Pattern of Medical Device Adverse Events in a Tertiary Level Hospital in Northern India: An Ambispective Study

Background: This is the first study to evaluate the pattern of adverse events related to medical devices in India. We aimed to evaluate medical device adverse events (MDAEs) reported at a tertiary level teaching hospital in northern India.Methods: This descriptive study was conducted ambispectively at PGIMER, Chandigarh. We used the medical device risk classification given by the Indian regulatory authority which was framed in line with the recommendation of the Global Harmonization Task Force. The prospective study (PS) was done from January 2020 to December 2020 with a concurrent retrospective study (RS) proceeding to three years so as to learn more about the reporting culture, demographics, risk class of devices and the type of adverse events.Result. We obtained 224 MDAE in the prospective study and identified 413 MDAE in retrospective study. Reporting culture of retrospective adverse events to the national materiovigilance programme of India (MvPI) was negligible. Marginally increased incidence of MDAE reported among male patients (PS; 52%, RS; 57%) and age group between 21-30 years (PS; 19.1%, RS; 23.2%) in both studies. Fewer number of MDAEs were also reported from infants (7.5%) and the elderly (6.9%) population. Regarding risk class, MDAEs were frequent in low to moderate risk devices (Class B: 66%) in the prospective study, while it was documented only for high-risk devices (Class C: 51% & Class D: 49%) in the retrospective study. However, serious adverse events (SAEs) were equally prevalent among moderate to high-risk devices (Class B: 33%, C: 34% &D: 33%). An increased frequency of SAE was observed among non-notified medical devices (60.4%). Concerning reporting culture, nurses reported the majority of MDAEs (65%). Overall 14% of the incidents were documented as near-miss events.Conclusion: Medical devices elicit adverse events irrespective of their risk class, notification status and patient demographic factors. Escalated reporting of MDAEs by surgeons and biomedical engineers is recommended at India.