Peer Review Article | Open Access | Published 16th July 2024
Inventory of the Sterilization Units at a Tertiary-Level South Tunisian University Hospital
Mouna Baklouti¹, Houda Ben Ayed¹, Mariem Ben Hmida¹, Nouha Ketata², Afef Bouazizi¹, Hbiba Hosni¹, Mariem jebli¹, Mondher Kassis³, Sourour Yaich², Jamel Dammak² | EJPPS | 292 (2024) | https://doi.org/10.37521/2903 | Click to download pdf
Abstract
Sterilization of reusable medical devices (RMD) is considered as one of the major components of healthcare associated infection (HAI) prevention that should be strictly maintained. Microorganisms responsible for HAI can be transmitted from a common inanimate vehicle such as medical RMD to patients. Sterilization is a complete process with a set of successive steps to finally achieve a sterile RMD. In addition to these steps, which must be carefully controlled, the whole environment of this process should also conform to quality and security standards and criteria in order to ensure a robust sterilization process and a secure RMD. Therefore, a complete and exhaustive evaluation of this process is highly recommended. This evaluation aimed firstly to examine the inventory of sterilization process, architecture, and environment as well as to present recommendations to be adopted to adjust the practices and failures recorded accordingly.
1.Introduction
Methods
The sterilization process should be the subject of a complete and exhaustive evaluation to ensure good quality of care. This study aimed to give an update about the inventory of the sterilization units at a university hospital in Southern Tunisia and to propose preventive recommendations to adjust practices’ non-conformities.
This was an exhaustive cross-sectional study conducted using an audit grid during the period May 22nd 2023 to Jun 8th 2023 in all sterilization units (13) of a university hospital in Southern Tunisia. Conformity as well as security rates and scores out of 100 were calculated for each unit.
Results
The mean global conformity score was 46.2±16.4/100. For the evaluation of the sterilization environment, the median global conformity scores of architecture, equipment, and personnel were about 60/100 (Inter Quartile Range (IQR)=[50-66.6]),7.69/100 (IQR=[7.69-20.19]), and 60/100 (IQR=[20-63.33]), respectively. As for the evaluation of the sterilization process, the median global conformity score of the pre-treatment step was 25/100 (IQR=[0-78.75]). It was 50/100 (IQR=[25-75]) for the packaging step. Traceability was respected in only two evaluated units (15.4%). Global security scores for patients, healthcare professionals, environmental and traceability were 34.54/100 [21.89-44.61], 58.4/100, 60/100, 14.28/100 and 50/100, respectively.
Conclusion
The low conformity and security rates revealed major malfunctions in the sterilization process notably for equipment, pre-treatment step, and traceability. Thus, there has been an urgent need to apply for corrective measures and to plan the sterilization centralization.
Highlights
Low conformity rates revealing major malfunctions in the sterilization process at a university hospital in Southern Tunisia
The most critical situation was noted for equipment, the pre-treatment step, and traceability
Urgent need to apply corrective measures and to plan centralization of the sterilization in order to ensure good quality of care
Keywords: Audit/ Inventory/ Reusable medical devices / Recommendations / Sterilization.
Introduction
Healthcare-associated infections (HAI) are some of the most frequent types of adverse events affecting hospitalized patients ¹. They are also a significant cause of excess number of deaths as well as morbidity prevalence and costs for hospitals. Recently, the World Health Organization (WHO) reported in the global report on infection prevention and control, that HAI prevalence was 7% in acute-care hospitals in high-income countries, and double that (15%) in low- and middle-income countries during hospital stay ². In Tunisia, the prevalence of this infection ranged between 9% and 14% (3–5). Although these infections are widespread in health-care structures, up to 70% of them are preventable ⁶. HAI control and prevention are based on standard precautions ⁷. Of these, sterilization and disinfection of the reusable medical devices (RMD) are considered as one of the major components that should be strictly respected to prevent surgical site infections ⁸. In fact, microorganisms responsible for HAI could be transmitted to patients from a common inanimate vehicle such as RMD to patients ¹. In addition to the intrinsic factors related to the patient's immune status and the severity of the pathology for which he is hospitalized, HAI could be a result of using invasive procedures such as the administration of temporary devices. Moreover, contact with RMD can expose patients 5 to 10 more times to HAI ⁹. Thus, the treatment of RMD must have a prominent place in any HAI prevention strategy. It differs according to the material type used as well as to the criticality or the infectious risk associated with it. Sterilization is recommended for critical or high-risk RMD¹⁰. In fact, these devices require a high-level of infection control since they are introduced into sterile or vascular cavities, which exposes patients to serious infections that can affect their vital prognosis.
