2.1 Aim and Objectives
The aim of the Review was to provide an assessment of current practice in the cleaning and sterilisation of re-usable surgical instruments by:
2.2 Methodology
2.2.1 Study Population and sample
The following were chosen from across Scotland from each the main types of providers of healthcare services:
There was no attempt to obtain randomisation or a ‘blind trial’.
The study was therefore composed of 15 healthcare sites, of which all but the private hospital were part of NHS Trusts. CDUs and/or LDUs included in the survey provided decontamination services to a variety of clinical departments on the sites. Clinical departments are: hospital wards, outpatient clinics, A&E departments, operating theatres, general medical and general dental practices. The survey encompassed:
2.2.2 Survey Methods
The survey was led by a Project Co-ordinator from SCIEH with a Technical Co-ordinator charged with ensuring consistency in the assessment of equipment performance.
A Development of Reporting Forms
Standardised reporting forms were developed by an NHS Estates multidisciplinary working group using assessment criteria based on the requirements of relevant European and British standards and of other guidance on best practice (see Appendix 3). They were designed to ensure a consistent and comprehensive approach to data collection. The forms incorporated a number of internal quality checks to validate the accuracy of the data obtained.
B Data Collection
Teams of trained assessors, led by a lead assessor, visited each site by appointment and completed a set of reporting forms. All of the assessors took part in a three-day training programme. The site visits consisted of 3 to 4 days on site, for 3 to 4 assessors, for each NHS hospital; 1 day for 2 assessors for the private hospital and up to 1 day for 2 assessors in each primary care site.
Data was collected through observing practices, inspecting equipment, interviewing staff and reviewing documentation. Although the focus was on cleaning, disinfection and sterilisation practices, information was obtained on associated activities, which might affect the efficacy of reprocessing. These included the management and location of decontamination processes, healthcare activity at each site, facilities and equipment at each location, and the validation, testing and maintenance of equipment. It was therefore necessary to visit all parts of each site where instruments were either decontaminated or used.
The following key personnel were interviewed wherever possible: Chair of Infection Control Committee, Consultant Microbiologist, Microbiologist (sterilizers), infection control doctors and nurses, Sterile Services Manager, Estates Manager, and managers of clinical departments.
C Data quality
The Lead Assessor for each site visit checked the consistency of the collected data at the end of the visit. The Technical Co-ordinator undertook quality control of the process as it related to technical standards by reassessing equipment previously examined.
D Data Processing & Analysis
Data was entered into a relational database and analysed using EXCEL and SPSS v10. Sites and decontamination units were allocated a code to ensure confidentiality.
Data were analysed and discussed by the Project Co-ordinator, the Technical Co-ordinator and staff from NHS Estates. The key findings from this process were presented to the Review Team members and discussed as to their accordance with their observations made during the survey.
E Data Presentation and feedback
Indicators of good practice in each of the separate processes in the decontamination cycle were derived from extant guidance and reported as they related to:
At the end of each visit, the Lead Assessor prepared a summary report and fed back key points to management representatives. The NHS hospitals in the survey subsequently received a full written report and a further visit to consider the report and resultant action.
2.3 Results
2.3.1 Management of the Decontamination Process
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Key Indicators of good practice |
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1. One senior manger responsible to an Executive Director in the healthcare organisation maintains an overview of decontamination processes. |
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2. Managers of CDUs and clinical departments with LDUs have defined roles and responsibilities related to decontamination. |
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3. Each Trust has an Infection Control Committee. |
The review found no evidence of a senior manager having specific responsibility for the range of decontamination processes (as defined in Figure 1.1), which took place in the healthcare organisation visited. There were a variety of organisational arrangements for managers of CDUs. The review found that managers of clinical departments with LDUs were often unclear as to their responsibilities with regard to the decontamination processes.
