Your initial point is valid, medical devices often have lives or at least health at stake for someone.
However; there's a lot of finger pointing at the FDA regulations and restrictions, only some of which is warranted. Yes, the FDA does regulate and restrict some repairs or modifications, but far more of this is the medical device vendors deliberately restricting the repair to in-house technicians, mostly for reasons of cash flow. It's a revenue stream for them. There are many trained biomedical equipment repair specialists working in hospitals all over the world who are very well trained and educated to repair medical devices, but the vendors prevent it by restricting distribution of service manual information and parts, and training courses, to do the repairs. I believe this is where the majority of finger pointing should aim.
I know this because I am a Biomedical Equipment Support Specialist working in a VA hospital. I have a college degree, and a number of vendor and product specific training certificates, and some years of experience. Many of my co-workers have literally decades of experience. Yet they (and I) cannot do some repairs because the vendor says so.
