Safe implantation of prosthesis/implants/devices - Standard Operating Procedure ( SOP )

Publication: 24/07/2014  --
Last review: 02/09/2019  
Next review: 02/09/2022  
Standard Operating Procedure
CURRENT 
ID: 3913 
Approved By: Trust Clinical Guidelines Group 
Copyright© Leeds Teaching Hospitals NHS Trust 2019  

 

This Standard Operating Procedure is intended for use by healthcare professionals within Leeds unless otherwise stated.
For healthcare professionals in other trusts, please ensure that you consult relevant local and national guidance.

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

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

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,  use 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.

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 (to 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. 

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.

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

Appendix 1

Appendix 2

Appendix 3


Appendix 4

Instructions.

Please audit a minimum of 4 patients to establish if the SOP for implantable devices, implants or prosthesis has been followed?


Question

1

2

3

4

Is the flow chart for the SOP implantable devices visible in theatre?

 

 

 

 

Does staff know where to access the policy?

 

 

 

 

Is there an implantable devices record book available in each theatre speciality?

 

 

 

 

When checking a device, implant or prosthesis is there an audible and visual check between the theatre team prior to opening?

 

 

 

 

Are the required implantable devices, implants or prosthesis discussed at team brief?

 

 

 

 


Please discuss the audit findings at your local CSU governance group.  
Areas of poor practice will require an action plan to rectify and re audit within 6 weeks.

Provenance

Record: 3913
Objective:
Clinical condition:
Target patient group:
Target professional group(s): Allied Health Professionals
Secondary Care Doctors
Secondary Care Nurses
Adapted from:

Evidence base

National Safety Standards for Invasive Procedures.  NHS England   September 2015

Association for Perioperative Practice (AfPP) Standards and recommendations for practice 2017

Healthcare safety investigation branch.
Investigation into the wrong prosthesis during joint replacement surgery. 2018.

Approved By

Trust Clinical Guidelines Group

Document history

LHP version 1.0

Related information

Not supplied

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