Medical Device Integration

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Medical Device Integration (MDI) is interoperability and connectivity between devices and EHRs. For these systems to communicate, they need to rely on standards such as HL-7, or on middleware capable of converting data to a format recognized by the downstream device. (1). MDI is increasingly common in the provision of health care, and the COVID-19 pandemic prompted the need for further device integration, especially for telehealth applications (2). Many types of data and devices can be integrated such as infusion pumps, ECG machines, and vital sign monitors, for example (1). It has been historically difficult to connect devices to patient outcomes but by way of MDI, observed patient data can be captured in the EHR and used to guide clinical decisions, determine patient outcomes, and assess efficacy of clinical management among other uses (3). Nonetheless, connectivity with devices remains under-utilized (4).

Reasons for MDI

Reasons for MDI may include:
1. Patient safety – MDI automates integration of relevant information, reducing ordering errors and data entry errors (1). Patient safety is also promoted by reducing the amount of interruptions in workflow (4).
2. Clinical efficiency – MDI can reduce the time to diagnosis or initiation of care (5).
3. Data collection for research – It can be difficult to link medical devices to patient outcomes (3), but MDI can allow for improved data collection for determining outcomes (2).
4. Remote monitoring – Remote monitoring can be conducted in real-time with MDI that allows for synchronization between device and EHR (6)
5. Device surveillance – Traditionally, device surveillance has mainly relied on reporting for documentation of adverse events. For this reason, device-related adverse events are significantly under reported (3).
6. Efficient data entry – MDI allows for direct information exchange, recuing the need for manual data entry (5).
7. Reimbursement – Medical device integration may not rely on direct clinician billing for cost reimbursement, but instead on saving resources over time (7).


Functional MDI

The process and optimization of MDI requires more than just computational processes (2). Challenges of implementation can be technical, policy-related, or human workforce related (4). When implemented, the presentation of data to clinicians should be in a familiar format (2).

The FDA has oversight of some aspects of MDI. Systems that are identified as Medical Device Data Systems (MDDS) by the FDA are subject to class I medical device regulations. From the FDA perspective, medical data transmission alone does not make a medical device. Instead, only systems that do something clinical are considered medical devices by the FD for regulatory purposes (7).

One of the concerns with MDI is that it can provide an avenue for cyberattacks to infiltrate health care systems, and devices themselves often contain sensitive patient information. In addition to the direct connectivity, some devices may be used past the time of which they stop receiving security patches (8).

References

1. Cohen, T. (2019). The integration and convergence of medical and information technologies. Chapter 81. Clinical Engineering Handbook 2nd ED. Ed: Iadanza, Ernesto. Academic Press. p543-549. 2. Cervenka, T., & Iber, C. (2020). EHR integration of PAP devices in sleep medicine implementation in the clinical setting. Sleep Medicine Clinics. 15, 377-382. 3. Callahan, A., Fries, J.A., Ré, C., Huddleston, J.I., Giori, N.J., Delp, S., & Shah, N.H. (2019). Medical device surveillance with electronic health records. NPJ Digital Medicine 2(94), 1-10.


Submitted by (Benjamin Collins)