Introduction

Healthcare environments present a variety of risks, with biological risk being the most common and the most prevalent. It is defined as the probability of occupational exposure to agents capable of causing adverse health effects and is frequently involved in the occurrence of occupational accidents involving exposure to biological material.(¹)

Among the hospital units with the highest number of occupational accidents involving exposure to biological material is the Central Sterile Supply Department, where workers are frequently exposed to various occupational risks, especially biological risks.(²) The Central Sterile Supply Department is one of the essential support units for the operation of a healthcare service, since it is the specific location for reprocessing reusable medical devices. It is divided into a dirty area, called the contaminated area, where the cleaning and drying procedures of materials are carried out, and a clean area, where reusable medical devices are prepared, packaged, sterilized, stored and distributed.(³,⁴)

Cleaning is one of the most important stages for a successful reprocessing of reusable medical devices, but it is also the one that poses the greatest risk to workers who constantly handle contaminated reusable medical devices. During cleaning, reusable medical devices from all healthcare units are subjected to several steps that require contact with workers’ hands, which increases the chance of occupational accidents involving exposure to biological material.(³-⁵)

Occupational accidents involving exposure to biological material are of high magnitude. In the United States, it is estimated that 385,000 hospital professionals suffer occupational accidents involving exposure to biological material each year.(⁶) In Brazil, occupational accidents involving exposure to biological material also represent an important public health concern. Between 2010 and 2016, 243,621 occupational accidents involving exposure to biological material among healthcare professionals were notified, corresponding to 34,803 notifications/year. The incidence rate of these accidents ranges from 3.65 cases/1,000 healthcare professionals/year in Paraíba to 24.7 cases/1,000 healthcare professionals/year in Paraná. The majority of professionals who suffer accidents are female and young adults. Furthermore, 76.4% of accidents in 2016 involved nursing staff (nurses or nursing assistants/technicians).(⁷)

Although they are common in Brazil, studies on the epidemiology of occupational accidents involving exposure to biological material that occur during the cleaning stage of reusable medical devices have been little investigated, especially among nursing professionals, the group with the highest incidence. There is a gap in the literature on the incidence of occupational accidents involving exposure to biological material and their risk factors, which is widened when considering national data analysis. Epidemiological studies that assess these aspects are useful to support nursing professionals’ health, allowing planning strategies to reduce the risks and magnitude of these injuries in Brazil.(⁸) Thus, this study aimed to assess the incidence and factors associated with occupational accidents involving biological material that occurred during the cleaning of reusable medical devices among nursing staff in Brazil.

Methods

This is a retrospective cohort study. The overall study population consisted of nursing professionals who suffered occupational accidents involving exposure to biological material and were notified, regardless of the type of accident circumstance, including those who suffered accidents during medication administration, improper disposal of materials, basic care procedures, among others. The population of interest included professionals who suffered accidents while cleaning reusable medical devices and were compared to those who suffered accidents in other circumstances. In this study, occupational accidents involving exposure to biological material were considered to be any case of accident involving direct and/or indirect exposure of workers to biological material potentially contaminated by pathogens, through sharp or non-sharp material,(⁹)whose International Classification of Diseases (ICD-11) code is Z20.9.(¹⁰) The following professionals were included, according to the Brazilian Classification of Occupations (CBO): nurses (CBO: 2235-05) and nursing assistants (CBO: 3222-30)/technicians (CBO: 3222-05).(¹¹)

Microdata on the absolute number of occupational accidents involving exposure to biological material were extracted from the Notifiable Diseases Information System (SINAN - Sistema de Informação de Agravos de Notificação). The data in this system comes from compulsory notification and investigation forms, including notifications of occupational accidents involving exposure to biological material. Access to the database was granted by the General Coordination of Workers’ Health of the Health Surveillance Department of the Ministry of Health. Moreover, microdata from the Brazilian National Registry of Health Establishments (CNES - Cadastro Nacional de Estabelecimentos de Saúde) were used, which contains information on the number of healthcare professionals in healthcare services in Brazil.

The study included notifications of occupational accidents involving exposure to biological material among nursing staff from all 27 states in the five major regions of Brazil, such as Southeast, South, Central-West, North and Northeast. The study covered notifications recorded between January 1, 2015 and July 27, 2020, the date of the last update of the microdata used. The data was extracted in December 2020.

