Standard 3: Healthcare Associated Infection

Reprocessing of reusable medical devices

Action 3.14

Where reusable equipment, instruments and devices are used, the health service organisation has:

a. Processes for reprocessing that are consistent with relevant national and international standards, in conjunction with manufacturers’ guidelines

b. A traceability process for critical and semi-critical equipment, instruments and devices that is capable of identifying

  • the patient
  • the procedure
  • the reusable equipment, instruments and devices that were used for the procedure

Intent

Where reusable equipment, instruments and devices are used, the health service organisation minimises infection risks to patients and the workforce by ensuring adequate identification of, and procedures for reprocessing, reusable medical equipment.

Reflective questions

What processes are in place to ensure that reprocessing of reusable medical devices follows relevant national standards and manufacturers’ instructions?

How does the health service organisation identify the patients, procedures, and reusable equipment, instruments and devices used during a procedure?

Key tasks

  • Identify the organisation’s need for reusable critical and semi-critical equipment, instruments and devices.

  • Review the organisation’s infrastructure for reprocessing services and workforce capacity to reprocess reusable instruments, equipment and medical devices.

  • Review policies, procedures and protocols used in sterilising services for reprocessing of reusable medical devices, instruments and equipment.

  • Review policies, procedures and protocols for decontamination of reusable medical devices at the point of use before reprocessing.

  • Review the methods used to reprocess reusable equipment, instruments and devices to ensure these processes are consistent with relevant national and international standards.

  • Implement or review processes for traceability or tracking of critical and semi-critical equipment, instruments and devices, and assess the processes’ ability to identify the patient, the procedure, and the equipment, instrument or device that was used for the procedure.

Strategies for improvement

Hospitals

Identify requirements and processes

Identify the organisation’s requirements for reusable equipment, instruments and devices (and associated consumables) as part of the organisational risk assessment.

Identify the organisation’s infrastructure and workforce capacity to safely reprocess reusable equipment, instruments and devices.

If reusable equipment, instruments and devices are required, assess the processes used to provide appropriately reprocessed items to the workforce and patients, and ensure that these processes are covered in the organisation’s policies, procedures and protocols. Questions to consider include:

  • Does the organisation have the facilities and ability to reprocess the required reusable medical equipment, instruments and devices?
  • Can sterilising services be centralised where there are several health service organisations under one administration?
  • Are specialised reprocessing techniques required for some reusable medical devices (for example, low-temperature sterilisation, ethylene oxide) and are processes in place to achieve this?
  • Should the organisation purchase commercial, pre-sterilised single-use items to meet its needs?
  • Could an external sterilising service be contracted to provide reprocessing services for critical or semi-critical equipment, instruments or devices?
  • If services are contracted, are contract development, documentation and record keeping conducted in consultation with key groups, including
    • sterilising services manager
    • hospital theatre manager or endoscopy unit manager
    • infection prevention and control
    • corporate services
    • governance.

Review policies, procedures, protocols and systems

Develop or review policies, procedures and protocols that are consistent with relevant national or international standards to cover:

  • Governance responsibility for the sterilising service
  • Infrastructure, including
    • enough dedicated space for all required steps for reprocessing
    • reprocessing equipment requirements and replacement schedules
    • appropriate storage to maintain the integrity of reprocessed equipment, instruments and devices before use, in all areas where they are stored
    • decontamination and safe packaging for transporting reusable equipment, instruments and devices from clinical areas that may be located away from the sterilising services (for example, wards, interventional radiology, outpatient clinics, other facilities)
  • Quality improvement systems, which should include
    • appropriate storage requirements for reusable medical equipment, instruments and devices
    • a fault or variance reporting process that includes responsibility, actions and risk management strategies
    • document control and record-keeping processes that allow data to be retrieved at any time
    • environmental controls, including water quality, air handling, access, maintenance schedules and cleaning activities
    • consumables, including packaging materials and personal protective equipment
    • suitably trained members of the workforce who are available in sterilising services, and wherever decontamination of used reusable equipment, instruments or devices is undertaken.

Use incident management and investigation system to report any incidents relating to the reprocessing of reusable equipment, instruments and devices. Review the incident management and investigation system in the organisation to identify any variation between practice and policy, procedure or protocol, and act to rectify the risks.

Review systems for identification and tracking

Review the existing quality improvement systems used to identify and track reusable equipment, instruments and devices during reprocessing and use. Consider how the following are identified:

  • Batch numbers
  • Individual items or sets of items
  • Patients
  • Date of reprocessing
  • Type of reprocessing undertaken
  • Identification details of the steriliser or disinfector used
  • Process cycle details
  • Results of chemical and biological monitoring undertaken
  • Operator responsible for the reprocessing and release of the items for use
  • Documentation, quality monitoring and tracking or traceability systems for reusable equipment, instruments and devices received from an external provider (for example, loan sets, clinicians’ own reusable medical devices).

Evaluate the quality improvement systems used to identify and track reusable equipment, instruments and devices to check that processes are adequate to identify any items and affected patients in the event of a fault or recall.

Day Procedure Services

Identify requirements and processes

Identify the organisation’s requirements for reusable equipment, instruments and devices (and associated consumables) as part of the organisational risk assessment.

Identify the organisation’s infrastructure and workforce capacity to safely reprocess reusable equipment, instruments and devices. For day procedure services, reprocessing may be managed by the Local Hospital Network, state or territory health department, or private hospital ownership group.

