Assessment of adverse events associated with medical devices among respiratory disorder patients at a tertiary care hospital

Materials & Methods

Results

During the study period, 90 individuals experienced 152 MDAEs, with men [60 (66.7%)] making up the majority of the reports, and elderly adult participants between the ages of 61-70 yr experienced the majority of MDAEs [20 (22.2%)]. Most adverse events occurred in the respiratory intensive care unit (RICU) [41 (45.6%)], followed by the medical intensive care unit (MICU) [32 (35.5%)]. All the medical devices were sterile [152 (100%)], of which 95.3 per cent were therapeutic, 76.9 per cent were reusable devices, and non-implantable devices accounted for 75 per cent.

The most common MDAE reported was VAP due to mechanical ventilator [59 (38.8%)], which is an invasive and non-implantable device, and the second most frequently encountered MDAE reported was respiratory distress with non-invasive ventilator (NIV) [30 (19.7%)]. The incidence of MDs causing adverse events has been depicted in table II.

The intermittent pneumatic compression (IPC) device risk classification guidelines, which were released in the guidance document version 1.2, served as the basis for adapting the device risk classification. The majority [106 (69.7%)] of the devices that were thought to be responsible for the majority of MDAEs were from the moderate-to-high-hazard category C of the risk categorisation. Conversely, category A devices, or low-hazard devices, were responsible for 7 (4.6%) occurrences, as presented in figure 1.

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Fig. 1.

Categorization of device risk. Here, category A represents a small portion of the chart; category B represents 25.6 per cent of the total and category C represents the largest portion.

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Of the recorded MDAEs, 84 (55%) were classified as probable, 65 (42%) as possible, and three per cent were considered doubtful in the causality evaluation. Almost all of the adverse incidents [71 (46.7%)] were the result of device-related errors like mechanical bed-related back pain and bed sores, cuff leak in endotracheal tubes, and adverse events caused by opportunistic infection [58 (38.1%)] such as urinary catheter-related pneumonia and ventilator-associated urinary tract infection and procedural errors were the type of events that were suspected of being caused by administration-related errors [19 (12.5%)] and miscellaneous error [4 (2.63%)] in which either type caused the events. Figure 2 illustrates the types of MDAEs reported.

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Fig. 2.

Type of MDAE.

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The seriousness of the events was classified based on reasons like death, life-threatening, disability, hospitalisation, or the event requiring preventive intervention. Of the MDAEs, 78 per cent were non-serious, and 23 per cent were severe. Among the total 152 medical devices involved in adverse events, almost all MDAEs [71 (46.7%)] were device /design-related errors, and device disposition within healthcare facilities was 96 (63.2%). At the same time, 27 (17.8%) of the devices were destroyed. Of the 152 MDAEs, subjects could recover from 141 (92.7%) adverse events.

The chi-square analysis showed no significant relationship between gender for most patient characteristics. The P value for age was 0.2, indicating no significant difference between males and females. In comorbidities, females had a higher percentage (P values was 0.04), so it was significant. Similarly, the length of stay and ICU specialty did not differ much between males and females, as the P-values were more than 0.05. Furthermore, males had more polypharmacy, which was statistically significant (P=0.04), as depicted in table III.

Discussion

Healthcare devices are crucial for the healthcare system, saving lives, and offering therapeutic benefits. However, they can also lead to potential adverse effects, including unexpected events or outcomes⁷. Materiovigilance helps improve the quality of medical devices and the safety of users by reporting problems and enabling the removal of unsafe products from the market. There are several studies conducted on devices and their adverse events for all in-patients, but there are only limited published studies on MDAE amongst respiratory disorder patients^8,9. Hence, in this cross-sectional study, the main goal was to assess the pattern of adverse medical device events. This study also discussed predictors of MDAEs.

In the current study, ventilator-associated pneumonia (VAP) was the most prevalent cause of MDAEs (38.8%), followed by non-invasive ventilator-associated respiratory distress (19.7%). Similarly, Weinberger et al¹⁰ reported a high incidence of VAP among COVID-19 patients on ventilators, highlighting the need for infection control measures. This type of pneumonia can primarily result from prolonged mechanical ventilation and extended hospital stays, which has a ripple effect on hospital-acquired infections¹⁰.