All hospitals reviewed had an Infection Control Committee (ICC). There were no committee structures found for infection control in primary care. In all but one hospital, ICCs had representation from Estates Departments. In all hospital sites, the roles and responsibilities of the various staff involved in infection control were documented. Only 1 of 10 Primary Care sites had the roles and responsibilities of personnel defined and documented.
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Key indicator of good practice |
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1. Risk assessments undertaken to identify hazards related to decontamination. |
Only one site had identified the risks attendant on poor decontamination practice. The risk assessment however was restricted to consideration of the process chemicals used and the risk of blood borne infection from needle stick injury.
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Key indicators of good practice |
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1. Infection Control policy contains decontamination section and guidance on TSEs |
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2. There is a documented policy on the procurement of medical devices and decontamination equipment. |
All of the hospital sites had a documented policy for infection control. Three of the 5 hospital sites’ infection control policy contained a reference to decontamination. However this related either to the disinfection of the clinical environment or to the use of specified chemical disinfectants in washer disinfectors. In only 2 hospital sites was there a policy concerning the use of CDU versus LDU services.
Two of 5 general dental and 3 of 5 general medical practices had a policy for infection control. In only one of the 10 primary care sites did infection control policy refer to decontamination but not as it related to medical devices. One primary care site had a policy concerning the choice of CDU or LDU.
In no sites did the infection control policy cover specifically the whole process of decontamination of flexible endoscopes. Clinical departments with endoscope washers had produced their own local policies. In some cases these were in direct conflict with the site control of infection policy on the suitability of particular disinfectants.
Only five sites (four hospitals, one primary care) had procedures in place through their infection control policy, to implement the guidance given in the ACDP/SEAC publication on Transmissible Spongiform Encephalopathy Agents15 or the recent Management Executive Letter on decontamination16.
Only one site (a hospital) had a policy on the purchase of medical devices, which included formal consideration of their decontamination. Four sites (3 hospital and one primary care) had evidence of a policy on the choice of re-usable or single-use medical devices where both were available for a given procedure. Eight sites had a policy prohibiting the re-use of medical devices designated as single use.
Fifty-two of the 152 clinical departments included in the survey responded to a request for information about a local policy for the acquisition of medical devices. Twenty-seven (26 hospital, 1 primary care) had a documented specification for a medical device drawn up prior to its purchase. Nine had undertaken reviews to establish the decontamination requirements of the devices involved.
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Key indicators of good practice |
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1. An Authorised Person (Sterilizers) provides independent auditing and advice on sterilization and on washing/disinfection. |
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2. Microbiologist (Sterilizers) provides guidance on various aspects of decontamination. |
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3. Infection Control Nurse undertakes periodic audits of LDUs. |
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4. Clinical and non-clinical staff are aware of key guidance relevant to their duties. |
Of the 5 hospital sites reviewed, 3 had appointed an AP(S). Only one of the AP(S) appointed was asked to discharge the full range of duties specified for this role. None of the five hospitals had appointed a Microbiologist (Sterilizers). Only 1 primary care site had appointed an AP(S). None had appointed a Microbiologist (Sterilizers).
All NHS hospitals had an Infection Control Nurse. All 5 general practices and 1 of the 5 dental practices could seek advice from local hospital Control of Infection Nurses. Only 2 out of 5 hospitals reviewed had a system for periodic audit of LDUs.
Staff on all sites were offered the opportunity to comment on the available guidance. The following summarises the main points raised:
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Key indicator of good practice |
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1. Documented evidence exists of training relevant staff in appropriate decontamination procedures. |
All CDUs reported that staff were trained in decontamination procedures. Documented evidence of the training received was found in only one CDU. Evidence was obtained of training in the other CDUs but this was not recorded. Thirty-five out of the 56 LDUs reported that they undertook training but documented evidence of the training received was only available in 11. Twenty-one LDUs (16 hospital and 5 primary care) reported that all staff involved in decontamination had received no training in this aspect of their work.
