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And add to that the machines are very expensive and there are laws that make it very difficult/illegal to make unapproved modifications to this equipment.
by eli 9y ago
And add to that the machines are very expensive and there are laws that make it very difficult/illegal to make unapproved modifications to this equipment.
- HeyLaughingBoy 9y agoThis is pretty much the answer. The medical device was validated with a certain version of the OS and any special configuration placed on it. If you change the OS/configuration setup in anyway, you (the manufacturer) have to analyze it for impact and potentially re-validate it. The user cannot make this change This would be a violation of FDA regulation. Now, the hospital can say that they're going to stop using your equipment until you "fix" it --- many such products are leased, not purchased and they may use the lack of security to break the lease. But that presumes they can get a replacement that works as well, train personnel in it, update the supply chain, storage, incoming inspection, etc. for this new product and any supplies it needs... It's not as simple as running down to MicroCenter and installing a copy of Windows 10!
- King-Aaron 9y agoFrom my experience (~5 years working as a PCA in a cardiovascular imaging and catheterisation lab), upgrades to large imaging equipment and such is scheduled throughout the year according to the lease plan, and these companies (i.e. Siemens) work together with the OS providers and know full well when operating systems are scheduled to be upgraded. However you're exactly right, it's got to be left specifically to the Siemens tech who comes out to work on the machine. (Bit of a moot point in agreement, but thought I'd share my 2c)