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Diana Shipp, Senior Project Officer, Australian Commission on Safety and Quality in Health Care delivered this presentation at the 2013 Operating Theatre Management conference in Sydney/Australia. The event offers attendees insights into the latest programs and practices being implemented across the country & key strategies and methods to help improve your skills and knowledge as a Theatre Manager. For more information, please visit www.healthcareconferences.com.au.
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Labelling of medicines and fluids on the perioperative sterile field 1
National Recommendations for User-applied Labelling of
Injectable Medicines, Fluids and Lines
Implementation in the perioperative setting
August 2013
Labelling of medicines and fluids on the perioperative sterile field 2
Labelling Recommendations Identification of injectable
medicines and fluids is a major
patient safety issue
A standardisation to identify
injectable medicines and fluids
removed from their original
packaging
Set of minimum requirements
Excludes anaesthetic drugs given
by syringe during anaesthesia
Mandated in Australia Nov 2010
and part of National Safety and
Quality Health Standards (NSQHS)
Labelling of medicines and fluids on the perioperative sterile field 3
Labelling Recommendations
Medicine administration consistent with ‘7 rights’ (wicks
RW and Wanzer L, AORN Journal 2011)
Right
patient
Right medicine
Right dose
Right route
Right time
Right indication
Right record
Medication errors Unintentional use of a wrong plan or failure to carry out a planned
action as intended
Trying to do right but getting it wrong
Trying harder may or may not be
successful
Processes and systems
intrinsically improve safety
Well-labelled syringes are more likely to have been prepared correctly
than poorly labelled or unlabelled syringes
Labelling of medicines and fluids on the perioperative sterile field 4
Labelling of medicines and fluids on the perioperative sterile field 5
Labelling Recommendations
Minimum requirements
All medicines and fluids removed from original packaging must be identifiable
All containers (e.g. bags and syringes) must be labelled on leaving the hands of the person preparing the medicine
Prepare and label one medicine at a time
Discard medicines or fluids in unlabelled containers
Perioperative setting - Case reports
A 69 year old woman died when she was injected with an antiseptic skin preparation fluid instead of contrast media
A patient died when glutaraldehyde was confused with spinal fluid and injected intrathecally
During angiography, a patient suffered a grand mal seizure after receiving lignocaine instead of contrast media
A seven year old boy died following elective surgery when mistakenly injected with adrenaline (1 in 1000) instead of lignocaine 1% and adrenaline 1 in 100,000, i.e. 100x the intended dose of adrenaline
Perioperative setting
Closed environment – a single patient with established identity (cf.
Open environment – more than one patient in the same area)
Multidisciplinary team – each member interacts with medication
use process in different ways and at different times
Patient transfer through multiple clinical areas and personnel
routinely perform multiple handoffs
Medications are transferred into a container system appropriate for
delivery to sterile field
Mixing, diluting multiple medications or solutions on the sterile field
is often time sensitive
Labelling of medicines and fluids on the perioperative sterile field 7
Safer use of injectable medicines in
perioperative setting
Performance Improvement Study – ‘scrub persons are likely to label medications and syringes more often and more accurately when pre-printed labels are provided’ (Jennings et al, AORN Journal 2007)
Provide pre-printed, sterile labels
Standardisation of user-applied labelling with minimum requirements
Purchase medicines in pre-filled, sterile, labelled syringes
Use commercially available applicators or swabs
Labelling of medicines and fluids on the perioperative sterile field 8
Labelling of medicines and fluids on the perioperative sterile field 9
Open environment
Bag and syringe labels
Labelling of medicines and fluids on the perioperative sterile field 10
Open environment
Bag and syringe labels
Labelling of medicines and fluids on the perioperative sterile field 11
Lines and catheters:
Route of administration
Labelling of medicines and fluids on the perioperative sterile field 12
Continuous infusion lines: Medicine
● Identify the medicine in lines dedicated continuous infusion lines
● Pre-printed line labels evaluated in ICUs
● Labels ‘fit for purpose’ and larger than anaesthetic labels
Labelling of medicines and fluids on the perioperative sterile field 13
Identifying target tissue/route of administration
Standard colours assist identification of target tissue/route of
administration
Target tissue Route of administration Colour
Intra-arterial Intra-arterial Red
Intravenous Intravenous Blue
Neural tissue Epidural / Intrathecal / Regional Yellow
Subcutaneous tissue Subcutaneous Beige
Miscellaneous Any other route not specified above Pink
Labelling of medicines and fluids on the perioperative sterile field 14
Discarding Content For all containers (bags, syringes, hollowware) discard
Any unlabelled container holding a fluid
Any container, where there is doubt over content
Any medicine remaining in a container at the end of a procedure
Labelling of medicines and fluids on the perioperative sterile field 15
Closed environment-Perioperative Setting 2 Labelling standardisations
ISO 2685:2008 (AS/NZS 4375:1996) for medicines in syringes used during anaesthesia.
