a tender.

        I used my comment to make a point: its all insider gibberish and bi-polar Mockingbird media punditry about the evil Chinese and very little about how to actually solve the problem.

        reply to this | link to this | view in chronology ]

    • identicon
      Anonymous Coward, 10 Apr 2020 @ 6:06pm

      Re: resources?

      You're not a very good salesperson if you have that much stock sitting around and nobody buying it.

      reply to this | link to this | view in chronology ]

  • icon
    danderbandit (profile), 10 Apr 2020 @ 6:12pm

    Building Ventilators

    There is an article that a group centered at MIT was developing a ventilator that would cost ~$500 compared to the $30K the big manufacturers are charging. It started as a class in Medical Device Design a decade ago, and when this crisis hit this new group went back to that design (which was just a proof of concept with no testing done) and are refining it and testing to get FDA approval. You can read the article at http://news.mit.edu/2020/ventilator-covid-deployment-open-source-low-cost-0326

    reply to this | link to this | view in chronology ]

    • identicon
      ROGS, 12 Apr 2020 @ 11:35am

      Re: Building Ventilators

      That is seriously a cool ventilator. Whoever you are, you belong here.

      You might like to know that I set that link to a major front line nation's trade association.

      And I thank you for that.

      reply to this | link to this | view in chronology ]

  • identicon
    Anonymous Coward, 10 Apr 2020 @ 6:25pm

    Huh. I didn't think Tero Pulkinnen worked in the manufacturing sector.

    reply to this | link to this | view in chronology ]

  • identicon
    Pixelation, 10 Apr 2020 @ 7:14pm

    one thing is clear

    A pandemic will clearly expose corporations that we as a society should eliminate.

    reply to this | link to this | view in chronology ]

  • identicon
    Anonymous Coward, 11 Apr 2020 @ 6:02am

    Don't forget to get an RMA number for each individual ventilator.

    And I hope you sent in your warranty card, otherwise you're not covered for repair or replacement.

    Also we're out of stock of ventilators so we sent you the closest alternative, a set of Venetian Blinds.

    reply to this | link to this | view in chronology ]

    • identicon
      ROGS, 11 Apr 2020 @ 10:30am

      Re: China bashing? Its not an Ebay item

      All US standard, FDA approved, and the same stuff used in Chinese, African, Singaporean, Malaysian, and many other hospitals.

      No RMA necessary, but will comply with local regulations, and pay return shipping on items that were shipped with volume purchases.

      reply to this | link to this | view in chronology ]

  • identicon
    Anonymous Coward, 11 Apr 2020 @ 6:30am

    Fix em anyway, screw their so called rights.

    reply to this | link to this | view in chronology ]

  • identicon
    Lydia, 14 Apr 2020 @ 1:32am

    $$

    It's all about the money, unfortunately. Greedy sob's. Everybody wants to control the world market. That's why China invented the CCP Virus in the first place; biological warfare, which was leaked out. Kudos to the Italian volunteers who made parts for respirators and saved lives. They have their priorities set straight.

    reply to this | link to this | view in chronology ]

    • identicon
      ROGS, 18 Apr 2020 @ 11:24am

      Re: $$

      Um, no.

      There is next to zero evidence that COVID19 started in Wuhan China; and even less evidence that China invented the virus.

      In fact, most evidence of its invention points to Pirbright, a guy from Harvard, and Bill and Melinda Gates ( whose progenitors/parents grand parents were all involved with eugenics).

      SO, its as likely that the international military games (where the US fielded the most inept gamers ever, who spent more time cruising the streets for local prostitutes than they did working out) is as likely as your propaganda.

      Try harder next time, troll.

      reply to this | link to this | view in chronology ]


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