Management of Handheld Ultrasound Devices in our Systemwide Ultrasound Program

Viveta Lobo MD, Stanford University School of Medicine

As point-of-care ultrasound continues to become the imaging modality of choice for clinicians for all specialties, portable ultrasound devices, such as handheld ultrasound (US) devices have gained increasing popularity due to their convenience and ability to efficiently acquire and interpret images at the bedside. Furthermore, in recent years over a dozen different brands and models of handheld US devices have appeared in the market at decreasing prices, making it very affordable and accessible for many clinicians to purchase their own individual device even with personal (and not institutional) funds. While the benefits of handheld US devices are obvious, concerns regarding device security, cloud storage, data ownership, operational qualification, infection control, reimbursement, patient confidentiality and safety are all serious concerns that need to be addressed.

There have been many proposed solutions and guidelines to address these concerns at individual institutions. In 2018, the ACEP policy statement Appropriate Use Criteria for Handheld/Pocket Ultrasound Devices was published and in which detailed guidelines and recommendations for management of handheld US devices were given.

In 2020, the system-wide ultrasound program team at Stanford hospital created a new policy (based on the ACEP guidelines) for how handheld US devices should be used within the clinical setting, and how we were going to enforce these new rules. While we encourage institutions to personalize their own system-wide handheld US device policies based on their institution's specific culture and scope of POCUS, we hope that our experience and lessons learned will be of value to you.

1. Information Security and workflow
   1. As with all POCUS use, all users must have demonstrated proficiency in particular POCUS exams to be able to use them for clinical decision making and procedural guidance. Educational use for handheld US devices must be supervised by qualified clinicians at all times.
   2. The brand and model of all handheld US devices must be approved by our hospital Biomedical department. A list of preferred handheld devices has been created by them, however should a clinician want to use another type of device not listed, they have to request assessment and approval by our Biomedical department before purchase and clinical use. All new devices must be registered through the Biomedical department before clinical use.
   3. All handheld devices intended for clinical use must be purchased using hospital or institutional funds and not personal funds.
   4. All handheld devices must fully integrate into the existing system-wide workflow solution; allowing users to easily acquire, save, interpret and upload images in the electronic healthcare record system.

2. Bioeffects and Safety
   1. All clinicians must be familiar and follow the manufacturer’s guidelines for safety and appropriate device use, especially those devices that generate heat.
   2. All handheld device parts (transducer, cords, screen) must undergo routine disinfection as specified by our hospital infection control department, which follows ACEP disinfection guidelines. At this time, no transducer that requires high-level disinfection can be used with handheld US devices.

3. Clinical use
   1. Clinical use of handheld US devices must follow all the expected POCUS clinical guidelines, ie, used for complete diagnostic exams and procedural guidance, and is not “an extension of the physical exam.” All users must have credentials in each specific POCUS exam and procedural guidance.
   2. All diagnostic POCUS exams using handheld US devices must be clinically indicated, complete, of high quality with full interpretation documented in the patient’s chart for each exam.
   3. If a handheld device is shared amongst multiple users, each user must log in to the device using their own unique login information.
   4. All clinically indicated POCUS exams performed using handheld ultrasound devices should be eligible for billing and reimbursement when appropriate.

Introducing and enforcing new policy and rules is often a challenging transition. In our experience we have had improved success with compliance by focusing on the following areas:

• Focus on patient safety. As clinicians, patient safety is top priority. Use this shared value to help clinicians understand this new policy.
• Go to leadership first. We first introduced this new policy to all the clinical chairs of all the departments in the hospital, and then reached out to all the ultrasound champions from the various specialities. Once we gained their support, they helped engage other clinicians from their specialties and share the policy.
• Keep it simple. We optimized and simplified any processes that involved clinician interactions such as registering a new handheld US device, or purchasing a new handheld device through the biomedical department.
• Streamline technology. It is important that you can easily integrate handheld US use into currently used and accepted workflow solutions. We also implemented a block where non-registered devices could not integrate into these clinical workflow pathways to discourage their use.
• Create vendor relationships. By directly working with popular vendors on a system-wide level, we were able to purchase institutional licenses and discounts, making it most efficient and affordable to purchase new devices through the hospital and not individually. This also allowed vendors to redirect new purchase requests from individual clinicians to the hospital biomedical department.

Resources

Hsieh A, Baker MB, Phalen JM, et al. Handheld point-of-care ultrasound: safety considerations for creating guidelines. J Intensive Care Med. 2022;37(9):1146-51.

McGahan J, Pozniak M, Cronan J, Pellerito J, Lee K, Blaivas, M. Handheld ultrasound: Threat or opportunity? Appl Radiol. March 09, 2015.

American College of Emergency Physicians. Appropriate Use Criteria for Handheld/Pocket Ultrasound Devices. [policy statement]. Approved June 2018.