• Colour coded for drug class
User-applied Labelling of Injectable Medicines, Fluids and Lines for all other situations in the perioperative environment
• Colour-coded for target tissue
Labelling of medicines and fluids on the perioperative sterile field 16
User-applied labelling of drugs in syringes in anaesthesia
ISO26825:2008 (AS/NZS4375:1996)
Labelling of medicines and fluids on the perioperative sterile field 17
User-applied labelling of drugs in syringes in anaesthesia
ISO26825:2008 (AS/NZS4375:1996)
Labelling of medicines and fluids on the perioperative sterile field 18
Perioperative sterile field
On the operating room sterile field use sterile abbreviated container labels
Or use sterile pre-printed labels with advantages
No sterile marker
Ready supply
Less time to select and apply
Use full container labels and check all remaining lines are labelled when the patient
moves into the open practice environment, e.g. PACU.
Labelling of medicines and fluids on the perioperative sterile field 19
Examples of pre-printed labels
(Calvary Wakefield Hospital)
Poster reproduced with kind permission of
Princess Alexandra Hospital, Woolloongabba, Queensland
Irrigations
Skin
Preparations
Heparin
Local Infiltration
without
Adrenaline
Local Infiltration
with
Adrenaline
Specialty specific
Labelling of medicines and fluids on the perioperative sterile field 21
Labelling of medicines and fluids on the perioperative sterile field 22
Example of pre-printed labels for
cardiac catheter laboratories
Labelling of medicines and fluids on the perioperative sterile field 23
Contrast media
Black text on white background with a brown (PMS 471) border
for contrast media.
Labelling is not required where contrast is decanted directly into a
high speed pump reserved solely for the purpose of contrast
injection.
Use the term ‘contrast’. Specifying contrast material by brand or
generic name(s) is unlikely to confer a benefit in the closed
practice environment of the operating room and may be
misleading.
Royal Australian and New Zealand College of Radiologists
(RANZCR) reviewing contrast labelling
in the Perioperative Setting • Standardised identification processes for medicines and fluids • Effectively implementing and communicating labelling strategies • How to overcome common process challenges – Open Discussion Diana Shipp, Senior Project Office, Australian Commission on Safety and Quality in Health Care
Drug class RGB colour PMS Examples of drugs
Induction agents Yellow Process Yellow Propofol, ketamine
Benzopdiazepines Orange 151 Diazepam, midazolam
Benzodiazepine antagonists
Orange with white diagonal stripes
Flumazenil
Muscle relaxants Flourescent red or warm red
Warm/Fluorescent red/ 811
Suxamethonium, pancuronium
Relaxant reversal agents
W/Flour red with stripes
Neostigmine, pyridostigmine
Opioids Blue 297 Morphine, fentanyl, pethidine
Opioid antagonists Blue with white diagonal stripes
Naloxone
Vasopressors Violet 256 Adrenaline, metaraminol
Hypotensive agents Violet with white diagonal stripes
Sodium nitroprusside, glyceryl trinitrate,
Local anaesthetics Grey 401 Procaine, lignocaine, bupivacaine, ropivacaine
Anticholinergic agents
Green 367 Atropine, glycopyrolate
Anti-emetics Salmon 156 Droperidol, metoclopramide
Heparin White with solid black border
Protamine White with black stripe border
Miscellaneous drugs White E.g. oxytocin, potassium chloride, antibiotics
Labelling of medicines and fluids on the perioperative sterile field 24
Labelling on the perioperative sterile
field
Medication errors are associated with medicines and fluids incorrectly identified or unidentified
Labelling medicines and fluids removed from original packaging provides a process for identification
Availability of sterile packed labels on the perioperative sterile field assists this process
Providing a generic abbreviated label requiring population with a sterile marker is a barrier to labelling (may be only option)
Pre-printed sterile labels have advantages
Labelling on the perioperative sterile field
Maintain label integrity with exposure to fluids and frequent handling
Maintain label adhesion throughout procedure.
