Opinion Review Article | Open Access | Published 7th January 2025
Audit of reusable medical devices sterilization in a tertiary-care surgical hospital
Bouthaina Trabelsi Werchfeni¹, Mariem Ben Hmida², Ahmed Trigui¹, Maroi Trigui¹, Houda Ben Ayed¹, Jihen Jdidi³, Sourour Yaich³, Mondher Kassis¹ | EJPPS | 294 (2024) https://doi.org/10.37521/ejpps29403 | Click to download pdf
Abstract
Introduction
Medical devices (MD) are a significant source of healthcare associated infections. Therefore, to break this chain, it is crucial to have an effective reprocessing of reusable medical devices (RMD. From this perspective, this study aimed to evaluate the steps of reprocessing RMD in Habib Bourguiba University Hospital (HBUH) as part of quality improvement project and establish recommendations.
Methods
This was an exhaustive cross-sectional study conducted during the period between July and September 2023 in all units involved in the sterilization process in HBUH Sfax Southern Tunisia. We used an observational checklist to evaluate the practice of different steps of reprocessing of RMD. We conducted one audit pass for each enrolled unit.
Results
This study included 10 operating units and a sterilization unit. The median value of the global conformity score (GCS) was 48/100 (IQR=[43.6-56]). We noted that 7 operating units (70%) had a poor level of conformity and 3 (30%) had a fair level of conformity. For the reprocessing environment evaluation, the median GCS was 30/100 (IQR= [20 – 50]). Seven units (70%) had a poor level of conformity. As for pre-disinfection, the median GCS was 40/100 (IQR=[40 – 60]). We noted that 7 operating units had a fair level of conformity (70%). The median conformity score of cleaning was 90/100 (IQR= [70 – 92]). All operating units had a high conformity score for the section of cleaning. We noted that the median of GCS of sterilization was 66.6/100 (IQR= [16.6-100]).
Conclusion
This audit has highlighted the majority of poor conformance scores that indicate significant flaws in the HBUH 's reprocessing of MD. It has become imperative to implement corrective measures, and to plan the centralization of the sterilizing unit.
Introduction
As a public health problem, healthcare-associated infections (HAI) significantly increase morbidity and mortality¹. A systematic review conducted in 2019 showed that 41 from 46 studies conducted in developed countries had a prevalence rate of HAI less than 20%, besides 7 surveys from 8 in developing countries reported a prevalence rate of HAI strictly higher than 20% (2). Among them, surgical site infections (SSI) were the most common kind of infection in Africa (51.1%)². This HAI site was the most common infection in low and middle-income countries, with a pooled cumulative incidence of 6 per 100 surgical procedures, which is significantly higher than the rates seen in developed nations³. Many factors could be related to this type of infection such as immunodepression, invasive procedures⁴ and inadequate reusable MD (RMD) reprocessing in different countries⁵⁻⁸ . This reprocessing includes the time between ending an act of care's MD usage and using a MD again⁹ . This process is composed of 4 steps: predisinfection, cleaning, packaging and sterilization¹⁰. It is a complicated process and requires training, infrastructure, supplies, and strong organizational principles to be successful.
To prevent HAI mainly SSI, an effective RMD reprocessing is required³,⁸,¹¹. This process is the set of quality assurance that permit safe reuse of previously contaminated MD⁹. In low and middle income countries (LMIC), RMD reprocessing according to guidelines has shown effectiveness in reducing the incidence of HAI³ and in promoting practice changes¹²,¹³. To ameliorate the quality of practice, Donabedian¹⁴ proposed measuring the quality of health care by observing its structure, processes, and outcomes as a part of the quality improvement project. This strategy has a huge impact in reducing the incidence of HAI in many countries¹⁵,¹⁶. Therefore, uunderstanding the extent of conformity of RMD reprocessing can help hospitals develop strategies and interventions to improve the practices and minimize the risks of transmission of pathogens through the RMD¹⁷.
In Tunisia, the prevalence of HAI was 7.2% in 2012 among them SSI represented 13.5%¹⁸. Besides, RMD process in Tunisian hospitals suffer from low conformity with international guidelines⁴. Nevertheless, in Sfax, the prevalence of SSI was 1.1% occupying fourth place after urinary infection, respiratory infection and blood stream infection¹⁹.
Thus, RMD reprocessing is a crucial step to ameliorate practice and to address an intervention plan to ameliorate the quality of this process. In this perspective, our study aimed to evaluate the steps of RMD reprocessing in Habib Bourguiba University Hospital (HBUH) by auditing as a part of a quality improvement project.
