Life cycle of reprocessing equipment, reusable medical devices and accessories

Life cycle of reprocessing equipment, reusable medical devices and accessories

The life cycle of reusable medical devices and their accessories spans from the determination of patient requirements, through design and development, purchasing, production, and calibration of monitoring and measuring devices. For devices already in use, the reprocessing stages (cleaning, packaging and sterilising) need to be risk assessed, validated, documented, and allocated to a relevant product family.

Purchasing

Procedures for purchasing the selected product are outlined in Table 10.4.

Table 10.4 Procedures for purchasing reusable medical devices

Identification and traceability of product

For semi-critical devices, practices need to maintain a tracking system that, at a minimum, enables identification of the individual cycle of the high-level disinfection system in which each device was processed.

Practices need to adopt a risk-based approach to traceability, ensuring that all semi-critical reusable medical devices, including complex devices stored after processing for later use, can be reliably tracked from disinfection to release for use.

Do not use colour-coded identification systems on reusable medical devices, such as coloured instrument tape, silicone rings, or adhesive labels. These can:

• detach during procedures, compromising patient safety
• trap microorganisms beneath the adhesive, interfering with effective reprocessing.

Where unique identification of a reusable medical device is required, high-quality etching methods, such as chemical or laser etching, are recommended. Engraving is not advised, as it can weaken the device and cause pitting.

In multi-practitioner or shared-use settings, devices such as forceps or scissors may be used by specific clinicians or require identification for:

• maintenance tracking
• practitioner preference
• procedural consistency
• reprocessing services provided to other practices.

In these cases, the practice needs to use identification methods that:

• are compatible with reprocessing requirements
• maintain traceability throughout the reprocessing cycle
• do not compromise patient safety.

Traceability records

To ensure effective traceability of reusable medical devices, practices need to record the following information for each sterilisation cycle:

• Date of sterilisation and sterilisation process cycle number
• Steriliser identification, for example unit number or code, if multiple sterilisers are in use
• Device identification – the name of the device or set of devices, and the number of items within the load
• Person accountable for loading the device into the steriliser
• Results of performance tests conducted prior to use, for example leak rate or functional checks
• Annual validation or as specified in the device instructions for use
• Sterilising agent details (where applicable), including batch number and expiry date
• Documented evidence that sterilisation parameters were met, for example a process record or printout (where applicable)
• Person accountable for releasing the device or sterilisation load.

Record-keeping:

Practices are encouraged to maintain electronic records for traceability wherever possible. Electronic systems offer greater reliability, accessibility, and auditability.

• Electronic records need to include processes to verify that all required conditions were met at the end of each cycle.
• Paper records, if used, must be legible, complete, and securely stored.
• Where paper records are used, practices are encouraged to scan or digitise them to support long-term retention and improve accessibility during audits or accreditation.
• Records must be retained for the period specified by the relevant State or Territory Health Department.

Patient-level traceability:

• Practices need to have a process to link each sterile item to the patient it was used on. This supports patient safety and allows for recall or investigation if reprocessing errors or infection risks are identified. Refer to criterion CG9.F in the Standards for general practices (6th edition).
• While non-critical devices do not require patient-level traceability, practices may choose to track their use if this supports consistency, quality monitoring, or workflow efficiency.

Labelling requirements:

• All packages need to be labelled with the load number and date.
• Labels do not need to be physically attached if the same information is reliably recorded in the patient’s electronic record or traceability system.
• Labels also allow tracking of the reprocessing method used for each device.

Action if information is missing:

• If traceability information is incomplete or incorrect, the reusable device needs to be reprocessed before use.

Control of monitoring and measuring equipment

Monitoring and measuring equipment needs to be:

• identified with its calibration status
• adjusted/re-adjusted as necessary
• protected from adjustments that would invalidate the measurement result
• protected from damage during handling, maintenance and storage.

If any equipment does not meet requirements, corrective action needs to be taken for both the faulty equipment and any affected products. A record of these actions needs to be kept.

Documentation

The annual calibration of all monitoring and measuring equipment needs to be performed by a competent person using measuring equipment that is traceable to international or national measurement standards.

A report is to be provided to the practice and needs to:

• be obtained from the competent person implementing calibration
• include calibration tests performed for each piece of monitoring and measuring equipment
• include the certification number of the calibration device used
• be kept and be readily accessible.