Sterilization is a complete process with a set of successive steps to finally achieve a sterile RMD. In addition to these steps which must be carefully controlled, the whole environment of this process should be also conformed to quality and security standards and criteria in order to ensure safe sterilization and then a secure RMD. The obligation to control the environment in the workplace and specifically in sterilization units, is therefore well evidenced ¹¹. Consequently, a complete and exhaustive evaluation of this process is highly recommended.
In the university hospitals of Sfax governorate, a capital South Tunisian region providing medical care to patients across the south of the country, there were missing data about the evaluation of the inventory of the hospital sterilization units. In light of this, this study aimed to give an update about the inventory of the sterilization process, architecture, and environment at a university hospital in Sfax, and to propose preventive strategies to adjust the recorded practices and failures, accordingly.
Methods
Study design and settings
This was an exhaustive cross-sectional study conducted during the period between May 22nd 2023 to Jun 8th 2023 in all units involved in the sterilization process at a university hospital in Southern Tunisia, a referral hospital in the region with an essentially medical vocation. It was performed using an audit grid filled by the interviewers on the day of the survey.
Inclusion criteria
All sterilization units of a university hospital in Southern Tunisia were included. In total, 13 units were evaluated. These included 6 units belonging to medical departments: rheumatology, dermatology, endocrinology, infectious diseases, hematology, and pediatric departments. There were 4 units from surgical departments: 2 units for the two operating rooms of obstetrics-gynecology, 1 unit for the pediatric surgery department, and 2 units for the stomatology department (one for the morning shift and one for the afternoon shift). Moreover, two units belong to intensive care units (ICU): the pediatric and the neonatology ICU.
Data collection
The audit was carried out in each department performing direct observation by an expert auditor (a senior hygiene technician). It was a one-day passage per sterilization unit lasting for almost one hour/unit. During the auditor's observation, each item was checked and compared to the international standards and guidelines of hygiene precautions according to the Tunisian National Agency for Sanitary and Environmental Control of Products (ANCSEP) Guide for Good Treatment Practices, Reusable Medical Devices ¹² and then was classified as conformed or non-conformed.
Study instrument
The measuring instrument used was an observation grid developed after a large literature review from national (the national survey tool of the sterilization unit’s evaluation carried out in 2011 ¹³) and international references. This audit was conducted by a team of specialists in the field of sterilization and health and safety under the direction of the ANCSEP. Data about the departments’ name and the visited unit, the passage date, as well as the auditor’s name were noted. The audit focused on the hospital environment and on all steps of the sterilization process, from the pre-treatment to the control of sterile RMD. The grid included 52 observation criteria which have been carried out in chronological order of the sterilization steps to facilitate data collection. The grid data were composed of two major themes divided into ten parts in total. The first thematic was about the sterilization environment. It was composed of 4 parts: (i) architecture (13 items: architecture suitability for the operations carried out, physical separation between the "dirty" sector and the "clean" sector, the forward march respect and conformity of surfaces), (ii) equipment (6 items: presence of functional heat sealer and autoclaves, quality of the water used), (iii) healthcare professionals’ practices and qualifications (5 items: number of staff working in the unit, staff qualification and presence of a continuing education programme), and (iv) bio-cleaning of premises (1 item). The second thematic was about the sterilization process evaluating 6 parts: (i) pre-treatment step (4 items : pre-disinfection immediately after use of RMD closest to the place of care, soaking the RMD in a specific tray and time respect), (ii) cleaning and drying step (9 items : sorting of material, particular attention is given to tubular medical devices and cleaning technique), (iii) packaging step (4 items : compatibility of packaging is compatible with the sterilization process and double packaging respect), (iv) sterilization process step (3 items : preparing the load, loading the sterilizer and unloading charge on the unloading side), (v) sterilization control step (6 items : vacuum test or leak test done and checking the dryness of the packaging), and (vi) traceability (1 item).