Several Control of Infection doctors expressed concern that documents published by the Health Department stated that ‘the advice of the microbiologist should be sought’ on topics for which they considered their training had been inadequate e.g. the quality of water for endoscope washer disinfectors.
2.3.2 Central Decontamination Units
The 4 NHS hospital sites included in the study each received decontamination services from a CDU. Two of these CDUs were part of the hospital complex and two at some distance from it. All the CDUs provided services to clinical departments in other hospitals and primary care sites in addition to those included in the survey.
The private hospital used an LDU. One primary care site had all its devices cleaned, disinfected and sterilised by a CDU, part of a hospital complex, which was not included in the survey.
Of the 136 clinical departments based in NHS hospitals included in the survey, 94 received all their decontamination services exclusively from CDUs. Of the remaining 42 NHS hospital clinical departments, 36 used both LDU and CDU for decontamination. One hospital received all decontamination services (except endoscope decontamination) for all its clinical departments exclusively from a single CDU.
The four CDUs in the survey contained the following major items of equipment (see Appendix 2):
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Key indicator of good practice |
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1. Environmental controls are present to reduce microbial or particulate contamination especially ventilation and separation of contaminated items from clean and sterilised items |
The facilities provided for 3 out of 4 CDUs did not meet the basic requirements for segregation of clean and ‘dirty’ processes. The mechanical ventilation systems in the wash/decontamination areas were found to be ineffective in 2 CDUs. This results in windows and external doors being left open.
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Key indicators of good practice |
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1.use of washer disinfector, if not available, a dedicated sink where washing by hand takes place under water |
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2.personal protective equipment including eye protection used by staff involved in cleaning |
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3.washer disinfector regularly validated to ensure capable of meeting the temperature, time and pressure requirements |
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4. each cycle monitored to ensure the temperature and time requirements are met |
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5. regular maintenance to ensure washer disinfector safe and working efficiently |
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6. devices undergoing sterilization should receive prior disinfection |
Manual washing
All CDUs had a dedicated sink for manual washing with separate handwashing facilities. Cleaning is carried out entirely under water in 2 of the 4 CDUs. Gloves and a waterproof overall were worn in all CDUs, eye protection in three and masks in two. All staff were trained in manual washing procedures.
Washer Disinfectors
Excluding ultrasonic washers, 9 of the remaining 13 washer disinfectors were 10 years old or more and of a type that it is unlikely could be economically upgraded to current standards. No washer disinfector had been validated and no periodic or routine testing was carried out (see Appendix 4). Excluding ultrasonic washers, only 9 of the 13 were fitted with independent temperature monitoring. Only three of the 13 documented process variables for each cycle.
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Key indicator of good practice |
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1. separation of contaminated items from clean and/or from sterilised items |
In 2 of the 4 CDUs the assembly of packages of disinfected instruments for sterilization did not take place in a dedicated area, segregated from cleaning and/or sterilization areas.
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Key indicators of good practice |
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1. equipment is regularly validated to ensure it is capable of meeting the steam quality, load, temperature, time and pressure requirements |
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2. each cycle is monitored to ensure the parameters relevant to the factors outlined above are met |
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3. regular maintenance occurs to ensure equipment is safe and working efficiently |
Three of the 4 CDUs did not comply with steam quality requirements
Of 18 porous load sterilizers surveyed, 6 were more than 15 years old. All sterilizers underwent daily and weekly testing and all but 2 underwent an annual revalidation. For no sterilizer was there a formal review of the nature of the loads processed. The one CDU operating ethylene oxide sterilizers was found to be reprocessing inappropriate loads, e.g. surgical gloves.
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Key indicators of good practice |
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1. labelling to identify devices or sets of devices |
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2.information system to match label or code to healthcare procedure and patient |
Two CDUs had a system (stick-on labels with cycle number and date printed) in place allowing the traceability of sterilised devices back to the sterilizer used.
