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Patient Safety Strategies
Whether you have already implemented remote patient monitoring or are thinking about it, consider the following strategies:
• Use a deliberate process to evaluate potential monitoring devices.
o Determine if the equipment is classified as a medical device by the U.S. Food and Drug Administration (FDA). Often, FDA classification as a medical device is required for billing, and it is a sign that the device has been objectively evaluated.
o Ask the device manufacturer for a list of current clients and contact them to review their experiences with the company and the device.
o Schedule an in-person product demonstration and consider ease of use from the patient’s perspective. Make sure that patient instructions are clear. Evaluate whether the device is man ageable in terms of size, portability, and application.
In the case scenario, the device did not adhere properly to the patient’s skin.
• Determine how the data will be collected, transmitted, and stored.
o Use a secure (encrypted) method for data collection, transmission, and storage. Data from remote patient monitoring devices are subject to privacy and security regulations.
o Use caution with applications that transmit data directly into the electronic health record (EHR). Determine the frequency and volume of data transmission. Test the process to confirm that the information populates appropriately and does not negatively affect EHR function.
o Determine who will review the data and how frequently, and verify what data will be incorpo- rated into the patient’s medical record. When patient information will be extracted, analyzed, and reported by a third party, it is incumbent on providers to ensure that the process is rigorous. How is the information parsed and interpreted? Is there a process for identifying and rapidly communicating critical or highly concerning results? Is there an internal quality review process?
In the case example, the data were stored in the device, which was returned to the manufacturer for
extraction and reporting. When the physician fol- lowed up with the device manufacturer about the report, the manufacturer was unable to provide a satisfactory answer as to why the result was reported as normal when the entire reporting period had not been completed.
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Ensure the patient is ready to participate.
o Check with the patient periodically during the monitoring process to determine if the device was received and is in use. This also provides an opportunity to assess the patient’s level of comfort and answer any questions.
o Advise patients to call the office about any device problems or concerns.
In the case example, the patient was planning to move. Since the patient’s condition was stable, it may have been more convenient for him to delay the monitoring until after the move. Instead, the patient forgot about the monitor, delayed application for several weeks, and then experienced problems using the device.
Plan and Prepare
This case study highlights the importance of careful planning and preparation when incorporating remote technologies into the patient care services offered by a medical practice. Providers who recom- mend products and services to their patients have a responsibility to apply due diligence in confirming that the device manufacturer is reputable, the device is safe, and the information it produces is accurate and reliable. Once a decision is made to use remote technology, the next steps should be to develop appropriate use guidelines that include preparing patients, managing device concerns/troubleshooting, tracking results, and following up with patients.
For more information on remote patient monitor- ing, see our articles “Remote Patient Monitoring” and “Wearables Offer Wealth of Data During COVID-19, but Liability Risks Remain,” or contact the Department of Patient Safety and Risk Management at (800) 421-2368 or patientsafety@thedoctors.com.
The guidelines suggested here are not rules,
do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider considering the circum- stances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.
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