|Year : 2013 | Volume
| Issue : 2 | Page : 72-77
Risk management status of anaesthesia equipment using standards of Emergency Care Research Institute
Arefeh Mousavi1, Saeed Asefzadeh2, Ahmad Reza Raeisi3
1 Health Services Administration, Qazvin University of Medical Sciences, Qazvin, Iran
2 Research Center for Social Determinants of Health, Qazvin University of Medical Sciences, Qazvin, Iran
3 Health Management and Economics Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
|Date of Web Publication||4-Mar-2014|
Ahmad Reza Raeisi
Health Management and Economics Research Center, Isfahan University of Medical Sciences, Isfahan
Source of Support: None, Conflict of Interest: None
Context: Anaesthesia equipment failure can lead to incidents during anaesthesia and surgeries. A comprehensive system for risk management of anaesthesia equipment is necessary. Aims: Identify risks related to anaesthesia equipment, identify deficiencies and problems, provide solutions, planning and prevention from adverse event due to anaesthesia equipment in teaching hospitals in Iran. Settings and Design: Collected data were analysed in six dimensions. Then, the statistical comparisons between hospitals were done. Subjects and Methods: A descriptive-analytic study was designed. Instrument for data collection was a standard structured checklist that had been developed by Emergency Care Research Institute (ECRI). Checklists were filled onsite through direct observation and interviews with anaesthesia personnel in 46 operating rooms. Statistical Analysis: To statistical analysis one-way analysis of variance was used. SPSS statistical program, version 16, was used for performance all statistical analyses. P < 0.05 were defined as the level of statistically significance. Results: Descriptive statistics in this study indicated that total mean score of risk management status of anaesthesia equipment was 2.52 from the scale of 3. In the studied operating rooms, 69% complied with pre-determined standards, 14% needed improvement and 17% had no compliance. Routine check and alarm control were at good level. Maintenance, training, evaluation and monitoring and availability were at medium level. Conclusions: The risk management status of anaesthesia equipments in the studied hospitals are in good condition. The best means for prevention of adverse event-related anaesthesia equipment is using a viable and effective risk management programme. Development of programme in alarm control, maintenance, routine check, training and evaluation and monitoring of anaesthesia equipment is necessary strategy for this subject.
Keywords: Anaesthesia equipment, assessment, risk management
|How to cite this article:|
Mousavi A, Asefzadeh S, Raeisi AR. Risk management status of anaesthesia equipment using standards of Emergency Care Research Institute. Int J Health Syst Disaster Manage 2013;1:72-7
|How to cite this URL:|
Mousavi A, Asefzadeh S, Raeisi AR. Risk management status of anaesthesia equipment using standards of Emergency Care Research Institute. Int J Health Syst Disaster Manage [serial online] 2013 [cited 2022 May 20];1:72-7. Available from: https://www.ijhsdm.org/text.asp?2013/1/2/72/128117
| Introduction|| |
Anaesthesia equipment failure can lead to incidents during anaesthesia and surgeries. Adverse events related to equipment in operating rooms and especially anaesthesia equipment may be directly caused to malfunction. Also user error can be affected on incidents indirectly.  Problems with equipment are as one of important causes of injury to patient. , It is frequently reported in different studies. , Cooper et al., in a retrospective study indicated that equipment failure as second reason of adverse events in anaesthesia activity.  Cooper et al., in another study, indicated that 4% of the incidents with substantive negative outcomes involved equipment failure. 
Because of capital resources limitations, hospital equipment and anaesthesia machines are very old. Based on the important role played by this equipment in delivering safe services, currently hospitals are moving toward improving safety of anaesthesia equipment and use of new technologies. Although the usage from new technologies is effective step in reduction of anaesthesia risks due to from equipment failure, but this lead to little more attention to assessing, evaluation and monitoring of performance and safety of older equipment. A different study indicated that a programme for solving this problem and probably complications in them is necessary .
Several national and international organisations are having concerns about risk and events during anaesthesia, hence they have published checklists and guidelines for improvement of the status and determined compliance and incompliance with described standards and peruse anaesthesia equipment checking practices. , For this purpose they set up checklists for initiation of anaesthesia, during anaesthesia and in post-anaesthesia care unit.  Despite many activities in this field, checking practices is poor. , A few quantitative studies are done on management of anaesthesia equipment. , It seem that studies on identification of the risk factors related to anaesthesia equipment on adverse pre-operative and post-operative events are not comprehensive and sufficient.
