« Previous | Contents | Next »
Listen
Section 4: Discussion
4.1 Scope
The data set was analysed by a multi-professional team with expert knowledge in decontamination and data handling / IT skills. The analysis focussed on the issues raised by the NI incident and the immediate actions sought on publication of HAZ(SC)04/05. If these actions had been implemented fully, one would have expected no non-compliances to be identified by the relevant elements of the EDAT review. However, the analysis would also be expected to identify any shortfall in other aspects of decontamination practice including the extent of non-compliance with SHTM 2030 and MDB 2000(5).
The questions did not address to any great extent the environment in which decontamination was carried out, the management structure, quality control procedures, traceability or staff training. A fully comprehensive review of endoscope decontamination would include also other important topics such as the design and furbishment of reprocessing facilities ( ERU), the transport of endoscopes before and after reprocessing, other decontamination processes such as sterilization, procurement and risk management.
There are no data available on the total number of endoscopy units. It was not possible, therefore, to estimate the level of response. However, data were received from all 15 NHS Boards and the range of endoscopes reported covered the broad spectrum of endoscopic activity. The findings may be regarded as broadly representative; the addition of further units is considered unlikely to change the overall picture.
4.2 Methodology
The review tool has produced a qualitative and quantitative technical dataset describing practices in endoscope decontamination across Scotland - November 2004 to May 2005. By producing EDAT as both a web-based application and CDROM, the 'self-assessment' tool was available for rapid distribution to users. The data has been collected in a standardized form, eliminating transcription error from questionnaire to database. In this form, or with further modifications to the question set as required, it is available for repeated application in on-going local and national reviews.
Although based on the questionnaire used by Northern Ireland, EDAT is more comprehensive and provides more detailed data on endoscopes, reprocessing equipment and practices. It is not limited to examination of issues related to flexible gastrointestinal endoscopes, as in the initial incident, but equally was not designed to address all aspects of decontamination equipment, facilities and management.
EDAT was issued for use as a self-assessment tool. Its effective use required both a basic IT competency and knowledge of the fundamentals of decontamination.
Where problems were encountered with the IT system, the provision of a support desk facility at HPS proved invaluable. By this means, it was possible to resolve the problems encountered. Most problems related to a failure to comply with the instructions provided with EDAT.
SEHD assigned (see Appendix 4) to NHS Boards' nominees the responsibility for ensuring the accuracy and completeness of the endoscopy decontamination dataset. HPS reiterated this in the 'instructions for use' provided with the software (see Appendix 5). The dataset included record fields for the name and contact details of the person responsible for the review and the name of the reviewer who collected the data. These data fields were completed for almost all the returned datasets.
Appendix 6 summarises the types of professional responsible for returning the datasets. It is apparent that, in almost all instances, the staff responsible for collecting the dataset (and ensuring its accuracy and completeness) were professional staff either directly involved in endoscope decontamination or were in close and direct consultation with those directly involved in decontamination of endoscopes.
The recorded responses have indicated gaps in knowledge of decontamination basics, e.g., failure to distinguish between a detergent and a disinfectant. This was despite the clear guidance in the instructions that accompanied EDAT on suitable personnel to participate in the review. This reinforces the value of using trained reviewers making direct observations in an independent review.
One potential weakness of a self-assessment is that the answers given may be skewed to provide what the reviewer thought should be there rather than what is actually there. The extensive nature of non-compliant responses would support the view that the reviewers had not been other than fair.
There is no mechanism within the EDAT tool, or the self-audit approach, to give complete assurance as to the accuracy of the data. The accuracy is entirely dependent on the personnel completing the review report forms.
As reported above (para 2.2.5), there were two areas where intervention was required to secure the integrity of the data. During the upload process some submissions suffered a loss of data. When this was detected all participants were requested to resubmit their data by a different route ( CDROM, or Email) and these data were used for analysis. When checking the integrity of the data it was noted that some reviewers had erroneously completed separate reviews for each endoscope in the same unit. This was obvious from the repetition of the same 'unit' for a number of endoscopes. These data were combined into one unit with a number of endoscopes.
