Medical Device Testing: Methods, Significance, and Clinical Applications

Abstract

ABSTRACT GENERAL PURPOSE To present a study conducting objective biomechanical testing of medical devices known to cause medical device-related pressure injuries (MDRPIs) in critically ill adults and comparing those results with clinical outcomes associated with each device. TARGET AUDIENCE This continuing education activity is intended for physicians, physician assistants, nurse practitioners, and nurses with an interest in skin and wound care. LEARNING OBJECTIVES/OUTCOMES After participating in this educational activity, the participant will: 1. Explain the results of the study of the relationships between objective biomechanical tests of medical devices and clinical outcomes that help inform clinicians using these devices. 2. Synthesize the background information that informed the study. OBJECTIVE To conduct bioengineering testing of devices that cause medical device-related pressure injuries (MDRPIs) in critically ill adults and compare testing results to the MDRPI clinical outcomes associated with each device. METHODS Following the identification of MDRPI from oxygen-delivery devices and nasogastric tubes in critically ill adults who were hospitalized between January 2016 and October 2022, the specific manufacturer and model number of the devices were identified. Twelve devices and two prophylactic dressings in original packaging were sent to a bioengineering laboratory for testing. Using an integrated experimental-computational approach, the compressive elastic moduli (E [MPa]) was measured for each device and prophylactic dressing and compared with the properties of normal adult skin. The authors hypothesized that devices with greater mechanical stiffness (ie, higher E [MPa]) would be associated with a greater number and severity of MDRPIs. RESULTS Researchers identified 68 patients with 88 MDRPIs. All PI stages except stage 4 were represented. Nasogastric tubes had the highest mechanical stiffness and were the most common MDRPI identified. In contrast, no soft nasal cannula MDRPIs were reported. Devices associated with the highest number of MDRPIs also had the highest E [MPa] values; researchers noted a moderate association between E [MPa] values and pressure injury severity. Prophylactic dressings had E [MPa] values within the range of normal adult skin. CONCLUSION The relative mechanical stiffness of a device is an important factor in MDRPI etiology. However, factors such as duration of device use, tightness when securing devices, correct fit, and heat and humidity under devices should be considered in predicting MDRPI severity.