Medical equipment: Difference between revisions

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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.

'''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.

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

== FDA report on repair restrictions ==

==FDA report on repair restrictions==

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...

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==Consumer issues==

*Right to repair - access to manuals, supplies and parts for maintenance and repair. (e.g., ~~Wheelchairs~~, ventilators, etc.)

*Right to repair - access to manuals, supplies and parts for maintenance and repair. (e.g., powered wheelchairs<ref name=":0">{{Cite web |last=Doctorow |first=Cory |date=2024-10-24 |title=Disability Rights Are Technology Rights |url=https://www.eff.org/deeplinks/2024/06/disability-rights-are-technology-rights |access-date=2025-10-07 |website=EFF}}</ref>, ventilators, etc.)

*Right to own -

**access to data from your personal device (e.g., CPAP, pacemaker, CGM).

**access to data from your personal device (e.g., CPAP, pacemaker, Continuous Glucose Monitor (CGM)).

**control of your devices. (e.g., ~~Insulin~~ pumps)

**control of your devices. (e.g., insulin pumps, powered wheelchairs<ref name=":1">{{Cite web |last=List |first=Jenny |date=9 Mar 2024 |title=The Insurance Buys The Wheelchair, But Not The App To Run It |url=https://hackaday.com/2024/03/09/the-insurance-buys-the-wheelchair-but-not-the-app-to-run-it/ |url-status=live |access-date=2025-10-07 |website=Hack a Day}}</ref>)

**Interoperability - proprietary supplies/consumables. (Insulin, CGM)

**Interoperability - proprietary supplies/consumables. (e.g., Insulin pumps, CGM)<ref name=":0" />

**Cost and ~~inconvenience~~ of third party support.

**Cost, inconvenience and availability of third party support.<ref name=":0" />

*Rug pull - loss of function/access to devices (including implanted devices). (~~Neural stimulators~~)

**Upgrade and support (e.g., add flashing light blockers to media players, also color shifters to accommodate color blind people<ref name=":0" />)

*Rug pull - loss of function/access to devices (including implanted devices). (e.g., neural implant<ref name=":0" />, bionic eye<ref name=":0" />)

*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<ref name=":1" />)

==Notable incidents==

===Terumo Cardiovascular restricts equipment repairs ===

===Terumo Cardiovascular restricts equipment repairs===

[[Terumo Cardiovascular]] blocks 3rd party repair of the Advanced Perfusion System 1 Heart Lung Machine.<ref>{{Cite web |last=Maxwell |first=Thomas |date=23 Jan 2025 |title=Medical Device Company Suddenly Stops Hospitals From Fixing Machines Themselves |url=https://gizmodo.com/medical-device-company-stops-hospitals-from-fixing-machines-themselves-2000554096 |url-status=live |access-date=16 Mar 2025 |website=[[Gizmodo]]}}</ref>

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[[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 get out of bed. A few companies control the market. Wheelchairs are often not built robustly, break down frequently, and companies make them hard and expensive to service or repair. 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.<ref name=":0" />

===Software===

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 {{StubNotice}}
-'''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.
+'''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.
@@ Line 7: / Line 7: @@
 Various medical equipment and the companies that produce them have come into scrutiny due to anti-consumer practices.
-== FDA report on repair restrictions ==
+==FDA report on repair restrictions==
 {{Incomplete section}}
 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...
@@ Line 13: / Line 13: @@
 ==Consumer issues==
-*Right to repair - access to manuals, supplies and parts for maintenance and repair.  (e.g., Wheelchairs, ventilators, etc.)
+*Right to repair - access to manuals, supplies and parts for maintenance and repair.  (e.g., powered wheelchairs<ref name=":0">{{Cite web |last=Doctorow |first=Cory |date=2024-10-24 |title=Disability Rights Are Technology Rights |url=https://www.eff.org/deeplinks/2024/06/disability-rights-are-technology-rights |access-date=2025-10-07 |website=EFF}}</ref>, ventilators, etc.)
 *Right to own -
-**access to data from your personal device (e.g., CPAP, pacemaker, CGM).
+**access to data from your personal device (e.g., CPAP, pacemaker, Continuous Glucose Monitor (CGM)).
-**control of your devices.  (e.g., Insulin pumps)
+**control of your devices.  (e.g., insulin pumps, powered wheelchairs<ref name=":1">{{Cite web |last=List |first=Jenny |date=9 Mar 2024 |title=The Insurance Buys The Wheelchair, But Not The App To Run It |url=https://hackaday.com/2024/03/09/the-insurance-buys-the-wheelchair-but-not-the-app-to-run-it/ |url-status=live |access-date=2025-10-07 |website=Hack a Day}}</ref>)
-**Interoperability - proprietary supplies/consumables. (Insulin, CGM)
+**Interoperability - proprietary supplies/consumables. (e.g., Insulin pumps, CGM)<ref name=":0" />
-**Cost and inconvenience of third party support.
+**Cost, inconvenience and availability of third party support.<ref name=":0" />
-*Rug pull - loss of function/access to devices (including implanted devices).  (Neural stimulators)
+**Upgrade and support (e.g., add flashing light blockers to media players, also color shifters to accommodate color blind people<ref name=":0" />)
+*Rug pull - loss of function/access to devices (including implanted devices).  (e.g., neural implant<ref name=":0" />, bionic eye<ref name=":0" />)
+*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<ref name=":1" />)
 ==Notable incidents==
 {{Incomplete section}}
-===Terumo Cardiovascular restricts equipment repairs ===
+===Terumo Cardiovascular restricts equipment repairs===
 [[Terumo Cardiovascular]] blocks 3rd party repair of the Advanced Perfusion System 1 Heart Lung Machine.<ref>{{Cite web |last=Maxwell |first=Thomas |date=23 Jan 2025 |title=Medical Device Company Suddenly Stops Hospitals From Fixing Machines Themselves |url=https://gizmodo.com/medical-device-company-stops-hospitals-from-fixing-machines-themselves-2000554096 |url-status=live |access-date=16 Mar 2025 |website=[[Gizmodo]]}}</ref>
@@ Line 41: / Line 43: @@
 [[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 get out of bed.  A few companies control the market.  Wheelchairs are often not built robustly, break down frequently, and companies make them hard and expensive to service or repair.  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.<ref name=":0" />
 ===Software===