Systems, which could ensure the traceability of theatre trays to patients, were in place in 3 of the 4 CDUs. However only one clinical department on a hospital site was found where every appropriate patient note contained a traceability label. No systems were in place, which allowed the traceability of instruments which were included as supplements to a standard set.
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Key indicator of good practice |
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1. separation of contaminated items from clean and from sterilised items |
Although sterile stores with good stock rotation and standards of hygiene were seen, storage facilities were inadequate in 2 of the 4 CDUs. In these, sterile items were found on the floor and where they could be exposed to splash contamination.
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Key indicator of good practice |
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1. separation of contaminated items from clean and from sterilised items |
Ninety-nine of the 152 clinical departments provided information about transport of devices to their CDU. Trolleys and/or vehicles were used for transport. In only 49% of the clinical departments did the trolleys or vehicle used have a physical separation between contaminated and sterile instruments.
2.3.3 Local Decontamination Units
Fifty-six LDUs were identified in the 15 sites: 13 on 9 Primary Care sites, 1 in the Private Hospital and 42 in hospital wards and departments. One hospital and 1 general practice prohibited any local decontamination, sending all items to a CDU. Many LDUs were located in clinical departments, which also received a CDU service even though 74% of CDU users surveyed in this review found the service reliable.
Table 2 provides details of the major items of equipment in the LDUs.
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Table 2 Type of Equipment in LDUs by type of site |
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TYPE |
Hospital |
General Medical Practice |
General Dental |
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Porous load sterilizers |
1 |
0 |
0 |
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Benchtop sterilizers |
35 |
6 |
10 |
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Washer-disinfectors |
26* |
0 |
7** |
* Includes 10 free-standing ultrasonic washers and 7 endoscope
washer-disinfectors
** All ultrasonic washers
The key indicators of good practice for LDUs were the same as for CDUs.
Thirty-one LDUs (55%) did not have a dedicated area for decontamination. Seventeen units (30%) were located in areas stated to be also used for patient treatment. Nine LDUs (18%) were in areas used for dirty procedures such as cleaning and waste disposal. In only 11 LDUs (20%) was there segregation between activities on soiled devices and those on clean, disinfected devices.
Cleaning of instruments took place in LDUs and also in clinical departments using CDUs. Manual washing of instruments was identified in 66 of the 152 clinical departments (57 hospital and 9 primary care). Forty-one (66% of those carrying out manual washing) used a suitable general purpose detergent or enzymic cleaner; 19 (28%) were using unsuitable detergents, of which 3 (5%) were hand-washing solutions. Detergent concentration was controlled in 12 (18%) and water temperature in 5 (8%).
With regard to the 56 LDUs, in only 24 (42%) (18 hospital and 6 primary care) was the sink used dedicated for manual washing only. In no LDU were manually washed instruments subsequently disinfected before sterilization. Although procedures in LDUs involved scrubbing instruments which generate aerosols, a minority of staff were wearing eye protection (40 %) and/or a mask (29%).
Observations in LDUs on hospital sites of the manual washing of flexible endoscopes prior to processing in washer disinfectors revealed this to be intricate and labour intensive. Staff commented upon the difficulty of undertaking this procedure because of time pressures.
Washer Disinfectors (including endoscope washers)
There was no evidence that any washer-disinfector met recommended performance
criteria. This was due to an absence of testing.
The 7 ultrasonic washers in LDUs in general dental sites did not meet maintenance and operational standards. No information about their age was available on site.
Fifty-one benchtop bowl and instruments sterilizers (see Appendix 2) were identified although only 36 were in routine use. Their location is shown in Table 3.
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Table 3 Location of Benchtop Sterilizers |
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Location |
Number |
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Ward |
1 |
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Operating Theatre |
7 |
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OP Clinic / A&E |
19 |
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General Practice |
6 |
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Dental Surgery |
10 |
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Estates Departments |
6 |
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Other |
2 |
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Total |
51 |
Nineteen bench-top sterilizers (37%) were less than 10 years old. Nine (18%) were more than twenty years old.