Conformity scores
Conformed items were scored “1” and non-conformed item were scored “0”. The conformity rate was calculated for each part by adding the corresponding conformed items and dividing them by the total number of the assessed items. Then, a global conformity score was calculated for each unit by summing up all conformity rates of the different evaluated items.
Security scores
The second items’ classification was done to evaluate the security in relation to the treatment process of reusable devices. Only items describing the sterilization security have been accounted for. Thus, 4 sections were obtained, namely the patient’s security (31 items), healthcare professionals (5 items) and environment security (14 items) as well as traceability (2 items). The calculated score represented the sum of the conformed items.
All scores and rates were adjusted out of 100.
Statistical analysis
Using the SPSS software, the continuous variables were first plotted, and the Shapiro-Wilk test was performed to verify the normal distribution. The results were presented according to the normality of the distribution as mean ± standard deviation or median and interquartile range (IQR). Categorical variables were presented as numbers and percentages.
Results
Conformity analysis
The mean global conformity score was 46.2±16.4. The highest score was 65.24/100, noted in the stomatology afternoon shift unit and the lowest one was in the endocrinology department (17.07/100) (Table 1).
Sterilization environment
For the architecture conformity, the median value of conformity score was 7.69/100 [7.69-20.19]. The highest conformity rate was 71.72/100, observed in the infant feeding room unit of the pediatric department and the lowest one was 7.69/100, noted in the operating room of the obstetrics-gynecology department. Architecture was suitable for the operations carried out in one unit (7.7%) and the forward march was respected in one unit (7.7%).
For the equipment, the median conformity score was 60/100 [50-66.6]. The highest rate was 83.33/100, noted in both the stomatology unit afternoon shift and the pediatric surgery departments, and the lowest one was noted in the stomatology unit (morning shift) (40/100). The presence of functional autoclaves was conformed in 12 units (92.3%) and the traceability was conformed in 1 unit (7.7%).
As for healthcare professionals’ practices and qualification items, the median conformity rate was 60/100 [20-63.33]. The highest rate was 100/100, noted in the stomatology unit (morning shift) and the lowest one was 20/100, noted in the hematology department. The presence of sufficient staff number working in the unit was conformed in 9 units (69.2%) and staff were qualified in 12 units (93.3%).
For premises’ biocleaning, the median global conformity rate was 100/100 [0-100] (Table 2).
Sterilization process
For the pretreatment step, the median global conformity score was 25/100 [1-78.75]. The highest conformity rate was 100/100, observed in the stomatology unit afternoon shift as well as in the dermatology department. The presence of sufficient staff number working in the unit was conformed in 9 units (69.2%) and the staff were qualified in 12 units (93.3%).
For the cleaning and drying step, the median global conformity score was 71.88/100 [55.9-88.8]. The highest conformity rate was 100/100, noted in the infant feeding room unit of the pediatric department and the lowest one was noted in the infectious disease department 33.33/100. Sorting material conformed in 9 units (69.2%) and the cleaning technique was conformed in 7 units (53.8%).
The median global conformity score was 50/100 [25-75]. The highest conformity rate was 100/100, noted in the operating room of the obstetrics-gynecology department: gynecology and the pediatric intensive care units. The lowest rate was 25/100, noted in the infectious disease and the endocrinology department. The packaging was compatible with the sterilization process in 6 units (46.2%) and the double packaging was respected in 4 units (30.8%).
