Optimizing Sterilization Packaging through Root Cause Analysis: An Exploration into Sealing Defects of Paper-Plastic Pouches

Background

The Central Sterile Supply Department (CSSD), a key department for nosocomial infection prevention and control, supplies a variety of sterile instruments, utensils, and articles for the hospital. The quality of CSSD work can directly affect medical treatment quality and patient safety [1,2]. The “Central Sterile Supply Department (CSSD) – Part II: Standard for operating procedure of cleaning, disinfection and sterilization” implemented in China in June 2017 [3] states that the sealing width of paper-plastic pouches should be ≥6 mm. Also, adhesive or the hot melt method could be applied to sealings to make the paper and plastic layers closely connected, ensuring the sealing integrity and avoiding contamination of sterile items in the storage process. Disposable paper-plastic pouches are a new type of packaging material that have the functions of providing a biological barrier and effectively blocking the entry of external dust. This means that sterile packaging can be stored for a long time, quality of the sterile packages and the safety of clinical use can be ensured, packaging cost can be reduced, and service life of the packaged articles can be extended [4].

The rapid developments in medical technology and increased stocktaking by surgeries in recent years have placed upon hospitals an increasing demand for instruments being packaged using paper-plastic pouches. Plastic sealing quality is one of the significant factors affecting the sterilization quality of the paper-plastic pouches, and modern hospitals must have in place effective measures for preventing quality defects in plastic sealing pouches [5,6]. In the process of using paper-plastic pouches, we found a high incidence of sealing defects, up to 0.15%. Not only does this affect their use in clinical departments, but it can affect the safety of patient lives, directly affect medical safety, and easily cause nosocomial infection [7].

Root cause analysis (RCA) is a systematic problem handling process that involves determining and analyzing the scope, frequency, and cause of a problem, finding the solutions, and formulating problem prevention and improvement measures. The process of problem handling includes defining the problem, analyzing the cause, planning the solution, implementing the solution, and tracking the feedback. Commonly used tools are the fishbone diagram and brainstorming method [8]. RCA, a retrospective error analysis tool that scientifically analyzes the occurrence of adverse events and is used to locate and correct their underlying causes, is a widely recognized scientific quality management method [9]. This approach can be used for continuous quality improvement in health systems to help hospital risk managers determine how to improve systems to reduce the number and severity of adverse events. In this study, we investigated the application of RCA in sealing defects of paper-plastic pouches.

Material and Methods

ETHICS APPROVAL:

This study was conducted in accordance with the Declaration of Helsinki. All research methods were carried out in accordance with the relevant guidelines and regulations. This study was approved by the medical ethics committee of the authors’ institution [2023 Medical Scientific research for Ethical Approval No. 008]. Verbal informed consent to participate in this study was obtained from all participants. The medical ethics committee of the authors’ institution approved the procedure of verbal informed consent of this study.

STUDY SETTING:

This was a retrospective study. A total of 35 762 instruments packaged using paper-plastic pouches by 11 packaging personnel in our hospital’s CSSD during July 2020 to June 2021 and during September 2021 to August 2022 were included in this study. Of them, 17 563 instruments packaged using paper-plastic pouches prior to RCA implementation during July 2020 to June 2021 were classified as the control group; 18 199 instruments packaged using paper-plastic pouches following the implementation of RCA and improvement measures during September 2021 to August 2022 were classified as the experimental group.

In adhering with appropriate sealing quality criteria of paper-plastic packaging [10], only the instruments packaged using paper-plastic pouches that met the following criteria were included in this study: (1) reusable instrument that could be assembled, sealed, packaged, and labeled; (2) paper-plastic pouches, the quality of which were found to conform with the criteria; and, (3) pouches could withstand the conditions during the sterilization process and were free from damage and wrinkles. Instrument packages that were larger than 30×30×50 cm or heavier than 7 kg were excluded from this study.

The packaging personnel meeting the following criteria were included in this study: (1) nurses who had worked in the CSSD for at least 3 years and had received paper-plastic packaging training; (2) workers who had worked in the CSSD for at least 5 years and had received paper-plastic packaging training; (3) those who packaged the instruments using paper-plastic pouches before and after implementation of the improvement measures. The included packaging personnel were aged 35 to 45 years. Visiting staff members, interns, CSSD workers with less than 5 years of work experience, and newly employed CSSD nurses were excluded from this study.

