Medical equipment

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Medical equipment/medical devices have some consumer issues that set them apart from many other common devices. Some devices are vital to a user’s life or ability to function, such as pacemakers, ventilators, or prosthetics. Ownership and payment may be more complex, with equipment owned by a care facility, or paid for by insurance. Some devices or supplies are only available with physician approval (e.g., oxygen concentrators, CPAP). Many devices fall under more careful regulation, such as by the Food and Drug administration, Health Insurance Portability and Accountability Act of 1996 (HIPAA), or the Americans with Disabilities Act (ADA). Data collected by medical devices can be extremely personal, but users are often shut out from accessing it. There may also be issues with users getting control of their devices. Even when the device is implanted in a users body, others sometimes assert that they should have control, and the user should be denied autonomy.

Standard consumer issues, like right to repair, right to own, interoperability, privacy, and security also apply.

Various medical equipment and the companies that produce them have come into scrutiny due to anti-consumer practices.

Startup companies often prioritize growth over security, safety, functionality and support. Most startups fail. When they struggle for money, or fail, their assets, including user data, parts and user support are often exploited to maximize monetary return. Some say that developers of implants should ensure that there is funding and resources available so that all users can be supported, even if the company discontinues the product or fails. Public funding of development, requiring that products be standard, open and replicable is one approach to protecting consumers.

When scans like MRI are done, implants may need to be set to a scan-safe mode. When a company abandons the device, that may not be possible. Thus patients may have to have a device removed, or lose access to important medical diagnostics.

FDA report on repair restrictions

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Manufacturers of medical equipment often cite safety precaution as the primary reason for their restrictions. However, a report by the Food and Drug Administration has otherwise...

Consumer issues

• Right to repair - access to manuals, supplies and parts for maintenance and repair. (e.g., powered wheelchairs, ventilators, etc.)
• Right to own -
  • access to data from your personal device (e.g., CPAP, pacemaker, Continuous Glucose Monitor (CGM)).
  • control of your devices. (e.g., insulin pumps, powered wheelchairs)
  • Interoperability - proprietary supplies/consumables. (e.g., Insulin pumps, CGM)
  • Cost, inconvenience and availability of third party support.
  • Upgrade and support (e.g., add flashing light blockers to media players, also color shifters to accommodate color blind people)
• Rug pull - loss of function/access to devices (including implanted devices). (e.g., neural implant, bionic eye)
• Hidden additional purchases (e.g., Alber powered wheelchairs where you need an app to unlock features, but insurance won't pay for the app and the app requires even more in-app purchases to unlock features of the chair)

Ownership of implanted devices

Whether a patient owns an implanted device, and what that ownership is worth, depends on how the device was supplied. Devices supplied under clinical trials typically remain the property of the manufacturer, as the NeuroVista case below demonstrates: the patient was served a termination order and the device was explanted against her wishes. Commercially supplied implants are generally owned by the patient, hospital or insurer, but the firmware, credential keys, pairing tools and service infrastructure remain with the manufacturer. The patient holds the hardware without holding the means to keep it working, which mirrors the pattern seen with DRM on consumer products generally, and with agricultural and construction equipment documented elsewhere on this wiki.

Repair is constrained by copyright law. Section 1201 of the United States Digital Millennium Copyright Act prohibits circumvention of technological protection measures, which extends to the software locks used in medical devices. In 2021 the Librarian of Congress granted an exemption permitting circumvention of digital locks in medical devices for the purposes of repair; a subsequent challenge by manufacturer trade groups AdvaMed and MITA was rejected, with the court finding that bypassing a lock to repair a device was fair use rather than infringement. In October 2024 the United States Copyright Office granted broader right-to-repair exemptions covering multiple industries, explicitly including medical devices, effective 28 October 2024. The Electronic Frontier Foundation notes that these exemptions must be re-petitioned every three years, so the right to repair rests on renewals of permission rather than a permanent entitlement.

Notable incidents

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The Glaukos (formerly Avedro) 1st Gen KXL system

Glaukos has announced that they're discontinuing support for their first generation KXL (crosslinking) system. The current system requires a RFID card that costs around $5000 per use of the machine. The new cost for RFID cards per use for the next generation of KXL system will be $75,000 per use ($150,000 for both eyes). This has forced all but one ophthalmology practice in Arizona to drop crosslinking as a service as the cost cannot and should not be pushed to the patient. Insurance companies most likely wont cover the service for such a high cost. Crosslinking serves to treat keratoconus which is a progressive disease that leads to blindness in young people if left untreated.

