Overview – Critical processes for reprocessing

Overview – Critical processes for reprocessing

Practices need to establish and maintain a comprehensive, quality-assured process for reprocessing reusable medical devices. This includes validated procedures and monitoring systems to ensure every instrument is cleaned, disinfected, packaged, sterilised, stored, and used safely and effectively. These processes cover the following core elements:

• Managing documentation and records
• Appointing a reprocessing team and defining responsibilities
• Providing adequate resources, including skilled staff and proper facilities
• Controlling and monitoring services or products from external providers
• Ensuring reprocessed items are identifiable and traceable throughout the process
• Managing any nonconforming products
• Calibrating and maintaining reprocessing equipment and instruments.

A clear process is required for calibrating and performing preventive maintenance on all reprocessing equipment, including any testing instruments.

Quality assurance also includes implementing and maintaining a risk management process, using a structured risk-based approach for identifying, evaluating, and controlling hazards throughout the reprocessing cycle. Following the quality systems outlined below, the IPC Guidelines provide a risk-based approach for practices reprocessing reusable medical devices (see Risk-based approach).