SEALING QUALITY CRITERIA FOR PAPER-PLASTIC POUCHES:

According to CSSD’s technical operation specification for cleaning, disinfection, and sterilization and relevant literature [10,11], the following sealing features are considered acceptable (and in this study were rated ‘pass’): sealing width ≥6 mm; the distance between the instrument inside the pouch and the seal was ≥2.5 cm; and, no bubbles, folds, crevices, or cracks in the seal.

RCA QUALITY MANAGEMENT TEAM:

A RCA Quality Management Team was established in July 2021. The team consisted of 1 head nurse (senior associate-level professional title), 4 supervising nurses (1 was a quality controller who was enrolled on a postgraduate program; the other 3 held undergraduate qualifications), 3 nurse practitioners (1 held a postgraduate qualification, and the other 2 held undergraduate qualifications), 2 packaging workers with more than 6 years of packaging experience, and 1 sterilization worker who possessed 8 years of work experience and a special equipment manipulation qualification certificate. The head nurse was the team leader. The other team members had received RCA training and passed the examinations prior to joining the team.

RISK FACTORS:

The RCA Quality Management Team collected the information concerning the sealing defects (eg, incomplete seal, seal width <6 mm, bubbles, folds, or crevices in the seal) of 17 563 paper-plastic pouches processed by our hospital’s CSSD during July 2020 to June 2021. They recalled the events and brainstormed at team meetings using the fishbone diagram (Figure 1) to analyze the risk factors for sealing defects posted by 5 components (manpower, machine, materials, environment, and methods) and identify the root causes of the sealing defects.

RCA RATING FORM:

The root causes of sealing defects in the paper-plastic pouches were analyzed to identify the true causes. A self-designed RCA rating form was used to evaluate 3 dimensions of risk: severity, occurrence, and detectability. The design of the RCA rating form was based on the failure mode quantitative evaluation form [12]. The potential root causes were the indicators in the RCA form. The scores of each of these 3 dimensions ranged from 1 to 10. The total score of an indicator is the sum of its severity, occurrence, and detectability scores. The higher the indicator’s score, the higher the risk.

For severity of defect, a score of 1–2 was considered ‘mild’; a score of 3–4 was considered ‘mild to moderate’; a score of 5–6 was considered ‘moderate’; a score of 7–8 was considered ‘severe’; and, a score of 9–10 was considered ‘extremely severe’.

For occurrence, a score of 1–2 indicated that a defect was likely to occur every year or occasionally; a score of 3–4 indicated that a defect was likely to occur at least quarterly; a score of 5–6 indicated that a defect was likely to occur monthly; a score of 7–8 indicated that a defect was likely to occur weekly; and, a score of 9–10 indicated that a defect was likely to occur every day.

For detectability: a score of 1–2 indicated a defect was likely to be detected every year or occasionally; a score of 3–4 indicated that a defect was likely to be detected at least quarterly; a score of 5–6 indicated that a defect was likely to be detected monthly; a score of 7–8 indicated that a defect was likely to be detected weekly; and, a score of 9–10 indicated that a defect was likely to be detected every day.

FORMULATION AND IMPLEMENTATION OF IMPROVEMENT MEASURES BASED ON RCA RESULTS:

The causes identified as significant in this study were as follows: lack of a standard operating procedure for inspection of plastic sealings; small size of the packing table; missed inspections by the inspector; insufficient training; and insufficient light through the pass-through window between the storage and distribution rooms. The RCA rating form was used to identify the true causes. The following improvement measures were formulated and implemented to address these influencing factors:

RCA SCORES:

The RCA scores of the sealing defects before and after RCA implementation were calculated.

COMPARISON OF RCA SCORES BEFORE AND AFTER RCA IMPLEMENTATION:

The RCA scores before and after RCA implementation was compared. An obvious reduction in RCA scores after RCA implementation compared with those before RCA implementation indicated that the improvement measures were effective.

