Decontamination of Surgical Instruments and Other Medical Devices: Page 1 Decontamination is the combination of processes, including cleaning, disinfection and/or sterilisation, used to render a re-useable medical device (e.g. surgical instrument) safe for further use. Today decontamination is an issue of public health importance because of concerns about preventing hospital acquired infections (HAI) and minimising the risk of iatrogenic transmission of transmissible spongiform encephalopathies (TSEs), especially the theoretical risk of variant Creutzfeldt Jakob Disease (vCJD). There is little collated routine data on the efficacy of decontamination in the NHS. There has not been an in-depth study of this area for more than 40 years. The Scottish Executive Health Department (SEHD) therefore established a Decontamination Working Group to advise it with regard to the following: 1. Are current guidelines on the cleaning and sterilization of surgical instruments adequate? 2. How effectively is that guidance being implemented? 3. What practical difficulties are there in ensuring good practice? 4. What measures need to be taken to improve the effectiveness of decontamination in the NHS in Scotland? The Working Group recommended that SEHD carry out a review. The Scottish Centre for Infection and Environmental Health were commissioned to carry this out with technical support from NHS Estates (England). A team of specially trained assessors reviewed decontamination practice in 4 NHS Hospitals, 1 private hospital, 5 general medical and 5 general dental practices. They investigated: The management of the decontamination process; Central Decontamination Units (serving one or more hospital); Local Decontamination Units (serving local clinical departments or general medical or dental practices). The safe use of medical devices Indicators of good practice in each of the separate decontamination processes were derived from extant guidance. Key findings were identified as they related to these indicators. Examples of excellent practice, with modern well maintained, validated, equipment in appropriate facilities with a controlled environment were found. Staff were on the whole hard working. This shows that high standards can be achieved. However most of the sites assessed were deficient in a number of key areas. In general decontamination processes have many shortcomings which could increase the likelihood of adverse health occurrences to both patients and staff. Current guidelines are adequate in terms of their technical content although as more evidence becomes available on prions and vCJD, they are likely to require updating. However guidance is often written in language which makes it difficult for operators to understand its meaning and relevance to their work. Current 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 meets performance criteria as indicated in British, European and other technical standards. This was a particular issue with washer disinfectors. There are many practical difficulties in implementing the guidance. Decontamination often takes place in unsuitable environments which constrain the ability to separate "clean" from "dirty" processes. Many items of equipment are in need of replacement or upgrading. Documented evidence of training in decontamination practices is uncommon and a significant proportion of staff in local units receive no decontamination training. With the exception of flexible endoscopes, the matching of medical devices (such as surgical instrument trays) to the patients on whom they have been used is usually not possible. The Working Group’s view is that the state of decontamination practice in the NHS in Scotland gives serious cause for concern. Urgent action is required to remedy a series of major deficiencies. It recommends the following: Awareness: SEHD urgently needs to increase NHS Trusts’ and other healthcare providers’ awareness of the importance of good decontamination practices. Guidance: At the present time no new guidance is required. As a matter of urgency however, SEHD should review the style and presentation of guidance and how it is disseminated. 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. 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. 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. 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. 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. 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. 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. Traceability: Trusts should ensure that mechanisms are in place and operating at ward level. 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 needed for decontamination units’ turn-around times for reprocessing. Infection control personnel should be consulted on the procurement of instruments. Single use instruments: SEHD should liaise with the other UK Health Departments and the Medical Devices Agency to ensure that the practice of re-using single use instruments ceases. Dentistry: SEHD should develop a programme to improve decontamination and infection control practice in dentistry. 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). Resources: SEHD should urge Trusts and other healthcare providers to invest the level of resource needed to improve decontamination practice to an acceptable level. Immediate priorities for investment are: To make guidance more understandable to users; To develop a framework for training staff working in decontamination; To increase stocks of surgical instruments to the levels necessary for good decontamination practice; To upgrade washer disinfectors; To install information systems which ensure traceability. SEHD should review performance in these areas.: page 1

Decontamination of Surgical Instruments and Other Medical Devices

EXECUTIVE SUMMARY

Decontamination is the combination of processes, including cleaning, disinfection and/or sterilisation, used to render a re-useable medical device (e.g. surgical instrument) safe for further use. Today decontamination is an issue of public health importance because of concerns about preventing hospital acquired infections (HAI) and minimising the risk of iatrogenic transmission of transmissible spongiform encephalopathies (TSEs), especially the theoretical risk of variant Creutzfeldt Jakob Disease (vCJD).

There is little collated routine data on the efficacy of decontamination in the NHS. There has not been an in-depth study of this area for more than 40 years. The Scottish Executive Health Department (SEHD) therefore established a Decontamination Working Group to advise it with regard to the following:

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

2. How effectively is that guidance being implemented?

3. What practical difficulties are there in ensuring good practice?

4. What measures need to be taken to improve the effectiveness of decontamination in the NHS in Scotland?

The Working Group recommended that SEHD carry out a review. The Scottish Centre for Infection and Environmental Health were commissioned to carry this out with technical support from NHS Estates (England).

A team of specially trained assessors reviewed decontamination practice in 4 NHS Hospitals, 1 private hospital, 5 general medical and 5 general dental practices. They investigated:

The management of the decontamination process;
Central Decontamination Units (serving one or more hospital);
Local Decontamination Units (serving local clinical departments or general medical or dental practices).
The safe use of medical devices

Indicators of good practice in each of the separate decontamination processes were derived from extant guidance. Key findings were identified as they related to these indicators.

Examples of excellent practice, with modern well maintained, validated, equipment in appropriate facilities with a controlled environment were found. Staff were on the whole hard working. This shows that high standards can be achieved. However most of the sites assessed were deficient in a number of key areas. In general decontamination processes have many shortcomings which could increase the likelihood of adverse health occurrences to both patients and staff.

Current guidelines are adequate in terms of their technical content although as more evidence becomes available on prions and vCJD, they are likely to require updating. However guidance is often written in language which makes it difficult for operators to understand its meaning and relevance to their work.

Current 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 meets performance criteria as indicated in British, European and other technical standards. This was a particular issue with washer disinfectors.

There are many practical difficulties in implementing the guidance. Decontamination often takes place in unsuitable environments which constrain the ability to separate "clean" from "dirty" processes. Many items of equipment are in need of replacement or upgrading. Documented evidence of training in decontamination practices is uncommon and a significant proportion of staff in local units receive no decontamination training. With the exception of flexible endoscopes, the matching of medical devices (such as surgical instrument trays) to the patients on whom they have been used is usually not possible.

The Working Group’s view is that the state of decontamination practice in the NHS in Scotland gives serious cause for concern. Urgent action is required to remedy a series of major deficiencies. It recommends the following:

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

Guidance: At the present time no new guidance is required. As a matter of urgency however, SEHD should review the style and presentation of guidance and how it is disseminated. 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.

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.

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.

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.

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.

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.

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.

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

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 needed for decontamination units’ turn-around times for reprocessing. Infection control personnel should be consulted on the procurement of instruments.

Single use instruments: SEHD should liaise with the other UK Health Departments and the Medical Devices Agency to ensure that the practice of re-using single use instruments ceases.

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

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).

Resources: SEHD should urge Trusts and other healthcare providers to invest the level of resource needed to improve decontamination practice to an acceptable level. Immediate priorities for investment are:

To make guidance more understandable to users;
To develop a framework for training staff working in decontamination;
To increase stocks of surgical instruments to the levels necessary for good decontamination practice;
To upgrade washer disinfectors;
To install information systems which ensure traceability.

SEHD should review performance in these areas.

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