Battery-Powered Medical Devices Workshop: Challenges …fdagov-meddev-gen/... · Battery-Powered...
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Battery-Powered Medical Devices Workshop: Challenges and Opportunities
July 30, 2013
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Experienced
Pioneering
Independent
Evidence-based
Medical Device Batteries – Blessing or Burden? July 30, 2013
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ECRI Institute is an independent, nonprofit organization that researches the best approaches to improving the safety, quality, and cost-effectiveness of patient care.
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ECRI monitors medical technology issues and advises hospitals through various services:
PRN problem reporting system Health Device Alerts product recall notification system Patient Safety Organization Member consultation services BiomedTalk list serve Accident and Forensic Investigation consulting services
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FDA MAUDE database – the past decade
Primary batteries
(implantable devices)
[PERCENTAGE]
Rechargeable batteries (capital
equipment) [PERCENTAGE]
Maude Reports by Battery Type
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FDA MAUDE database – the past decade
0
1
2
3
4
5
6
7
8
2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Percent of MAUDE reports discussing batteries
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Surge in battery powered devices Evolution of miniaturized low-powered electronics Demand for portable or mobile devices More wireless devices Avoids software boot up time when mobile Maybe, just because we can …
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Sampling of battery powered devices Vital Helpful Questionable
Defibrillators Patient Lifts Sequential compression devices
Transport ventilators Ventilators Patient scales
Patient transport monitors Infusion Pumps Stationary infant incubators
Telemetry monitors Electric beds OR tables
Heart-lung machines Surgical saws Enteral feeding pumps
VADs Suction pumps Diagnostic ultrasound
IABPs Mobile x-ray Pulse oximeters
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But it’s not a free ride…
Many types of batteries – lead acid, NiCad, NiMH, Li-Ion – each has different characteristics and maintenance requirements
Batteries have been associated with fires and explosions Charge status indicators aren’t accurate Batteries need to be assessed during IPM Costly and time consuming to replace Finding suitable less expensive 3rd party batteries can be
challenging
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To summarize… Batteries are being used in a growing number of devices Hospitals need to recognize that there is a tradeoff between the
convenience of battery power and the burden to maintain them More accurate charge status indicators would be helpful for
critical care devices Battery replacement cost should be considered in life cycle
computations Hospitals need a practical way to identify reliable, and less
costly replacements
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Do you believe that the batteries in some of the medical devices your facility has purchased are clinically unnecessary?
A. Yes B. No C. I don’t have an
opinion
A. B. C.
26%
59%
15%
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THANK YOU