Transcript jones - RFID CUSP

U. S. Department of
Health and Human Services
Center for Devices and
Radiological Health
Component Composition
Medical Device Regulatory Challenges
Paul L. Jones
Senior Systems/Software Engineer
Division of Electrical and Software Engineering
Office of Science and Engineering Laboratories
Dec 3, 2007
Medical Devices Containing Software
Center for Devices and
Radiological Health
Application specific calculator
U.S. Blood Bank System
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Digital Thermometer
Center for Devices and
Radiological Health
Proton Beam Therapy System
The Gantries:
Resembling giant ferris wheels can rotate around the patient and direct
the proton beam to a precise point. Each gantry weights about 90 tons
and stands 3 stories tall. It supports the bending and focusing magnets
to direct the beam.
The Injector:
Protons are
stripped out
of the nucleus
of hydrogen
atoms and
sent to the
accelerator.
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Synchrotron:
(Accelerator)
A ring of magnets,
20 ft. in diameter,
through which
protons circulate in a
vacuum tube.
Steel-reinforced
concrete walls are
up to 15 feet thick.
Beam Transport System:
Carries the beam from the accelerator to one of four treatment
rooms. This system consists of several bending and focusing
magnets which guide the beam around corners and focus it to
the desired location.
Medical Device Systems
Past

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
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
Present
Center for Devices and
Radiological Health
Future
Discrete Systems
Discrete Hybrid* Systems
Discrete Integrated Hybrid Systems
Networked Hybrid Systems
Distributed Hybrid Systems
Pervasive Hybrid Systems
*Hybrid – something of mixed origin or combination (AHD)
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Past State
Discrete system properties
 Analog / digital based
 Proprietary hardware / software
 Relatively simple design
 Relatively long product life span
 Competent human intervention
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Center for Devices and
Radiological Health
Present State
Center for Devices and
Radiological Health
Discrete hybrid system properties
 COTS / SOUP hardware / software
 Design complexity increasing
 Product life spans shrinking
 Competent human intervention (main RCM)
e.g. Imaging systems
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Present State
Center for Devices and
Radiological Health
Discrete integrated hybrid system properties
 Accessory to a device
 Proprietary interfaces
 Human becoming part of the loop
 Competent human intervention (main RCM)
e.g. Imaging used by TPS used by Linac systems
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Future State
Networked hybrid system properties
 Networked device systems
 Standardized interfaces
 Closed loop systems
 Centralized
e.g. HIS and PnP
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Center for Devices and
Radiological Health
Future State
Distributed hybrid system properties
 Distributed resources
 Decentralized
e.g. Telemedicine, Remote Surgery
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Center for Devices and
Radiological Health
Future State
Pervasive hybrid system properties
 Autonomous
 Omni-present
 Biomedical
e.g. Star Trek
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Center for Devices and
Radiological Health