The main indicator analyzed was the mean incidence rate of occupational accidents with exposure to biological material that occurred during the cleaning of healthcare devices, from 2015 to 2020, according to the formula:

For the analysis of associated factors, the dependent variable was occurrence of occupational accidents with exposure to biological material during the cleaning of reusable medical devices. This binary qualitative variable, classified as zero (“0”) or one (“1”). Independent variables were sociodemographic - age group, in years, categorized from 18 years old (18-29 years old, 30-39 years old, 40-49 years old, 50-59 years old, ≥60 years old), sex (male or female), geographic region of residence (Southeast, South, Central-West, North or Northeast), education (technician level or higher education)); labor - professional category (nurses and nursing assistants/technicians), employment relationship (employee with a formal contract, public servant or others); related to accident - percutaneous exposure (no or yes), exposure to intact skin (no or yes), exposure to non-intact skin (no or yes), exposure to oral/ocular mucosa (no or yes), organic material (blood/serum/plasma, cavity fluids, blood-containing fluids and other fluids) and device (needle/intracath, blade/blood lancet or others); and hepatitis B virus (HBV) vaccine, categorized as no or yes. Professionals who notified at least three doses of the vaccine before the accident were considered vaccinated.

The year of notification and use of Personal Protective Equipment (PPE) at the time of accident were considered in descriptive analysis. The following PPE were analyzed: gloves (no or yes); safety goggles (no or yes); mask (no or yes); boots (no or yes); and apron (no or yes).

The data were analyzed using STATA version 16.0. Data analysis was performed in two stages, one being descriptive analysis and the other being inferential analysis.

In descriptive analysis, the population characteristics were estimated according to groups 1 and 2 using absolute (n) and relative (%) frequencies. The mean incidence rate of occupational accidents with exposure to biological material occurring during the cleaning stage of reusable medical devices was estimated for Brazil, regions, Federation Units and for each professional category.

Inferential, bivariate and multiple analysis were used to analyze factors associated with occupational accidents with exposure to biological material that occurred during the cleaning of reusable medical devices. Thus, the group of professionals who suffered accidents during cleaning was compared with those who suffered accidents in other work situations. In bivariate analysis, Poisson regression was performed to verify the association between each independent variable and dependent variable. P-values <0.20 were added to a Poisson multiple regression model with robust variance, using the single-entry method. The final model adjustment quality was assessed by goodness-of-fit. The magnitude of the effect of the multiple regression model was established by Adjusted Relative Risk (ARR) and respective 95% Confidence Interval (95%CI). The Wald chi-square test was used to establish statistical significance. McFadden’s coefficient (McFadden’s R2) was used to analyze the explanatory power of the model.

In the present investigation, there was no need to submit the study project to the Research Ethics Committee for review, since this is research on secondary data, without identification of participants and sensitive data, as provided for in Resolutions 466 of December 12, 2012 and 510 of April 7, 2016 of the Brazilian National Health Council.(¹²,¹³)

Results

A total of 167,093 occupational accidents involving exposure to biological material in nursing professionals notified between January 1, 2016 and July 27, 2020 were analyzed. The mean incidence rate of occupational accidents involving exposure to biological material during the cleaning stage of reusable medical devices was 115.0 cases per 100,000 nursing professionals in Brazil. The lowest rate was observed in Amapá (18.7 cases per 100,000 nursing professionals), and the highest, in Santa Catarina (300.2 cases per 100,000 nursing professionals), as summarized in Figure 1.

In the professional category of nurses, the mean incidence rate of occupational accidents involving exposure to biological material during the cleaning stage of reusable medical devices was 22.0 cases per 100,000 nurses. In the categories of nursing assistants and technicians, the mean incidence rate was 6.89 times higher (151.6 cases per 100,000 professionals). Table 1 summarizes the characteristics of the nursing staff included in the study, stratified by those without (n = 161,398; 96.6%) and those with involvement in occupational accidents with exposure to biological material during the cleaning stage of reusable medical devices (n = 5,695; 3.4%). The mean age of the nursing staff involved in occupational accidents with exposure to biological material during the cleaning stage of reusable medical devices was 37.1 years (standard deviation = 10.6), with 27.2% and 35.8% in the age range of 18-29 years and 30-39 years, respectively. The majority were female (91.1%), nursing technicians (75.9%) and employees with a formal employment contract (72.1%). The Southeast region accounted for 42.6% of notified cases among these professionals. Of the total, 76.5% were percutaneous exposures and, in 70.3%, the organic material involved was serum/blood/plasma; other agents were involved in 65.1% of accidents. The frequency of PPE use at the time of the occupational accident was 93.3% for gloves, 68.1% for aprons, 46.1% for safety goggles, 50.1% for masks and 26.4% for boots. The majority of professionals (95.9%) had completed the HBV vaccination schedule.

