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, 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. | '''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. | 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. | 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.<ref name=":2">{{Cite web |last=Doctorow |first=Cory |date=12 Dec 2022 |title=Orphaned neurological implants |url=https://pluralistic.net/2022/12/12/unsafe-at-any-speed/#this-is-literally-your-brain-on-capitalism |access-date=8 Oct 2025 |website=Pluralistic |archive-url=http://web.archive.org/web/20260112111256/https://pluralistic.net/2022/12/12/unsafe-at-any-speed/ |archive-date=12 Jan 2026}}</ref> 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.<ref name=":3" /> Public funding of development, requiring that products be standard, open and replicable is one approach to protecting consumers.<ref name=":2" /> | |||
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== | ==FDA report on repair restrictions== | ||
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==Consumer issues== | ==Consumer issues== | ||
*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 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 |archive-url=http://web.archive.org/web/20260217110909/https://www.eff.org/deeplinks/2024/06/disability-rights-are-technology-rights |archive-date=17 Feb 2026}}</ref>, ventilators, etc.) | ||
*Right to own - | *Right to own - | ||
**access to data from your personal device (e.g., CPAP, pacemaker, Continuous Glucose Monitor (CGM)). | **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<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>) | **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 |archive-url=http://web.archive.org/web/20260218174858/https://hackaday.com/2024/03/09/the-insurance-buys-the-wheelchair-but-not-the-app-to-run-it/ |archive-date=18 Feb 2026}}</ref>) | ||
**Interoperability - proprietary supplies/consumables. (e.g., Insulin pumps, CGM)<ref name=":0" /> | **Interoperability - proprietary supplies/consumables. (e.g., Insulin pumps, CGM)<ref name=":0" /> | ||
**Cost, inconvenience and availability of third party support.<ref name=":0" /> | **Cost, inconvenience and availability of third party support.<ref name=":0" /> | ||
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==Notable incidents== | ==Notable incidents== | ||
{{Incomplete section}} | {{Incomplete section}} | ||
===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 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= | [[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 |archive-url=http://web.archive.org/web/20250723103321/https://gizmodo.com/medical-device-company-stops-hospitals-from-fixing-machines-themselves-2000554096 |archive-date=23 Jul 2025}}</ref> | ||
===Ventilator shortage during Covid 19 pandemic=== | ===Ventilator shortage during Covid 19 pandemic=== | ||
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===Neural stimulators=== | ===Neural stimulators=== | ||
Implanted devices become inoperable when companies abandon them. | Hundreds of thousands of people rely on neural implants.<ref name=":3">{{Cite web |last=Drew |first=Liam |date=6 Dec 2022 |title=Abandoned: The human cost of neurotechnology failure |url=https://www.nature.com/immersive/d41586-022-03810-5/index.html |access-date=8 Oct 2025 |website=Nature |archive-url=http://web.archive.org/web/20251024093159/https://www.nature.com/immersive/d41586-022-03810-5/index.html |archive-date=24 Oct 2025}}</ref> 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.<ref name=":3" /> Devices may need to be recalibrated to remain effective, batteries need replacing, or they need repair.<ref name=":3" /> | ||
====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.<ref name=":4">{{Cite web |last=Strickland |first=Eliza |last2=Harris |first2=Mark |date=15 Feb 2022 |title=Their Bionic Eyes Are Now Obsolete and Unsupported |url=https://spectrum.ieee.org/bionic-eye-obsolete |access-date=8 Oct 2025 |website=IEEE Spectrum |archive-url=http://web.archive.org/web/20260201073706/https://spectrum.ieee.org/bionic-eye-obsolete |archive-date=1 Feb 2026}}</ref> Users could not get device put into MRI safe mode to have brain scans<ref name=":4" />. Users lost support without warning.<ref name=":4" /> Nonfunctional implants can still cause problems like crippling vertigo.<ref name=":2" /> | |||
===Pacemakers=== | ===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 | 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. | ||
===Positive Airway Pressure (CPAP/APAP/BiPAP)=== | ===Positive Airway Pressure (CPAP/APAP/BiPAP)=== | ||
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===Powered wheelchairs=== | ===Powered wheelchairs=== | ||
These devices are essential for millions of people to work, interact with society, or simply | 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.<ref name=":0" /><ref>{{Cite web |last=Doctorow |first=Cory |date=2022-06-07 |title=When DRM Comes For Your Wheelchair |url=https://www.eff.org/deeplinks/2022/06/when-drm-comes-your-wheelchair |access-date=2025-10-06 |website=EFF |archive-url=http://web.archive.org/web/20250914141305/https://www.eff.org/deeplinks/2022/06/when-drm-comes-your-wheelchair |archive-date=14 Sep 2025}}</ref><ref>{{Cite web |last=Hawryluk |first=Markian |date=2 Jun 2022 |title=Despite a First-Ever ‘Right-to-Repair’ Law, There’s No Easy Fix for Wheelchair Users |url=https://kffhealthnews.org/news/article/power-wheelchair-users-right-to-repair-law-no-easy-fix/ |access-date=8 Oct 2025 |website=KFF Health News |archive-url=http://web.archive.org/web/20260112105050/https://kffhealthnews.org/news/article/power-wheelchair-users-right-to-repair-law-no-easy-fix/ |archive-date=12 Jan 2026}}</ref> | ||
===Software=== | ===Software=== | ||
A study was conducted in Cambridge in relation to software-dependent medical devices and how they would benefit from right to repair.<ref>{{Cite web |last=Lindgren |first=Lars |last2=Kesselheim |first2=Aaron S. |last3=Kramer |first3=Daniel B. |date=8 Mar 2023 |title=The Right to Repair Software-Dependent Medical Devices |url=https://www.cambridge.org/core/journals/journal-of-law-medicine-and-ethics/article/abs/right-to-repair-softwaredependent-medical-devices/F08B93DD92327BAA34D4D67476A424C9 |url-status=live |access-date=16 Mar 2025 |website= | A study was conducted in Cambridge in relation to software-dependent medical devices and how they would benefit from right to repair.<ref>{{Cite web |last=Lindgren |first=Lars |last2=Kesselheim |first2=Aaron S. |last3=Kramer |first3=Daniel B. |date=8 Mar 2023 |title=The Right to Repair Software-Dependent Medical Devices |url=https://www.cambridge.org/core/journals/journal-of-law-medicine-and-ethics/article/abs/right-to-repair-softwaredependent-medical-devices/F08B93DD92327BAA34D4D67476A424C9 |url-status=live |access-date=16 Mar 2025 |website=Cambridge University Press |archive-url=http://web.archive.org/web/20250709090406/https://www.cambridge.org/core/journals/journal-of-law-medicine-and-ethics/article/abs/right-to-repair-softwaredependent-medical-devices/F08B93DD92327BAA34D4D67476A424C9 |archive-date=9 Jul 2025}}</ref> | ||
==References== | ==References== | ||
<references /> | <references /> | ||
[[Category:Medical industry]] | [[Category:Medical industry]] | ||