Label removal from reusable containers, e.g. stainless steel
Minimise packaging to minimise waste and facilitate handling
Sterile pens fit for purpose. Some have tendency to run
Label availability at point of use (Stock, storage, obsolete)
Labelling of medicines and fluids on the perioperative sterile field 25
Labelling of medicines and fluids on the perioperative sterile field 26
Calvary Wakefield Hospital Labelling Trial
Pre-printed labels with medicine name and concentration
Abbreviated container label where pre-printed unavailable
Colour coding to follow ISO26825:2008
A) Miscellaneous medicines in ISO26825:2008 to remain black on white
B) Heparin and protamine borders
C) Combination products with 2 medicines, e.g. local anaesthetic/adrenaline – use a
single label
Labels must be intact for duration of procedure
Label must adhere for duration of procedure
Label may be removed at the end of the procedure for reusable hollowware containers
Labelling of medicines and fluids on the perioperative sterile field 27
Perioperative sterile field label
procurement
● Steam sterilisation unsuitable for paper dyes
● Small scale - ethylene oxide (CWH)
● Large scale - gamma irradiation ideal for paper products, consider
● Packaging composition
● Radiation levels
● Test sterilisation
● Label manufacturers and suppliers of customised procedure packs with labels Paper stock and glue must be fit for purpose
Labelling of medicines and fluids on the perioperative sterile field 28
Reusable vs. disposable containers
Stainless steel and other reusable containers still used in preference to disposable containers in a high proportion of health facilities in Australia
Labels must be removed from stainless steel/reusable hollowware for reuse
Labelling Recommendations specify ‘peel off’ labels for container labels on the perioperative sterile field
Apply label at the time the container is filled.
Pre-labelling disposable containers with medicine name is a source of medication error.
Reusable vs. disposable containers
St Vincent’s Hospital evaluation 1
SVH Darlinghurst evaluated sterile labels and adherence to reusable containers used in the perioperative area
Tested labels from 3 suppliers after exposure to 3 fluids
Labels from 2 manufacturers could be removed either with or without application of alcohol wipes and/or eucalyptus oil. Note limitations:
only 3 fluids were tested and labels appeared to perform differently with exposure to different fluids
fluids were tested by adding a 'wipe' of fluid not by making the label very wet
Labelling of medicines and fluids on the perioperative sterile field 29
Stirling Fildes
Baypac Defries
Industries
Sodium chloride
Contrast Water
Reusable vs. disposable containers
St Vincent’s Hospital evaluation 2
SVH tested labels from 5 suppliers after exposure to 3 fluids including the
CWH trial labels
Labels from 2 manufacturers could be swiftly removed
One label could be removed entirely provided this was done slowly
2 sets of labels left too much residue to be viable for disposable
containers
Labelling of medicines and fluids on the perioperative sterile field 30
Stirling Fildes (CWH)
Mayo
Big Green Surgical
(E-Z Peel)
Big Green Surgical
(Permenant)
Mermed
Sodium chloride
Contrast Water
Labelling of medicines and fluids on the perioperative sterile field 31
Feedback and support www.safetyandquality.gov.au
Frequently Asked Questions
Common issues addressed with reference to Labelling Recommendations, explanatory notes, implementation guide or
the pilot test experience
Issues Register
Issues not addressed by Labelling Recommendations and referred to the
Labelling Recommendations Reference Group (LRRG)
3rd edition
Labelling of medicines and fluids on the perioperative sterile field 32
Labelling Recommendations Reference Group
(LRRG) includes representatives from
Australian and New Zealand College of
Anaesthetists (ANZCA)
Australian College of Operating Room Nurses (ACORN)
Australian Nursing Federation (ANF)
College of Emergency Nursing
(CENA)
Australian an New Zealand Intensive
Care Society (ANZICS)
Australian College of Critical Care
Nurses (ACCCN)
The Cardiac Society of
Australian and New Zealand (CSANZ)
Australian Commission on
Safety and Quality in Health Care
State and Territory jurisdictions
Acknowledgements Australian Commission on Safety and Quality in Health Care acknowledges
contribution from health services and label manufacturers involved in
Pilot testing labels
Evaluation on perioperative sterile field
Adherence to containers on perioperative sterile field
Evaluation in intensive care
setting
Evaluation in cardiology and
radiology
Feedback to inform Issues Register and other health
services