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Decontamination of Surgical Instruments and Other Medical Devices

SECTION 3 —DISCUSSION AND RECOMMENDATIONS

3.1 Discussion

The remit of the Working Group was to answer the following questions:

  1. Are current guidelines on the cleaning and sterilisation of surgical instruments adequate?

    2. These appear to be adequate in terms of their technical content although as more evidence becomes available on prions and vCJD transmission, they are likely to require amendment. However outside the engineering function and Central Decontamination Units, there was a widespread ignorance of guidance on decontamination. Often guidance was written in language which made it difficult for operators to understand its meaning and its relevance to their work.

  2. How effectively is that guidance being implemented?

Overall guidance is not being implemented effectively for two main reasons. The first is the lack of any organisation-wide, coherent management control of re-usable medical devices and their re-processing. The second is the lack of resource put into ensuring equipment met performance criteria as indicated in British, European and other technical standards. This was a particular issue with washer disinfectors.

  1. What practical difficulties are there in ensuring good practice in this area?

    2. These are many. Facilities often do not meet recommended standards. Many items of equipment are in need of replacement or upgrading. Documented evidence of training in decontamination practices is rare. Staff turnover in central decontamination units is high and this constrains the effectiveness of training initiatives. With the exception of flexible endoscopes (but including endoscopic accessories such as biopsy forceps) re-usable medical devices (such as surgical instrument trays) are often not uniquely identified and cannot be traced through re-processing and use on patients.

  2. What measures need to be taken to improve the effectiveness of cleaning and sterilisation in the NHS in Scotland?

Overall the Working Group’s view is that the state of decontamination practice in the NHS in Scotland gives serious cause for concern and requires a series of actions to remedy a number of major deficiencies. The necessary actions are presented in the recommendations (see 3.2).

The benefits from taking these measures would be:

 

  1. Improving the cost-effectiveness of services decontaminating or using medical devices

    2. Not considering decontamination when purchasing medical devices (especially those which are difficult to clean), is likely to have important on-going economic consequences. Decisions based on the immediate purchase price do not consider the total cost over the life of an instrument.

    As with purchasing instruments, failing to take action on LDUs and CDUs will have an economic cost. Many clinical departments in hospitals receive decontamination services both from a CDU and LDU. Given the number of the latter with major deficiencies and the resources needed to remedy these, a high proportion of LDUs are unlikely to be cost effective in the medium to long term. A significant proportion of the equipment in CDUs is old and facilities need improved. The cost of upgrading means that rationalisation of the number of CDUs in Scotland is likely to be the most economic option.

    For most devices there are likely to be few savings by reprocessing items intended for single use. In addition, single use items are not designed to undergo the rigours of decontamination and may be damaged by the process. This could be an obstacle to achieving a suitable outcome from the procedure involved.

  2. Meeting the requirements of the Health and Safety at Work Act

    3. Inadequate segregation of clean and dirty items can lead to recontamination of sterile equipment. Poor training can mean that staff may fail to decontaminate instruments properly. Failure to comply with maintenance regimes does not necessarily mean that items of equipment are not working. However they may be and this is likely to lead to a greater chance of breakdown. All these factors indicate that healthcare providers may not be fulfilling their health and safety obligations in this area.

  3. Reducing the risk of infections in hospitals and other healthcare facilities

    4. The evidence of poor practice in cleaning and disinfection is of concern. Good standards in manual washing can be achieved but the process is difficult to reproduce and thus open to error. If medical devices are poorly washed, protein materials such as blood or tissue may remain.

  4. Managing incidents related to HAI or TSEs.

The lack of a traceability system for medical devices can obscure links between patients with similar hospital acquired infections where a decontamination failure may be the cause. It can impede the management of incidents where it is necessary to trace the use of surgical instruments.

 

3.2 Recommendations

  1. Awareness: SEHD urgently needs to increase NHS Trusts’ and other healthcare providers’ awareness of the importance of good decontamination practices.

  2. Guidance: At the present time no new guidance is required. As a matter of urgency however, SEHD should review the style of and methods used in disseminating guidance on decontamination and other related areas. Based on the findings of the review, actions should be taken to ensure that the right information on decontamination reaches the right person at the right time so that the recipient understands and can act on it.

  3. Standards: Trusts, hospitals and primary care organisations require to audit their achievement of decontamination standards. SEHD should collaborate with other UK Health Departments in developing the methodology utilised in the review as a tool for this and should include monitoring the achievement of adequate standards in decontamination practice in its performance review and risk management processes.

  4. Compliance: SEHD should collaborate with the other UK Health Departments in instituting any measures necessary to ensure that Trusts and other health care providers take action to improve poor levels of decontamination practice as soon as these are detected.

  5. Management: Trust senior management should undertake an assessment of the infection and decontamination risks associated with their services, ensure that overall standards of decontamination practice are monitored and co-ordinate decision-making on decontamination, infection control, health and safety and the acquisition and disposal of surgical instruments. Infection control personnel should have a recognised role in advising on the purchase and planning of decontamination facilities and equipment.

  6. Staff performance: Trusts should ensure that decontamination of re-usable medical devices is managed and undertaken only by suitably trained personnel. Trusts need to assess the recruitment, retention and training requirements of Central Decontamination Units and put in place measures which motivate staff to deliver an improved level of service.

  7. Training: SEHD should develop a national framework for training in decontamination which determines the level of knowledge and skills required by NHS staff, indicates available accredited courses, integrates training in this area with continuous professional development and defines standards for monitoring Trusts and other organisations.

  8. Washer disinfectors: Trusts should be requested to review whether their current equipment is meeting or is capable of meeting current standards, prepare plans for remedying any deficiencies and ensure that ongoing monitoring is undertaken by appropriately trained personnel. SEHD should collaborate with other UK Health Departments in investigating the efficacy of washer disinfectors in removing potentially infective tissue.

  9. Traceability: Trusts should ensure that mechanisms are in place and operating at ward level.

  10. Surgical instruments: SEHD should continue to collaborate with other UK Health Departments and professional organisations in defining standard sets of instruments for specific procedures. Trusts should review their stock of instruments to identify the level necessary for decontamination to be carried out effectively. Infection control personnel should be consulted on the procurement of instruments.

  11. Single use instruments: SEHD should liaise with the other UK Health Departments and the Medical Devices Agency in ensuring that the re-use of single use instruments ceases.

  12. Dentistry: SEHD should develop a programme to improve decontamination and infection control practice in dentistry.

  13. Decontamination Units: A review should be carried out to determine the most cost-effective configuration of decontamination units and operational practices (building on a previous SEHD report on their provision).

  14. Resources: SEHD should urge Trusts and other healthcare providers to invest an appropriate level of resource and improve practice in this area to an acceptable level. Immediate priorities for non-recurring revenue investment are:

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