Quality standard

Quality statement 4: Preventing implant selection errors

Quality statement 4: Preventing implant selection errors

Quality statement

Adults having hip, knee or shoulder replacement have 2 'stop moments' during surgery so that implant details and the compatibility of all components can be checked.

Rationale

During surgery, healthcare professionals carry out sequential checks of implant details. The first check enables them to confirm whether the correct implant is about to be inserted and verify whether the implant components are compatible. The second 'stop moment' also provides the opportunity to identify and potentially correct implant selection errors before the end of the operation.

Quality measures

The following measures can be used to assess the quality of care or service provision specified in the statement. They are examples of how the statement can be measured, and can be adapted and used flexibly.

Structure

Evidence of surgical protocols which include 2 'stop moments' for predefined and systematic checks, during intraoperative formal 'time outs', to confirm that implant details are correct and all components are compatible.

Data source: No routinely collected national data for this measure has been identified. Data can be collected from information recorded locally by provider organisations, for example, from surgical protocols and local surgical safety standards for invasive procedures which align with the Centre for Perioperative Care's (2023) National safety standards for invasive procedures (NatSSIPs 2), full version ('implant verification').

Process

Proportion of hip, knee or shoulder replacement operations during which there are 2 'stop moments' to check implant details and the compatibility of all components.

Numerator – the number in the denominator during which there are 2 'stop moments' to check implant details and the compatibility of all components.

Denominator – the number of hip, knee or shoulder replacement operations.

Data source: No routinely collected national data for this measure has been identified. Data can be collected from information recorded locally by provider organisations, for example, completed surgical checklists.

Outcome

The proportion of hip, knee or shoulder replacement operations during which an incorrect implant (wrong side or size) or incompatible components have been inserted.

Numerator – the number in the denominator during which an incorrect implant (wrong side or size) or incompatible components have been inserted.

Denominator – the number of hip, knee or shoulder replacement operations.

Data source: The National Joint Registry (NJR) records details of the final implants used. Data can be collected from information recorded locally for implant selection errors that were corrected during hip, knee or shoulder replacement operations, for example, from hospital records. Data can be collected from information recorded locally on compatibility mismatches for partial knee or shoulder replacements, for example, from hospital records.

What the quality statement means for different audiences

Service providers (secondary care services) ensure that they have effective surgical protocols to support carrying out and documenting 2 'stop moments' during surgery to check implant details and the compatibility of all components. They monitor cases of failed implant verification, wrong implant insertion and 'near misses' which occur during hip, knee or shoulder replacement operations, and report them locally and to national reporting systems.

Healthcare practitioners (surgeons and operating theatre staff) carry out and document 2 'stop moments' during surgery in which they check implant details and the compatibility of all components. The first check takes place every time an implant component is inserted and may occur more than once, depending on the type of joint replacement implant used. The second involves a final check of the compatibility of components before wound closure and provides an opportunity to identify and correct implant selection errors before the operation finishes. They report cases of failed implant verification, wrong implant insertion and 'near misses' locally and to national reporting systems.

Commissioners ensure that they commission services from providers who have protocols in place for carrying out and documenting 2 'stop moments' during surgery to check implant details and the compatibility of all components. They report and monitor cases of failed implant verification, wrong implant insertion and 'near misses' during hip, knee or shoulder replacement operations, along with monitoring existing safety checks.

Adults having hip, knee or shoulder replacement are cared for by healthcare professionals who stop twice during the operation to check that the correct implants have been used before the operation finishes.

Definitions of terms used in this quality statement

2 'stop moments'

These refer to 2 different checks, and are done at different stages of the operation. 'Stop moments' are formal 'time outs' in which all staff stop other actions.

The number of checks will vary according to the procedure and implants used.

The first 'stop moment' consists of a series of predefined and systematic checks each time an implant is inserted. Dependent on the context, when the operator requests the implant, it may be appropriate for the runner (or another team member) to write down the requested implant on the whiteboard (or on paper). The runner obtains the implant and shows it to the operator, who reads aloud the details:

  • type of implant

  • laterality

  • size (all relevant dimensions)

  • expiry date

  • sterility.

If the implant is custom made, the patient's name, date of birth and another identifier (NHS number or hospital number) should be cross-checked with the patient's identity band.

The runner opens the implant and the operator receives it. All packaging is kept. Labels are placed in the theatre record and patient notes (or electronic equivalent).

If there are subsequent implants (including screws), the same process is followed and, in addition, the operator should check:

  • compatibility with the previous implant

  • any other information (such as size).

The operator is defined as the surgeon, or any other healthcare professional or practitioner, performing the joint replacement. The NJR's Implant Scanning Interface can be used before implantation to provide a real-time alert on incorrect implants (size or side) or component incompatibility during hip or total knee replacements.

The second 'stop moment' is done before wound closure. It consists of an overall final check of the compatibility of implant components. The second 'stop moment' also provides a final opportunity to identify and potentially correct implant selection errors before the operation is completed. [Adapted from NICE's guideline on joint replacement (primary), recommendations 1.6.1 and 1.6.2 and the Centre for Perioperative Care's NatSSIPs 2, full version: 'During the procedure', implant verification chapter pages 44 to 45 and terminology]