Several hospitals around the world are integrating medical devices into their wireless networks. The benefit is to improve the effectiveness of data transfer and the dependability of the equipment. In January 2011, I read an article that mentioned the involvement of the FDA with hospital networking. This article made me curious about what the FDA had to offer. With some further research, I found that in February 2008, the FDA released a statement based on 21 CFR Part 880 that addresses “Devices: General Hospital and Personal Use Devices; Reclassification of Medical Device Data System.”1
According to the FDA, a medical device data system (MDDS) is a computer-based software product that poses a minimal risk. The FDA defines a MDDS as a device intended to provide one or more of the following uses:
- The electronic transfer or exchange of medical device data from a medical device, without altering the function or parameters of any connected devices. For example, this would include software that interrogates a ventilator every 15 minutes and transfers information about patient CO2 levels to a central patient data repository.
- The electronic storage and retrieval of medical device data, without altering the function or parameters of connected devices. For example, this would include software that stores historical blood pressure information for later review by a health care provider.
- The electronic display of medical device data, without altering the function or parameters of connected devices. For example, this would include software that displays the previously stored electrocardiogram for a particular patient.
- The electronic conversion of medical device data from one format to another format, in accordance with a preset specification. For example, this would include software that converts digital data generated by a pulse oximeter into a digital format that can be printed.
- Examples of medical device data systems that would be used in the home are systems that periodically collect data from glucose meters or blood pressure devices for later review by a health care provider.
Medical device data varies among different types of formats (numerical or other), whichever is compatible with the processing computer. The data could represent several types of information, such as clinical alarms, error codes, error messages, patient information, or equipment functionality. Several health care providers would like to have a unified system where all medical devices could be connected into one system and integrated along with the IT backbone. This would be impossible due to differences in compatibility. Different vendors may require various network requirements to ensure that medical devices function properly. A telemetry system, which utilizes wireless technology, does not work on the same system as an imaging device that utilizes a PACS, for instance. However, it is possible to integrate medical device networks to enable them to operate together or interact with other networked devices.
The FDA is helpful in raising awareness and guiding clinical engineers and BMETs to work together and resolve network problems that may arise due to uncontrollable events, such as Daylight Saving Time changes. For example, in 2010, the FDA released a public health notification to warn health care professionals about the hazards that may be associated with the Daylight Saving Time change.2 There was a concern that the time changes would affect medical devices on the network, especially where a synchronization of clocks was necessary. The FDA stated that the change could potentially affect medical devices and their networks, and cause a patient treatment or diagnostic result to be incorrectly prescribed, provided at the wrong time, missed, given more than once, given for longer or shorter durations than intended, and/or incorrectly recorded.
It is up to the IT and clinical/biomedical engineering departments to work together and ensure that time changes do not affect patient care. The take-home message should be that if you connect a medical device to another source, and this source is able to extract, display, store, and consolidate the data, then this source, according to the FDA, would be defined as a medical device. So, according to the FDA definition, this would reclassify hospital wireless networks as medical devices. The only FDA regulations pertaining to wireless networks actually originated from IEC 80001-1:2010, which addresses risk assessment of wireless networks and the medical devices.
It would be great to have a unified wireless network that would allow and facilitate the convergence of various networks into one. The issue would be that if that were to happen, then the network would need to adhere to the FDA guidelines, since it would be handling medical devices.
Personally, I would disagree to have a unified network since it poses many risks. If a virus or software malfunction were to occur and cause the systemwide hospital network to collapse, then how would it be possible to continue to provide adequate patient care? How would various medical devices be able to communicate with one another? How would providers be able to respond to alarms and codes that are transmitted via the network?
For today, it is best to have an independent and discrete network dedicated solely to medical devices to ensure that the hospital equipment will not fail and patient safety will not be jeopardized, in case a health care data system were to go down.
Robert Hijazi, MS, MHA, CBET, is a clinical engineer at Palmetto Health Hospital, Columbia, SC. For more information, contact .
- Food and Drug Administration. Devices: General Hospital and Personal Use Devices; Reclassification of Medical Device Data System. Federal Register. 2008;73(27):7498-7503.
- Food and Drug Administration. FDA Public Health Notification: Unpredictable Events in Medical Equipment Due to New Daylight Saving Time Change. Accessed June 8, 2011.
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