This report discusses the analyses completed to date. It is evident that the data set is sufficiently comprehensive to allow further analyses, for example to compare specific sites and specific types of clinical unit.
As outlined previously data were anonymised prior to analysis by an experienced professional with specific expertise in endoscope decontamination. These analyses were independently verified by one or more similarly qualified professionals. This assured the robustness of the analyses. However, because the analysis was carried out using anonymised data, the findings for individual sites cannot be identified. Therefore, feedback on the analysis for each participating site is not possible.
The preliminary findings of the review were shared with SEHD Sterile Services Review Group (Glennie Group). Discussion took place on their significance. The Group's views were taken into consideration by HPS in framing the recommendations of this report.
A draft of the report was sent to the Scottish Action Group members for their comments and amendments were made. Before being finalised the report was reviewed by HPS professionals not directly involved in the review and further amended.
4.3 Results
The tool required individual sites to identify clinical units where endoscopy is carried out, identify the number and type of endoscopes and automated endoscope reprocessing machines and to record key aspects of the total decontamination process from patient use to re-use. This information has been used to provide a valuable over-view of current national practices. For participating sites, the process of identification, observation and recording practices for manual and automatic endoscope decontamination will have continued to raise local awareness and reinforced the actions given in the earlier publication of HAZ(SC)04/05.
4.3.1 Identification of units that undertake endoscopy
It is clear from the data submitted that endoscopic procedures are widely undertaken by healthcare providers in Scotland.
The range of clinical units in the EDAT analysis covered all five categories listed (endoscopy suite, operating theatre, outpatient department, primary care clinic, day surgery unit) but included only one primary care unit. Information on the nature and extent of endoscopy and endoscope reprocessing in the community is essential for the planning of effective decontamination overall but is likely to have been under-reported in this study. Other initiatives aimed directly at primary care, such as PCAT, may provide the impetus for a more comprehensive audit of local endoscope reprocessing.
4.3.2 Identification of sites that undertake endoscope reprocessing
Most endoscopes were reported as being reprocessed within their clinical unit, thus minimising the risks associated with transport of dirty and cleaned devices between locations. The reason for choosing an off-site reprocessing unit (nine of 153) was not sought in this questionnaire. The expectation would be that this offered better facilities for decontamination and preferably the full facilities of an endoscope reprocessing unit ( ERU). However this option would also have a number of disadvantages, for example delays in residual soil removal and extended 'turn-round' time. Local decontamination planning should include verification of any off-site processing as meeting best practice guidance.
Care must be taken to ensure that the conditions of transport for endoscopes, whether off-site or within the same site, are secure and do not permit damage or recontamination of the reprocessed device. There must be a facility to decontaminate the transport containers after each use. These aspects were also outwith the scope of the EDAT questionnaire.
4.3.3 Identification of endoscopes
The complementary database of recognised models of endoscope ( EMID) created from the information supplied by endoscope manufacturers on EDAT endoscopes has proved to be a valuable tool in assessing the accuracy of information on each endoscope reported by the clinical unit.
Only 59% of endoscopes of recognised model number gave a complete match for the different channels. Failure to recognise and/or record specific endoscope details has a number of implications, particularly if endoscopes are sent off-site for repair or loan. Details such as model number and serial number are frequently marked on the device but limitations of size and deterioration (possible chemical effects) over time may hinder clarity. Units are recommended to record the various identifiers for each endoscope at the time of purchase.
The confusion of the CE mark with its notified body code for either a model number or serial number is of concern because this combination of letters and numbers is likely to be found on more than one endoscope in a unit (as observed in this study). It confirms the compliance status of the device manufacturer under the Medical Device Directive 11 as accredited by a specific notified body. Unlike the serial number, it is not a unique identifier for the device. Use of the CE mark/ NB code in error or as the sole record for traceability would confound the system.
