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