Poisson regression model with robust variance showed that the risk of accidents was 1.48 times (95%CI=1.32-1.65) higher in women than in men. A positive gradient in the risk of accidents was observed with increasing age after 40 years, increasing 1.54 times (95%CI=1.27-1.88) in those aged 60 years or older when compared to the youngest age group (18-29 years). Individuals from the Central-West, South and North presented a risk of accidents 1.30 times (95%CI=1.16-1.46), 1.45 times (95%CI=1.35-1.55) and 1.27 times (95%CI=1.09-1.49) higher when compared to those from the Southeast, respectively. Nursing assistants and nursing technicians presented a risk of accidents 3.70 times (95%CI=3.17-4.31) and 2.83 times (95%CI=2.46-3.25) higher when compared to nurses, respectively. Employees with a formal employment contract presented a risk of accidents 1.44 times (95%CI=1.22-1.70) higher when compared to those with other employment situations (Table 2).

It was observed that the risk of accidents was 1.87 times (95% CI = 1.70-2.06) higher when the biological material involved was fluid with blood and 1.37 times (95% CI = 1.28-2.52) higher in other liquids when compared to materials involving serum/blood/plasma. It was found that the risk of accidents was 2.49 times (95% CI = 2.26-2.75) higher in percutaneous exposures and 0.35 times (95% CI = 0.31-0.40) lower in exposures to the oral/ocular mucosa than accidents without these types of exposure, respectively. The risk increased further when the device involved was a blade/blood lancet (ARR=8.40; 95%CI 7.55-9.34) and others (ARR=22.37; 95%CI=20.50-24.41) when compared to needles/intracaths. Finally, the risk was 1.37 times (95%CI=1.17-1.59) higher in individuals without a complete HBV vaccination schedule when compared to those vaccinated (Table 2).

Discussion

This study has some limitations. Firstly, it used secondary data from SINAN, with different levels of completeness of information. Many variables presented missing data, suggesting low quality of information, which may underestimate incidence rates and influence the analysis of risk factors. Secondly, it does not rule out the possibility of incorrect completion of notification forms by notifying professionals, which may lead to bias in information on accidents. Thirdly, the notification form does not present important variables that could help in understanding the epidemiology of accidents, such as the place where the occupational accident occurred with exposure to biological material (e.g., inside or outside the Central Sterile Supply Department, in Primary Health Care units), type of glove used at the time of accident, type of cleaning (e.g., manual or automated) and time of occurrence of the accident (e.g., reception, pre-cleaning, cleaning and drying). Fourthly, the comparison group consisted of professionals who had accidents in other circumstances (e.g., venipuncture) instead of a comparison group of professionals who performed similar activities but did not have accidents during the cleaning stage. Thus, the use of this comparison group may have influenced the results of risk factors.

It was found that nursing assistants and technicians had a higher risk of accidents when compared to nurses. This result was similar to that of other studies that assessed accidents in the Central Sterile Supply Department and in other care units.(¹⁴,¹⁵)Furthermore, nursing assistants and technicians are the categories that suffer the most accidents in other care units.(⁷) This occurs because these professionals more frequently perform technical activities with greater risks of exposure to biological material, such as handling sharp objects, caring for patients with infectious diseases and, more recently, with the disease caused by coronavirus 2019 (COVID-19), among others.(¹,¹⁶)

The Central Sterile Supply Department stands out compared to any other care unit, as it is an unhealthy place with exposure to contaminated reusable medical devices that are frequently handled, which poses a high risk, especially in the cleaning process, whose activities are carried out almost exclusively by nursing assistants and technicians.(¹⁴) This fact justifies the higher occurrence of accidents in these categories. In addition to the greater risk caused by activities developed at the technical level, it is necessary to consider the exhausting working hours, associated with multiple jobs, frequent reshuffling of staff composition, accumulation of functions due to insufficient human resources that result in greater professional exhaustion, decreased productivity and reduced attention to work, increasing the probability of occupational accidents with exposure to biological material.(¹⁷)Thus, the importance of focusing accident prevention policies on this professional category is highlighted, aiming to reduce the occurrence of accidents involving biological material.

