Mr Roel Castillo1, Miss Laura Johnston2
1Southern NSW LHD, Australia, 2Nanosonics, Sydney, Australia
Biography:
Roel has been in healthcare for 23 years and lead CSSD teams in the last 17 years. Currently the District Manager for Sterilising Services at Southern NSW LHD. Holds an MPH and is pursuing HDR. He works collaboratively between with the Academic and Sterilising Industry on medical device reprocessing safety.
Abstract:
Introduction
Endoscopes are widely used medical devices with high potential to become contaminated during use. The Therapeutic Goods Administration (TGA) monitors the safety of medical devices using adverse event reports recorded in the Database of Adverse Event Notifications (DAEN). This analysis reviewed the pattern and type of adverse events related to endoscopes recorded on the DAEN.
Methods
The DAEN was searched for relevant keywords (colonoscope, gastroscope, duodenoscope, bronchoscope, cystoscope) using the date range 1 July 2012 – 31 December 2024. The list of reports was converted to Excel Version 2502. The reports were grouped by type of endoscope, year, and event description. The number and percentage of AEs related to contamination of the endoscope or transfer of material such as tissue or clips between patients was calculated. The number of patient-to-patient transfers of tissues or infection was recorded by endoscope type.
Results
There were 401 adverse reports associated with endoscopes (238 in 2023-2024); of which 68% related to colonoscopes and 19% to gastroscopes. 336 (84%) reports were associated with either bacterial contamination or foreign material transfer between patients; 8 patient-to-patient transfers of tissues and 2 patient-to-patient transfers of infection (1 colonoscope transfer of pseudomonas, 1 bronchoscope transfer of fusarium) were reported.
Conclusion
The DAEN shows a number of adverse event reports associated with endoscopes, with colonoscopes being the most commonly involved device. A significant proportion of incidents were linked to bacterial contamination. Further research is required to identify potential causes.