Different approaches have been expressed about the risk management of equipment during anaesthesia. Therefore we try to investigate these aspects in this study. Assessment of these aspects helps us to identify the existing risk and provide the list of risks related to anaesthesia equipment. So, the aim of the present study is to assess the management status of risks related to anaesthesia equipment in academic hospitals in Iran, identify deficiencies and problems, provide solutions, planning and finally prevention from adverse events due to the anaesthesia equipment.
| Materials and Methods|| |
A descriptive-analytic study was designed in 2011 to assess management status of risks related to anaesthesia equipment in Iranian academic hospitals. Instrument for data collection was a standard checklist that had been developed by Emergency Care Research Institute (ECRI) in November 2007. , ECRI is an independent non-profit organisation whose mission is to benefit patient care by promoting the highest standards of safety, quality and cost-effectiveness in healthcare. They accomplish this through research, publishing, education and consultation. Goal of this institute is to be the world's most trusted, independent, organisation providing healthcare information, research, publishing, education and consultation to organisations and individuals in healthcare. The questions are gathered from important standards and guidelines of American Association of Nurse Anaesthetists, American Society of Anaesthesiologists and Joint Commission. , This checklist includes 57 questions about anaesthesia equipment risk management and assesses the hospitals based on the six dimensions including maintenance, routine check, training, alarm control, evaluation and monitoring and availability. Our study population were the hospitals of Isfahan University of Medical Sciences. Four hospitals were selected as sample in this study. The numbers of elective surgery beds in these hospitals were more than in other hospitals. At first, the relevant checklist was prepared through library and internet resources. Next, the researcher directly refers to hospitals. Checklists were filled through direct observation and interviews with operating room managers, anaesthesiologists and anaesthesia technicians in 46 operating rooms of four hospitals. Each room were surveyed for six consecutive days in one week.
Continuous, descriptive statistics were examined. The qualities data converted to quantities data and then these were compared together. Total score of 3 was selected for excellence status of anaesthesia equipment risk management in hospitals. Score 1-2 introduced as weak status, score 2-2.5 showed the medium level and 2.5-3 score as a good status. Collected data were analysed in six dimensions and expressed as means and percentile. Then, the statistical comparisons to assess significant difference in variables between hospitals were done. For statistical analyses, one-way analysis of variance (ANOVA) was used. SPSS statistical program, version 16, was used for performance of all statistical analyses. P < 0.05 were defined as the level of statistically significance. The authors had full access to the data and take responsibility for its integrity.
| Results|| |
Descriptive statistical comparison according to standards of the ECRI was done. Score mean of anaesthesia equipment risk management in A, B, C, D hospitals are indicated in [Table 1]. Total score was 2.52. Hence, Isfahan University of Medical Sciences Hospital's put in good level of risk management status. Also, analytical statistics showed a significant difference between mean of anaesthesia equipment risk management status in the four hospitals [Table 1].
|Table 1: The means of risk management status related to anaesthesia equipment in Isfahan teaching hospitals|
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Classification of hospital based on the determined standards showed that the mean of compliance standards is higher in B hospital than in other hospitals. In all of the considered hospitals, 69% of standards were complied with determined standards; 14% of determined standards needed improvement and 17% had no compliance. Needs improvement is defined as when planning was not exactly or implementation was not accurately [Table 2].
|Table 2: The percentile of observed standards related to anaesthesia equipment in Isfahan teaching hospitals|
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Total mean scores of maintenance, routine check, training, alarm control, evaluation and monitoring and availability is presented in [Table 2]. Comparison of these classified standards showed that no significant differences were observed among the studied hospitals. Overall, based on the total score, routine check had higher score (2.78) than other sections and standards. Alarm control with (2.50) score, put in the next place. Evaluation and monitoring with (2.24) had the lower score.
In B hospital, maintenance, routine check, alarm control, evaluation and monitoring had higher score, other information are presented in [Table 3].
|Table 3: The means of risk management status related to anaesthesia equipment startified by subsets in Isfahan teaching hospitals|
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This table indicates that the total status is in medium level in maintenance, training, evaluation and monitoring and availability. Only routine check and alarm control are in good level. Also, D hospital, only in evaluation and monitoring with (1.71) is weak. Hospitals in other situations were in medium and good level.
| Discussion|| |
Although problems due to fault equipment are not being eliminated but these are preventable and can be controlled. Indeed an effective strategy for prevention of problems and correcting these is necessary. 
