Standard Operating Procedure (SOP) for safe implantation and removal of prosthesis/implants/devices

This includes the process for all custom made or patient specific implants, devices and or prosthesis.

• Definition
• Principle
• Process to follow when removing a device/implant or prosthesis in any procedure room or theatre
• Appendix 1 - Pathway to follow for custom made prosthesis implants or devices.
• Appendix 2 - Procedural document
• Appendix 3 - Custom made prosthesis / implant / device request form
• Appendix 4 - Annual audit form for SOP Implantable devices/implants/prosthesis

Definition

The National Safety Standards for Invasive Procedures defines a surgical prosthesis as:

“…an internal or external medical device for artificial replacement of an absent or impaired structure.”

Principle

The standard operating procedure (SOP) for implantable devices is written to ensure all devices, implants and prosthesis are implanted into a patient using a series of checks to ensure the patient receives the correct device, implant or prosthesis. In addition, this SOP also identifies a clear process for the removal of devices, implants and or prosthesis.

The team, including the operating clinician, will ensure that, on every single occasion we implant the correct type, size and manufacturer of any device, prosthesis or implant which is intended to be permanently or temporarily implanted into the correct site/side of the correct patient.

This procedure includes all prosthesis/implants and devices which are custom made and/or patient specific.

There are many different types of implant/prosthesis/devices used in each speciality throughout the Trust. It is essential that all members of the team are aware of the types of prosthesis/implants/prosthesis used within the specific specialty. Any team member who is required to open any package for a device, implant or prosthesis needs to be familiar with the product.

Knowledge of the properties of each implant is essential and the manufacturer’s instructions on how to handle them must be adhered to implicitly in all patients.

During implantation of any implant/prosthesis or device, an aseptic/sterile technique is essential to prevent the introduction of clinical infection.

All devices/implant or prosthesis packaging should contain the following information in order to ensure the correct item is being opened and passed to the operator.

The following information should be included in all parts of the device/implant or prosthesis packaging;

• Manufacturer
• Type/name
• Size
• Code number
• Batch number
• Sterilisation date
• Expiry date
• Name of component
• Size of the component

    This information will be the basis of the check prior to opening.

Custom made implants and prosthesis’ for a specific patient will be identified by the Patients NHS number only and where possible a company reference number. This is sometimes difficult as the manufacturers have different processes for the labelling of custom made implants. This is why there is a specific process for custom made implants.

The process for sterilisation of a custom made prosthesis is described in Appendix 1.  This appendix should be followed for all custom made prosthesis or implants.

Prior to sending the implant/device or prosthesis for decontamination and sterilisation, the B Braun Sterilog PD103 (patient specific devices request form) should be completed and the process followed on each occasion.  The form is attached as Appendix 2

B Braun Sterilog have a process which will be used for each individual custom made prosthesis to be processed. 

Deviation from this process may result in the prosthesis or implant to be lost or unusable.  By completing the necessary paper work and following these steps will ensure the prosthesis or implant will be available at the correct date and time for the named patient only.

Step by step guidance is included as Appendix 3 which should be printed and available as a reference of the process by each theatre team.

Custom made prosthesis, by speciality, requires an internal recording process to ensure there is a record of movement of the custom made implant or prosthesis. 

Clear documentation will enable a formal tracking of the item through all processes from ordering to sterilisation and ready to be used.

Process to follow when checking the device/implant or prosthesis in any procedure room or theatre.  

During team brief the team will;

Discuss the required manufacturer device, implant or prosthesis at the team brief prior to any patient being brought into the procedure room or theatre.

There will be a confirmation by the operator of the range of sizes required to be available.

During the operation or procedure, the circulator will;

STOP and CHECK

Prior to the package being opened, the following characteristics need to be checked;

• Component
• Size
• Laterality
• Manufacturer
• Dioptre for lens implant
• Compatibility of multiple component prosthesis

• There will be minimal noise in the procedure room and no interruptions allowed during any checking process.  Personnel should not change during the opening of the implant/device or prosthesis

• During the procedure the consultant will ask for the device/implant or prosthesis specific to be used by manufacturer, component and size.

