ANZCA Bulletin June 2011 - Australian and New Zealand College of ...

Quality and safety
Acetazolamide
sodium
Phebra has informed the College the
supply of Glaumox (acetazolamide
sodium) is critically short, and has
advised normal supply could possibly
resume in October 2011. Acetazolamide
for Injection USP 500 mg (in the form of
a powder for injection) has been sourced
from a manufacturer in the US, this
product is approved by the FDA. This
product is not currently registered
in Australia.
Prior to use of this product please
ensure you discard the package insert
and refer only to the Australian
Product Information for Glaumox
available on the Phebra website
www.phebra.com or the TGA website
www.eds.tga.gov.au.
If you have any questions in relation
to this information, please contact the
Phebra sales representative or Customer
Service Department:
Vic, Tas, SA, NT: Gios Auteri
0458 096 318
Qld, NSW, WA: Vikki Pennington
0434 124 766
Phebra Customer Service: 1800 720 020
Warning
Esmolol Hydrochloride, concentrated
Injection Ampoule 2500mg in 10 mL.
This is a new product and Phebra
Company Ltd draw attention to the risk
of error as the drug presentation is 25
times the concentration of standard
Brevibloc, which preparation has
esmolol hydrochloride 100mg in 10 mL.
Extreme caution should be exercised by
all clinicians, pharmacists and nursing
staff if this formulation is to
be introduced to the hospital.
The ECRI Institute
The institute is a non-profit organisation
which issues alerts derived from
four sources: the ECRI International
Problem Reporting System, product
manufacturers, government agencies,
including the US Food and Drug
Administration and agencies in
Australia, Europe and the UK, as well as
reports from client hospitals.
It is recognised that some alerts may
only involve single or small numbers
of cases, there is no denominator to
provide incidence and there is not
always certainty about the regions
where the equipment is supplied. This
section of the Bulletin can only highlight
some of the alerts that may be relevant
and it is the responsibility of hospitals
to follow up with the manufacturers’
representatives if they have not already
been contacted.
The following alerts may be relevant to
Australia and New Zealand:
1. Maquet-SERVO-i and SERVOs
Ventilator Systems may malfunction
if employed during high dose
radiotherapy, with the potential for
hypoventilation and hypoxia. Maquet
states that there have been no reports
of patient injury as a result of this
problem.
2. Phillips Invivo-Expression Magnetic
Resonance Imaging Systems: The
display control unit may become
disengaged from the docking plate
due to the nuts falling off over time
and close scrutiny is recommended.
3. Spacelabs-Model 91387 Patient
Monitors: The circuit that supplies
backup power may be faulty and if
a power interruption occurs the 3
minute backup may not operate and
changes to alarms may be lost. If
power loss is >3 minutes the modules
will return to default settings which
Spacelabs states are considered safe
in most applications and the company
has not received any reports of
adverse outcomes.
4. Phillips-Microstream Infant/
Neonatal Filter Line and Vital Line
Breath Sampling H Sets. The airway
adaptor may contain fine plastic
strands which have the potential to
be dislodged and inhaled, and may
cause a local inflammatory response
or granuloma formation. Phillips
states that while the possibility of
a strand breaking free is high the
probability of patient harm is low.
5. Phillips HeartStart XL and HeartStart
MRx may transmit a message of “No
Shock Delivered” when there is high
transthoracic impedence. However the
message does not adequately describe
why the shock was not delivered,
which has the potential to delay
treatment. Transthoracic impedence
may be intrinsically high in some
patients but more commonly it is due
to the electrode pads being incorrectly
placed or insufficient pressure being
applied to the paddles.
Dr Patricia Mackay
Communications/Liaison Portfolio
National
Recommendations
for User-applied
Labelling of
Injectable Medicines,
Fluids and Lines
In August 2010, the Australian
Commission on Safety and Quality
in Health Care released a publication
entitled National Recommendations
for User-applied Labelling of Injectable
Medicines, Fluids and Lines. This
publication and related resources
have been endorsed by ANZCA and
are available at www.anzca.edu.au/
resources/endorsed.
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ANZCA Bulletin June 2011