By Jerri-Lynn Scofield, who has worked as a securities lawyer and a derivatives trader. She is currently writing a book about textile artisans.
The United States faces a dire shortage of ventilators for treat ing its COVID-19 patients. The coronavirus crisis has elevated the importance of the right to repair, since keeping machines currently in service operating properly is imperative to saving as many lives as possible.
U.S. PIRG, a public interest group that sponsors a Right to Repair Campaign, among other activities, delivered a petition Friday to the ventilator manufacturers, including GE Healthcare, Phillips, Siemens, Drager, Hamilton, Medtronic, calling on them to release immediately service manuals, service keys, schematics and service keys.
It has become commonplace – indeed, in many areas, it’s a standard operating procedure – for many manufacturers to restrict access to repair documentation. Yet even though that’s the case surely manufacturers keep and maintain such information someplace. They must release it now. To do so would allow third-party medical repair companies or in-house medical engineers to try and fix things. when they break, as U.S. PIRG notes. It is far from certain that original equipment manufacturers have sufficient healthy personnel at this time to ensure they can maintain their products so that all who need to use them can do so. Wide access to repair information is nothing less than a matter of life and death.
U.S. PIRG points out in a Friday press release:
Some manufacturers are making socially responsible changes to their repair policies as a result of the pandemic. For example, Medtronic has gone a step beyond releasing its manuals, providing access to certain part design files. However, so many companies have increased their repair restrictions in recent years, that the repair ecosystem is fragile in this time of crisis.
Additionally, according to the same source:
…iFixit, a leading online provider for service information for all kinds of products, is organizing ventilator service information so that technicians can quickly find the information they need.
“A single hospital might have ventilators made by four different manufacturers and it can be a headache trying to find the right information, so iFixit is trying to help make that easier,” said Kyle Wiens, IFixit.com CEO. “We want to make sure that a technician
doesn’t have to hunt for these manuals — every second counts right now.”
3D Printing: Repair of Ventilators in Italy
It’s not just U.S. engineers who have stepped up to find creative ways to repair ventilators. Readers might recall a couple of weeks ago an OEM allegedly threatened to sue a start-up that had supplied 3D printed versions of valves that the OEM couldn’t produce. After a flurry of bad press, I note that that the OEM denied these initial reports.
I don’t hope to be able to get to the bottom of this incident in this post and determine whether the OEM did indeed threaten to sue, and then backed down when confronted with a public relations nightmare. Equally plausible, however, is that nothing of that sort occurred.
What I do want to highlight instead is the importance of supplying repair information, quickly and widely, in crisis conditions. For those who missed the original story, this Forbes account covers the gist, Meet The Italian Engineers 3D-Printing Respirator Parts For Free To Help Keep Coronavirus Patients Alive:
Christian Fracassi, founder and CEO of Isinnova, an Italian engineering startup, heard the call for help last Friday. The hospital in Chiari, in the Brescia area of northern Italy where the coronavirus pandemic has hit hard, urgently needed valves for its respirators in order to keep patients who required oxygen alive. The manufacturer couldn’t provide them quickly enough and the hospital was desperate.
Fracassi immediately started tinkering with his engineers to reverse-engineer a 3D-printed version of the official part. Called a venturi valve, it connects to a patient’s face mask to deliver oxygen at a fixed concentration. The valves need to be replaced for each patient.
By Saturday evening, Fracassi had a prototype, and, the next day, he brought it to the Chiari hospital for testing. “They told us, ‘It’s good. It works. We need 100,’” says Fracassi, who is 36 and holds a Ph.d. in materials science with a focus on polymers. “We printed 100 of them on Sunday, and we gave all the pieces to the hospital. They are working very well.”
Now, I understand the 3D printing kludge should only be regarded as a stopgap solution, suitable only in emergency conditions. There is no doubt a great deal of legitimate engineering concerns in replacing part of a precision medical device with such an alternative, which has not been designed for this use, nor been subject to testing or confirmation that basic quality standards were met.
In such an emergency, it was necessary to ignore such considerations. As Forbes notes:
Still, in the face of the coronavirus pandemic, 3D printing offers a smart stop-gap solution at least. Davide Sher, the 3D printing analyst who wrote the original story about Isinnova for trade publication 3D Printing Media Network, subsequently created an online Emergency AM Forum to help hospitals, 3D printing companies and inventors share ideas in the fight against COVID-19. As he writes there: “While there are both copyright issues and medical issues that need to be taken into account when 3D printing any medical product, and a critical one such as a venturi valve, in particular, this case has shown that a life-and-death situation could warrant using a 3D-printable replica.”