Terumo Cardiovascular restricts equipment repairs

Terumo Cardiovascular blocks 3rd party repair of the Advanced Perfusion System 1 Heart Lung Machine.

Ventilator shortage during Covid 19 pandemic

Main article: Medical ventilator

At the beginning of the Covid 19 pandemic, ventilators were suddenly in very high demand. Digital rights management and lack of right to repair made the equipment shortage worse, and probably increased mortality.

Neural stimulators

Hundreds of thousands of people rely on neural implants. Neural stimulators are used to reduce pain, to reduce trembling in Parkinson's patients, to provide substitutes for senses like hearing or sight. Implanted devices sometimes become inoperable when companies abandon them. Devices may need to be recalibrated to remain effective, batteries need replacing, or they need repair.

Second Sight Retinal Implants

Abandonware. Retinal implants gave patients a limited ability to perceive their environment, a substitute for sight. The company stopped supporting the devices, and later merged with another company, which abandoned users entirely. Users could not get device put into MRI safe mode to have brain scans. Users lost support without warning. Nonfunctional implants can still cause problems like crippling vertigo.

NeuroVista seizure advisory implant

Loss of ownership, rather than loss of support. A patient, Rita Leggett, received a NeuroVista brain-computer interface in 2010 to warn of impending seizures, allowing prophylactic medication to be taken. The device reduced her seizures from an average of three per month to none. When the company failed financially and the trial was discontinued, the patient received a termination order from the manufacturer. She asked to keep the device and was refused, and the device was explanted against her stated wishes. The case report, published in Brain Stimulation, records that the device was the property of the company rather than the patient, and that the removal caused documented psychological harm; the authors describe the implanted device as having been integral to the patient's sense of self, such that its removal terminated that person.

Because the device was supplied under a clinical trial, it remained company property, so the manufacturer's claim was legally straightforward. This contrasts with the Second Sight case, where patients nominally owned their implants but could not keep them functional. Both cases reach the same outcome, dispossession, by different routes: ownership of the atoms, and control of the function, rest with different parties. See Ownership of implanted devices.

Medtronic HeartWare HVAD

Heart pump. Medtronic stopped distribution and sale of its HeartWare HVAD ventricular assist device in June 2021 on safety grounds, after data showed a mortality rate for the device roughly two and a half times that of the alternative Abbott device over the period October 2018 to June 2021. Around 1,200 patients had the pump implanted at the time of discontinuation, for the rest of the patient's life for those on destination therapy. The device is threaded through the skin to an external controller and battery pack, so patients depend on the continued supply of consumables, spares and support for a product the manufacturer has withdrawn from the market.

Pacemakers

Lack access to your data. For example, some unusual heart rhythms may be affected by diet, activity, etc. Having detailed information about when these episodes happen can enable the user to improve their health. However the data is often not readily available to the patient.

Manufacturer lifecycle decisions also force removal of devices that patients would otherwise keep. In December 2024 the FDA issued a Class I recall, its most serious level, for Boston Scientific Accolade family pacemakers and CRT-Ps, after 832 reported injuries and two deaths. Affected devices can enter an irreversible Safety Mode during remote telemetry, and devices that enter Safety Mode must be removed and replaced. The remedy for a defect in a product inside a person's chest is another operation, at the patient's risk, regardless of who holds title to the device.

Positive Airway Pressure (CPAP/APAP/BiPAP)

Data access. Control.

3B CPAP Devices (3b Medical) (ReactHealth) access to patient data removed, forcing users to use more expensive 3rd parties, or lose autonomy.

Powered wheelchairs

These devices are essential for millions of people to work, interact with society, or simply move around their homes. In the United States, two companies control the market. Medicare only covers indoor wheelchairs, which are often not built robustly, break down frequently, and companies make them hard and expensive to service or repair. Even simple adjustments often require a service call. This locks people people out of their lives and puts them at risk for health effects of being bedridden. Some US states, such as Colorado have enacted right to repair legislation in this area.

Software

A study was conducted in Cambridge in relation to software-dependent medical devices and how they would benefit from right to repair.