Changes in healthcare suggest that more and more medical devices will begin to utilize the information technology (IT) network infrastructure in the hospital, particularly the wireless network. Due to the increased risk of operating medical devices on the converged wireless IT network, there are multiple steps required to safely and effectively implement these types of devices. A key component of the implementation should be to perform testing of wireless devices for interference and functionality. In order to perform this testing, development of a test environment within the hospital is required. While recent focus has been on electromagnetic interference and the risk assessment and mitigation via IEC 80001-1— the new standard for the application of risk management for IT networks incorporating medical devices—more progress is needed in the development of a test lab and performance of testing within the hospital environment. There are many potential benefits of deploying medical devices on the wireless network; however, there are multiple risks, including loss of data or missed patient alarm notification due to a loss of wireless network connectivity. Testing can be vital in identifying and developing mitigations for these risks. Creating the Lab In order to create a test lab, a location first must be selected. In theory, an ideal wireless test environment would be shielded from all external sources of radio frequency (RF) interference. To achieve this goal, physical space and a substantial budget would be required. A stand-alone wireless network infrastructure would have to be developed in this shielded space to enable the connection and testing of any wireless medical devices. This type of test environment is impractical for clinical engineering use due to resource constraints and the inadequacy for realistic simulation of the true deployment environment. A more realistic and beneficial location to create the test lab would be a clinical engineering shop or a storage area in the basement of the hospital. The value of this type of location is that the physical space is relatively distant from clinical floors, thereby limiting the interference between the current patient-care equipment and the test lab and reducing the potential risk to either the device under test or to the devices on the clinical floor. It is also advantageous to be in the hospital in order to utilize a segregated portion of the network infrastructure that is already in place. Also, although a test lab in this environment would not be totally isolated About the Author
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