If reusable equipment, instruments and devices are required, assess the processes used to provide appropriately reprocessed items to the workforce and patients, and ensure that these processes are covered in the organisation’s policies, procedures and protocols. Questions to consider include the following:

  • Does the organisation have the facilities and ability to reprocess the required reusable equipment, instruments and devices?
  • Can sterilising services be centralised (for example, if there are several day procedure services under one administration)?
  • Are specialised reprocessing techniques required for some reusable medical devices (for example, low-temperature sterilisation, ethylene oxide) and are processes in place to achieve this?
  • Should the organisation purchase commercial, pre-sterilised single-use items to meet its needs?
  • Could an external sterilising service be contracted to provide reprocessing services for critical or semi-critical equipment, instruments or devices?
  • If services are contracted, are contract development, documentation and record keeping conducted in consultation with key groups, including
    • sterilising services manager
    • hospital theatre manager or endoscopy unit manager
    • infection prevention and control
    • corporate services
    • governance?

Review policies, procedures, protocols and systems

Develop or review policies, procedures and protocols that are consistent with relevant national or international standards to cover:

  • Governance responsibility for the sterilising service
  • Infrastructure, including
    • enough dedicated space for all required steps for reprocessing
    • reprocessing equipment requirements and replacement schedules
    • appropriate storage to maintain the integrity of reprocessed equipment, instruments and devices before use, in all areas where they are stored
    • decontamination and safe packaging for transporting reusable equipment, instruments and devices from clinical areas that may be located away from the sterilising services (for example, interventional radiology, clinical procedure areas)
  • Quality improvement systems, which should include
    • appropriate storage requirements for reusable equipment, instruments and devices
    • a fault or variance reporting process that includes responsibility, actions and risk management strategies
    • document control and record-keeping processes that allow data to be retrieved at any time
    • environmental controls, including water quality, air handling, access, maintenance schedules and cleaning activities
    • consumables, including packaging materials and personal protective equipment
    • suitably trained members of the workforce who are available in sterilising services, and wherever decontamination of used reusable equipment, instruments or devices is undertaken.

Use incident management and investigation system to report any incidents relating to the reprocessing of reusable equipment, instruments and devices. Review the incident management and investigation system in the organisation to identify any variation between practice and policy, procedure or protocol, and act to rectify the risks.

Review systems for identification and tracking

Review the existing quality improvement systems used to identify and track reusable equipment, instruments and devices during reprocessing and use. Consider how the following are identified:

  • Batch numbers
  • Individual items or sets of items
  • Patients
  • Date of reprocessing
  • Type of reprocessing undertaken
  • Identification details of the steriliser or disinfector used
  • Process cycle details
  • Results of chemical and biological monitoring undertaken
  • Operator responsible for the reprocessing and release of items for use
  • Documentation, quality monitoring and tracking or traceability systems for reusable equipment, instruments and devices received from an external provider (for example, loan sets, clinicians’ own reusable medical devices).

Evaluate the quality improvement systems used to identify and track reusable equipment, instruments and devices to check that processes are adequate to identify any items and affected patients in the event of a fault or recall.

Examples of evidence

Select only examples currently in use:

  • Policy documents about reprocessing reusable equipment, instruments and devices
  • Policy documents about tracing critical and semi-critical reusable equipment, instruments and devices
  • List of critical and semi-critical equipment, instruments and devices used in the health service organisation
  • Committee and meeting records in which reprocessing and tracing of reusable equipment, instruments and devices were discussed
  • Audit results of the traceability system
  • Training documents for the workforce about reprocessing and tracing of reusable equipment, instruments and devices.
    MPS & Small Hospitals

    MPSs or small hospitals that are part of a local health network or private hospital group should adopt or adapt and use the established processes for reprocessing of reusable devices.

    Small hospitals that are not part of a local health network or private hospital group should:

    • Identify the organisation’s reusable critical and semi-critical equipment, instruments and devices to be reprocessed
    • Implement quality monitoring activities for critical and semi-critical equipment, instruments and devices that review storage and handling to maintain sterility
    • Review the organisation’s reprocessing services infrastructure and workforce capacity to reprocess reusable equipment, instruments and devices
    • Review policies, procedures and protocols used in sterilising services for reprocessing reusable equipment, instruments and devices
    • Review policies, procedures and protocols for decontamination of reusable medical devices at the point of use before reprocessing
    • Review the methods used to reprocess reusable equipment, instruments and devices to ensure that these processes are consistent with relevant national and international standards
    • Implement or review processes for traceability or tracking of critical and semi-critical equipment, instruments and devices, and assess the processes’ ability to identify the patient, the procedure, and the equipment, instrument or device that was used for the procedure.

    Questions to consider when determining process and need for reprocessing include:

    • Does the organisation have the facilities and ability to reprocess the required reusable medical equipment, instruments and devices?
    • Can sterilising services be centralised if there are several health service organisations under one administration?
    • Are specialised reprocessing techniques required for some devices (for example, low-temperature sterilisation, ethylene oxide) and are processes in place to achieve this?
    • Should the organisation purchase commercial pre-sterilised single-use items to meet its needs?
    • Could an external sterilising service be contracted to provide reprocessing services for critical or semi-critical equipment, instruments or devices?
    • If services are contracted, are contract development, documentation and record keeping conducted in consultation with key groups, including
      • sterilising services manager
      • hospital theatre manager or endoscopy unit manager
      • infection prevention and control
      • corporate services
      • governance?
    Last updated 28th May, 2018 at 12:59am
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