Surgical Instruments and replacement periods

How frequently should reusable medical devices be replaced ?

(An article in the series in which we write about interesting defect reports sent to SMTL from the Welsh NHS.)

Recently SMTL were sent a defect report regarding a rasp introducer. The device failed when in use by an orthopaedic surgeon during a total hip replacement, and had to be 'hammered out' by the surgeon from the femur.

After reporting to the manufacturer, a reply was received stating :

The returned device was found to conform to specification. The manufacturer further reports that the introducer appears to have fractured due to a fatigue fracture caused by an appropximate period of use of 5 years. I trust you find this information of interest.

We were definitely interested, and wrote to the supplier, asking them what the recommendation was regarding replacement of these devices, and whether this was stated in the IFU or packaging of the device.  The reply said:

The manufacturer states that the instrument is constructed of no materials that require a replacement period. they further state that the period of replacement is attributed to the frequency the instrument is used in procedures.

The packaging insert states:

PRECAUTIONS: "While rare, intra operative fracture or breaking of instruments can occur. Instruments which have experienced extensive use or excessive force are more susceptible to fracture. Instruments should be examined for wear, or damage, prior to surgery."

This raises the interesting question of what can be done to reduce the risk of instrument failure during surgery. Is instrument inspection by theatre or SSD staff able to detect damage which can lead to fracture ?  If not, the only viable alternative to 'wait and see if it breaks' would appear to be monitoring the number of uses and implementing a planned replacement policy based on the manufacturers recommendations. In this instance the manufacturer was reluctant to provide advice on replacement, and we accept that this is a difficult calculation.  If the advice is to replace too frequently, the manufacturer can be accused of profiteering, whereas if the advice is to replace less frequently they can be accused of putting patients at risk.

At present we have no advice to give, but it is an issue worth discussing both amongst SSD managers and surgical instrument manufacturers alike.


P. Phillips

Joomla Templates: from JoomlaShack