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Subject: | Re: Is there anyone using EPICS for a FDA approved device? |
From: | Simon Rees <[email protected]> |
To: | [email protected] |
Date: | Tue, 19 Aug 2008 10:56:21 +0200 |
> I am wondering if there is any documentation on the FDA's opinion > of EPICS software.
I've not heard of anyone using EPICS in such an environment, although there are EPICS sites that provide medical treatment facilities. However I don't believe that EPICS is ever used directly to control those facilities, the code is not rigorously audited to the standards of verification and validation that would be needed. Here at the APS the general rule is that EPICS software plays no part in implementing personnel safety, and is rarely responsible for machine protection either, other than to report on the current status of other (hardware-based) protection systems.
Just to pick up on Andrew's comment... here at the Paul Scherrer Institute (PSI) in Switzerland we are currently operating a medical facility that relies on the therapeutic benefits of proton radiation to treat cancer patients.
By maintaining a clear separation of concerns between aspects critical to patient safety (non-EPICS) and those that aren't (where we do make increasing use of EPICS) we are able to comply with the requirements of the Swiss Federal Office of Public Health (which is presumably the equivalent of the US FDA).