Expert insights
Pharmacovigilance and Materiovigilance: What a PSAD Must Track
Two distinct vigilance obligations, one shared imperative: detect, trace and act fast when a device or treatment poses a risk.
A PSAD (home healthcare provider) works with medical devices and health products on prescription. Two vigilance regimes apply to this scope: pharmacovigilance, focused on medicines and their adverse effects, and materiovigilance, focused on incidents linked to medical devices. Both pursue the same goal — detect, report, correct — but cover different products and different reporting procedures.
A materiovigilance report typically triggers a database compliance check, a risk assessment for each affected patient (via a structured questionnaire, for instance on active implants), and, if needed, a technician visit to replace or adjust the device.
Documenting this process is a pure traceability exercise: who was notified, when, with what response, and what action followed. This is exactly the kind of administrative and coordination process eBop operates for its clients — never touching the clinical decision itself.