Surgical instrument packaging is an important part in the recycling and reuse of medical instruments. The surgical instrument packaging quality directly influences the final quality of sterile items, quality of medical care, and patient safety [
7]. Common surgical instrument packaging defects included insufficient number of instruments in the package, worn-out instrument with poor performance, inconsistency between labeling outside the package and instruments inside the package, unclear or altered marking outside the package, incorrect date, wrong instrument specification, wrong packaging materials, missing internal chemical indicator, and stains or holes in the cloth wrapping material. Most of these defects may be attributed to human factors such as mental fatigue, lack of energy, lack of concentration [
8], heavy workload, lack of strict and standardized training, lack of rigorous work attitude, or insufficient number of staff dealing with packaging. Staff members with long work experience generally had a better understanding of packaging quality criteria.
The results of this study show that the possible factors contributed to the occurrence of surgical instrument packaging defects are as follows: (1)
Length of service. Our study shows that the packaging staff who had served for fewer than 3 years had a higher defect rate in packaging compared with those who had served for more than 3 years, which is consistent with the result of Pan et al. [
9] who pointed out that staff with insufficient work experience tend to lack vocational skills and may not foresee the potential hazards to surgery caused by surgical instrument packaging defects. (2)
Educational background and number of staff dealing with packaging. This study shows that the packaging staff members who had undergraduate qualification or above had a lower defect rate in packaging compared with those who did not have an undergraduate qualification. This is consistent with the study of Wu et al. [
10] who found that highly educated staff members generally possess solid and comprehensive theoretical knowledge and are more capable of discovering and reporting problems; moreover, they probably had a better understanding of the importance of patient safety culture and exhibited a more rigorous work attitude. Thus, quality of packaging handled by highly educated staff members might be satisfactory, even when there were insufficient staff to handle it. By contrast, staff members with low levels of education might lack professional self-identity, and were more likely to experience job burnout [
11], and might be less capable of ensuring that packing met the necessary standards. (3).
Time period of packaging. The results of this study also show that there were more defects in instrument packaging in the afternoon compared with that in the morning. Staff members tended to be less patient and meticulous when approaching the end of their work shift. Towards the end of the shift, staff members were more likely to rush through their work and pay less attention. Some staff might become drowsy in the afternoon and more likely to make mistakes. Furthermore, instruments from morning operating lists arrived in CSSD in the late morning or early afternoon. and instruments from afternoon operating lists also arrived in CSSD in the afternoon, therefore, there might be an increased workload for afternoon packaging staff members. There were more defects in instrument packaging in the afternoon, which may be also explained by the insufficient afternoon staffing levels. (4)
Instrument structure. In this study, there was a high percentage of defects in the instruments of a complex structure. It is because dirt and bacteria are more difficult to remove in the instruments of a complex structure. If the instrument cleaning process does not meet the cleaning criteria, i.e. dirt or blood stains remaining on the instruments [
12], then the instrument packaging quality in the next step of the packaging process is affected. (5)
Packaging materials. Packaging materials were used to isolate bacteria inside the package from that outside the package. The usage of instruments taken from packaging materials that are non-intact or unclean can lead to nosocomial infections in patients [
13]. Li et al. [
13] reported that different types of packaging materials have different degrees of bacterial retention. Our study shows that the efficient group had high wrapping perfection and wrapping cleaning compliance rates, but we did not research the relationship between packaging material types and packaging defects. A further study about it will be needed. (6)
Instrument cleaning. Surgical instruments become contaminated during operations, and must be thoroughly cleaned, disinfected and sterilized [
14]. Due to inadequate implementation of inspection procedure, cleaning for instrument packaging was not always carefully checked, leading to packaging defects.
Recommended prevention strategies
Online and offline training concerning required methods and skills of surgical instrument packaging, infection, and sterilization is recommended for packaging staff in order to enable them to improve their understanding of packaging/instrument names, purposes, specifications, structures, performance, performance testing methods, standard assembly methods, arrangement order, instrument placement, and significance of surgical instrument packaging [
12,
15]. Situational simulation training could enable packaging staff to become familiar with packaging defects prior to inspecting them in practice. It is advisable to place the notices bearing details of packaging standards and clear instructions in conspicuous positions in the workplace for the edification of the packaging staff.
It is also recommended that Surgical Instrument Packaging Reference Drawings be supplied as a standardized reference for packaging procedures. Reference drawings of instruments comprising pictures and texts should detail the shapes, structures, assembly, arrangement order, and instrument placement. The texts should explain the name, model, specification, type, assembly method, arrangement order, and instrument placement, and highlight the instruments that are likely to cause confusion and errors.
Surgical instruments should be maintained prior to packaging. It is necessary to check the cleanliness of the surgical instruments and wrapping, and ensure normal function of instruments and intactness of wrapping. Defective instruments and wrapping need cleaning and replacement before packaging. Instruments should be assembled, arranged, and placed according to the reference drawings, and chemical indicators appropriately assembled. After checking, the package is sealed and labeled. Thereafter, the consistency between labels outside the packages and the instruments inside the packages should be checked [
16].
The packaging materials meeting the requirements of surgical instrument packaging criteria are recommended [
17]. A non-conformance tracking system is recommended for prompt identification of defects and for determining the causes of packaging defects. It is advisable to create a mentoring system where a senior person and a junior person or a highly educated person and a person with a lower level of education, work as a team. Flexible scheduling is recommended. More senior or highly educated persons need to be added to the staff pool during busier hours.