Pattern and occurrence of medical device adverse events at a medical device monitoring centre in Central India: A three-year surveillance study

  • Ahmad Najmi Assistant Professor, Dept. of Pharmacology, AIIMS Bhopal
Keywords: Medical device adverse events, Materiovigilance, medical device, pattern


Background: Various horrific adverse events have been reported due to malfunctioning of medical devices. To safeguard the health of Indian population and to promote the patient safety and welfare of Indian population by monitoring adverse events related to medical devices, Ministry of Health & Family Welfare (MOHFW) has started Materiovigilance program of India (MvPI) in July 2015. Under the program of Materiovigilance (MvPI), nationwide medical device monitoring centers (MDMC) have been established.  This study was conducted to analyze and present the occurrence and severity of spontaneous MDAE reports registered at an MDMC in Central India. Methods: This non-interventional study was a part of MvPI and presents the data collected from one of the MDMC under MvPI. All MDAE reports received from the hospital of AIIMS Bhopal between August 2019 and September 2022 at the MDMC –AIIMS Bhopal in Central India; were included in the study. The medical device adverse event (MDAE) reporting form, recommended by the IPC Ghaziabad, was used as the data collection tool. The personal identification variables were masked before analyses, to maintain full confidentiality. Results: Spontaneous MDAEs reports were collected and analyzed during 3 years at the MDMC. A total of 309 MDAE reports were generated from 151 medical devices and 291 patients. Out of total 309 MDAE, 88% were non serious in nature, 10% were serious in nature & 2% were near miss events. Causality was conducted as per WHO adapted UMC criteria. Maximum MDAEs came in probable category (58%) followed by possible (25%), unlikely (09%), not related (04%) & un-assessable (04%). Maximum reporting was done from covid wards & ICUs, followed by obstetrics & gynecology, orthopedics & radiology department.

Conclusion: Allergic contact dermatitis from sanitizers and PPE kits was the most commonly reported MDAE, followed by invalid urine pregnancy test kits, orthopedic implant related adverse events & intravenous infusion pump. Underreporting of MDAEs at our MDMC is evident and a major factor for the pause in performing severity and causality assessment. To deal with the problem of under-reporting, we suggest continuous sensitization and training program for HCPs. We also suggest involving all stakeholders in MvPI, including government hospitals, private hospitals, and AYUSH hospitals. All the stakeholders should be assured that reporting MDAEs has no legal implications.