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.