for Invasive Procedures (NatSSIPs)

OFFICIAL
4.10.2 DURING THE PROCEDURE
i. Before removal of the prosthesis from its packaging, the operator should confirm
the following prosthesis characteristics with the procedural team:
ii.
• Type, design, style or material.
• Size.
• Laterality.
• Manufacturer.
• Expiry date.
• Sterility.
• Dioptre for lens implants.
• Compatibility of multi-component prostheses.
• Any other required characteristics.
Once the correct prosthesis has been selected, any prostheses not to be used
for that patient should be clearly separated from the correct prosthesis to
minimise the risk of confusion between prostheses at the time of implantation.
4.10.3 AFTER THE PROCEDURE
i. A record of the implants used must be made in the patient’s notes and
appropriate details should be shared with the patient after the procedure.
When a manufacturer’s label is available, this should be placed in the notes.
When it is not, the following should be recorded:
• Manufacturer.
• Style.
• Size.
• Manufacturer’s unique identifier for the prosthesis, e.g. the serial
number.
ii. Compliance with local, national and international implant registries is
encouraged, and in certain cases may be a mandatory legal requirement.
iii.
iv.
The organisation must have a process in place for recording which prostheses
are used for which patients.
The organisation must ensure that appropriate and agreed stock levels of
prostheses are maintained.
v. Instances of failed prosthesis verification, wrong prosthesis insertion and “near
misses” should be reported, recorded and openly discussed at the debriefing,
and fed into local governance processes to act as the basis for learning and
the development of new or altered procedures to promote patient safety.
vi.
vii.
Audit of prosthesis verification data must be performed.
When manufacturers’ labelling, packaging or implant defects contribute to
failure of prosthesis verification, a process must be in place through which
both the manufacturers and the MHRA (Devices) are informed.
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