Medical devices, digital health and remote monitoring — viva

Opening (must-hit)

"A paediatric medical device is any regulated instrument or software used to diagnose, monitor or treat a child. The four classes are implantable or long-term, wearable or on-body, home monitoring and telehealth platforms, and the candidate must distinguish a regulated medical-grade device from a consumer wellness product. The two highest-yield sensor physiologies are the continuous glucose monitor — interstitial glucose lagging plasma by five to fifteen minutes — and the pulse oximeter, which is biased by dark skin pigmentation and low perfusion. The ISPAD 2024 ambulatory glucose profile targets are time in range over 70 per cent, time below 70 mg/dL under 4 per cent, time below 54 mg/dL under 1 per cent. Every device is deployed only after the clinical question, the age validation, the thresholds and the escalation pathway are agreed with the family." [4] [8]

Branch A — The smartwatch arrhythmia flag

Examiner: A parent's smartwatch has flagged atrial fibrillation in their eight-year-old. The child is asymptomatic. What is your response? Candidate: I treat the consumer device's output as a screening signal, not a diagnosis. The first step is the structured assessment of the child — is there a history of palpitations, syncope, chest pain, exercise intolerance or a family history of sudden death or arrhythmia — and a careful cardiovascular examination for the murmur of a structurally abnormal heart. I obtain a 12-lead ECG and arrange a clinician overread of the device tracing, because the algorithmic label is not the diagnosis. I run the paediatric differential of the irregular rhythm: sinus arrhythmia — the normal physiological variation of heart rate with respiration and the most common source of consumer-device flags — premature atrial contractions, which are usually benign in the structurally normal heart, supraventricular tachycardia, and true atrial fibrillation, which is rare in children and warrants a search for a structural, metabolic or thyroid cause. I would not act on the algorithmic label without the device-independent confirmation. [9]

Branch B — The CGM and the night-time alarms

Examiner: A four-year-old with type 1 diabetes is on a CGM. The family report recurrent night-time alarms and a recent reading of 48 mg/dL at three o'clock in the morning, treated with juice. They are considering stopping the device. What do you do? Candidate: I assess the family's experience, review the ambulatory glucose profile, and tune the thresholds rather than abandon the device. The AGP shows me the time in range, the time below range, and the clustering of the lows — if they cluster at night the basal insulin pattern is the likely driver. I confirm the immediate hypoglycaemia protocol is in place: any CGM reading under 54 mg/dL is confirmed with a fingerstick, treated with 10 to 15 grams of fast-acting oral carbohydrate if the child is conscious, or glucagon 0.5 milligrams intramuscularly for a child under twelve years or 1 milligram at twelve years and over if the child is unconscious, and rechecked in fifteen minutes. On the shared decision, I would not stop the device — the recurrent alarms are a threshold-tuning problem. I would raise the low alert threshold to silence the non-critical alarms, schedule a period of protected sleep with only the critical alarm audible, review the basal insulin pattern, and arrange a follow-up AGP review. Abandoning the device without a safety-net would expose the child to unrecognised hypoglycaemia. The CGM is the standard of care, and the Wadwa and SENCE trials support its use in this age group. [1] [3] [4] [8]

Branch C — Pulse oximetry in the dark-skinned infant

Examiner: A six-month-old with bronchopulmonary dysplasia is on home oxygen with a pulse oximeter. The parents are dark-skinned. What are the equity pitfalls, and what is your mitigation? Candidate: The pulse oximeter is biased by dark skin pigmentation and by low perfusion, and the consequence is occult hypoxaemia — a SpO2 in the normal range when the arterial saturation is low. The Sjoding cohort showed occult hypoxaemia was nearly three times more common in Black patients than in White patients across over ten thousand paired measurements; the Gudelunas study extended the finding into low-perfusion states, where darkly pigmented skin was again associated with missed hypoxaemia; the Rathod collaborative framed the mitigation as equity-aware thresholds, clinical correlation and an arterial blood gas when the reading does not fit. My mitigations for this family are three: first, I train the parents to read the child before the device — the colour, the work of breathing, the feeding, the alertness — and to use the device's number in that context; second, I give them a written action plan that explicitly names the equity limitation and the threshold to escalate to the emergency department; third, I keep a low threshold to obtain an arterial blood gas with co-oximetry when the family is concerned, even if the SpO2 is in the normal range. A normal number in an unwell dark-skinned infant does not exclude hypoxaemia. [5] [6] [7]

Branch D — The lost device signal

Examiner: The pulse oximeter of a high-risk technology-dependent child goes offline at midnight and the family call you. The reading has been lost for forty minutes. What do you do? Candidate: Silence is not safety. I take the call seriously, ask the family to assess the child clinically — the colour, the work of breathing, the alertness, the feeding — and use the clinical pathway as the safety-net. If the child is unwell, the family come to the emergency department or I arrange retrieval. If the child is well, I troubleshoot the device with the family — the probe, the battery, the connectivity — but I do not accept the silence as evidence that the child is well. The Foster AAP policy frames the high-risk technology-dependent child as the child whose remote-monitoring data must reach a clinician who can act, and the written action plan is the safety-net the family executes at any hour. I document the call, the assessment, the plan, and the next review point. [8]

Branch E — Telehealth in the rural family

Examiner: A rural family three hours from the nearest paediatric service ask whether telehealth can replace their clinic visits for their child's complex chronic disease. How do you counsel them? Candidate: Telehealth extends the reach of subspecialty care into rural and remote Australia, and the Li 2024 systematic review supports mHealth effectiveness in adolescents and young adults with chronic disease, particularly for self-management and transition. But telehealth cannot examine the abdomen, cannot palpate the abdomen, cannot auscultate the chest with the fidelity of the bedside, and cannot resuscitate. The decision turns on whether the clinical question can be answered without a bedside examination. I would offer a hybrid model — telehealth for the medication review, the AGP review, the care-coordination conversation; in-person for the annual examination, the acute presentation, the procedural visit. I would also name the equity issue: the broadband and device ownership that telehealth assumes may not be present in the rural family, and the deployment must include an access plan. Telehealth is a support to the local service, not a substitute for it. [9]

Branch F — The hybrid closed-loop in the very young child

Examiner: The parents of a three-year-old newly diagnosed with type 1 diabetes ask about a hybrid closed-loop system. What does the evidence show, and how do you counsel them? Candidate: The Wadwa NEJM 2023 trial randomised young children with type 1 diabetes to hybrid closed-loop control versus sensor-augmented pump therapy and showed a substantially higher time in range in the closed-loop arm — around 80 per cent versus around 55 per cent — a near-doubling that moved the technology into the standard of care for the very young. The SENCE trial in very young children established CGM feasibility with family behavioural support. I would counsel the family that the closed-loop system automates the basal insulin but not the whole of diabetes care: the child still requires meal announcement, still requires site changes, still requires the family to respond to alarms. I would discuss the adhesive tolerance, the alarm burden, and the family's capacity to operate the system at three o'clock in the morning. I would set the ISPAD 2024 targets — time in range over 70 per cent, time below 70 mg/dL under 4 per cent, time below 54 mg/dL under 1 per cent — as the shared goal, and arrange a structured education and follow-up. The system is a tool that supports the family, not a replacement for them. [1] [3] [4]