July 3, 2013 ONC HIT Health IT Policy Committee FDASIA WG. Event Reporting Paradigms. Slides for Discussion by FDASIA WG, Regulations Subcommittee Prepared by J. M. Goldman, MD, Co-Chair. V4. Contact: www.jgoldman.info. Data for Adverse Event Analysis.
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“An intravenous infusion pump is capable of securely being programmed via WiFi with a new drug library, or have the infusion rate adjusted for a closed-loop artificial pancreas function.
Due to newly installed wireless equipment in proximity of the IV pump, WiFi commands to the pump are delayed (many minutes) or dropped, resulting in safety issues.
The pump functions as ”specified". The manufacturer of the pump is contacted and states that the cause of the WiFi interference should be addressed.”
*Supporting Medical Device Adverse Event Analysis in an Interoperable Clinical Environment: Design of a Data Logging and Playback System, International Conference on Biomedical Ontology: Workshop on Representing Adverse Events, 2011
§ 15.5 General conditions of operation. (a) Persons operating intentional or unintentional radiators shall not be deemed to have any vested or recognizable
right to continued use of any given frequency by virtue of prior registration or certification of equipment, or, for power line carrier systems, on the basis of prior notification of use pursuant to § 90.35(g) of this chapter.
(b) Operation of an intentional, unintentional, or incidental radiator is subject to the conditions that no harmful interference is caused and that interference
must be accepted that may be caused by the operation of an authorized radio station, by another intentional or unintentional radiator, by industrial, scientific and medical (ISM) equipment, or by an incidental radiator.
(c) The operator of a radio frequency device shall be required to cease operating the device upon notification by a Commission representative that the device is causing harmful interference. Operation shall not resume until the condition causing the harmful interference has been corrected.(d) Intentional radiators that produce Class B emissions (damped wave) are prohibited.
[54 FR 17714, Apr. 25, 1989, as amended at 75 FR 63031, Oct. 13, 2010]
· Unlicensed radio frequency devices such as digital electronic equipment (i.e., personal computers, e-readers, etc.) and low power radio transmitters such as Wi-Fi and Bluetooth are subject to the conditions that they do not cause harmful interference to authorized radio stations. The operator of the device must cease operation if notified by the FCC that the device is causing harmful interference. (See Section 15.5 of the FCC rules pasted below)
· Licensed radio services (i.e., commercial cellular radio services, TV and radio broadcasting, etc.) generally operate on the principle that the most recently authorized services must avoid causing harmful interference to pre-existing services, and that having secondary frequency allocations may not cause harmful interference to services that have primary status. The FCC rules may be more specific about the responsibilities of that apply for any given service. In most cases, interference among licensed radio services is resolved directly by the licensees.
· Most radio devices and transmitters must meet technical standards designed to minimize the risk of harmful interference are subject to equipment authorization requirements to ensure compliance. If an equipment manufacturer were to discover that its equipment is not in compliance with the standards or certification requirements it could be subject to FCC enforcement action.
· In general there are no requirements to report harmful interference to the FCC, although here again there can be exceptions such as in instances where a device is authorized under a waiver with a condition that any harmful interference must be reported. However, the party receiving the interference could choose to file a complaint with the FCC which we would then investigate
· FCC rules address interference to radio communications, not to devices such as electronic equipment that is not designed to transmit or receive on the airwaves.
IOM 2011: Health IT and Patient Safety: Building Safer Systems for Better Care
“The mission of NHTSA is to “save lives, prevent injuries, reduce vehicle-related crashes”. To do so it must consider the effect on safety of factors as diverse as road surface composition, tire performance, signage, headlights, human factors, biomechanics, and, for when things don’t go well, crashworthiness, air bags, and child seats. Significant changes to the system must be evaluated in the context of all the other elements. NHTSA maintains data files and knowledge banks for research to improve vehicle safety, and has regulatory oversight.”
Example: System perspective to safety
*From briefing to Health Information Technology Innovation and Development Environment (HITIDE) group of the WH OSTP NITRD Health Information Technology Research and Development Senior Steering Group (HITR&D SSG) , Julian Goldman, MD, July 2011