Right to Repair and Ventilators: Saving COVID-19 Patients

Right to Repair and Ventilators: Saving COVID-19 Patients 1

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, and 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. For given current conditions, it is far from certain that original equipment manufacturers have sufficient healthy personnel 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.

Print Friendly, PDF & Email

Leave a Reply

Your email address will not be published.