The present study is the first of its kind, to evaluate the pattern of medical device adverse events according to GHTF risk classification of MD as well as to highlight the nature of adverse events concerning to notification status of MD followed in India.
We received 224 MDAE in the prospective study and identified 413 MDAE in the retrospective study. Since the retrospective analysis was performed for a three-year (2017-2019) period and the prospective study was performed for a one-year (2019) period, the discrepancy in cumulative counts might have occurred. But, none of the MDAEs that happened during the retrospective study period were reported to the same hospital's functional MvPI centre. The number of MDAE in our prospective study was lower than a previous study by Samore MH et al(2004), who detected 552 MDAE over 9 months [19]. However, their study was based on computer-flag-based surveillance while our study was based on spontaneous reporting approach. In our prospective study, we identified low to moderate risk devices (Class B) as being responsible for the majority (66%) of adverse events, followed by moderate to high risk (Class C,24%) and high risk (Class D,8% ) devices. But, in our retrospective study, it was found that class C& D devices were associated with all the adverse events. The disparity may be due to the adverse event by Class B devices which are not commonly recorded in patient's case files and nurses reported most of MDAE in the prospective study (65%).
We found that the majority (74%) of MDAE were non-serious, while a quarter (26%) resulted in serious consequences, including death. But these findings were inconsistent with the MvPI study, which indicate that majority (66.1%) of reported cases to MvPI were serious adverse events. This may be due to stakeholder's preference to report merely serious adverse events to MvPI. Further, the incidences of SAEs were equally prevalent among Class B (33%), C (34%) & D (33%) devices and higher in non-notified (60.4%) medical devices. So we recommend bringing all the devices under the purview of the notified list, irrespective of risk class as early as possible.
In the prospective study, the devices associated with frequent MDAE were PPE kits (25.89%), followed by Kojak syringe (16.07 %) and infusion pumps (14.73%). Since the prospective study was conducted during the Covid-19 pandemic there is an increased reporting of AE associated with PPE. Furthermore, AE correlated with PPE have a significant impact on the health of health care professionals, and their experience of monitoring and reporting MDAE may have contributed to increased reporting of AE with PPE. This coincidental result indicates that improved recognition of medical device adverse events by recipients (patients) would aid in the early detection and reporting of MDAE. A study by Kavanagh et al (2019) found patients and their relatives were the most frequent submitter of reports directly to the US FDA manufacturer and user facility device experience (MAUDE) database[20]. So, Indian regulatory agencies should extend post-marketing monitoring to recipients (patients) rather than limiting it to healthcare professionals. Another study by Samore et al(2004) found foleys catheters (57%) and arterial catheters were the devices most commonly associated with MDAE in their study[19]. However, in the present study, no cases with these devices were reported. But a study by Gagliardi et al(2017) showed that infusion pumps are the most common device associated with priority 1 recall in Canada[21]. Conversely to prospective study, in the retrospective study, it was found that orthopaedic implants were responsible for almost half (49.1%) of the adverse events followed by Copper T (28 %) and then by Intra Ocular Lenses (22.9 %). However, no adverse events associated with these devices were reported during the prospective study period. Since adverse events associated with these devices are primarily detected by treating clinicians, especially by surgeons, there is an urgent need to promote MDAE reporting behaviour among surgeons in our country. And also the pattern of MDAE will be influenced by which professional category reports more MDAE.
All the patients who have been exposed to medical devices, regardless of age or gender, are at risk for MDAE, since we found the incidence of MDAE in adults (85%) including the elderly population (6.9%) and children (15%) including infants (7.5%). The age group of 21 to 30 years has the highest prevalence of MDAE in both retrospective (23.2%) and prospective studies (19.1%). Male patients outnumbered females in both studies. (RS: M=52%, F=48%. PS: M=57%, F=43%). But this finding is contradictory to the findings of Peterson et al, who reported female patients are more likely than men to have procedure-related adverse events in-hospital[22]. The male sex predominance in our study may be attributed to the fact that the majority of admitted patients were male. The mean age of the patient population in the retrospective study was 41.8 years, while the mean age in the prospective study was 33.7 years.
The overall incidence of near-miss adverse events was 14%. Near-miss adverse events mean a patient is exposed to a potentially dangerous scenario but is spared from injury due to chance or early identification by the reporter. Further, most of the adverse events were reported among non-invasive devices (89%). So the regulators need to ensure the quality and safety of non-invasive material as well.
In this study, nurses reported the majority of adverse effects (65%), followed by doctors, a few by OT technicians and negligible reporting from biomedical engineers. A study by Kavanagh et al also found nurses report MDAE 2.77 times more often than doctors directly to the US FDA-MAUDE [20]. Another study by Shamim et al(2016), was also of the same opinion where the reporting of AE was found significantly more among nurses (P = 0.006)[23]. However, a study conducted by Alsohime et al(2019), among ICU nurses in Saudi Arabia found that even though 66% of nurses experienced medical device adverse events, only 2% of nurses reported it correctly to the existing national reporting system[24]. Therefore there are chances that the adverse events reported in this study might be an iceberg of the total medical device adverse events that originally occur. Currently, in the United States, it is mandatory for the manufacturers to report, while health providers can report voluntarily. In Spain, health care workers must report MDAE.
The present study also identified that more than one-third of (36.84%) SAE were caused by software-supported medical devices. A previous study by Gagliardi et al (2017) reported that software-supported medical devices (Laboratory software, diagnostic software, patient management software) caused recalls including priority-1 [21]. Therefore a separate surveillance system for software used in the health care field is a need of the hour.