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Health Edge Manual Tracking, Traceability and Quality Audit Trail Systems

Manual & Ultrasonic Washing Quality Audit Trail

The Manual and Ultrasonic Washing Quality Audit Trail system is designed specifically for use in surgical instrument decontamination units. This system enables the user to comply with medical device decontamination requirements when the instrument specification states that the item must be manually washed or ultrasonic cleaned. It also enables the user to track the manual washing and ultrasonic cleaning process for reusable medical devices that are unable to be exposed to an automated wash process.

System Features and Benefits

  • It provides a manual log for recording all medical devices processed
  • Processed date is recorded
  • Responsible operator is recorded
  • It provides a means of recording the wash method used
  • It provides a means of recording the detergent used

Washer Plus Quality Audit Trail

The Washer Plus Quality Audit Trail system is designed specifically for use in surgical instrument decontamination units. This system enables the user to track reusable medical devices through the automated wash process.

System Features and Benefits

  • Washable paper is utilised to identify each basket that is being processed
  • Washable paper is utilised to record all medical devices processed
  • Automated washer and washer cycle number are recorded
  • Processed date is recorded
  • It provides the user with a means of identifying the automated washer cycle type
  • It provides a means of recording quarantined items
  • It provides a means of recording items sent for repair
  • It provides a means of recording missing items
  • It provides a means of recording the cycle result (pass/fail)
  • Reason for failure can be recorded
  • Users are able to add the wash details onto the packing label
  • Responsible operator is recorded
  • Independent audit conducted by Health Edge who are ISO9001 accredited to provide traceability systems to the Health Service for the tracking of sterile instruments and the auditing of those systems

Gold Plus

The Gold Plus Quality Audit Trail system is designed specifically for use in surgical instrument decontamination units. This system enables the user to track reusable medical devices through the packing and sterilization process.

System Features and Benefits

  • Users are able to record the wash details onto the unique tray set or supplementary item packing label
  • Processed date is recorded
  • Responsible operator is recorded
  • Autoclave and autoclave cycle number are recorded
  • Shelf life date is recorded
  • It provides the user with a means of identifying the autoclave run type
  • It provides the user with a means of recording the number of items loaded into the steriliser and the number of items failed
  • It provides the user with a means of uniquely identifying a packed tray set or supplementary item
  • It provides the user with a means of accurately recording the sterilisation process for tray sets and/or supplementary items
  • Uses graphical symbols in line with BS EN 980 for the labelling of medical devices on batch release labels
  • Failed items and reason for failure can be recorded
  • It provides the user with a means of identifying which tray set and/or supplementary items were used on a patient and tracking back if required
  • Independent audit conducted by Health Edge who are ISO9001 accredited to provide traceability systems to the Health Service for the tracking of sterile instruments and the auditing of those systems

Scope Plus Quality Audit Trail

The Scope Plus Quality Audit Trail system is designed specifically for use in endoscope decontamination units. This system enables the user to track the decontamination of an endoscope through manual wash, automated reprocessing, storage and finally to use on a patient.

System Features and Benefits

  • It provides a means of recording the manual wash process
  • It provides a means of recording that the scope has been leak tested during manual wash
  • It provides a means of recording that the scope channels have been flushed and brushed during manual wash
  • It provides a means of recording the reprocessor run type
  • It provides a means of recording the reprocessor load details
  • It provides a means of recording the reprocessor cycle number
  • It provides a means of recording the reprocessor unload details
  • It provides a means of recording the cycle result (pass/fail)
  • Shelf life date and time can be recorded
  • It provides a means of recording patient details against a specific endoscope and tracking back if required
  • It provides a means of recording the storage method
  • It provides a means of recording the packaging method
  • It has a provision to retain the machine print out
  • Responsible operator is recorded
  • Independent audit conducted by Health Edge who are ISO9001 accredited to provide traceability systems to the Health Service for the tracking of sterile instruments and the auditing of those systems

Bench Top Plus Quality Audit Trail

The Bench Top Plus Quality Audit Trail system is designed specifically for use in surgical instrument decontamination units using bench top sterilisers. This system enables the user to track the decontamination of reusable medical devices through the wash and sterilization process.

System Features and Benefits

  • It provides a record specific to each sterilizer
  • Wash method can be recorded
  • Responsible operator is recorded
  • It provides the user with a means of identifying the cycle type
  • It provides the user with a means of recording the number of items loaded into the steriliser
  • Autoclave and autoclave cycle number are recorded
  • It provides a means of recording the cycle result (pass/fail)
  • It provides a means of clearly identifying when a tray set or supplementary item was sterilised
  • It provides the user with a means of identifying which tray set and/or supplementary items were used on a patient and tracking back if required
  • Independent audit conducted by Health Edge who are ISO9001 accredited to provide traceability systems to the Health Service for the tracking of sterile instruments and the auditing of those systems

Archive Retrieval System

The Archive Retrieval system has been designed to provide a history of the documents that have been archived, where they are stored and who was responsible for archiving them.

System Features and Benefits

  • It provides a manual log to identify which documents have been archived
  • It provides a means of identifying the location of the documents
  • It provides a means of recording the person responsible for archiving the documents
  • It provides a means of recording machine type and number
  • It provides a means of recording cycle from and cycle to dates
  • It provides a means of recording the person to contact for retrieval and their contact details
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