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The popular website iFixit has provided consumers mountains of literature including repair manuals, replacement guides, teardown instructions, tool information, and Q/A support to help those willing to dive into their home electronics an opportunity to do so without having to buy, rent, or lease anything, just bring your positive attitude and your aptitude to open up your device at your own risk. Additionally, iFixit, a wiki-based site, allows people to create a repair manual for a device and even edit existing site documentation.
This is great for a user wanting to save some money and put their skills to the test, but is this the right approach for medical devices in a clinical setting? For years the medical device community has been begging for access to service materials (information including software, replacement parts, schematics, and tools necessary to perform preventative and corrective maintenance actions in accordance with manufacturers recommendations), and to make these materials available to the device owner even when equipment ownership changes, on fair and sensible terms.
The issue has been stressed so much that the FDA released the Reauthorization Act (FDARA) which became a law on August 18, 2017 and in section 710 of the FDARA issued a report on "the continued quality, safety, and effectiveness of medical devices with respect to servicing" in May of 2018. The report indicated "the continued availability of third-party entities to service and repair medical devices is critical to the functioning of the U.S. healthcare system," and third-parties "provide high quality, safe, and effective servicing of medical devices." Yet, many hospitals and third-party biomedical equipment technicians struggle to obtain access to documentation and information they need to service the hospital-owned medical equipment.
The argument about right-to-repair is valid, and the ability to obtain documentation is necessary, but should it be in this context with accessibility by the general public? The biggest concern is patient safety, and although we are currently in a pandemic with stretched resources, should anyone be allowed to repair a ventilator or anesthesia machine? Undoubtedly, this question will cause disputes between all the affected parties, but is this medium for this type of content the most appropriate? We all want our ventilators to run and we want to support our healthcare delivery organizations in their fight against COVID-19 but should anyone be allowed to repair life-support medical devices?
The concern I have here is the type of content being presented by iFixit and I prefer to err on the side of caution. Ventilators and anesthesia machines are considered life-support equipment, they don't necessarily require high levels of education to take apart and put back together, but they do require proper documentation. If a regulatory body such as the State Board of Health, The Joint Commission, Healthcare Facilities Accreditation Program, DNV, or any CMS deeming authority, do you want to be responsible and liable? How about if your imaging equipment does not meet quality assurance requirements and you determine it doesn't after scanning or imaging 100's of patients? Do you blame the guy who found a manual online?
Medical devices range in sophistication and complexity when it comes to their clinical abilities and how they are engineered and used. It may not require an advanced degree to disassemble, but it requires a level of knowledge not presented in the manuals provided on the iFixit site to know what to do. It does not offer that level of assurance, using only an HTML page or PDF document that may offer insightful information to get your hospital back up and running but at what risk?
The collection of data the iFixit site is hosting is quite impressive and well designed, but before you plunge in thinking you will be the next hero for the local hospital, ponder this, "if your loved one is lying in a hospital bed connected to a ventilator do you want someone highly qualified with a degree in biomedical engineering technology with advanced training and knowledge repairing that device or is your neighbor who may have acquired the manual from the internet good enough for you?"
Matt is a dedicated clinical engineer with knowledge, skills, and experience in all technological facets of healthcare. Proven experience in servicing and managing medical devices and systems, developing and teaching university courses, and medical device cybersecurity and risk management.
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CynergisTek Inc. published this content on 15 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 15 January 2022 22:44:06 UTC.
