Talk:TeleHealth Hardware: Difference between revisions
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: Fear not! For one we're not deploying in the US, so the FDA isn't a problem. And yes, we have a team that includes biomedical engineers, electrical engineers and doctors that will vet this device out at great length before it is ever used in the field. The current discussions are ranging around a 6 month trial before a trial deployment. These pages should be updated soon. Stay tuned for details. [[User:Sethwoodworth|Seth]] 23:29, 22 April 2008 (EDT) |
: Fear not! For one we're not deploying in the US, so the FDA isn't a problem. And yes, we have a team that includes biomedical engineers, electrical engineers and doctors that will vet this device out at great length before it is ever used in the field. The current discussions are ranging around a 6 month trial before a trial deployment. These pages should be updated soon. Stay tuned for details. [[User:Sethwoodworth|Seth]] 23:29, 22 April 2008 (EDT) |
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::Or maybe [http://www.phrases.org.uk/meanings/be%20afraid,%20be%20very%20afraid.html "Be afraid, be very afraid."] I would not recommend dismissing the potential regulatory hurdles so quickly. [http://www.fda.gov/cdrh/devadvice/39.html This FDA flowchart] diagramming the regulatory decision-tree on manufacturing and exporting an unapproved medical device looks to be about an order of magnitude more complicated than the entire circuit diagram for your ECG rig. I'm sure you are all very bright guys, but take some friendly advice from someone who works in an FDA-regulated industry and find yourself a regulatory affairs professional '''soon'''. Leave it to them to walk you through the regulatory minefield. Maybe your local IRB can steer you towards the right person. [[User:Cjl|Cjl]] 01:40, 23 April 2008 (EDT) |
Revision as of 05:40, 23 April 2008
Pics
Please post pics. Many people would love to see them. --Arjs 01:34, 31 January 2008 (EST)
Supplementary resources
Existing equipment and alternative designs - mostly digging these out from Ian's email/IRC messages.
- Create USB interface - USB sensor input board. Cool but expensive. PIC.
- PC USB scope - oscilloscope peripheral that attaches to normal computers via USB. Bloody expensive, Windows-only software... interesting to imitate (and a possible development tool for people with Windows desktops that don't have scopes, until we can make Measure a lovely o-scope interface.)
Hardware development
In regarding to the different projects that have been started would be nice to have a common heading in regarding to the implementation of a circuit that could handle all the peripherals or at least the majority of them..i thing is necessary to have an all in one circuit.
Medical Devices Regulations
Little consideration appears to have been given to complying with medical devices regulations. These are indeed very onerous however this is for good reason. Any electrical device attached to a person has the potential to kill in ways you probably cannot imagine. You need more than just optical isolation between the sensor and any interface circuitry.
Nobody but a skilled and knowledgeable designer of medical devices should attempt this. I did a course that covered the basics some 12 years ago as part of my masters in Medical Physics. I know enough to know I don't know remotely enough to design any of this stuff. The concept of high school children even extremely talented ones doing this is a complete none starter.
Finally Any shipping product will need FDA or similar approval before it can be used and this is going to cost big $$$
Don't get me wrong this has great potential, I am sure that organizations like MSF etc. would bite OLPC's arms off for some of these devices (not that OLPC is interested in talking to them though). Without out appropriate approval the devices under consideration would be simply too risky to use from a liability standpoint.
--Jabuzzard 13:39, 30 March 2008 (EDT)
- Fear not! For one we're not deploying in the US, so the FDA isn't a problem. And yes, we have a team that includes biomedical engineers, electrical engineers and doctors that will vet this device out at great length before it is ever used in the field. The current discussions are ranging around a 6 month trial before a trial deployment. These pages should be updated soon. Stay tuned for details. Seth 23:29, 22 April 2008 (EDT)
- Or maybe "Be afraid, be very afraid." I would not recommend dismissing the potential regulatory hurdles so quickly. This FDA flowchart diagramming the regulatory decision-tree on manufacturing and exporting an unapproved medical device looks to be about an order of magnitude more complicated than the entire circuit diagram for your ECG rig. I'm sure you are all very bright guys, but take some friendly advice from someone who works in an FDA-regulated industry and find yourself a regulatory affairs professional soon. Leave it to them to walk you through the regulatory minefield. Maybe your local IRB can steer you towards the right person. Cjl 01:40, 23 April 2008 (EDT)