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  3. Re-usable and disposable equipment with specific emphasis on the decontamination practices of anaesthetic airway management equipment.

Re-usable and disposable equipment with specific emphasis on the decontamination practices of anaesthetic airway management equipment.

Introduction

Infection control and hospital hygiene have increasingly attracted public and Government concern regarding the issues of infection risks, particularly risks associated with the use of medical equipment and their decontamination. A additional issue relates to the use and re-use of disposable medical equipment, one high risk area is anaesthetic equipment and their decontamination. In the UK The Department of Health (2002) have produced guidelines for the rigorous decontamination of surgical instruments, as well as promoting the use of disposable surgical and anaesthetic instruments for certain surgical procedures. Similarly, the guidelines of the Association of Anaesthetists of Great Britain and Ireland (2002) state that single-use intubation equipment should be used wherever possible. In particular, it has been recommended that laryngeal mask airways (LMA’s) should be disposed of after just one use, and if laryngoscopy is to be performed, disposable blade covers or disposable laryngoscopes blades should be used. Consequently, many medical companies and manufacturers have developed single use anaesthetic equipment, much of this equipment has not been formally tested and when it has been, it has been found to be of variable quality and efficiency (Cook et al, 2002).

Therefore, with these growing concerns about the use of single use equipment and the practice, by some practitioners, of decontaminating single use equipment, this edition of MICKS will review the advantages and disadvantages of reusable and disposable equipment with specific emphasis on the decontamination practices of anaesthetic airway management equipment.

On analysis of the research literature (n = 41), a large number of the studies found were British (n = 27), the other research studies included Dutch (n = 4), American (n = 3), Australian (n = 2), Japanese

(n = 2), French, South African, and Scandinavian. Many of the studies reviewed examined the contamination of laryngoscope blades and handles, only two studies mentioned blade covers and no research was obtained evaluating handle covers.

For this edition of MICKS the identified articles on reusable and disposable anaesthetic airway equipment will be categorised into four broad themes that reflect the research areas studied. These themes are:

  • Contamination, Decontamination and Cleaning,
  • Design and Safety,
  • Cost and
  • Legal Issues.

Contamination, Decontamination and Cleaning

Traditionally, medical equipment has been multiple-use with the need for cleaning or sterilisation between patients. According to Galinski et al (2003), the risks have been higher over recent years because no perfect decontamination procedures exist. Just as hand hygiene is the single most important means of infection control for healthcare workers, cleaning and decontamination of instruments and equipment is the single most important means of ensuring that sterilisation processes will be effective (Sharbaugh, 2001). Sterilisation may not be achieved if cleaning is inadequate and many cleaning practices vary (Merritt et al, 2000). Several studies (Shah, 2000; Haltia, 2000; Antloga et al, 2000; Jackson, 2003; Hilton et al, 2004; Tomkinson et al, 2005) raised concerns about the unsatisfactory levels of decontamination for many reusable items of equipment in anaesthesia and in medicine generally, which has resulted in a move towards the use of disposable equipment as the only way to be certain of no risk of cross transmission of infection.

