Safety evaluation of a Medical Device Data System.
Our hospital became interested in the extraction of electronic data from our bedside monitor network to enrich clinical care, and enable various quality improvement projects, research projects, and future applications involving advanced decision-support. We conducted a range of tests to confirm the safety of deploying BedMaster (Excel Medical Electronics, Jupiter FL, USA), which is third-party software sold expressly to provide electronic data extraction and storage from networked General Electric Healthcare bedside patient monitors. We conducted a series of tests examining the changes in network performance when the BedMaster system was on our isolated patient monitor network. We found that use of BedMaster led to measurable, but trivial increases in network traffic and latency. We did not identify any failure scenarios in our analysis and testing. The major value of this report is to highlight potential challenges inherent in data and electronic device integration within the healthcare setting. In describing our strategy for testing the BedMaster system, it is our intention to present one testing protocol and to generate thought and discussion in the broader community about what types of problems can arise with inter-operability, and what types of testing are necessary to mitigate against these risks. Standards for inter-operability would surely reduce the inherent risks.
Massachusetts General Hospital, Boston, Massachusetts, USA.
Stephanie
S
Liddle
Lata
L
Grover
Rachel
R
Zhang
Maxim
M
Khitrov
Joan C
JC
Brown
J Perren
JP
Cobb
Julian
J
Goldman
Joseph
J
Chou
Daniel
D
Yagoda
Brandon
B
Westover
Andrew T
AT
Reisner
D004864:Equipment and Supplies / Q000009:adverse effects*; D008991:Monitoring, Physiologic; D019095:Point-of-Care Systems; D017751:Safety Management