PACKAGING PERSONNEL’S PERCEPTIONS OF SEALING QUALITY:

A self-designed questionnaire survey was conducted to investigate the same 11 packaging personnel’s perceptions of sealing quality of paper-plastic pouches before and after RCA implementation. The questions involved 4 components: plastic sealing procedures, perceptions of sealing defects of paper-plastic pouches, plastic sealing cautions, and perceptions of criteria for sealing quality of paper-plastic pouches. For each component, they had to answer 20 questions. The maximum score of each component was 100. The 5-point Likert scale was used. The higher the score, the better the packaging personnel member’s perception of sealing quality.

SEALING DEFECT RATES:

As mentioned, data relating to the sealing quality were collected by the RCA Quality Management Team members during 2 sampling periods (July 2020 to June 2021, September 2021 to August 2022) for a total of 35 762 instruments.

DATA COLLECTION:

The sealing quality of the included instruments was evaluated by the CSSD quality controller. The evaluation results were recorded in the quality control register. The following data were collected: (1) number of the instruments packaged using paper-plastic pouches; (2) number of sealing defects in the pouches before and after RCA implementation; and, (3) clinical departments’ feedback about the sealing quality control during the 2 sampling periods.

STATISTICAL ANALYSIS:

SPSS 25.0 was used for data analysis. Normally distributed measurement data are presented as mean±standard deviation and were analyzed further using the t test. Abnormally distributed measurement data are presented as means and interquartile ranges, and were analyzed further using the rank sum test. The enumeration data are presented as frequencies and percentages and were analyzed further using the chi-square test or rank sum test. A difference was considered statistically significant when P<0.05.

Results

RCA SCORES:

The RCA shows the following true causes of the sealing defects: a lack of a standard operating procedure for inspection of plastic sealings; small size of the packing table; missed inspections by the inspector; insufficient training; and insufficient light through the pass-through window between the storage and distribution rooms. Any of these factors could impact the sealing quality of paper-plastic pouches. Paper-plastic pouches with sealing defects are more likely to cause nosocomial infections. Therefore, these defects could have extremely severe consequences (Table 1).

COMPARISON OF RCA SCORES BEFORE AND AFTER RCA IMPLEMENTATION:

The scores of the risk factors (lack of a standard operating procedure for inspection of plastic sealings; small size of the packing table; missed inspections by the inspector; insufficient training; and insufficient light through the pass-through window between the storage and distribution rooms) prior to RCA implementation were higher than those after RCA implementation, and statistically significant differences existed (P<0.05). No statistically significant differences were found for the incorrect distribution procedures (P>0.05). The RCA scores after RCA implementation were obviously lower than those before RCA implementation due to formulating an SOP for inspection of plastic sealings, widening the packing table, providing training for inspectors, emphasizing the significance of inspection in ensuring sealing quality, and adding lighting for the pass-through window between the storage and distribution rooms (Table 2).

PACKAGING PERSONNEL’S PERCEPTIONS OF SEALING QUALITY:

The packaging personnel’s scores relating to plastic sealing procedures, perceptions of adverse events caused by sealing defects of paper-plastic pouches, plastic sealing cautions, and the criteria for sealing quality of paper-plastic pouches following the implementation of RCA and improvement measures were significantly higher than those prior to RCA implementation (P<0.05; Table 3).

SEALING DEFECT RATES:

The sealing defect rate following the implementation of RCA and improvement measures was significantly lower than that prior to RCA implementation (P<0.05; Table 4).

Discussion

LIMITATIONS:

This study was based on the sealing defects of paper-plastic pouches in a single center. There could be some limitations in the search for human and equipment factors. In this study, the content of the previous literature should have been cited as the basis of the research, and the review of the literature could have provided a theoretical basis for the research topic. However, due to the different research topics involved, the relevant literature might be limited.

Conclusions

Through an analysis of the root cause of the sealing defects of paper-plastic pouches, we found the root cause affecting the sealing quality, developed and implemented corresponding improvement measures, and achieved good effects. RCA can effectively improve the CSSD staff’s perception of sealing quality and team execution and is beneficial in reducing the incidence of sealing defects of paper-plastic pouches. We found that there were few studies on the sealing defects of paper-plastic pouches in the world, so further research on the subject should be undertaken to improve understanding.