How long must annual and routine maintenance reports be kept on file?

The requirement to retain annual and routine maintenance reports for the lifetime of the equipment is grounded in the necessity for thorough documentation and accountability in sterile compounding environments. This practice ensures that all maintenance performed on the equipment can be traced back accurately for quality assurance, regulatory compliance, and safety evaluations. Keeping these reports for the entire lifetime of the equipment allows facilities to have a complete history of the equipment's performance and any issues that may have arisen over time.

This thorough documentation can be pivotal during inspections or audits, where demonstrating that all maintenance protocols have been followed properly can impact regulatory compliance evaluations. Additionally, in the event of malfunction or failure of the equipment, having an extensive maintenance history can aid in diagnosing problems and improving practices that enhance the longevity and safety of the equipment utilized in sterile processing.