Senior biomed technician denied parts
A senior technician of biomedical equipment (BMET), J. Scot Mackeil, reported seeking a part replacement for a ventilator shipped from the federal stockpile to Massachusetts General Hospital[1]. They reported that the damage was of a single DC power connector and called the manufacturer for the part to this minor repair[1]. The unnamed manufacturer reportedly denied the senior technician's request, stating Mackeil's lack of training from the manufacturer's proprietary technician training program despite Mackeil's experience as the hospital's senior technician[1]. Mackeil also sought repair for a device used in cancer surgeries in which a plastic latch to the battery cover was broken. The manufacturer quoted high costs and stated that the device must be shipped to them over a common and trivial repair[1].
Legal action against advocacy
Owned by a biomed technician in Tanzania[2], Frank's Hospital Workshop is an independent database hosting hundreds of manuals to make the repairing of hospital equipment more accessible[3][4]. The website is frequently forced to remove manuals from their database upon receiving cease-and-desist letters from manufacturers due to "copyright infringement" and other reasons[5][3][citation needed - weak].
Other manufacturers have threatened to sue volunteers aiming to 3D-print parts of ventilators to help COVID-19 patients[6].
AdvaMed
Anti right-to-repair propaganda
The trade association, AdvaMed, published a propaganda piece titled "Fallacy of Right-to-Repair" which aims to discredit advocacy of medical equipment repairs[7], doing so against the FDA's detailed report saying otherwise[citation needed]. Some companies under AdvaMed that produce ventilators include Draeger, GE Healthcare, Hillrom, Medtronic, Philips, ResMed, and Vyaire Medical[8].
Medtronic
In his interiew on CNBC, CEO Ishraq stated that Medtronic would open-source their generic, low-end ventilators to allow other manufacturers to produce those same models. However, as stated by Ishraq, the low-end models are not equipped for acute situations[9]. "Acute" in the medical context is defined by rapid onset symptoms of an illness[citation needed] such as viral infections like COVID-19[citation needed]. Ishraq states that the high-end models are developed with more complex parts and are used for more critical patients.
When asked by the interviewer on the possibility of using one ventilator machine for multiple patients, Ishraq replied that it was dangerous to do so and that the machines are designed for one-person usage[9]. However, a study in Academic Emergency Medicine described how one machine may be safely and easily used by up to four people for twelve hours during an emergency situation[10][11].
Faulty manuals and failure to open-source
While Medtronic promised to supply manuals for their generic, low-end models and the equipment open-sourced, repurposed, and otherwise used without restriction[9], The American Society of Mechanical Engineers published a report stating that the Medtronic manuals provided are outdated, complex, missing core files, and simply do not qualify as quality schematics capable of remaking the product[12]. The manual for the specific product, the Puritan Bennett 560, had been posted on the official Medtronic website but now leads to a broken webpage[13], and the item is no longer listed on their website. Additionally, the report states that the files have not been released open sourced; instead, the permissive license will expire when the World Health Organization declares the COVID-19 threat to be over, or on October 1, 2024, depending which comes first[12].
Terumo Cardiovascular
Discontinues certification classes
In December 2024, Terumo Cardiovascular sent out an email stating they will discontinue certification classes to hospital technicians in regards to one of their equipment products, requiring the manufacturer to service the machine[14]. The equipment in question is a perfusion system that reroutes blood throughout a patient's body during open-heart surgery, which costs six figures to procure from Terumo Cardiovascular[14]. Hospital technicians already certified will keep their certification until the expiration date, and their certification will not renew[14].
References
- ↑ 1.0 1.1 1.2 1.3 Smith, Peter Andrey (20 Jul 2021). "Who Has the Right to Repair Medical Equipment?". Proto Mag - Massachusetts General Hospital.
- ↑ Detrick, Paul (13 Apr 2020). "Hospital Technicians Ignore Copyright Law to Fight COVID-19". Reason.
- ↑ 3.0 3.1 Frank's Hospital Workshop http://www.frankshospitalworkshop.com/equipment.html.
{{cite web}}: Missing or empty|title=(help) - ↑ Wiens, Kyle (19 May 2020). "Introducing the World's Largest Medical Repair Database, Free for Everyone". iFixit.
- ↑ Koebler, Jason (18 Mar 2020). "Hospitals Need to Repair Ventilators. Manufacturers Are Making That Impossible". Vice.
- ↑ Moody, Glyn (17 Mar 2020). "Volunteers 3D-Print Unobtainable $11,000 Valve For $1 To Keep Covid-19 Patients Alive; Original Manufacturer Threatens To Sue". TechDirt.
- ↑ "The Fallacy of Right to Repair for Medical Devices" (PDF). AdvaMed.
- ↑ Newmarker, Chris (1 Apr 2020). "U.S. ventilator manufacturing is rapidly expanding: Here's how". Mass Device.
- ↑ 9.0 9.1 9.2 "Medtronic CEO Omar Ishrak on ramping up ventilator production". CNBC. 25 Mar 2020.
- ↑ Neyman, MD, Greg (2006 Nov). "A Single Ventilator for Multiple SimulatedPatients to Meet Disaster Surge".
{{cite web}}:|archive-url=requires|archive-date=(help); Check date values in:|date=(help) - ↑ Babcock, Dr. Charlene (14 Mar 2020). "COVID-19 How to Use One Ventilator to Save Multiple Lives". YouTube.
- ↑ 12.0 12.1 Thilmany, Jean (27 Apr 2020). "Medtronic Opens its PB560 Ventilator Files to Makers". The American Society of Mechanical Engineers.
- ↑ "User Manual – Puritan Bennett™ 560 Ventilator" (PDF). Medtronic. Retrieved 26 Oct 2025.
- ↑ 14.0 14.1 14.2 Koebler, Jason (22 Jan 2025). "Medical Device Company Tells Hospitals They're No Longer Allowed to Fix Machine That Costs Six Figures". 404 Media. Archived from the original on 22 Jan 2025.