The lack recognition of manufacturer and model number has important implications for endoscope decontamination. Reprocessing instructions supplied by the endoscope manufacturer may have general application but will also include specific requirements such as valves to be dismantled or channels to be irrigated, dependent on the model. Advisory Notices issued by manufacturers. Hazard Notices and MDA Alerts also require awareness of model numbers. In the forthcoming standard for EWDs, ( ENISO 15883-1 13, -4 14) information on endoscope types/model numbers is required to be supplied by the EWD manufacturer to confirm ' those devices and/or device families for which the EWD manufacturer has evidence that they can be processed satisfactorily and any precautions necessary for particular devices or operational conditions' and from the user ' to list all types of endoscopes and devices that the user intends to process in the EWD'. Confusion or misunderstandings about specific models could result in the attachment of an ill-fitting connector designed for a different model or the processing of an endoscope in an EWD with which it has already been stated to be incompatible.
4.3.4 Identification of channels in endoscopes
The importance of identifying channels in endoscopes has been stressed in recent notifications, including HAZ(SC)04/05, following the NI incident. The review described in the Hazard Notice required identification of channels for various purposes:- to identify channels that cannot be decontaminated in an AER, to identify channels that are not used during every procedure and to confirm that all channels of each endoscope are accessible to the decontamination process.
It is evident from the comparison of channels reported for recognised model numbers of endoscopes in EDAT with the matched EMID data, that the recognition of channels remains problematic. As long as this situation remains, effective decontamination will be compromised. Endoscope manufacturers provide a range of information on channels in training manuals, through training courses and in specific notification of design features that may require particular attention for decontamination. It is possible that this information does not effectively reach those responsible for endoscope decontamination. The analysis related to the KeyMed advisory notice in respect of certain Olympus endoscopes is illustrative of the difficulty if such information is neither received nor acted upon. More direct means of permanently indicating the presence of specific channel/s, for example by colour coded markings or specific codes on the device may assist. Model number and serial numbers are already directly marked on endoscopes and manufacturers have successfully affixed CE marks onto devices to meet current regulations.
4.3.5 Availability of information about the device and its reprocessing
Instructions provided by the endoscope manufacturer should be readily available to all those using or decontaminating the endoscope. This may not be easily achievable as the device moves between clinical use and reprocessing facilities, which may be on different sites.
As with other reusable devices, endoscope reprocessing units should ensure that they have all necessary information about each endoscope (including the number and type of channels) and the manufacturers' instructions for reprocessing before agreeing the decontamination procedures. This information, presented in as accessible and visual form as possible, should be available throughout the decontamination process i.e., at the clinical area and in the endoscope reprocessing unit.
Irrespective of the quality of any connector necessary for the EWD or LCD, (and the importance of this being a correct attachment in all respects cannot be overemphasised), the role of the operator in knowing that a channel exists and physically making the correct attachment is vital.
4.3.6 Availability of endoscope reprocessing equipment
The reprocessing of endoscopes by manual processes only, unless specifically confirmed by endoscope and automated equipment reprocessing manufacturers, is in conflict with current best practice. The use of a 'stand' for endoscope decontamination should be reviewed and a compliant alternative sought.
The use of LCDs, lacking a cleaning stage, in preference to EWDs in some units is surprising. These units would either have to rely on manually cleaning alone, which falls short of good practice or use an EWD in addition to the LCD. This has happened in some units but it raises the question as to why an LCD is needed in addition to the EWD. A validated EWD in compliance with current guidance will provide high level disinfection and drying as in the LCD, and in some cases would be using the same disinfectant. The issue about connectors in the LCD and importance of validating the penetration of disinfectant into all the endoscope channels is critical. If the expectation is that the LCD would provide a higher level of disinfection that that provided by the same chemical in an EWD or that the device would be sterilized, as claimed by the manufacturer, Steris, in some literature, then this needs to be demonstrated by validation to BSENISO 14937 27. The commitment to detailed and independent programmes of tests to demonstrate continued compliance with SHTM2030 and BSENISO 14937 would require an improvement on the current position which relies predominantly on the LCD manufacturer for testing, and typically for planned preventative maintenance only.
