Device Data Part 2: What is Device Data?

This post is Part 2 of a series based on Nursine Jackson’s article, “What about that Device Data?”.

What is Device Data?

Biomedical devices are commonly integrated into electronic medical record systems as a means to simplify workflow and actually enhance the value of the EMR and its adoption by clinical staff. When deployed, vital signs data are automatically sent from biomedical devices directly to the nursing documentation system. The nurse can focus more on direct patient care by quickly validating the vital signs data in the EMR and submitting them to the patient’s record. Elimination of manual entry reduces errors in data entry, increases clinical satisfaction and improves patient care and safety.[1]

The FDA describes Medical Device Data Systems (MDDS) in section 520(o)(1)(D) as hardware or software products intended to transfer, store, convert formats, and display medical device data. Medical Device Data Systems (MDDS) are hardware or software products intended to transfer, store, convert formats, and display medical device data.[2]

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Following are examples of common medical devices that may obtain and store Personal Health Information (PHI):

• Devices that monitor vital signs, such as pulse oximeter and automated blood pressure cuffs

• Medication Dispensing Cabinet

• Infusion Pumps

• Telemetry monitors

• Central station monitors

• Lab devices

• Dialysis Machines

• EKG & EEG Devices

• Portable x-ray equipment

• Radiology equipment (e.g., CTs, MRIs, Ultrasounds, Angiograms, Mammograms)

• Anesthesia Machines

• Exercise Stress Testing equipment

• Point of care testing and bedside devices that measure glucose, cholesterol, blood gases, cardiac markers, pregnancy testing, and fecal occult blood tests; electrolyte and enzyme analysis, test for drugs of abuse and for infectious diseases, etc.

• Endoscopy devices

• Urimeters

• Ventilators

• Stress testing devices

• Home care/monitoring devices

• Printer

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Each system and device work differently and have unique naming conventions.

During eDiscovery, obtaining tutorials, cheat sheets, tips and tricks, or whatever tool the facility uses to educate staff in proper utilization of electronic records, can help the patient advocate use the correct language to ask for the device data sought.

It is also important to seek device data from the entire period the patient was monitored by a device in order to have access to the full set of serial values obtained by the device, not just the values “accepted” into the flowsheet. Sometimes the select data fed to the flowsheet does not accurately represent the patient’s status, as the data may only be fed into the flowsheet in 15 -minute intervals. For example, the patient may have had a period of hypotension in the interim between the vital signs that were reported every 15 minutes. In this case, the nurse would have to look at “unvalidated values” for this patient and select a value that best represents the patient’s status for the interim time to validate it. If a nurse has not taken these extra steps to import additional or more representative values into the system, then the hypotensive period will not appear on the flowsheet.

Stay tuned for Part 3 of this series, “Why should the Plaintiff have Access to Device Data?”

[1] McAlpine, Brian. (2009, July/August). Biomedical Device Integration: The Impact on Clinicians at the Point of Care. Retrieved from https://www.psqh.com/analysis/biomedical-device-integration/

[2] US Food & Drug Administration. Medical Device Data Systems/Products and Medical Procedures/General Hospital Devices and Supplies/Medical Device Data Systems. Retrieved from https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/medical-device-data-systems. Content current as of 9/26/2019.