Complexity and infections CHPSO reports suggest increased risk of infection with complex devices.
Initial reports suggest that, as medical devices become more complex, the risk of infection and intra-operative problems rise. Preliminary reports from member hospitals raise the possibility of increased infection risk with the use of complex medical equipment (e.g., robotic surgery devices).
While the reports do not provide sufficient information to draw conclusions, there are enough concerns related to reprocessing challenges to merit further investigation.
Nationally, there is growing awareness that device complexity has brought new risks both during and after procedures — during because of the number of instruments (and associated opportunities for mechanical failure) and the need for extensive training and experience to develop competency, and after due to the complexity of preparing devices for their next use.
The Federal Drug Administration (FDA) is currently working with manufacturers to improve device design and instructions specifically to improve reprocessing reliability. Device reprocessing, which several decades ago was fairly simple, has become highly technical and varied — device manufacturers often have different and sometimes contradictory requirements for disassembly and cleaning. Further complicating matters, manufacturers often use different names for common device parts. Instructions may be difficult to understand, remember and follow.