Methods
Study design:
To evaluate the steps of RMD reprocessing, we led an observational audit. It was conducted during the period between July and September 2023 in HBUH Sfax, Southern Tunisia. It had a surgical vocation. It is composed of 17 departments for hospitalization, a central operating area composed of 10 operating units and a sterilization unit.
Study population:
To assess practice, we observed all steps of RMD reprocessing: pre-disinfection, cleaning, drying, packaging, which were done in the central operating area. We enrolled all operating units of HBUH which were responsible for RMD reprocessing. Included units were cardiovascular unit, maxillofacial unit, otorhinolaryngeal unit, ophthalmology unit, general surgery unit, orthopedics unit, urology unit, neurosurgery unit and stomatology unit. We included also the anesthesiology unit where the anesthesiologists were carrying out the reprocessing of anesthesiology RMD. Finally, an evaluation of the sterilization step was done. This step was performed in the sterilization unit.
Data collection and study tool:
We conducted one audit pass for each enrolled operating unit using direct observation by an auditor from the hygiene department. At each crossing, we assessed the process of heat resistant RMD from pre-treatment to sterilization, for 2 hours. The pre-sterilization steps from pre-disinfection to packaging were performed in the operating units and the sterilization step was performed in the central sterilization unit. The practice was considered to conform or not conform with hygiene standards. If there was a nonconformity, we made the necessary corrections and recommendations for the healthcare professionals.
We used an observational checklist developed in Ontario Canada²⁰. The checklist contained 45 conformity criteria, grouped into 2 items: pre-sterilization steps; and sterilization steps.
The pre-sterilization item was composed of 6 sections: evaluation of the environment of RMD reprocessing (8 conformity criteria), evaluation of personal protective equipment (PPE) (2 conformity criteria), evaluation of chemical products used (CP) (3 conformity criteria), evaluation of pre-disinfection step (3 conformity criteria), evaluation of cleaning (10 conformity criteria) and evaluation packaging (5 conformity criteria). For the evaluation of sterilization step (14 conformity criteria)
Scoring Methods:
For each section, the conformed criteria were scored “1” and each non-conformed criterion was scored “0”. The conformity rate was calculated for each section by adding the corresponding conformed criteria. Then, a LMIC (CS) was established for each item, by summing up the relevant scores of the corresponding sections and then was adjusted out of 100(0-100). Scores were graded as follows:
Good level of conformity [75-100[
Fair level of conformity [50-75[
Poor level of conformity [0-50[
Statistical analysis
Statistical analysis was performed using IBM SPSS.23 Software. Categorical variables were expressed as numbers and percentages. Non-Gaussian continuous variables were expressed as medians and interquartile ranges (IQR).
All p values less than 0.05 were considered to be statistically significant.
Results
Global conformity score:
In total, we audited 10 operating units and a sterilization unit where RMD reprocessing was done. The median value of the global conformity score (GCS) was poor (48/100; (IQR= [43.6-56])) (Table I). By department, the high CS was noted in the general surgery unit. The level of conformity was fair in 7 units (70%) (Figure1).
Table I : The global level of conformity of RMD reprocessing by units
Figure 1 : The global level of conformity of RMD reprocessing by units
Conformity of pre-sterilization steps:
The GCS of the environment where RMD were treated was 30/100 (IQR = [20-50]). We noted that 7 units had a poor level of conformity (70%). According to the environment criteria. All operating units didn’t have a designated reprocessing area for preparation and packaging. Only one operating area (10%) had a one-way workflow from dirty to clean to prevent cross-contamination. The sinks available in the space designated to treat RMD did not conform in 70% of cases. Furthermore, a regular environmental cleaning schedule in the reprocessing area included a written procedure found in 4 units (40%).
The median GCS for PPE was 50/100 (IQR = [0-62.5]). The level of practice was poor in 4 operating units (40%) concerning the PPE section. We noted that PPE was worn in 30% of cases (N=3). They were available in 50 % of cases (N=5).
For the section on evaluation of chemicals used during MD reprocessing, the median GCS was 42.86/100 (IQR = [28.57-42.86]). Overall, a good level of practice was noted in 8 operating units (80%). According to the criteria, chemical products were used according to the manufacturer's instructions in 10 % of cases (n=1 unit).
With regard to the pre-disinfection step, the median GCS was 40/100 (IQR = [40-60]). According to the criteria for pre-disinfection of RMD, none of the operating units had a transport container to keep the MD moist if the cleaning could not be done immediately. The MD were immediately pre-cleaned at the point of use before transport for further cleaning in 10% of cases. We noted that 7 operating units had a fair level of conformity (70%).