Different approaches have been expressed about the risk management of equipment during anaesthesia. So in our study, these approaches were discussed and risk management status of anaesthesia equipment was considered. In the next stage, domains of risks related to anaesthesia equipment were determined. The result of our study indicated that risk management status of anaesthesia equipment at Isfahan University of Medical Sciences Hospitals have a similar pattern and are in good level. Thus, a common strategy, by related organisation to management of risks, is helpful.
The result based on classified risk factors indicated that status of anaesthesia equipment maintenance is in medium level. Hence, results based on ECRI standards reveal that these are not sufficient for promotion and improvement of equipment maintenance status; additional attempts are necessary. For realisation of this subject, a department such as biomedical/clinical engineering should design a documented preventive maintenance programme. Maintenance can be delivered by hospital staff or from an outside service organisation.
The studies showed that maintenance as a major dimension helps to promote care and preventive of adverse events due to equipment. Policies should be identified by which personnel must approve the representative's presence in maintenance, establish a time frame for receiving approval and ensure that the medical engineering department approves the device that will be used in anaesthesia. Methods for documenting needs representative approvals and forwarding documentation to anaesthesia services. Often, sales representatives bypass this approval and devices are used in these procedures. In such a situation, incidents occur and so this is necessary for the risk managers who investigate them. Policies also need to address who is responsible for the operation and maintenance of the device. 
Alarm of anaesthesia machines as other dimension has a major role in response from anaesthesia personnel. These can indicate the condition of the patients or bad condition of equipment.  Sometimes because alarms cannot keep up pace during surgery, these are silenced. This study observed status in alarm control, which is relatively good in all the hospitals. Based on the considered standards in this study, all the alarms on the anaesthesia machine should be checked to ensure audibility before induction begins. Audible alert sound should exist if any tubing or connection to a machine disconnects during the procedure or a detection of low fraction of inspired oxygen in the aspiratory portion of the anaesthesia circuit occurs. Also all bulk O 2 and N 2 O systems should have low-pressure alarms that are audible in each operating room. Audibility of all equipment must be checked daily and before any case. This study approved the result of previous study and consists on reduction of anaesthesia event through plans for better management of alarms. According importance role of an equipment alarm in preventing incidents during anaesthesia, Seagull and Sanderson in a study indicated that the organisation and management of alarms in environment is an aspect of the alarm problem.  Also, they interpreted the significance of development of effective alarm systems to promote and improve anaesthesia safety.  Hence, problems of anaesthesia alarms must be viewed as part of the risk management of anaesthesia equipment.
The results of our study indicate that the status of evaluation and monitoring of other dimension of anaesthesia equipment risk management was in medium level. According to recommended standards in diverse studies, anaesthesia and surgical team should closely monitor compliance with standards and take appropriate action to address non-compliance in anaesthesia processes. This study indicated that deviations of standards should be detected and cautioned. 
Some anaesthesia machines are faulty but these are not detectable because those are not unusable. So those are not tagged immediately and are not taken out of services and can create problems during surgeries. So, the routine checks of machines are inevitable task. The result of our study indicated that the studied hospitals in 'routine check' are in good level. But for achieving to excellent level, check up of the anaesthesia system should be strengthened at least before the first case every day.
'Routine check' as other domain of anaesthesia equipment risk management includes high and low pressure system, breathing circuit, ventilator, gas flow, manual ventilation system, backup battery, hypoxic guard, O 2 monitors and alarms, O 2 flush function, vaporiser function and interlock, backup cylinder supplies, connection and proper function of the scavenging system, proper function of suction, adequacy of CO 2 absorbent, proper function of physiologic and gas monitors, availability of emergency ventilation equipment. The studies showed that a systematic programme for routine check of the anaesthesia equipment and machines by clinicians decreases probability of an accident. Charles et al., indicated that a check of the equipment just before use also will be effective in detecting concealed fault and decrease of incidents.  Stefan et al., discussed that anaesthesia machines should be checked by anaesthesia technicians early in the morning before the first usage by the anaesthesia provider.  Groves et al., found that the use of the visual aid produced based on the checklist of the Association of Anaesthetists Britain resulted in overall improvement in fault detection. 
