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B4.1 Taking a Risk-Management Approach to Procedures
All procedures involve some risk of infection. Minimising the infection risk associated with a procedure should be an integral part of considering
the overall risks and benefits of that procedure to the patient. The aim should be to perform the procedure with the lowest level of perceived
infection risk that will meet the treatment goals for that patient. When performing the procedure, associated infection risks should be identified
and minimised.
In developing local policies for a healthcare facility, it is useful to refer to guidelines developed to inform practice in performing specialised
procedures.
B4.1.1 Classifying procedures
Procedures can be classified according to the level of perceived risk, by applying the principles of Spaulding’s criteria for assessing the risk of
medical instruments and equipment according to their intended use (see Section B1.5).
Table B4.1: Level of risk to patients from different types of procedures
Level of Criteria
risk
Example
High risk
Abdominal surgery
Any surgical entry into tissue, body cavities or organs, or repair
of traumatic injury.
(critical site)
Medium risk
Dental surgery
Contact with mucous membranes or non-intact skin
(semi-critical site)
Respiratory procedure
Internal/instrument examination (e.g. ultrasound,
endoscopy)
Minor skin surgery
Minor dental procedures
Low risk
Contact with intact skin
Non-invasive examinations or procedures (e.g.
abdominal ultrasound)
(non-critical site)
Blood pressure measurement, ECG, injection through
intact skin
Extra-oral dental examination
B4.1.2 Appropriate use of devices
Appropriate use of devices is integral to reducing the risk of procedures. Single-use or single-patient items should be used wherever practical,
and items designed for single use must not be used for multiple patients. Healthcare workers should be aware of situations where crosscontamination may occur during routine procedures.
Healthcare workers must adhere to infection control principles, including safe injection practices and aseptic technique for the preparation and
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administration of parenteral medications.
Single-dose vials
Medications or solutions that come into contact with normally sterile tissue should be sterile. The most effective way to avoid cross-infection via
injection of medication is through the use of single-dose vials or ampoules and single-use sterile injecting equipment. Single-dose vials or
ampoules, or prefilled syringes, should be used wherever these are available. These include the use of a sterile, single-use needle and syringe for
each injection given, and adherence to practices that prevent contamination of injection equipment and medication.
Multi-dose vials
The Australian Drug Evaluation Committee (ADEC) has advised that injectable products packaged in multi-dose vials should not be used except
where products such as insulin are intended solely for the exclusive use of an individual patient (ADEC 2005). In these particular cases, specific
protocols should be in place to ensure the products are used for those individuals only, and there is adherence to practices that prevent
contamination of injection equipment and medication.
Currently some injectable products (e.g. Bacillus Calmette-Guérin [BCG] and botulinum toxin) are only available in multi-dose vials. When singledose vials or ampoules are not available, there is a high risk of cross-contamination if injectable products are used on multiple patients. Steps
should be taken to ensure these become available in single dose vials, however the risk of infectious disease transmission may be mitigated by
(Siegel et al 2007):
compliance with manufacturer’s recommendations (adhere to instructions for refrigeration, storage, use within a specified time, expiry
date);
establishing a separate area designated for the placement of these medications away from any work area;
having only the current patient’s medication in the immediate working environment;
using a sterile needle and syringe to draw up the required dose from the vial or ampoule on every occasion;
using a sterile needle to draw up all the contents of the container into individual syringes before administering to patients;
discarding any open ampoule(s) at the end of each procedure; and
discarding product if sterility is compromised or questionable.
The use of multi-dose vials has been associated with the transmission of infectious diseases including HIV (Katzenstein et al 1999), hepatitis B
(Hutin et al 1999; Dumpis et al 2003; Samandari et al 2005), hepatitis C (Widell et al 1999; Massari et al 2001; Trasancos et al 2001; Kokubo et al
2002; Silini et al 2002; Dumpis et al 2003; Germain et al 2005; Verbaan et al 2008), Staphylococcus aureus (Kellaway et al 1928), and Streptococcus
pyogenes (Stetler et al 1985; Olson et al 1999). International agencies such as the CDC and WHO recommend that single-dose vials be used for
parenteral additives or medications whenever possible, especially when medications will be administered to multiple patients (Hutin et al 2003;
Siegel et al 2007).
There may be some exceptional circumstances where for short periods (e.g. a few months) multi-dose vials may be the only way to deliver
vaccines or drugs to a large proportion of the population in a timely fashion. An example would be when a health emergency is declared because
of an infection that has a high associated mortality and rapid spread (e.g. smallpox outbreak) and when there may be a delay in single-dose
vaccines or drugs becoming available for a period of time.
Table B4.2: Summary of processes for appropriate use of devices
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Injection equipment
Avoid contamination of the needle
Single-use items
Do not use the same needle, cannula or syringe for more than one patient nor to access a medication or
solution that might be used for a subsequent patient
Do not administer medications from a single syringe to multiple patients, even if the needle or cannula on the
syringe is changed.
Single-patient items
Use single-patient items for one patient only and dispose of them appropriately.
Single-use medications
Only use single-dose vials when administering drugs, therapeutic agents and vaccines to multiple patients
Do not administer medications from single-dose vials or ampoules to multiple patients or combine leftover
contents for later use
Multi-dose vials
Multi dose vials should not be used except where they are intended solely for the exclusive use of an individual
patient (e.g. insulin)
Fluid infusion and
administration sets
Use for one patient only and dispose of appropriately after use
Do not use bags or bottles of intravenous solution as a common source of supply for multiple patients
(i.e. intravenous bags, tubing
and connectors)
Consider syringes or needles/cannulae as contaminated once they have been used to enter or connect to a
patient’s intravenous infusion bag or administration set
Use closed intravenous delivery devices as standard practice
Use premixed intravenous bags of medication wherever possible, in order to reduce the risk of contamination
or infection during mixing, dilution or preparation
Avoid disconnection of administration sets if possible to minimise the potential of contamination of IV lines
Should be changed on a regular basis, depending on their use (see Section B4.2.2)
B4.1.3 The care bundle approach
The Institute for Healthcare Improvement (IHI) in the US developed a structured ‘care bundle’ approach to help healthcare workers consistently
deliver the safest possible care for patients undergoing treatments with inherent risks. A bundle is a set of evidence-based practices that, when
performed collectively and reliably, improve patient outcomes.
Many bundle elements are well-established practices, combined in a structured protocol that is agreed upon and is the responsibility of the
whole clinical team. Bundle characteristics include the following.
A bundle is a cohesive unit of steps that must all be completed to succeed.
The elements are all based on randomised controlled trial evidence.
The elements involve all-or-nothing measurement, making implementation clear-cut.
Bundle elements occur at a specific time and in a specific place (e.g. during morning rounds every day).
Examples of care bundles are given in each section of this chapter. These can be used to monitor, assess and improve performance as well as to
increase consistency of care.
Existing care bundles can be used as a tool and be developed by each facility to meet its needs. For more information, refer to the IHI website at
www.ihi.org.
Source URL (modified on 05/10/2010 - 10:26): https://www.nhmrc.gov.au/book/australian-guidelines-prevention-and-control-infectionhealthcare-2010/b4-1-taking-risk-managem
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