For the cleaning section, the median GCS was 90/100 (IQR = [70-92]). All operating units had a high CS for the cleaning section, with all units achieving a high level of conformity (100%). According to different criteria, in all operating units, RMD were cleaned manually and completely immersed in the cleaning solution. However, only in 5 units (50%), the brush was cleaned, disinfected, dried, and stored after each use. Furthermore, contaminated MD were kept separate from clean ones in 4 units (40%). There was an absence of the three-bowl use in all units.
This method is typically employed when mechanical washers are unavailable or impractical. Here's a breakdown of how it works: The first bowl is for pre-disinfection. It contains clean water with detergent, in which instruments are submerged to remove visible soil, blood, or other contaminants from the surface. The second bowl is for the cleaning step. It contains detergent, where instruments are submerged and scrubbed to further break down organic material. The third bowl is for the final rinse. It contains clean or sterile water (the choice varies based on the organ where the device will be applied or used) to remove any residual detergent or disinfectant²¹.
The GCS for packaging was 20/100 ± 10. All units had a poor level of conformity for this section. According to criteria, RMDs were packaged in a manner that allows steam to move around the item and contact all surfaces in 3 units (30%) (Table II).
Table II: The global level of conformity of reprocessing RMD according to the different sections
Conformity of the sterilization step:
The median GCS for sterilization was 66.6/100 (IQR = [16.6-100]). According to conformity criteria, we noted that RMDs were not organized in the autoclave in a manner that allows steam to move around the item and contact all surfaces. The packages were not labeled with the date processed, sterilizer used and cycle or load number. Furthermore, MD were not sterilized using an approved sterilization process. The conformity rate of the sterilization control system was 100%. A Bowie-Dick test was performed every day. The use of chemical indicators was conforming 100% in our sterilization unit. According to the different criteria, there were no contingency plans in the event of reprocessing failures. Storage in the sterilization unit was conforming 100%. There was no person responsible for the sterilization cycle.
MD were in the unlocked and open position for sterilization in 100 % of cases (such as scalpels, forceps, and cystoscopes). If not properly exposed, the joints and hinges on these instruments have the potential to trap biological material. All surfaces, particularly those in corners and crevices, can be properly cleaned and disinfected by keeping them fully open and unlocked during the different stages of disinfection and sterilization. The processed packages were allowed to dry inside the sterilizer chamber before being removed and handled. Also, processed packages that had become unsealed, damage or have been dropped on the floor were considered contaminated and were reprocessed through the full reprocessing cycle. The sterilized MD were not used until the chemical indicators were checked.
If a failed chemical indicator was found, the contents of the package were reprocessed again before use. Sterile MD were stored in their sterile packaging until time of use. Concerning policies and procedures regarding the use of MD, the conformity rate of policies regarding RMD reprocessing in our hospitals was 33.3%. According to different criteria, there was no written policy stating that if RMD cannot be reprocessed according to MIFU, they were designated as single use.
Discussion
Synthetic raw materials are usually free from all but incidental microbial contamination. Although microorganisms may contaminate all types of raw material, the potential for growth in synthetic materials is very low. In general, these incidental organisms are considered to be of little practical significance. Contamination by pathogens is extremely unlikely. Exceptions to this rule can occur, for example, where one of the preparation stages involves washing with, or crystallizing from, water of poor microbiological quality. In relation to these types of materials, microorganisms cannot thrive in nonaqueous environments and many of the organic solvents commonly used in the manufacture of products are inherently bactericidal, although not sporicidal due to the protection dipicolinic acid affords bacterial endospores.
To the best of our knowledge, there were few studies about MD reprocessing in our region. There was a noticeable lack of adherence to the recommended preventive measures when reprocessing RMD. A low global level of conformity was noticed. This was comparable to multicenter research that showed a CS of 47/100⁴ from Tunisia. It was higher than the CS in Nepal¹⁷. According to a recent assessment, the GCS for steam sterilization was 57 % with greater failure rates in LMIC⁸.
We noted that 7 units (70%) had a poor level of conformity in the section of the MD reprocessing environment. That was lower than a previous study conducted in Hedi Chaker University Hospital in 2020 where in 50% of units, the environment conformity level was low. A study carried out in two university hospitals in Tunisia revealed that the structure of the spaces did not provide a one-way work flow from dirty to clean in order to prevent cross-contamination⁴. This issue was present in many other hospitals in LMIC²².
