Ms Joe-anne Bendall1, Dr Kate Clezy, Dr Paul Curtis, Ms Amy Bisson, Ms Tracy Clarke, Ms Jane McArthur
1Clinical Excellence Commission, Haymarket, Australia
In October 2016 an issue was raised with the Clinical Excellence Commission (CEC) regarding a supply shortage of a brand of Povidone-Iodine (PVI) pre-operative skin antiseptic on NSW State Contract. The alternate product on contract was not registered with the TGA for use as a pre-operative skin antiseptic. A Safety Notice (SN011/16)) was distributed.
Feedback and concerns from the Safety Notice:
- PVI was not being used according to the manufacturer’s instructions and TGA registered indications (external use only or it is considered ‘off-label’)
- Non-sterile formulations of PVI were being used ‘off-label’ in sterile procedures, increasing the risk of HAIs
- Some PVI solutions are not TGA registered as a pre-operative surgical antiseptic but are being used for this purpose.
The CEC responded to the off-label use of PVI by undertaking an intraoperative PVI usage survey, literature review, authoring of a discussion paper and organisation of a multidisciplinary working party to explore the practice of off-label and the evidence to support the practice.
Survey results on the intraoperative use of PVI from clinicians across a NSW identified a significant amount of off-label use of PVI solution and a misunderstanding that all PVI is sterile. PVI use was predominantly during surgery and included:
- intra-cavity lavage
- wound irrigation e.g joint replacements
- soaking or rinsing of implantable items e.g. breast implants, hernia/gynaecological mesh and CVADs prior to insertion.
A second Safety Notice (005/17) was issued in April 2017 and CEC plan to evaluate the implementation of recommendations in August.
Joe-Anne Bendall has worked in various nursing, management and consultancy positions since 1977. Her infection control career commenced in 1990 and has enabled her to work in private and public hospitals, public health and NSW Ministry of Health.
Joe’s current role in the Clinical Excellence Commission enables her to use her passion for patient quality and safety.