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• W2313888325 abstract "Editor, Recent studies from France1 and United Kingdom2 on device-related adverse events show that the use of medical technology plays an important role for the provision of well tolerated anaesthesia. As Germany does not have a national database for adverse events, learning from medical device related incidents is generally limited to an in-hospital level and is often based on only a few voluntary incident reports.3 The dissemination of knowledge on device-specific risk situations is therefore slowed down and opportunities for inter-organisational learning to enhance patient and staff safety are reduced. With a focus on anaesthetic machines and ventilators, we screened and analysed anaesthesia device related voluntary incident reports gleaned in 2010 from three co-operating hospitals of the German state of North-Rhine Westphalia, as well as from the website of the German Patient Safety Optimizing System (PaSOS). The analysis of reports was performed by an interdisciplinary team consisting of an anaesthesiologist, the head of medical technology, and an economist who specialised in incident reporting. It was based on descriptions in the title and free text of the report form in addition to relevant data on severity, frequency, location and time of the incidents. Reports were classified as equipment failure or user/application error, with the latter further subdivided into different types of unsafe acts as defined by Reason.4 We also aimed to determine whether incidents could have been avoided by a preanaesthetic equipment check and at what stage of device usage they were first detected by staff. Finally, the reported types of anaesthetic equipment were categorised, and similar and frequently mentioned risks recorded. A total of 151 critical incident reports were analysed. Of these, 104 (69%) resulted from user/application errors, 36 (24%) from equipment faults and 11 (7%) could not be classified because of insufficient information. Of the non-equipment errors, 69 (66%) were classified as violations and 35 (34%) as errors. In the violations category, routine violations of device testing procedures were most frequent. A total of 92 incidents (61%) were originally caused during preparation of equipment, 46 (30%) while connecting or using the equipment, six (4%) during postprocessing and seven (5%) could not be classified. In contrast, 129 incidents (85%) were first detected while connecting or using the equipment. Of these, 67 (52%) could have been prevented during preparation by a properly conducted pre-use check of the anaesthetic equipment. Table 1 lists the ten most frequently occurring risk situations and equipment faults that made up 52% of the overall reported critical incidents. A total of 63 incidents (42%) involved only the anaesthetic machine, while the remainder (58%) involved at least one additional component, reflecting the special risks of a highly complex work and equipment environment. According to the staff involved, the severity of patient harm could have been ‘serious’ in 43 incidents (28%) and ‘very serious/fatal’ in 44 (29%). For 66 incidents (44%) the frequency was reported as ‘seldom/rare’ and for 34 (22%) as ‘singular/very rare’. Filtering of reports, however, revealed that this individual low rating could also be found in some of the frequently occurring risk situations reported in different healthcare facilities.Table 1: The ten most frequently occurring causes of voluntary reported critical incidents related to anaesthetic machines and ventilatorsIn summary, the incidents analysed were primarily caused by organisational and managerial conditions influencing human performance, rather than by lacking or misapplied expert knowledge. Our results indicate, however, that proper checks prior to equipment use (to ensure completeness and correct functioning) might have identified and avoided many of the voluntarily reported critical incidents. Thus, our findings are in agreement with previous studies showing that routine violations of this principle in practice constitute an important factor in patient safety in anaesthesia.5 To avoid a ‘normalisation of deviance’, a safety culture is required that neither tolerates such behaviour nor necessitates it, for example due to undue time pressure.6 It is the hospital management's responsibility to create the required conditions. An established safety culture, optimal structures/procedures, training/practice in routine procedures/simulations and organisational learning are essential principles and strategies for healthcare organisations to address safety aspects and routines.6 Our results give a first impression of the causes of frequently reported critical incidents related to anaesthetic machines and ventilators. It may improve safety to sensitise staff to single serious or most frequent risk situations and equipment faults in medical device user instructions. Hospitals can additionally strengthen their internal risk management strategies7 by considering interorganisational risk knowledge on equipment-related critical incidents for procurement planning or anaesthesia training. Finally, a number of limitations must be kept in mind. Voluntary incident reports constitute only a fraction of the device-related incidents that occur during the 10 million anaesthetic procedures performed in German hospitals every year. Further studies pooling more anaesthesia device related reports from different healthcare facilities are needed. Other limitations relate to the accuracy of the database of incident reporting that may be affected by factors such as lack of time, feedback and legal concerns, and reporter subjectivity. Furthermore, the quality of reported data is limited in some cases. This is mainly due to incomplete report forms and varying degrees of information in title and free text, which do not always give a clear picture of the event sequence. Our available results, therefore, do not permit a quantitative assessment but do provide a first description of the type and causes of reported incidents related to anaesthetic equipment in German hospitals. Acknowledgements relating to this article Assistance with the letter: the authors thank Marcus Rall, MD, and Head of InPASS – Institute for Patient Safety & Simulation Team Training. Financial support and sponsorship: the study has been developed in context of research project titled ‘Knowledge Communities in Medical Engineering’, supported by the Federal Ministry of Economics and Technology on the basis of a decision by the German Bundestag (support code: VI B 2-00 30 70/27). Conflicts of interest: none." @default.
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• W2313888325 date "2014-05-01" @default.
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• W2313888325 title "Many critical incidents could be avoided by preanaesthesia equipment checks" @default.
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