By evaluating the sterilization process step, the median global conformity score was 66.66/100 [66.66-100]. The highest conformity rate was 100/100, observed in the hematology unit and the lowest one was noted in the dermatology department (33.33/100). The selected sterilization cycle was adapted to the type of the load to be sterilized in all units and the unloading was done on the unloading side in 2 units (15.4%).
In terms of sterilization control, the median global conformity score was 33.33/100 [33.33-55]. The highest rate was 80/100 noted in the pediatric ICU and the lowest one was 20/100 in the endocrinology department. The leak test was done in all units and the check of cycle parameters was conformed in 3 units (23.1%).
Traceability was maintained in two units (15.4%): the pediatric surgery department and the gynecology unit (Table 3).
Security score analysis
The global median security score was 34.54/100 [21.89-44.61]. The highest score was 64.05/100, noted in the pediatric surgical department and the lowest one was noted in the endocrinology department.
The mean patients’ security score was 58.4±19.8/100. The median values of security scores were respectively 60/100 [20-63.33] and 14.28/100 [7.1-21.8] for professional and environmental security items. The traceability security score was 50/100 in the gynecology unit and 100/100 in the pediatric surgery department. It was not done in all other units (Table 4).
Discussion
In light of the scarcity of data in terms of sterilization unit evaluation at the regional and national level, we conducted this survey in order to evaluate the inventory of the sterilization units at a university hospital in Southern Tunisia via an observational audit grid.
For architecture conformity, a previous Tunisian similar study was in accordance with our findings showing a high non-conformity rate (>50%) ¹⁴. Similarly, the national evaluation survey of sterilization carried out by the ANCSEP showed low rates of architecture conformity 40% ¹⁵. Not having a dedicated and centralized unit for sterilization and using benchtop autoclaves in different units make it difficult to control architecture. For equipment conformity evaluation, another audit from France in 2014, showed results in accordance with our findings (83%) of equipment conformity rates. In contrast, a previous study from Tunisia demonstrated that the unit's weak points were linked to equipment malfunctions ¹⁶. The quality of water needed in this unit was conformed in almost all units in our survey. This was a good point. In fact, water is the most critical resource in sterilization and its quality affects not only the effectiveness of sterilization but also the durability of equipment (washer disinfector and autoclave) as well as that of sterilized RMD ¹⁶. Healthcare professionals play an important role in HAI prevention and medical errors¹. In fact, whatever the sector of activity, professional training is an obligation for any employer, and it is governed by law in some other countries ¹⁷. The absence of legislation obligating professionals to assist in continuous training could explain our results. Ideally, personnel in the sterilization unit should be specific to this workplace in order to minimize the risk of infection transmission ¹⁸. This fact might be due to the lack of recruitment in public stores in recent years in our country. In terms of premises bio-cleaning, our results were similar to the ANCSEP audit (55% of non-conformity) ¹⁵. This rate needs to be improved through staff training and continuous evaluation of bio-cleaning technics because providing correct cleaned localities is essential and the lack of bio-cleaning premises increases the risk of contamination of cleaned RMD and packaging ¹⁹.
For the sterilization process, particularly the pretreatment step, soaking the RMD in a specific tray and the soaking time were respected in only 4 units. These percentages were 32% and 34% respectively in a previous Tunisian audit ¹⁵. It is currently impossible to judge precisely the quality of the pretreatment step. Thus, the establishment of pre-mechanized pretreatment can ensure the quality of this step. ²⁰. For the cleaning and drying step, this rate was 10% in the previous study from Tunisia ¹⁶ and 38% in a similar study from Burkina Faso²¹. These disparities could be related to the differences in study tools and the items evaluated between the different studies. For the packaging step, the rates remained considerably low. In fact, this step is an important one in terms of sterilization and errors or non-compliance can be the cause of surgical infections and perioperative morbidity ²¹. The centralization of the sterilization activity seemed to be the only way to guarantee the quality of the sterilization process ¹⁴. A previous study from a developing country showed no control of the sterilization process ²² and it was 45% in a previous national audit ¹⁵. This fact could be related to the lack of necessary equipment for control in our hospitals. The lack of training could also be a reason for this fact. The most neglected step in the sterilization process was traceability. The absence of computerized traceability software may explain this failure. In fact, with this innovation, we can have an identification of the material, an improvement of the sterilization process by preventing risks of contamination, in particular by prions and a strengthening of health security in the context of devices’ vigilance ²³.
