Can a medical technology be too easy to use? It’s hard to imagine how that could be a problem – but it’s not too far from the truth when it comes to Hazard No. 2 in the 2020 edition of ECRI Institute’s Top 10 Health Technology Hazards. This new addition to the annual list highlights safety concerns associated with the rapid adoption of point-of-care ultrasound (POCUS) technology.
POCUS scanners are highly portable, comparatively inexpensive and easy to use – or seemingly so. These characteristics have fueled the technology’s rapid growth, to the point that POCUS scanners are changing the practice of health care in many specialties. But the change is happening so quickly that safety policies and practices have struggled to keep up.
And that’s where the problems creep in.
Ultrasound at the Bedside
POCUS imaging refers to the use of medical ultrasound by the treating clinician at the bedside, as opposed to referring the patient to an imaging specialist when an ultrasound exam is indicated. The main benefit of POCUS is that it allows clinicians to quickly determine whether an abnormality is present so they can immediately make patient management decisions. Because patients don’t need to be referred to imaging specialists, they don’t need to make an additional appointment for the imaging exam, and they don’t need to wait for the diagnosis to be provided to their treating physician. The result is more time-efficient and effective patient care.
POCUS scanners come in a variety of formats – including handheld, tablet and laptop models – all of which are highly portable and battery operated. These devices are generally inexpensive and simple to operate, which has led to their rapid adoption. In fact, “many clinicians are choosing to use POCUS scanners independently from the institution,” notes Daniel A. Merton, BS, RDMS, FAIUM, FSDMS, a principal project officer and the diagnostic ultrasound specialist in ECRI Institute’s Health Devices Group. “Physicians are buying their own devices and using them as they see necessary to enhance patient care.”
The Potential for Harm
POCUS is a powerful tool for diagnoses and for guiding interventional procedures in many clinical environments. At many health care facilities, however, the safeguards needed to ensure that all POCUS users have the requisite training, experience and skill to use the technology appropriately and effectively – as well as to correctly interpret the findings – have not kept pace with the speed of adoption.
The lack of sufficient oversight, policies and procedures increases the potential that patients will be adversely affected by problems associated with use, or lack of use, of the technology. Patient safety concerns include:
- Misdiagnoses – For example, a user who is not sufficiently skilled at interpreting ultrasound images could confuse air-filled bowel for a gallstone.
- Inappropriate use of the modality – That is, using POCUS for a clinical application for which ultrasound is not indicated, or for an entity that could be better assessed using other imaging modalities.
- Overreliance on POCUS when a more comprehensive exam by an imaging specialist is indicated.
- POCUS not being used when warranted – In addition to potential clinical consequences, several published reports describe litigation and legal awards from the misuse of POCUS, including the failure to perform a POCUS exam when one was clinically indicated and available. Legal cases have the potential to affect a facility’s finances and reputation.
“Clinicians just want to do the best they can for the patient in front of them, and they’ll use whatever tool they have at their disposal to do that job,” explains Merton. “Particularly in acute settings such as an emergency department, care providers may be less concerned with policies, procedures and other aspects of proper use, such as properly documenting exams, communicating results in a timely manner, etc.” Health care institutions, on the other hand, must have plans in place for dealing with all of these considerations to meet the standards of care and to avoid potential litigation.
ECRI Institute Recommendations
Despite POCUS being the fastest-growing segment of the diagnostic ultrasound market, there are no universal guidelines or recommendations regarding POCUS use, training, licensure/credentialing or competency testing. The only existing guidelines are those that have been developed for specific clinical applications. Some health care systems have created relevant policies and procedures, but those may not be consistent between users, departments or individual facilities. Similarly, POCUS training is inconsistent, with some users having greater exposure to the technology than others.
To rectify this situation, ECRI Institute recommends that health care facilities consider instituting a multidisciplinary POCUS committee tasked to provide oversight, with the goal of standardizing the use of the technology throughout the facility or health care system. The committee should include relevant stakeholders to establish policies and procedures that address, for example:
- Training, including ultrasound physics and instrumentation, specialty-specific clinical utilization, scanning techniques and exam interpretation
- Competency, as demonstrated using formal testing instruments and/or demonstration of scanning skills
- Credentialing, including initial credentialing requirements and ongoing maintenance of the clinician’s credentials
- Interpretation competency, defining the qualifications required for staff to interpret POCUS data and provide formal reports
- Communicating/documenting POCUS results, including: who is responsible for communicating the results and how the results are to be communicated; when and how results are to be incorporated into the electronic health record (EHR); and what methods should be used for archiving images, preliminary findings and final reports so they are available for review, as needed.
- Continuing medical education specific for POCUS
- Device processing, specifying cleaning and disinfection procedures for scanners, probes and accessories
- Technology management, including device tracking within a facility, routine maintenance and required service
- Technology acquisition
- Billing and reimbursement
For ECRI Institute’s complete recommendations, including department-level responsibilities, refer to the report cited below.
This article is adapted from ECRI Institute’s “Top 10 Health Technology Hazards for 2020” (Health Devices 2019 Sep 26). The nonprofit research organization produces its list each year to raise awareness about critical hazards associated with medical devices and systems and to promote solutions that can help prevent patient harm.
An Executive Brief version of that report is available for complimentary download at www.ecri.org/2020hazards. The full report, accessible to ECRI Institute members, provides detailed steps that organizations can take to prevent adverse incidents. To learn more about membership, visit www.ecri.org/solutions/evaluation-and-comparison, or contact ECRI Institute by telephone at (610) 825-6000, ext. 5891, or by email at clientservices@ecri.org.