These problems are not unique to the UK, in a structured telephone questionnaire study of decontamination of laryngoscopes in the Netherlands; Bucx et al (2001) concluded that there are substantial differences in decontamination procedures in Dutch hospitals, which compares with the situation in Britain. In order to investigate the problem, a very interesting nationwide survey of 239
hospitals was conducted in the UK by Esler et al (1999), they found no rationale regarding the aim of laryngoscope cleaning or agreed methods to achieve that aim, with wide-ranging cleaning methods in use. They reported that only three units sent their laryngoscope blades to a specialist unit for cleaning. The handle was not cleaned at all in one third of the units, and others only do so when there is evident gross soiling. 12 units used disposable blades, but one quarter of these admitted to reusing them. Visible inspection of equipment is not a reliable means of detecting blood contamination as highlighted by Hall (1994) who reported 33% of anaesthetic equipment surfaces were contaminated with blood, sites with the highest prevalence of contamination were monitor cables (82%), drawer handles (64%) and pulse oximeter probes (62%). These findings are supported by Philips & Monaghan’s (1997) study into the incidence of occult blood on laryngoscope blades and handles; they reported that out of the 65 laryngoscopes tested, 13 blades and 26 handles were found to be positive for the presence of occult blood. None of the laryngoscopes showed visual signs of blood and all had been identified as ready for patient use. Similar results showing contamination of laryngoscope blades have been shown by Hirsch et al (2005) and Ballin et al (1999) Miller et al (2001). In a much larger study, Tordoff and Scott (2002) looked at blood staining of 501 laryngeal mask airways (LMA's) used for a variety of operative procedures. Of the 501, 92 (18.4%) were visibly stained with blood, and of those masks that were not visibly stained, 93.6% (383 of 409) were tested positive for blood. These figures are similar to another study performed by Coetzee (2003). Clearly, this research shows that our current practice of decontamination or the lack of effective decontamination procedures relating to certain medical equipment, presents potential infection risks to patients and staff.

Design and Safety

Many practitioners are concerned that the materials and standards to which single use medical equipment are manufactured are not of the same quality as their reusable counterparts (Caesar and Scott, 2004). The introduction of a variety of disposable airway devices from various companies appears to have occurred without rigorous assessment, research or comparison with traditional reusable equipment. Cook et al, (2005) demonstrated that the traditional re-usable laryngeal mask airway (LMA) is a superior airway to the single-use mask. This randomised comparison study was stopped when it became clear that the single-use LMA was associated with a greater incidence of airway trauma, patient complications and airway failure. Holtham and Weaver (2001) felt that disposable laryngeal mask airways are more difficult to insert, primarily due to the additional stiffness of the device, and that their use in the emergency situation was of particular concern.

A contrary opinion, however, is expressed by Paech et al (2005) who in a randomised cross-over comparison study among 168 patients undergoing anaesthesia, found that the single-use and reusable LMA was equivalent in terms of successful insertion at the first attempt. The findings of this study are supported by Van Zundert et al (2003), Orlikowski (2004) and Glaisyer and Yule (2005) all who reported equivalence in terms of insertion success, improved fibre optic positioning, slightly more successful ventilation and an improved airway seal with the disposable LMA.

In order to reduce the potential infection risks some practitioners have used blade covers. However, there have been reports of problems with difficult laryngoscopy and tracheal intubation with blade covers in place (Babb and Mann, 2002).

Twigg et al, (2003) compared six different designs of single-use laryngoscopes with a reusable Macintosh in both easy and difficult intubation, using a patient simulator. One of the important issues of this randomised study is that it demonstrates a potential increase in the risk of difficult intubation
using either a single-use laryngoscope or plastic sheaths over reusable blades, secondly, it is a level one study and is considered important because one of nursing's major research priorities is documenting outcomes to provide a basis for changing or supporting current nursing practice. Two studies contradict these views (Asai, 2004; Anderson & Bhandal, 2002) found the disposable blades to be as effective as reusable equipment, with a significantly higher illumination than a standard Macintosh blade with a disposable cover.

However, problems with the quality and design of these specific medical instruments remain an issue. Medical devices and associated equipment are used every day by healthcare professionals in the treatment and care of patients. Professionals play a vital role in ensuring that devices are used safely for the purpose intended, minimising risk to patients and their professional liabilities through misuse. Current research has demonstrated that from a safety point of view, the only alternative is to identify single-use equipment that functions adequately and therefore does not increase the risk of infection to patients.

Cost

The use of disposable or single use medical equipment involves an increased cost which has resource implications for the any department or hospital. Although the primary reason for equipment reuse is cost savings, few institutions undertake a thorough analysis of the total cost of reuse (Reichert, 1997). A thorough cost analysis should include equipment costs (to clean, re-sterilise, repackage); tracking system costs; processing costs; environmental costs (ecological impact of disposable vs. cleaning/sterilisation agent exposure) and costs of managing patient complications related to reused equipment.