Fracassi says that Isinnova is now working to design other medical products that hospitals need during the coronavirus pandemic. The first is a mask. The startup created a prototype earlier this week, and sent it to the hospital for testing, he says. “We are waiting for a response, and if it works, we are ready,” Fracassi says. “Then every hospital can make their own masks.”
EU Right to Repair for Electronics
To turn away from the COVID-19 crisis and return for a moment to our regular programming on advances in the right to repair front: The European Commission in March announced its intention to introduce legislation that will extend the existing right to repair beyond some household appliances to include electronics devices (see EU Adopts Right to Repair for Household Appliances and Right to Repair: Will the European Commission Have the Guts to Stand Up to Apple et al? Details on Wednesday…).
According to a March European Commission press release:
Today, the European Commission adopted a new Circular Economy Action Plan – one of the main building blocks of the European Green Deal, Europe’s new agenda for sustainable growth. With measures along the entire life cycle of products, the new Action Plan aims to make our economy fit for a green future, strengthen our competitiveness while protecting the environment and give new rights to consumers. Building on the work done since 2015, the new Plan focuses on the design and production for a circular economy, with the aim to ensure that the resources used are kept in the EU economy for as long as possible. The plan and the initiatives therein will be developed with the close involvement of the business and stakeholder community.
Whether or not the Commission will pursue this policy as European Union member states seek to rebuild their economies in the aftermath of the current crisis is unclear. That crisis certainly provides the opportunity to commit to sustainable growth – and I guess those of us who care about such issues must seek to ensure that opportunity is not wasted.
Nonetheless, the press release is the European Commission’s latest word on this issue and it commits itself as follows:
The transition towards a circular economy is already underway, with frontrunner businesses, consumers and public authorities in Europe embracing this sustainable model. The Commission will make sure that the circular economy transition delivers opportunities for all, leaving no one behind. The Circular Economy Action Plan put forward today as part of the EU Industrial Strategy presents measures to:
- Make sustainable products the norm in the EU. The Commission will propose legislation on Sustainable Product Policy, to ensure that products placed on the EU market are designed to last longer, are easier to reuse, repair and recycle, and incorporate as much as possible recycled material instead of primary raw material. Single-use will be restricted, premature obsolescence tackled and the destruction of unsold durable goods banned.
- Empower consumers. Consumers will have access to reliable information on issues such as the reparability and durability of products to help them make environmentally sustainable choices. Consumers will benefit from a true ‘Right to Repair’. [Jerri-Lynn here: Emphasis in original.]
Further, the Commission says it will launch concrete actions on electronics and ICT, batteries and vehicles, packaging, plastics, textiles, construction and buildings, and food. And the Commission also addresses the issue of waste – although I won’t discuss that commitment at this time.
As The Daily Swig notes in EU signals future ‘right to repair’ legislation for smartphone users in member states:
Part of the EU’s green competitive strategy involves placing increased regulation on the manufacturing supply chain and “transforming” the way certain products are made.
…
For electronics, this means prospective legislation aimed at ‘ecodesign’, as well as ensuring consumers have the right to repair their devices – both of which have been welcomed by environmental activist groups such as Right to Repair Europe.
“In the past, pressure from manufacturers has delayed any action on this front at the European Commission level,” Chloé Mikolajczak, a spokesperson from Right to Repair Europe, told The Daily Swig.
“Similarly, industries get to do their influence work in the ecodesign process behind closed doors, which means it’s often unchallenged and allowed them to considerably water down the first right to repair provisions.”
The Bottom Line
The European Commission commitment on its face looks promising. Whether it will be achieved during these difficult times, and according to what timetable, especially in the far of massive pushback from industries that have in the past aggressively resisted adopting a right to repair, remains to be seen.
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Medtronic has made the design files of their PB560 ventilator open source in an effort to combat the COVID19 pandemic.
You can download the design files here (you have to register):
https://www.medtronic.com/us-en/e/open-files.html
It’s a 2008 design…
If the parts were drawn in 3D, printable files for small parts like the valve could be available online from the original manufacturer with specifications about appropriate materials to use.
While quality control might suffer, the upside is the immediate availability of replacement parts long after the originals are gone from warehouse shelves.
Can one assume that some repaired ventilators will fail during operation leading to death of the patient?
