Pocket ultrasound devices have arrived! With their price points set at less than $3,000, the era of personally owned ultrasound machines has begun. We finally have devices we can throw into our bags that upgrade easily, help us get images for “teleguidance,” transmit images wirelessly, and improve diagnostic accuracy via machine learning. Their scalability is enticing for many reasons, but there are important considerations when trying to integrate them into clinical practice. The 2018 Appropriate Use Criteria for Handheld/Pocket Ultrasound Devices produced by the ACEP Emergency Ultrasound Section and available at www.acep.org/patient-care/policy-statements/appropriate-use-criteria-for-handheldpocket-ultrasound-devices serves as a starting point when contemplating use of these systems.
Who Should Buy It: Me or the Hospital?
The physician consumer is most protected when the hospital approves and purchases these devices, using the same processes that we use with our traditional cart-based machines. Advancing technologies bring increasing security fears and information technology (IT) challenges, particularly regarding HIPAA compliance, transmission of wireless data, and cloud storage. Purchasing decisions need to be made in conjunction with the vendors, department administration, IT and security, risk management, and clinical engineering departments. Emergency departments pursuing this technology often use hospital-encrypted phones or tablets. If these units are lost, tablets can be wiped of patient information quickly and the probes deactivated.
However, their relative inexpensiveness entices people to purchase their own devices for novelty and convenience. This may be fine for use in nonclinical educational settings, but bringing personal devices into clinical environments for either diagnostic or educational purposes without appropriate approval can lead to trouble, including HIPAA or other statutory or regulatory violations. The ACEP Emergency Ultrasound Section has heard accounts of early adopters being fired for using personal systems and encourages those interested to thoroughly explore the requirements with their facility prior to purchasing.
Are They Good Enough?
The image quality of these latest devices has improved dramatically from prior units, given advances in smartphone microprocessing and the ability to tweak software algorithms via application updates. However, the capabilities are not equivalent to traditional cart-based units that use more powerful processors. Images on smartphone devices can be fuzzy and grainy, and some functions will be limited. While most pathologies that emergency physicians are looking for should be discernible using tablet devices, subtle findings may not be fully visualized, and novices may overlook pathological clues. Tablet ultrasounds are not replacements for cart-based machines. Interested physicians should get a hands-on demo to assess appropriateness for their environments.
How Do Images Get Stored for Documentation and Billing?
Image storage is more essential than ever. Proliferation of these units brings increasing danger of “phantom scans” (scans that are never recorded or documented), leaving users open to medico-legal liability, particularly if an error is made. The latest devices allow easier storage options than previous portable units, with wireless image transmission and patient work-list retrieval. Local device storage is not ideal given space limitations and the possibility of theft. Images can be set to upload to hospital servers for archiving, a necessary step for documentation and linkage to electronic medical records. However, companies that transmit images to the cloud (eg, Butterfly) require careful consideration.
Most tech giants are data mining our online searches to develop their own products and market strategies. Images sent to cloud-based services are accessible by those companies, who could use them to develop other products for profit. Since users pay subscription fees to access cloud storage, are we then paying to provide data that will later be used for proprietary reasons? Who owns the data? Who consents for data use? Many business and ethics questions arise, further validating that hospital purchase with the backing of IT security and risk management is important. Some institutions have discovered ways to retrieve cloud information for permanent local storage onto hospital servers, but this is not an easy process.
If units are hospital-purchased, reimbursement claims could be submitted for both the professional and technical components. However, if units are personally bought or bought by academic departments separate from the hospital, then the technical fee would not apply and could potentially cause billing confusion.
The Bottom Line
Pocket ultrasounds will change the accessibility of imaging in patient care and point-of-care ultrasound education. Their imaging is good enough to cover emergent applications and procedures, such as the core applications listed in the ACEP Ultrasound Guidelines (except for transvaginal pelvic ultrasound), but they are not as robust as cart-based systems. Their color flow Doppler is limited, and they cannot offer more advanced features such as spectral Doppler. For security and risk management purposes, investing the time to involve hospital or group IT early on can avoid a lot of headaches later.
(click for larger image) Comparison of Pocket Ultrasound Machines
Definitions: AI = artificial intelligence; CMOS = complementary metal–oxide–semiconductor; CMUT = capacitive micromachined ultrasonic transducer; DICOM = digital imaging and communications in medicine; PACS = picture archiving and communication system; REACTS = Remote Education, Augmented Communication, Training and Supervision
Dr. Liu is assistant professor in the department of emergency medicine, fellowship director of the section of emergency ultrasound, and director of clinical ultrasound education at Yale University School of Medicine in New Haven, Connecticut. She is immediate past chair of ACEP’s Emergency Ultrasound Section.
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