Field Experiences with Handheld Diagnostic Devices to Triage Children under Five Presenting with Severe Febrile Illness in a District Hospital in DR Congo

Abstract

As part of a field study (NCT04473768) in children presenting with severe febrile illness to Kisantu hospital (DR Congo), we retrospectively compiled user experiences (not performance) with handheld diagnostic devices assisting triage: tympanic thermometer, pulse oximeter (measuring heart rate, respiratory rate and oxygen saturation), hemoglobinometer and glucometer. Guidance documents for product selection were generic and scattered. Stock rupture, market withdrawal and unaffordable prices interfered with procurement. Challenges at implementation included environmental temperature, capillary blood sampling (antisepsis, order of multiple tests, filling microcuvettes and glucose strips), calibration (environmental temperature, cold chain) and liability-oriented communication with a manufacturer. Instructions for use were readable and contained symbol keys; two devices had printed French-language instructions. Shortcomings were poor integration of figures with text and distinct procedures for the oximeter and its sensor. Usability interview revealed appreciations for quick results, visibility of the display and memory function (three devices) but also problems of capillary blood sample transfer, cleaning, too long of a time-to-results (respiratory rate) and size, fitting and disposal of thermometer probes. Pictorial error messages were preferred over alphanumeric error codes but interpretation of symbols was poor. Alarm sounds of the oximeter caused unrest in children and caretakers perceived the device as associated with poor prognosis.

Keywords: children under five; danger sign; handheld diagnostic device; instructions for use; label comprehension; low-resource setting; severe febrile illness; triage; usability.

Figure 1

Life cycle of a diagnostic device at the end-user’s level as described by WHO. At the end-user level, it starts with selection of the diagnostic device based on a needs assessment. Target product profiles, technical specification sheets and independent product evaluations based on the REASSURED criteria provide guidance for selection. Close interaction with the manufacturer and a healthy market is pivotal for the phase of procurement and shipment. Subsequent adoption, training and use rely on user-adapted instructions for use while manufacturer’s support needs to continue during the maintenance, repair and disposal. End-user’s experiences should be integrated in post-market surveillance and feed improvements in device and service. For an extended version of this figure, we refer to Supplement S1. Abbreviations: SOP: Standard Operating Procedure; QC: quality control.

Figure 2

Geographical location of Kisantu hospital in DR Congo.

Figure 3

Field experiences reported by end-users during the lifecycle of handheld diagnostic devices to measure tympanic temperature and respiratory rate. Abbreviations and references: IPE: Independent Product Evaluations [38,39,40,41,42,43,44,45,46,47,48,49], PMD: WHO Priority Medical Devices [23], TPP: Target Product Profile [50], TSS: WHO Technical Specification Sheet [24], Tack et al. [28].

Figure 4

Field experiences reported by end-users during the lifecycle of handheld diagnostic devices to measure blood glucose & hemoglobin. Abbreviations & references: EDL: WHO Essential in vitro Diagnostics List [26], IPE: Independent Product Evaluations [51,52,53,54], TPP: Target Product Profile [55,56,57].

Figure 5

Pictures illustrating the blue dot observed in the microcuvettes of the hemoglobinometer (black arrow) and application of blood to the front edge (green arrow) and not on the top (red arrow) of the glucometer strip.