With the growing awareness of health care costs during the past decade, which has centered on the risk of transmission of disease, particularly new variant Creutzfeldt-Jakob disease (Anderson and
Bhandal, 2002), it has become increasingly important for staff to be aware of the cost of various components of health care. The need for mass production of single-use devices has been met by producing cheaper but poorer quality products, which are often introduced into clinical practice without adequate evaluation of their clinical effectiveness. It seems that disposable products are purchased because they save reprocessing costs (Watcha and White, 1997). According to Rassam et al (2005), the cost of a re-usable laryngoscope blade is about 40-50 times that of a plastic single-use blade. It appears from the literature that the environmental issues relating to resources and disposal have been outweighed, especially since the price of single-use airway device has fallen in a rapidly growing and increasingly competitive commercial market. Though a more costly option, the single use approach may have a number of operational advantages in the long term. The misplaced desire to reuse single use equipment, usually due to financial pressures, also needs to be firmly resisted.

Every solution has a cost implication but cost containment should never be achieved at the expense of patient safety.

Legal Issues

In recent years an unfortunate practice has developed, where by disposable medical devices intended and marketed for single-use have increasingly been reprocessed and recycled. If reprocessing of medical devices intended and produced for single-use is at all possible, it requires special equipment and involves professional legal consultation. In general, hospital sterilising departments are not technically equipped for reprocessing single-use devices nor prepared to cope with the legal aspects that may be very serious if infection is transmitted (Parsons ,1997). There are a number of potential hazards associated with the reprocessing and reusing of medical devices intended for single use only and is of concern from a quality and clinical risk stance. Despite sparse scientific evidence in relation to the safety of reusing single-use medical devices, many healthcare organisations still repackage,
re-sterilise and re-use equipment. Reprocessed equipment may be more vulnerable to breakage, alteration in composition, reduced performance or biological agent contamination, and infection arising from inadequate cleaning and sterilisation procedures (Nye & Wilson, 1998). Manufacturers' warranties no longer apply once a single-use item is reprocessed. Although there is little case law on this topic, patient or employee injury could lead to allegations of negligence or even product liability, which is strict liability based on product failure not fault. Best practice recommends that this is not done. Reuse of single-use medical equipment is considered substandard and with regard to the transmissible prion diseases, including new variants such as vCJD, reprocessing and reuse of single-use devices represents a quite unacceptable infection risk.

Conclusion

Progress in patient care, decontamination and infection control will only be made through the development of new equipment, which relies heavily on investment and innovation from manufacturers. Patients must be protected from untested devices that do not perform to an acceptable standard, and practitioners must ensure that re-usable equipment is clean and appropriately decontaminated. This edition of MICKS has shown that current research evidence from around the world, indicates that he decontamination of certain medical devices is not adequate and places patients and staff at risk of infection. Furthermore, issues relating the re-use of single use medical equipment haves a number of implications not just those relating to infection control.

High standards of infection control are vital across the whole spectrum of healthcare. Preventing healthcare-associated infections is the responsibility of every healthcare worker. A significant number of infections can be prevented, but to achieve this, healthcare workers need to put into practice the knowledge that is currently available, with regards to effective processes for decontamination of medical equipment, and the use of disposable medical equipment.

REFERENCES

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University of Wales
Dr. John Gammon
Profile


Dr Gammon is recognised as an international authority on infection prevention and control. Currently, he is a Non -Executive Director of Carmarthenshire NHS Hospital Trust and Deputy Head of the School of Health Science, at Swansea University, Wales, UK. He has practiced as an infection control practitioner for many years and been instrumental in Wales in establishing infection control services. Furthermore he has lead on the establishment infection control courses, and national guidance on hospital and community infection prevention strategies. He has been central to the development of, evidence based, international guidance on patient isolation. His research interests include patient isolation, standard precautions and hand decontamination. He has published a number of research papers and continues to advise the Welsh Government on infection control practice and strategy. He acts as key advisor to a number of commercial companies involved in infection control. His focus of academic interest for the last few years has been the education and professional development of practitioners and specifically infection control practitioners. This has included e-learning course as well as Masters programmes in infection control.