4.3.7 Decontamination process stages
The results indicate that considerably less than half the endoscopes were cleaned and disinfected by the 'preferred method' which is derived from current guidance and endoscope and EWD manufacturer's instructions. However, when allowance is made for endoscopes in which the channels were not correctly identified the overall estimated rate of compliance with the 'preferred method' fell to 17%.
The demonstration that the decontamination process for some endoscopes was incomplete or not done for all channels may be balanced against the observation that some endoscopes received full processing using all process stages in line with best practice guidance. The shortfall is disappointing, given the nature of recent guidance and the expectation that these issues would have been dealt with by local review.
Flushing stage
The reported failure to flush any channels before removing the endoscope from the endoscopy equipment and transferring it for further processing will compromise subsequent decontamination phases. Removal of bulk soil and contamination should be undertaken as soon as possible, minimising the tendency for contaminating material to dry or otherwise collect in the lumened device.
Visual inspection to ensure free flow of water
This stage appears to be applied in most cases with very few recognised channels omitted from this check. However, the failure to recognise a channel and therefore exclude its inspection for patency will further contribute to the implications for channel blockage on the overall decontamination process, particularly for the narrowest lumens that are difficult to clean manually.
Manual cleaning stage
The reported failure to manually clean channels of various types is of concern. Manufacturers provide instructions for reprocessing endoscopes which includes all channels, even those with the most narrow lumen which may require specific equipment for example syringes for effective irrigation. All channels should be cleaned, irrespective of whether the channel has been used in the clinical procedure, or not.
The failure to manually clean channels before processing on the EWD may result in restriction of flow for both cleaning and disinfection in the automated irrigation. Depending on the monitoring capability for each channel on the EWD, this restriction may remain undetected and the decontamination outcome compromised. Even with the improvements in EWD performance. In the new standard ENISO 15883-1,-4 the EWD manufacturer's instructions are required to recommend that any requirements for manual cleaning prior to be processing should be followed. Performance tests of cleaning efficacy at validation allows for any recommended pre-treatment eg cleaning to be included as part of the test procedure. Users of the EWD should be aware of the process limits set at performance validation for cleaning efficacy using an agreed procedure and should not deviate from this procedure without re-validating the process.
Prior cleaning is essential for LCDs, such as the Steris system, because no cleaning stage is included in the automated process.
Disinfection stage
Again, channels across the range were reported as not disinfected by manual or EWD processes. The majority of endoscopes were disinfected using automated processes, which is the preferred process because it can be validated for individual endoscopes or 'families' of endoscopes and, unlike a manual disinfection process, minimises exposure of the user to the chemical disinfectant. Some manufacturers may recommend manual disinfection alone for a specific endoscope and this instruction may be based on the lack of evidence of a compatible EWD or LCD. Such restrictions need to be reassessed in the light of developments in EWD design which may increase the range of compatible devices.
The conclusion that less than half the endoscopes had their 'known' channels cleaned and disinfected by the preferred method (flushing, inspection for free flow of channel rinse water, manual irrigation with detergent, single use brush, automated cleaning and disinfection in EWD) indicates a serious shortfall in good practice.
4.3.8 Manual cleaning procedure and facilities
Deficiencies in equipment and facilities include the lack of a dedicated sink for manual washing, limited space for accommodating the endoscope during disassembly and reassembly and, in single reported instances, the reuse of single use brushes and the failure to reprocess re-usable brushes. The detergents used included products, which were not formulated for the cleaning of medical devices, most notably the use of surgical handwash formulations. Mains water was typically used for rinsing although some units had improved the quality of water by specific treatment (softened or deionised) or the use of bottled rinse water. Of greater concern was some manually cleaned endoscopes were not rinsed. Carry-over of detergent residues into the next stage, which in some instances may be manual disinfection, could interfere with the process efficacy.
4.3.9 Endoscope reprocessing equipment
The EWDs ranged in age from 1 year to 12 years, with a median age of 4 years coinciding with the publication of SHTM2030, which was predated by similar guidance in England. Manufacturers of EWDs would by that time have been designing machines to meet the extant guidance and the more recent purchases should provide all the required cycle stages. Over the whole range of EWDs there were variations in specification, which reflects the age span. For future purchases, attention is drawn to the new standard ENISO 15883-1,-4 on endoscope washer disinfectors which is being prepared for publication, also as a British Standard, in 2006.
