Medical Device Testing: Methods, Significance, and Clinical Applications.

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.

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. 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. 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. 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.

Characteristics of Critically Ill Adults With Sacrococcygeal Unavoidable Hospital-Acquired Pressure Injuries: A Retrospective, Matched, Case-Control Study.

PURPOSE: To identify characteristics of critically ill adults with sacrococcygeal, unavoidable hospital-acquired pressure injuries (uHAPIs). DESIGN: Retrospective, matched, case-control design. SUBJECTS/SETTING: Patients admitted to adult intensive care units (ICUs) at an urban academic medical center from January 2014 through July 2016. METHODS: Thirty-four patients without uHAPI were matched to 34 patients with sacrococcygeal uHAPI. Time points of interest included admission to the ICU, the week preceding the definitive assessment date, and hospital discharge status. Variables of interest included length of stay, any diagnosis of sepsis, severity of illness, degree of organ dysfunction/failure, supportive therapies in use (eg, mechanical ventilation), and pressure injury risk (Braden Scale score). RESULTS: All 34 sacrococcygeal pressure injuries were classified as uHAPI using the pressure injury prevention inventory instrument. No statistically significant differences were noted between patients for severity of illness, degree of organ dysfunction/failure, or pressure injury risk at ICU admission. At 1 day prior to the definitive assessment date and at discharge, patients with uHAPI had significantly higher mean Sequential Organ Failure Assessment (SOFA) scores (greater organ dysfunction/failure) and lower mean Braden Scale scores (greater pressure injury risk) than patients without uHAPI. Patients with uHAPI had significantly longer lengths of stay, more supportive therapies in use, were more often diagnosed with sepsis, and were more likely to die during hospitalization. CONCLUSION: Sacrococcygeal uHAPI development was associated with progressive multiorgan dysfunction/failure, greater use of supportive therapies, sepsis diagnosis, and mortality. Additional research investigating the role of multiorgan dysfunction/failure and sepsis on uHAPI development is warranted.

Predictors of pressure injury development in critically ill adults: A retrospective cohort study.

OBJECTIVE: The purpose of this research was to identify predictors of pressure injury, using data from the electronic health records of critically ill adults. METHODOLOGY: A retrospective cohort study was conducted using logistic regression models to examine risk factors adjusted for age, gender, race/ethnicity and length of stay. SETTING: The study cohort included 1587 adults in intensive care units within an urban academic medical centre. MAIN OUTCOME MEASURES: The presence or absence of a hospital-acquired pressure injury was determined during monthly skin integrity prevalence surveys. All pressure injuries were independently confirmed by two Certified Wound Care Nurses. RESULTS: Eighty-one (5.1%) of the 1587 cohort patients developed pressure injuries. After adjusting for confounders, the clinical variables associated with pressure injury development included mean arterial pressure <60 mmHg and lowest Total Braden score up to two weeks prior to the date of HAPI development or date of prevalence survey for the comparison group. CONCLUSIONS: This study provides a more comprehensive understanding about pressure injury risk in critically ill adults, identifying extrinsic and intrinsic factors associated with pressure injury development. Prospective multisite studies are needed to further examine these potential contributors to pressure injury development within the context of adherence to prevention interventions.

Differentiating Deep Tissue Pressure Injury (DTPI) From Other Causes of Purpura in the Sacrococcygeal Area: A Multiple Case Series.

BACKGROUND: Recent revisions to the pressure injury staging system include guidance on differential diagnoses for deep tissue pressure injury (DTPI). Accurately identifying DTPI is critical; however, purpura in the setting of vascular disorders and systemic infectious processes can share similar features confounding diagnosis. CASES: In this three-case series, we describe suspected DTPI with an uncharacteristic shape or occurring in the presence of additional lesions distributed outside of typical pressure areas prompted further evaluation. CONCLUSIONS: The interdisciplinary approach we adapted was useful in determining the cause of purpura when the DTPI was ruled out by the certified wound care nurse.