This study indicated that the health organisations need to review their current policies on anaesthesia equipment checks, and attempt to improve teaching programme as the major step in improving patient safety in anesthetised patients.  Although adverse event related to equipment are uncommon but it is as a major concerning for anaesthesia personnel and anaesthesiologists especially as described earlier. , Many studies demonstrate that anaesthesia personnel cannot detect 70% of fault equipment because adequate training in use of checkout procedure does not exist.  Safe performance with medical devices and especially anaesthesia system is a major element in medical activity in critical care environments too.  This subject illuminate the importance of a comprehensive system for training in risk control of anaesthesia equipment to preventive and reduction of anaesthesia mishaps due to malpractices of personnel and training ways to detection characters of fault machine. Therefore, anaesthesiologist and residents should be able to manage these conditions and effectively measure skills of them in managing anaesthesia equipment failure.  Michael et al., indicated that detection of fault anaesthesia machines is improved after intensive instruction.  Investigation of training status indicated that educational standards to work with anaesthesia equipment base on recommended standard by ECRI put in medium level. Therefore, training to improve staff awareness in exploration and diagnosis of anaesthesia equipment defects is a necessary task. An arrangement of anaesthesia equipment simulations could be used to assess personnel skills in management of equipment and assure that these skills are obtained through training.  Design of multiple scenario assessment is an effective method to evaluate individual performance in detection of equipment failure. From these result, we can use from successful current methods for acquiring skill in managing adverse events due to equipment.  Thomas and Galvin identified and classified the incidents related to equipment in critical care. They concluded that adverse events are often the result of false use of equipment, and training of personnel improved them.  We can use anaesthesia simulator as a novel approach to train anaesthesia personnel in the detection of machine faults. 
According to the need for receiving the best care and advanced technology, today's hospitals should prepare the complex medical equipment and essential devices for delivery of care to patients.  This is basic for preventive of incidents due to faulty equipment or availability to equipment and devices in emergency situation. Kumar et al. surveyed the anaesthesia machines and ancillary monitors in 45 hospitals. They conclude that proper regular maintenance, update or replacement of equipment as needed, use of appropriate monitoring devices and a peruse equipment checklist may help in improving the quality of patient care and decreasing the morbidity and mortality associated with anaesthesia equipment. Also this study concludes that state departments of health should be encouraged and must conduct regular inspections of equipment.  This study concludes that checklists can be valuable in routine aesthetic practice to improve patient safety. 
| Conclusions|| |
Overall, in spite of good status of risk management of anaesthesia equipment in this study, it seems that the techniques require considerable improvement when compared with European standards expressed in ECRI.
According to the results of this study, the risk management status of anaesthesia equipment in studied hospitals is in good level. Hence, we can expect that the patients be exposed to a few incident-related anaesthesia equipments. As regards that no significant difference was observed among four hospitals in different dimensions, risk management status of anaesthesia equipment was almost similar to each other and a policy for all of the academicals hospitals in Iran via relevant organisations can help to improve and achieve higher levels in management of risks related to equipment in anaesthesia and surgical wards.
[Figure 1] Shows that the status anaesthesia equipment risk management has a partly similar pattern in the maintenance, routine check and training in all of hospital. Despite that the steep of chart rise in alarm control in B, C, D hospitals, but this dimension was decreasing in A hospital. D hospital indicated the steep of chart declined in evaluation and monitoring dimension
|Figure 1: Pattern of risk management status related to anesthesia equipment stratified by subsets in Isfahan teaching hospitals|
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In general, the best means for prevention of adverse event-related anaesthesia equipment is using a viable and effective risk management programme. The hospital managers and medical engineering should be aware of the available risks and base on the recommended standards, establish the clarification and comprehensive system for management of these risks. Based on the standards of ECRI, firstly all equipment in Isfahan University of Medical Sciences Hospitals must be commensurate with the modern medicine, volume of services and presented care. Next, management system should include development programme for control of alarms, maintenance of anaesthesia equipments, quality improvement and risk management. Thirdly, education to personnel in working with anaesthesia cars and doing right tasks should be delivered. Fourthly, a schedule of ongoing monitoring and evaluation conformity with published standards for checking procurers and systems to exploration of damages and prevention of probability risks is inevitable. Based on ECRI, operating rooms should be reviewed once a year by the risk manager or the chief of anaesthesia and the clinical engineer responsible for maintaining the anaesthesia equipment. Additional review should be considered when significant organisational changes such as the introduction of new procedures, facility changes, equipment changes and new guidelines or practices happen. Finally, work practice controls, personal protective equipment, modification of procedures to improvement of activity should be considered. It is suggested that for future study, factors such as event reporting and work practice, human error as most common cause of medical device mishaps  be evaluated in these teaching hospitals.
| Acknowledgement|| |
The authors would like to acknowledge and appreciate from all of hospital managers and other participant in interviews that help to reach to object of this research
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[Table 1], [Table 2], [Table 3]