A suitable workstation is necessary to ensure disinfection and sterility compliance¹². The work area should adhere to architectural hygiene guidelines, which call for a one-way work flow that divides pre sterilization steps into different sectors²³. This control of the architecture is challenging because there isn't a single, centralized sterilization unit. This fact could be explained by our establishment's lack of resources, which prevents the sterilizing unit from being properly set up and equipped¹². It is imperative to note that the division of the various zones to enable the forward movement principle and the presence of compliant surface lighting in these instruments are crucial for preventing equipment contamination, facilitating the maintenance of these architectures, and minimizing the chance of cross-contamination⁴,²⁴. Concerning the level of conformity of the PPE, it was poor in 4 (40%) operating units. Similarly, in the Republic of Congo, the use of PPE was almost non-existent²⁵. Further studies showed that the risk of infection among cleaning staff was further increased by very poor compliance with the recommended use of PPE¹⁷,²⁶. For the predisinfection step, the median GCS was 40/100. That was better than 32/100 in a previous audit in Tunisia²⁴ but it was similar to other studies in LMIC²². This step is vital in safeguarding both the environment and people⁴,²⁷. In fact, ineffective sterilization of MD could arise from a mishandling of the pre-disinfection procedures²². Organizational and material difficulties were highlighted, and the most important problem was that MD were not pre-cleaned at the point of use before transport for further cleaning. These findings were similar with another study¹⁷. Most MD can have good pre-disinfection if pre-mechanized disinfection was established²⁹. For that, a compliance with WHO guidelines for pre-disinfection steps must be ensured.
All operating units had a high GCS for the section of cleaning. A manual cleaning was performed in MD reprocessing. While automated washers were widely utilized in many nations to clean RMD, research has shown that both manual and automated cleaning procedures, when carried out correctly, can effectively lower the microbial load on MD²⁸,²⁹. The most critical problem was the absence of three bowls use. We must aim for the use of three bowls if we aim to centralize all steps of MD reprocessing. That was supported by many studies³⁰,³¹.
The sterilization process itself presented several failures. The GCS was 66.6/100. That was similar to a study conducted in Tunis in 2014¹⁸. The healthcare personnel who were in charge of MD reprocessing were the primary source of nonconformity. That was similar to other studies where healthcare workers may take on multiple and occasionally discordant roles, such as working in laundry or morgue areas in addition to the sterilization unit²⁵,³². These findings indicate that there could be several reasons for poor compliance related to management and support processes including infrastructure, human resources, equipment, guiding documents, steering, performance monitoring and documentation¹³.
As part of the improvement quality project, we recommend to preparate protocols for RMD reprocessing according to Tunisian guidelines, assign an appropriately equipped place for pre-disinfection, as close as possible to the place of patient treatment. As for sterilization process, we recommend the creation of a quality management system and the centralization of all sterilization operations at a single sterilization unit. On the other hand, we recommend to the allocation of human resources, and the provision of qualified staff for the exclusive task of sterilization. We would also recommend the organization of periodic staff training covering hygiene topics to improve the knowledge for relevant staff. Therefore, we must provide conformed architecture to respect the one workflow and allocate a conformed area for the storage of sterile RMD.
The survey's findings may serve as a reference for our hospital's quality improvement and the relevant health authorities. However, there were certain restrictions. First of all, this was a single-center study conducted in a tertiary hospital engaged in medical care. Besides, it was a single passage and there was no follow-up over time so we have no idea of the evolution of practices. There was also a lot of use of estimates in accounting. The auditor cannot measure or comment on the exact accuracy of these estimates. Our study is still a useful tool for gaining a comprehensive understanding of the state of reprocessing of RMD in HBUH. However, it should be supplemented by additional passages to monitor changes in practices following the implementation of multiple planned corrective actions.
Conclusion
This audit has highlighted poor conformance scores in the HBUH's RMD reprocessing. Our study is still a useful tool for gaining a comprehensive understanding of this process in HBUH. Thus, to guarantee high-quality of RMD reprocessing, it has become imperative to implement corrective measures and plan the centralization of the sterilization unit. We should ameliorate the architectural compliance and recruit qualified personnel and conformed equipment. On the other hand, it will improve practices of healthcare workers in all sterilizing units. It is therefore omit to introduce these ideas during internship and postgraduate programs in order to give students a strong foundational education.
Keywords: Conformity score, Reusable medical devise, Sterilization
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Authors
Bouthaina Trabelsi ¹, Mariem Ben Hmida², Ahmed Trigui¹, Maroi Trigui¹ , Houda Ben Ayed¹, Jihen Jdidi³, Sourour Yaich³, Mondher Kassis¹
01 Hygiene Department, Habib Bourguiba University Hospital, University of Sfax, Tunisia
02 Preventive Medicine and Hygiene Department, Hedi Chaker University Hospital, University of Sfax, Tunisia
03 Community Health and Epidemiology Department, Hedi Chaker University Hospital, University of Sfax, Tunisia
Corresponding Author: Bouthaina Trabelsi Werchfeni
Address: Hygiene Department, Habib Bourguiba University Hospital, University of Sfax, Tunisia
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