Twelve sterilizers (24%) had been subjected to installation and commissioning tests to SHTM 2010 (see Appendix 3). Documented validation and testing was found in only one site (primary care). Weekly tests were being carried out on 29 (57%) of bench-top sterilizers, quarterly thermometric test and instrument calibration were being carried out on 19 (37%) and yearly test on 32 (62%) (see Appendix 4).
Seventeen of the 29 sterilizers (55%) in use on hospital sites were being filled with sterile water for irrigation or injection as recommended but only 1 of 16 (6%) in primary care. The reservoir of 8 sterilizers in primary care was being filled with tap water. Inappropriate loads (e.g. wrapped or narrow lumen instruments) were processed in 13 (25%) of the bench-top sterilizers (8 in primary care, 5 in hospital).
Flexible endoscopes were traceable to patients in all LDUs where cleaning and disinfection took place. Their accessories however e.g. biopsy forceps, were not. Apart from these devices, no records were present in LDUs, which would allow traceability of instruments.
Storage of sterile goods was found to be a considerable problem in many local decontamination units. Sterile items were stored in the decontamination area in 15 (27%) LDUs.
2.3.4 Safe use of medical devices
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Key indicators of good practice |
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1. Medical devices designated as single-use by the Medical Devices Agency should not be re-used. |
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2. Stocks of surgical instruments should be sufficient to facilitate their effective decontamination |
Tonometer heads used in ophthalmology, designated as a single use item, were being reprocessed on 4 hospital sites.
Of the 56 LDUs included in the survey, 6 (11%) (4 hospital and 2 primary care) reported that they were reprocessing single use devices on cost grounds.
Staff commented that the surgical instrument inventory was too small to allow the "turn around" time required by a CDU in all except one CDU.
2.4 Conclusions
Examples of excellent practice, with modern, well maintained, validated equipment, in appropriate facilities with a controlled environment were found in the review. Staff were on the whole hard working. This shows that good practice 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. The following text summarises these shortcomings:
The management of the decontamination processes
Senior management control of the decontamination processes is limited. There appears to be no coherent policy on surgical instrument procurement. An approach, which links decontamination with the procurement of medical devices, health and safety and infection control, is lacking. There is little evidence that mangers were aware of the risk posed to staff and patients from inadequate decontamination. As a result quality systems for reusable medical devices in acute and primary care are rarely used.
Guidance at national and local level is not ‘user friendly’. Awareness of what constitutes good practice is often low. There is little documented training at all levels. Hard working staff are often conscientiously applying inappropriate decontamination procedures.
Central Decontamination Units
Many decontamination processes are being carried out in unsuitable environments, which constrain the ability to separate "clean" from "dirty" processes. There is no evidence that any washer disinfector complies with current performance standards due to a lack of testing. Many items of decontamination equipment are of an age, which indicates that they are likely to require replacement.
Matching trays of surgical instruments reprocessed in CDUs to the patient on whom they have been used is possible but with a few exceptions, this is not being undertaken.
Local Decontamination Units
A majority of LDUs are located in inappropriate facilities with no physical separation between clean and dirty processes. Almost all units demonstrated evidence of poor practice in one or more of the decontamination processes. This was common to both hospital and primary care sites. Many units were carrying out sterilization in clinical departments, which were also receiving the services of a CDU with no identifiable need for the LDU being evident.
As with CDUs, there was a lack of testing of washer disinfectors. A high proportion of sterilizers are not routinely used and of those which are, many are inadequately maintained with regard to on-going testing and calibration.
With the exception of flexible endoscopes, matching medical devices decontaminated in LDUs to the patient on whom they have been used is not possible.
The safe use of medical devices
A significant minority of units were reprocessing single use instruments. Current stocks of surgical instruments held by healthcare providers may be inadequate to permit the desired turnaround times for the decontamination cycle.