If subsequent legal actions are pursued by the patient’s family, what parties might be held liable?
1. the person who did the, possibly inadequate, repair?
2. the entity who may have supplied a non-OEM, possibly defective, part used in the repair?
3. the original ventilator manufacturer?
To me, it seems there must be a “Good Samaritan law” in place to shield people from legal liability during these emergency times.
Is it already there?
To be honest, I seriously doubt this will apply in Italy, a much less litigious society than the US one.
In the United States: Under the “Public Readiness and Emergency Preparedness Act (PREP) almost everyone engaged in addressing the pandemic has liability protection. “Specifically, liability immunity is afforded (1) To manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population, and (2) to program planners and qualified persons when the countermeasure is either used by or administered to this population or the program planner or qualified person reasonably could have believed the recipient was in this population.”
There is a lot more detail in PREP, but it helps to explain Trump’s cavalier performances delivering misinformation to the public, his lavish praise for corporate solutions to the pandemic and their willingness to be coopted. PREP is easier to read than many federal regulations. See who has legal cover and for what at
https://www.federalregister.gov/documents/2020/03/17/2020-05484/declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical-countermeasures
Apple, Samsung,caterpillar and the other corporate aholes fighting right to repair cite safety or copyright protection as the rationale behind their motivations. If I can buy a car battery and install it, I’m pretty sure the iPhone battery poses a much lower risk.
They never mention what part of a Honda’s battery is copyright protected. Or an engine part on a caterpillar tractor.
It’s actually even worse than that. These companies make agreements with the companies that they purchase parts from to make sure that only they can purchase replacement parts. Consumers cannot. The military cannot. Hospitals cannot. So even if you wanted to repair on your own, you can’t get the parts to do it. Where are the free-market cheerleaders?
Sometimes these companies have legitimate concerns.
Here’s an example.
About 30 years ago, in January, the gas house heater in my house would not work (it was Super Bowl time, so it was somewhat cold here in Northern California).
I traced the problem down to the spark igniter module in the heater, that would turn the gas on, spark ignite the flame but would then turn the gas flow off (as if it did not detect the flame was established).
I checked with the local heater servicing company.
They had no modules in stock with several back ordered.
But they had a number of bad modules they would give me.
I then called the company that made the module and asked for a schematic.
They responded that the schematic was not something they would give me as I might change the circuitry enough so the “turn off the gas if flame is not burning” feature would not work and un-burned natural gas would accumulate in the house if I botched the repair.
In those days, electronics was a lot simpler, so I held up the printed circuit assembly to a light and traced out the connections between the circuit elements and drew my own schematic.
Then I had to determine how the flame detection circuitry worked.
It turned out the high voltage ignition coil was defective. It was used in a high voltage mode to spark ignite the flame and then used in a low voltage mode to detect that the flame was burning.
My suspicion was that a small break in the high voltage secondary coil wire allowed high voltage sparks to occur, but low voltage flame sensing was disabled.
I found a good coil in a bad donor module, removed it and soldered it in place in my module and the module worked again.
I still do NOT fault the module manufacturing company for failing to supply a schematic to me (or spare parts), for corporate liability reasons alone.
What about the company making the schematic available to HVAC companies who can then troubleshoot? It’s not just about us as individuals being able to fix things.. it’s about small companies offering that service.
I believe the release of the data could come back to haunt the parent company if an improperly repaired module, using parent company service data, were put into service and malfunctioned.
But I’m no lawyer.
For several decades, I worked in the electronics industry for a company that was VERY concerned that their products were well-built and met world wide safety standards.
The schematics, service manuals and parts lists of many products were made available.
But an improper repair of this equipment by customers would likely only “let the smoke out” and not pose a threat to life or property.
One can imagine many products that should raise concerns about the opening of repair data to possibly unqualified vendors.
Some examples: patient monitoring equipment, medical diagnosis equipment, X-ray equipment, drug infusion equipment, harmful gas detection equipment, and building components such as elevators and automatic doors.
How does one judge the competency of “small companies offering that service” when it involves a product whose malfunction could cause loss of life/limb?
This argument is nonsensical. Holding GM, Bosch, Apple, etc responsible for an independent repair company is settled law.
It’s akin to claiming that if someone shocks themselves changing a car battery that it is Honda’s fault or Interstate Battery’s fault. That’s absurd.