Security analysis allows for a future follow-up of the situation after the implementation of corrective measures. In our study, all security levels were far from the necessary level of security for the four studied sections. The most critical situation is that of environmental and patients’ security. Thus, all sterilization steps should be ensured to be technically correct in order to have devices with a minimum level of contamination. In fact, these devices were associated with a very high infection risk by coming into contact with sterile or vascular cavities. This high risk makes it necessary to provide patient security ²⁴. For healthcare professionals’ security, it must be also improved. In fact, the lack of professional security could lead to inadequate practices. Environmental security should be ameliorated because inadequate or contaminated environmental surfaces are a critical component in HAI transmission and a well-recognized cause of common source nosocomial epidemics ²⁵. The traceability as well needs to be improved in order to achieve the required level of security because having ultimate traceability is indispensable to ensure the sterilization quality and to be in compliance with the standards, to protect personnel and institutions in the medico-legal framework ¹⁴ ²⁶.
In terms of this study, we propose several recommendations, starting with the centralization of all sterilization activities and the establishment of a quality management system, the assignment of competent qualified healthcare professionals solely dedicated to this unit and in sufficient number, training staff continuously, providing suitable protective equipment for them as well as equipment needed for the sterilization process. In addition, providing an adequate and conformed architecture to the sterilization unit with a controlled environment is highly recommended. Finally, labeling sterilized RMD, storing them in a dedicated and well-maintained room, as well as keeping a sterilization file for each cycle or ideally having computerized traceability software is critically needed in order to ensure good sterilization quality.
The results of this exhaustive survey could be a reference document to our hospital administration and health authorities to have an idea about the current situation of our hospitals in terms of sterilization, in order to target effective interventions. Nonetheless, there were some limitations to our work. Firstly, it was a single-centre study in a hospital with an essentially medical vocation, we cannot therefore have a global idea at a regional level on practices in terms of sterilization. Moreover, it was a descriptive study that did not study associations or cause-effects; however, it remains a starting point to have an in-depth vision of the situation in health-care structures that should be supported by further passages.
Conclusion
This audit has underlined mostly low conformity rates revealing major malfunctions in the sterilization process at a university hospital in Southern Tunisia, notably for equipment, pre-treatment steps, and traceability. Thus, there has been an urgent need to apply corrective measures and to plan centralization of the sterilization process in order to ensure good quality of care. Moreover, training sessions should be maintained for healthcare professionals working at all sterilization units in order to improve their practices at work. Therefore, introducing these concepts during internship and postgraduate programmes to provide solid foundational training is highly recommended.
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Authors
Mouna Baklouti¹, Houda Ben Ayed¹, Mariem Ben Hmida¹, Nouha Ketata², Afef Bouazizi¹, Hbiba Hosni¹, Mariem jebli¹, Mondher Kassis³, Sourour Yaich², Jamel Dammak²
¹Preventive Medicine and Hygiene Department, Hedi Chaker University Hospital, University of Sfax, Tunisia
²Community Health and Epidemiology Department, Hedi Chaker University Hospital, University of Sfax, Tunisia
³Preventive Medicine and Hygiene Department, Habib Bourguiba University Hospital, University of Sfax, Tunisia
* Corresponding author:
Mouna Baklouti
Email: mouna.baklouti92@gmail.com
Tel: +216 44480018
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