Measurement, analysis and improvement
Identifying and managing nonconforming reusable medical devices
Reusable medical devices that do not meet required standards after cleaning, disinfection, sterilisation, packaging, handling, or storage need to be classified as nonconforming. Practices need to investigate each instance in accordance with their documented risk assessment and quality assurance procedures.
Examples of nonconforming devices include:
- devices that fail acceptance criteria after cleaning, disinfection, or sterilisation
- incorrectly wrapped or inadequately sealed items
- devices with damaged or opened sterile barrier systems
- wet packs or devices exposed to moisture post-processing
- items dropped or placed on contaminated surfaces after reprocessing
- devices with missing or defective batch control labels
- expired or non-functional devices
- devices with unclear or incomplete traceability.
Common causes of nonconformity may include:
- inadequate cleaning of reprocessing or storage areas
- exposure to moisture, incorrect temperature, sunlight, or pests
- use of inappropriate packaging materials or sealing methods
- mishandling during transport or storage.
Corrective actions need to include:
- identifying the nature and potential impact of the nonconformity (including staff concerns or complaints)
- implementing an action plan to address the issue, such as quarantining or recalling the device
- documenting all actions taken
- evaluating the effectiveness of corrective actions
- applying additional measures if needed to prevent recurrence.
⚠️ All nonconforming devices need to be quarantined and reprocessed before use. Practices must maintain records of nonconformities and corrective actions as part of their continuous improvement and accreditation processes.
Recall procedure
The practice needs to recall a reusable medical device in a timely manner if there is evidence of failure during the cleaning, disinfection, packaging or sterilisation processes, or during transport and storage of a reprocessed device.
Recall procedures need to:
- identify examples of situations where recall of a distributed reusable medical device is warranted
- emphasise that recall activities need to be performed in a timely manner
- identify the team member/s accountable for coordinating recall activities
- identify the team member/s to be notified in the event of recall within or outside of the facility
- identify the team member/s accountable for reporting on recall activities
- identify the critical information to be included in a recall notice, such as reusable medical device to be recalled, the reason for recall and the action to be taken by team members receiving the recall notice
- reconcile the quantity of reusable medical devices with the device distribution records.
The recall report needs to be completed in accordance with the practice policies. At a minimum it needs to include:
- identification of why a recall was necessary
- identification of the recalled reusable medical device and reconciliation of quantities of the recalled device with the device distribution records
- where applicable, identification of patients impacted by the recall activity and follow up action taken
- identification of the causes for the recall
- identification of corrective action taken in relation to the recall
- identification of the consequences of the recall, for example the cost and time of reprocessing a recalled reusable medical device, cost of replacing equipment, impact on surgical procedures and where applicable, the need for staff retraining
- recommendations to prevent a recurrence of the circumstances that led to the recall.
Preventive action
The potential causes of nonconformities – including those that result in recall – can be identified and addressed to prevent recurrence. At a minimum, preventive action needs to include:
- identification of potential causes of nonconformities or recall incidents
- development of an action plan to prevent recurrence
- documentation of actions taken to address identified risks
- evaluation of the effectiveness of preventive actions
- where applicable, implementation of additional measures to further reduce the risk of recurrence.