Adverse Effects of IV Cannula a Medical Device - Patient’s Perspective and Its Regulation in India

Abstract

Intravenous (IV) access is very common procedures performed in hospitals for administration of therapeutics. It has various complications some may be serious/life threatening. However, their incidences are often underestimated during treatment and reporting them to regulatory authorities. Reporting of adverse effects of them will help in development of better-quality devices to ensure better outcomes. Aims: The aim of this study was to document the various local complications of cannula and to identify the risk factors associated with it and reporting to regulatory authorities. Settings and Design: The study was carried out in seven hundred fifty and the period of study was 1 year. Methods and Material: Indication of IV access, site, size of IV cannula used, category of personnel involved as well as local complications at access site were documented. Statistical Analysis Used: Results analysed using SPSS software (IBM Inc). Frequency calculated as average and percentage. Chi‑square test was used for statistical significance. Results: Females, overweight, diabetics and smokers were found at more risk and some patients had serious complications. Conclusions: Our study shows that local complications of cannula are very common in more than fifty percent patients. Several risk factors are identified. However many of the complications are observed but none of them are being reported to regulatory authorities and investigated also none of the device has been recalled in India. Investigations and studies will help in development of better quality devices and improved reporting systems.