In this study it was observed pneumothorax was observed in 2.2 per cent of the study participants undergoing prolonged mechanical ventilation. Correspondingly, Taha et al¹¹ reported that 10 per cent of critically ill COVID-19 patients on ventilators developed pneumothorax, particularly those requiring prolonged mechanical ventilation and vasopressor support¹¹. Our lower incidence suggests that strict ventilator management protocols and timely monitoring may help reduce the risk of pneumothorax in ICU patients.

Among the observed endotracheal tube associated adverse events, including tachypnoea (3.3%), bleeding (5.5%), and aspiration, were comparable to findings by Jaber et al¹², who reported bleeding (3.4%) and aspiration (2.6%). These findings emphasise the importance of proper airway management and close monitoring.

NIV and Respiratory Distress were reported in 20 per cent of our study cases, with no reintubation cases. In contrast, De Jong et al¹³ found a 14 per cent reintubation rate and six per cent mortality, suggesting that patient selection and tolerance may differ between studies.

In the current study, BiPAP device discomfort was noted in 2.2 per cent of the participants but did not lead to worsening vital signs. In line with this, Lin et al¹⁴ reported BiPAP intolerance due to neck pain. This correlation suggests improved mask fitting and patient comfort strategies could enhance BiPAP adherence¹⁴.

Catheter-associated urinary Tract Infections (CAUTIs) occurred in 15.5 per cent of cases in this study. In contrast, Mota et al¹⁵, who reported an 80.6 per cent CAUTI rate, a lower incidence in the present study suggests that strict aseptic techniques and infection control measures were effective.

In context of device-related errors vs. human errors this study found that most MDAEs were due to design-related errors (49.7%) and opportunistic infections (38.1%). In contrast, Beydon et al¹⁶ found that human errors (32%) were more common than device-related issues (60%), indicating that device design and user training play crucial roles in MDAE prevention.

In our study, most MDAEs were observed in the elderly adult population, particularly those aged 61-70 yr (22.2%). This aligns with findings from studies such as Griesdale et al¹⁷, where older individuals were at a higher risk. This situation likely stems from the inevitable physiological transformations of ageing, compounded by the prolonged reliance on mechanical ventilation¹⁷.

The analysis identified comorbidities in 54.5 per cent of the participants who experienced MDAEs, with (P=0.04). This intriguing finding resonates with the research conducted by Letvin et al¹⁸, which revealed that underlying health conditions like diabetes and hypertension significantly increased the risk of complications, including infections and procedural errors, attributed to the extended use of medical devices. This correlation underscores the importance of carefully monitoring and managing patients with multiple health issues to mitigate potential risks associated with device reliance¹⁸.

The duration of hospital stays emerged as a factor causing MDAE, with 24.5 per cent of participants remaining hospitalised for more than 22 days. However, this was not statistically significant (P=0.18). This extended period not only heightened their exposure to various medical devices but also increased the potential risk of developing infections, including VAP and cognitive impairment, as seen in the study by Patel et al¹⁹ (P=0.11), highlighting the critical link between prolonged hospitalisation and the likelihood of encountering such healthcare-associated infections.

Lastly, hyper-polypharmacy (≥10 medications) was observed in 55.5 per cent of the participants (P=0.04), contributing to increased MDAEs, similar to findings by Lin et al²⁰, where multiple medications, particularly sedatives and steroids, increased respiratory suppression and device dependence.

Our study observed a notably higher prevalence of MDAEs among the participants with comorbidities (P=0.04) and individuals with more than 10 medications (P=0.04). In this context, age and prolonged stays in the ICU could have influenced the occurrence of MDAE, however, this was not found to be statistically significant. These findings shed light on the critical need for rigorous monitoring and the implementation of proactive intervention strategies to reduce associated risks. However, it is important to note that only the more extended ICU stay and comorbidities were statistically significant factors in individuals who experienced MDAEs.

The primary limitation of this study was that the researchers did not follow up on the participants with a poor prognosis. Secondly, the study was conducted solely at one site and only in intensive care unit. Additionally, a more thorough root cause analysis was not performed. Thirdly, the study’s outcome may have been influenced by the limited number of available covariates, as unknown confounders could have affected the results.

In conclusion, although this study only looked at a small portion of adverse events brought on by medical devices, it underlines the patterns and predictors of MDAE in individuals with respiratory disorder. If an adverse event goes untreated or the patient continues using the faulty medical device, the consequences can be severe. A MDAE has the potential to be life-threatening, extending the duration of critically ill individual’s hospital stay, or even lead to fatal outcomes. It is crucial to address these events promptly to mitigate risks and ensure patient safety.