An increased risk of occupational accidents involving exposure to biological material was observed in professionals with increasing age when compared to the younger age group, which supports other findings that occurred in healthcare units.(¹,⁷) Some authors argue that, although this group generally presents greater dexterity and experience in activities, these facts do not ensure a reduction in occupational accidents involving exposure to biological material, probably due to greater confidence, which may have underestimated adherence to standard precautions and offered resistance to the use of PPE,(¹⁷)requiring more attention to these professionals during daily supervision in work performance.

Blood lancets and blades are frequently involved in accidents, accounting for up to 12.0% of accidents notified.(¹⁸,¹⁹)In this study, among nursing staff, an increased risk of occupational accidents with exposure to biological material during the cleaning stage of reusable medical devices was observed when the contaminant involved was fluid with blood in percutaneous exposure and when the device involved was blades/blood lancets. A study in the Central Sterile Supply Department identified that 81.82% of accidents occurred during the cleaning of reusable medical devices, and of these, 90% notified blood as the contaminating agent.(²⁰) It is important to mention that accidents occurring under these circumstances are considered serious, with a high risk of exposure and transmission to various infectious agents.(²¹)

Other studies have also notified blood as the most common substance in accidents occurring in various sectors of hospital units,(²²,²³)and a worrying fact is the occurrence of accidents involving blades/blood lancets or needles with lumens in the context of work in the Central Sterile Supply Department when cleaning reusable medical devices, when the presence of sharp waste would not be expected. Such accidents represent failures in waste management, specifically in its first phase, segregation, and affect professionals who, due to the logic of the activity performed, do not have direct contact with patients, but handle the waste resulting from this care, such as the Central Sterile Supply Department staff. This study therefore verified the consequences of inadequate handling of sharp materials by professionals and the incorrect segregation of waste in healthcare sectors, directly resulting in occupational accidents with exposure to biological material among professionals responsible for cleaning processes in the Central Sterile Supply Department.(³,⁴)

Due to the handling of reusable medical devices contaminated with body fluids, the use of PPE and automation of cleaning methods become essential. The findings of this study show low frequencies of PPE use at the time of occupational accidents with exposure to biological material in the nursing staff. The frequency of records on gloves usage shows that 6.7% of professionals did not use them when cleaning reusable medical devices at the time of occupational accidents with exposure to biological material. This data is worrying when considering the potential for contamination from cleaning reusable medical devices. It is known that, although gloves do not prevent puncture, they act as a mechanical barrier that helps reduce exposure to pathogens, as they remove a large part of the organic fluid from a needle when there is a puncture.(²⁴) It is also worth noting that the database does not allow identifying the type of gloves used, preventing an analysis of compliance with the recommendation to use thick, long-sleeved gloves.(³)

The use of protective goggles and masks at the time of occupational accidents involving exposure to biological material was also noteworthy, at 46.1% and 50.1%, respectively. It is known that the generation of aerosols is a consequence of manual cleaning, which is common in Brazil.(¹⁴,²⁵) The SINAN form does not identify the site of the exposed mucosa, but in this study, exposure to the mucosa accounted for 11.5% of accidents among the nursing staff, a fact also observed in another investigation.(²⁶)

Furthermore, the importance of a policy of continuing education for workers responsible for cleaning reusable medical devices is emphasized, aiming at reprocessing safety and, consequently, patient safety, in order to make workers understand the importance of adhering to PPE, seeking worker safety. It is known that professionals who are unprepared and unmotivated to perform their duties often neglect the use of PPE, and the occurrence of occupational accidents involving exposure to biological material is higher.(²⁷) Therefore, it is considered essential to implement monitoring policies to ensure compliance with current legislation regarding the availability and use of PPE and automation of cleaning methods in the context of the reprocessing of reusable medical devices at all levels of care. It is known that manual cleaning should still remain a practice in Central Sterile Supply Departments, but limited to reusable medical devices with complex shapes,(²⁸)which will obviously be much less frequent.

Conclusion

The mean incidence rate of occupational accidents involving exposure to biological material during the cleaning stage of reusable medical devices among nursing staff in Brazil was 115.0 cases per 100,000 nursing professionals, and was higher among nursing assistants and technicians when compared to nurses. Regression analysis showed a higher risk of accidents among women, older age groups, and public servants. Sharp objects were the most frequently involved in accidents; blood-containing fluid was the main biological agent; and gloves were the most frequently used PPE among workers at the time of accidents. Masks and goggles were used less frequently at the time of accidents.

References

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