• The scrub practitioner verbally requests the circulating person to present the implant/device or prosthesis implant as stated by the surgeon.

• The circulating person, before opening the implant, shows the package to the surgeon AND the scrub practitioner who will confirm that it is the correct component, size, type and manufacturer of device, implant or prosthesis required.

• The operator/surgeon MUST acknowledge and confirms the manufacturer, size and component of the prosthesis/implant/device as requested, prior to it being opened?
• If a custom made prosthesis the NHS number must be used for confirmation.

Where a custom made/bespoke patient specific  device, implant or prosthesis has been made and provided by a manufacturer, the surgeon must check it is the correct during team brief.

This will provide assurance to the whole team that the correct implant, by patient detail is ready and available. The standard checks will continue when the patient is in the procedure room/theatre.

Where a patient specific or custom made prosthesis, device or prosthesis there has been confirmation that it is the correct prosthesis/ implant/device and the correct patient, will the implant be opened.

Prior to opening, the circulating person will check;

• The integrity of the packaging
• Confirmation of sterility
• Expiry date

• The circulating person MUST record the details of the device, implant and or prosthesis to be placed in the patient’s notes and the theatre implant record.  

• Theatres and departments which have Scan4safety capability will scan each component along with the patient details/wrist band

• If scanning is not available, Identification product barcode stickers will be placed in the patients records, care plan and theatre implant book

• The National Joint register will be updated with the devices used, if applicable?

• The surgeon will record details of the implant/device or prosthesis inserted into the patient’s operation record.

Untoward events during any procedure using implantable devices must be escalated immediately, with the speciality team and theatre and anaesthetic CSU. 

Process to follow when removing a device/implant or prosthesis in any procedure room or theatre. 

On listing the patient for surgery for removal of radiopaque implants or devices:

The person listing the patient for surgery should ensure that there is an up to date xray demonstrating the full extent of the implant/device/prosthesis to be removed and this should be available in theatre.

During team brief the team will:

Discuss the items that are to be removed, expected amount of parts/screws etc... “Do we know what we are expecting to remove today and how many parts do we expect?”

If the amount of parts is not known this should be confirmed prior to the start of the procedure and noted in the team brief and sign in.

During the operation or procedure:

• There will be minimal noise in the procedure room and no interruptions allowed during any checking process.  Personnel should not change during the procedure.  If this is necessary then this should be documented in the theatre care plan.

• During the procedure the consultant will confirm what they have removed the implant/device/prosthesis from the patient verbally and visually with the scrub practitioner.

• If any implants/devices/prosthesis is intentionally retained the surgeon should communicate this to the scrub practitioner. This should be documented in the operation note by the surgeon. The scrub practitioner will document this in the theatre care plan.

Untoward events during any procedure involving implantable devices must be escalated immediately, to the speciality team and theatre and anaesthetic CSU and a datix completed. 

This SOP has been developed using information from a range of references.  Its aim is to develop a standard which contains steps to prevent harm to patients and can be used across LTHT theatres and departments where devices, implants and prosthesis are used.

Monitoring of the SOP

Instances of failed prosthesis verification, wrong prosthesis insertion and “near misses” should be reported on the Trust’s Incident Reporting System (Datix).

Appropriate action should be taken to record and escalate any issue identified.

This Standard Operating Procedure will be audited annually, Appendix 4.

The annual audit will provide assurance that the steps indicated in this SOP are followed to ensure a safe and equitable process for all implantable devices, prosthesis or implants whether they are custom made or off the shelf?

Any issues with the audit results should be raised at local speciality governance CSU meetings and the risk management team to raise awareness across the Trust.

Every member of every team is responsible for delivering safe care.