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, or Health Insurance Portability and Accountability Act of 1996 (HIPAA). 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.

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., Wheelchairs, ventilators, etc.)
• Right to own -
  • access to data from your personal device (e.g., CPAP, pacemaker, CGM).
  • control of your devices. (e.g., Insulin pumps)
  • Interoperability - proprietary supplies/consumables. (Insulin, CGM)
  • Cost and inconvenience of third party support.
• Rug pull - loss of function/access to devices (including implanted devices). (Neural stimulators)

Notable incidents

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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

Implanted devices become inoperable when companies abandon them.

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.delivery).

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.

Software

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