Workers comp insurance exists so that if a trained HVAC tech, electrician, roofer,etc. is hurt on the job, they are protected. No one is suing Carrier for a poor repair job.
Incompetent repair is the most flimsy argument against right to repair I’ve heard yet.
My concern is about the competence of the repair process.
If the repair is done poorly (improper procedure, incorrect or counterfeit parts substituted) the repaired product may appear to function fine when returned to use..
An example could be a drug infusion pump.
Then the improperly repaired product manifests a failure that damages, perhaps even kills, an innocent user of the repaired item.
Might the legal system in the USA sweep the original manufacturer of the product into court for failure to document the repair process clearly enough or provide more support to the independent repairman?
This is usually referred to as going for the “deep pockets” in the USA legal system.
Are you quite sure this is “settled law”?
“I still do NOT fault the module manufacturing company for failing to supply a schematic to me (or spare parts), for corporate liability reasons alone.”
You may be right, but I hope you are wrong. In the 1960s and 70s pretty much anything you bought containing electronics had detailed schematics attached, at least in my part of woods. Somehow, personal liability lawyers did not destroy electronics industry back then. Accepting corporate liability argument is a capitulation to growing corporate power, opacity and crapification of their products and services.
Having some hi-tech industry background, I know that one of the reasons manufacturers would have problems providing accurate documentation, is stretched and fluid supply chain. I repaired my HVAC system a couple of times during last three decades. Fortunately, there was a block diagram inside the unit and enough details in user manual to make it fairly straightforward. What I noticed is variety of controller boards and model numbers for similar HVAC units in short period of time. I’m pretty sure they didn’t have a good handle on specifics of a product made two decades earlier.
Internet is a good vehicle to handle repair information of discontinued products. Given enough data by the manufacturer, enough attempts to repair and large number of skilled people, which are still around, invaluable knowledge base is created, sometimes surpassing what manufacturer’s own service can provide.
My specific case required a repair to a flame detection system that, if working incorrectly, may have led to a uncontrolled high volume gas leak in the house.
While I was willing to repair my own ignition module, I would have refused to repair anyone else’s module for personal liability reasons alone.
How does one defend oneself if someone’s house burns down (from another cause) and they point to your “repaired” ignition module as the cause?
I still try to repair items (old woodworking tools, metalworking tools and electronics) and am unhappy when I have to fabricate small items that were last available 10 years ago.
But manufacturers do not want to stock repair parts longer than they have to.
Some companies do want to help, as I bought an obscure power tool from the 1950’s and corresponded with the “still around” company that sold it then.
One employee was willing to supply scans of old catalog pages without charge.
Most electronic devices have only a handful of failure modes. It would be trivial for an engineer stuck at home right now to write up a short service guide for technicians – “if the ventilator is giving this error, check these two voltage regulators. If these lights don’t turn on, test continuity in this cable. If the machine doesn’t turn on at all, repair is not feasible, move onto the next unit.” I bet something like that could cover 90% of the problems in the field right now. Medical devices are expensive and meant to be repaired, in fact service contracts are big money for OEMs.
I mentioned this the other day but…there needs to be a method to easily test and verify if that a repaired ventilator is working correctly. Usually this requires special software and equipment at the OEM, it is usually developed in-house and it can be very expensive and hard to use. If those tests aren’t feasible to provide to the public, there are probably a few “smoke tests” that could be provided to at least help build some confidence that the ventilator you just fixed is going to work once it is hooked up to a patient. This is the type of information that is the hardest to reverse engineer because that type of knowledge can only be gained after working on a device daily and getting to know it more intimately.
I had a Series II Land Rover, no rust because of the climate, bought in 1972 after being rolled.
We tool it down to the axles and chassis, and rebuilt it.
Parts were plentiful.
Today? Don’t believe that would be possible with a less than 10 year old vehicle.
You can still do this with a pickup truck, but it’s still much harder than with an older vehicle. My 94 pickup is simple enough I can actually keep it running with occasional help from youtube. And a 2003 is still pretty much the same animal as a 94, in my experience. They still keep running and running – they just burn a lot of gas.
This is going to sound harsh – but if my information is correct, the survival rate for people with covid-19 who are sick enough to be intubated and ventilated is less than 20%. Ventilators are a hail mary pass, and all this focus on ventilators IMHO represents a flawed process of priorisation.
The post is about Right to Repair. Ventilators are just another in a long line of examples.
This is still a lot of people who would have otherwise died without a ventilator. It is a game of numbers right now.