Handheld Point-of-Care Ultrasound: Safety Considerations for Creating Guidelines

Area of Science:

• Medical Devices
• Point-of-Care Diagnostics
• Ultrasound Technology

Background:

• Handheld point-of-care ultrasound (HPOCUS) systems offer advantages in portability and affordability over traditional machines.
• HPOCUS adoption is increasing in intensive care settings, yet patient safety data and regulatory guidelines are scarce.
• Existing literature highlights benefits like expedited diagnosis and concerns regarding device security and patient safety.

Purpose of the Study:

• To critically appraise the literature on HPOCUS, focusing on benefits, patient safety concerns, and existing guidelines.
• To propose a framework for developing future regulatory guidelines for HPOCUS.

Main Methods:

• A comprehensive literature review was performed using PubMed with keywords related to HPOCUS and guidelines.
• Articles were analyzed for reported benefits, patient safety concerns, and existing POCUS practice guidelines.
• Data was synthesized thematically to inform proposed guideline recommendations.

Main Results:

• Key benefits of HPOCUS include portability, affordability, enhanced imaging, and expedited diagnosis.
• Major barriers to HPOCUS adoption are device security, patient confidentiality, and patient safety.
• Few national regulatory guidelines exist, with the ACEP policy being a notable exception.

Conclusions:

• HPOCUS is a valuable tool for rapid diagnosis and management but requires further investigation into patient safety.
• Current regulatory guidelines for HPOCUS are insufficient, necessitating the development of a structured framework.
• Proposed guidelines should address training, credentialing, bioengineering approval, and electronic medical record integration for safe HPOCUS implementation.