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Published on National Health and Medical Research Council (https://www.nhmrc.gov.au) Generated on 16 June 2017 @ 6:20pm 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 '1' 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 '2' 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 '3'