Medication Safety Alert
Medication Safety Alert 1 / 16 page 1 of 2
Issued by Medicines and Technology Programs,SA Health
www.sahealth.sa.gov.au/medicationsafety
Medications on the sterile field
Background
A patient Safety
Alert advises of
safety matters
needing immediate
attention and
mandatory action to
address high risk
safety problems.
We recommend
you inform:










Operating Theatres
Procedural suites
General Managers
Pharmacy Directors
Medical Directors
Nursing/Midwifery
Directors
Drug & Therapeutic
Committees
Medication safety
Committees
Safety and Quality
Units
Clinical Departmental
Managers
There have been recent incidents reported whereby non-sterile containers of medications
have been placed onto the sterile field for surgical procedures. This has been due to
confusion about whether the outside of the medicine container was sterile.
The placement of non-sterile medicine containers within the sterile field increases the risk of
infection.
For injectable products:
o the medicine and/or fluid inside the primary container (ie the syringe, bag, vial
ampoule) is sterile;
o in most cases, the outside of the primary container, is NOT sterile;
o any outer packaging e.g. covering bags are NOT sterile.
Labelling of medicines used on the sterile field can lead to confusion regarding the sterility of
the container as opposed to the sterile medicine and/or fluid contained within. The following
examples are provided for clarity around sterility of products.
1. Sterile medicine or fluid ONLY
Confusion may occur when products are
labelled as ‘sterile’ e.g.
1a) Intravenous fluid bags

The outer plastic bag acts as a ‘cover’ to
protect the inner bag and is NOT sterile.

The outside of the inner bag is NOT
sterile.

The IV fluid or medicine inside the inner
bag is sterile.
Contact details:
1b) Pre–filled medicine syringes
T: (08) 8204 1944
F: (08) 8463 5540
June 2016

The outer yellow bag acts as a ‘cover’ to
protect the syringe and is NOT sterile.

The outside of the syringe is NOT sterile.

The contents of the syringe are sterile.
Medication Safety Alert
Medication Safety Alert 1 / 16 page 2 of 2
Issued by Medicines and Technology Programs,SA Health
www.sahealth.sa.gov.au/medicationsafety
2. Sterile Contents and Primary Container
Some products are specifically manufactured for
use on sterile fields. These have labelling to indicate
sterility of the primary container.
e.g. Bupivacaine Injection 0.5%
A patient Safety
Alert advises of
safety matters
needing immediate
attention and
mandatory action to
address high risk
safety problems.

The outer plastic packaging is NOT sterile.

The outside of the vial is sterile (until the outer
plastic packaging is removed).

The contents of the vial are sterile.
In this case, the vial may be placed into the sterile
field once the outer plastic packaging has been
removed.
Action required by health professionals
We recommend
you inform:
1.
Be aware of potential confusion with the wording ‘sterile’ on medicine and fluid labels
which may refer to the internal contents and not the primary container or outer
packaging.






2.
Unless the product is clearly labelled to indicate that the primary container is sterile –
ALWAYS ASSUME IT IS NOT STERILE.
3.
Seek written advice from SA Pharmacy sites if there is uncertainty regarding the
sterility of medicine or fluid containers that are intended for use within the sterile field.




Operating Theatres
Procedural suites
General Managers
Pharmacy Directors
Medical Directors
Nursing/Midwifery
Directors
Drug & Therapeutic
Committees
Medication safety
Committees
Safety and Quality
Units
Clinical Departmental
Managers
Contact details:
T: (08) 8204 1944
F: (08) 8463 5540
Action required by SA Health services
1. Review current practice for all medicines and fluids placed onto sterile fields to assess
the sterility of all containers.
2. Ensure recommendations and actions are consistent across all sites/areas within Local
Health Networks
3. Ensure that all staff are aware of the risk associated with the use of non-sterile
medicine containers on sterile fields.
Notification of Compliance
Safety Alert Broadcast System Officers are to:
1.
Immediately confirm receipt of this alert by email to [email protected]
2.
Circulate this information to all clinical areas and those recommended on this alert within
24 hrs of receipt.
3.
Please ensure actions required by SA Health Services in this alert are confirmed and
reported back via email to [email protected] to be received by 22 June 2016. A
reporting template has been issued with this alert.
June 2016