The types of detergents reported for use in the EWD included various inappropriate products such as disinfectants and general-purpose detergents, not formulated for device cleaning. Relatively few reports were given for chemical disinfectants and again, there was some confusion between detergents and disinfectants. It is assumed in these instances that this was lack of awareness on the part of the reviewer rather than an accurate record of the process chemical used in the 'disinfection' stage. In this respect, as with earlier issues, it highlights the need for on-going training in technical aspects of decontamination.
EWDs are complex items of equipment, which are relied upon to achieve automated cleaning and disinfection. The lack of evidence to verify this capability on installation in the unit and throughout the equipment's use i.e., by validation and subsequent testing is demonstrated by the observation that only one in four EWDs are tested periodically for cleaning efficacy. Even fewer units tested the eluate from rinsed endoscopes for process residues, to confirm cleanliness of processed devices in clinical use. The efforts of those clinical units undertaking these important performance tests is commendable.
The chemical, microbiological and endotoxin quality of final rinse water is important as it determines the final quality of the device before use on the patient. Contaminated rinse water will potentially negate the effects of previous cleaning and disinfection and provide a source of microbial and other contamination in the endoscope and EWD. Relatively few units tested the quality of chemical or microbiological final rinse water, although some reported programmes of testing including weekly microbiological tests.
Advice on validation and test programmes for EWDs is available from AP(S) and just over half the sites reported the involvement of an AP(S) for some of their reprocessing units. It is evident that not all sites are taking aboard the guidance available from such sources. Only one in five EWDs were validated with full programmes of on-going testing, as described in SHTM2030. This may reflect a shortfall in trained test persons which would need to be addressed before this aspect of decontamination activity can be brought up to the required level.
Planned preventative maintenance of EWDs and LCDs was largely undertaken by the equipment manufacturers. The development of training for in-house engineering staff may extend and enhance this provision.
As in other decontamination reviews, an important objective to remedy some of the reported deficiencies is by the development of training programmes in decontamination for all staff involved in reprocessing. Opportunities should be taken to share good decontamination practice across the various professions.
4.3.10 Remedial action
The findings of the report strongly suggest that following best practice guidance to keep the risk of infection from endoscopy as low as possible in healthcare settings in Scotland, cannot currently be guaranteed. One can therefore assume that there is an increased risk of patients undergoing endoscopy being exposed to infective agents over that which could be achieved if there were strict adherence to best practice guidance. Although the risk remains low, and is greatly outweighed by the benefits of the procedures, remedial action to correct these deficiencies is essential. Should there be an adverse incident following endoscopy, healthcare providers not following best practice guidance may find themselves legally liable even if there was scant evidence for transmission of infection directly from the endoscopic procedure. Furthermore, the publicity surrounding such an event could, in the current climate of concern about healthcare associated infection, lead to significant public anxiety. It would be against the patients' best interests if this were to deter them from undergoing endoscopy
Four factors have been identified as underlying the problems identified in the previous sections and requiring remedial action:
1. Training for staff involved in endoscope identification and decontamination. There is a need for a standardised method for delivering training and assessing competency and skills. The training must include the correct identification of endoscopes, their channels and the decontamination procedures necessary for each type of endoscope.
2. Inadequate facilities for manual cleaning.
3. More careful consideration to equipment procurement in particular to ensuring that endoscope washer disinfectors fit the requirements of the endoscopes being cleaned and vice versa;
4. Validation and periodic testing of EWDs by qualified staff.
The most important remedial action is to ensure that the requirements of the HAZ(SC)04/05 have been fully implemented. Medium to longer term action is required on the factors described above. Remedying them will entail not inconsiderable effort. This should be coordinated through an agreed National strategy and should only be commenced after a review of current priorities related to the control of HAI and in particular those related to medical device decontamination
« Previous | Contents | Next »