Diagnosis of compliance of health care product processing in Primary Health Care 1

ABSTRACT Objective: identify the compliance of health care product processing in Primary Health Care and assess possible differences in the compliance among the services characterized as Primary Health Care Service and Family Health Service. Method: quantitative, observational, descriptive and inferential study with the application of structure, process and outcome indicators of the health care product processing at ten services in an interior city of the State of São Paulo - Brazil. Results: for all indicators, the compliance indices were inferior to the ideal levels. No statistically significant difference was found in the indicators between the two types of services investigated. The health care product cleaning indicators obtained the lowest compliance index, while the indicator technical-operational resources for the preparation, conditioning, disinfection/sterilization, storage and distribution of health care products obtained the best index. Conclusion: the diagnosis of compliance of health care product processing at the services assessed indicates that the quality of the process is jeopardized, as no results close to ideal levels were obtained at any service. In addition, no statistically significant difference in these indicators was found between the two types of services studied.


Introduction
Health care products manufactured from raw material that permits repeated cycles of cleaning, preparation, disinfection or sterilization can be processed until their functionality is lost. This process should be executed by qualified professionals and includes functionality and quality tests, guaranteeing that the transmission of microorganisms through this route is prevented (1) .
The practice of health care product processing is guided by regulatory policies that are based on risk management and public health safety (2)(3) . These recommendations differ among countries though, being more or less restrictive, in view of technical-operational, economic, environmental, legal and political issues (2) . In Brazil, this theme is regulated by RDC 15, a resolution by the Brazilian Health Surveillance Agency -ANVISA (1) .
Studies on the processing of health care products have identified that the quality of this procedure can interfere in patient safety, as it can take place ineffectively, whether in or outside the hospital (4)(5) , demonstrating infection outbreaks associated with the use of health care products, involving distinct microorganisms in different health care scenarios (2,6) .

Considering the expansion and diversification
of extra-hospital care, including Primary Health Care (PHC), deeper knowledge is needed on health care product processing in this care context.
A study developed at rural health services in Nepal describes that 72% of the health professionals interviewed reported using unprocessed equipment and 50% did not have appropriate autoclaves at their services, illustrating the need to improve the infection control practices in PHC (7) .
Actions undertaken in PHC and the availability of health care products for single use or processing vary according to the country's level of economic Another aspect to be taken into account in this study is a possible difference in the quality of the product processing, depending on the type of service analyzed.
In Brazil, Primary Health Care Services working in the traditional model (UBS) and Services working in the Family Health Strategy (USF) constitute PHC (8) .
Both have particular characteristics, related to human and structural resources. Studies that analyze these services (9)(10) suggest that, in terms of functionality, the USF are better assessed, despite problems in terms of infrastructure.
This study aimed to identify the compliance of the health care product processing in a sample of PHC services, using a specific validated tool (3) , and to assess possible differences in the compliance rates observed between the services characterized as UBS and USF.

Method
Quantitative, observational, descriptive and inferential study. The objective was to identify the compliance index (CI) of health care product processing at ten PHC services in an interior city in the state of São Paulo.
The city under analysis has 221,950 inhabitants (11) , offering 29 health services in PHC, with 15 USF and 14 UBS, distributed across five Regional Health Administrations (ARES), which coordinate the services within their area.
Convenience sampling was used (randomly using Microsoft Excel® 2010) to define the number of services, with a view to including two representatives (one USF and one UBS) from each of the five ARES in the city, resulting in a sample of ten health services (34.5% of all PHC services in the city).
One of the authors collected the data between January 22 nd and July 23 rd 2013, using a previously validated tool (3) to assess the health care product processing in PHC. The tool (3) assesses the structure, process and outcome and is organized by indicators in these three dimensions.
Departing from these three dimensions, the assessment was based on Donabedian's model, which is widely used in health, concerning the assessment of service quality based on health indicators in different contexts (12)(13)(14) .
As structure indicators, the assessment indicator of Therefore, 38 items should be observed at each of the ten health services studied. Due to the varying frequency of the products' use at the health services, this number could not be reached in all situations though, as presented in Table 1. Table 1 -Sample of health care products analyzed to assess the compliance index of the health care product processing quality, according to the processing steps and service type. São Carlos, SP, Brazil, 2013 Step of health care product processing UBS * USF † Total  Based on the analysis of the p-value, no statistically significant difference was observed between the types of health services concerning any of the indicators used.
Overall, the structure analysis (CI< 50%) was found closer to an appropriate CI when compared to the process indicator L.2, which obtained CI < 20%.

Discussion
The structure of the health care product processing services The professionals engaged in the processing of health care products at the services studied had profiles similar to what was found in the literature, which appoints the nursing team (auxiliary nurses and nursing technicians) as the main responsible for this practice, followed by the dental aid in PHC (4) .
As regards the physical structure, no statistically significant difference was found in the CI between UBS and USF (p-value equal to 0.3 and 0.9 for L.1 and PE.5, respectively), and the mean CI were inferior to 50% for both structure indicators applied. As opposed to the expected difference, considering studies that assessed the structure of health services in PHC and identified that the USF had larger problems related to the physical structure, as these services are frequently domestic adaptations (9,15) .
Structurally, according to the legislation in force (3) , MSC in PHC can be classified as class I MSC, so that there is no need for physical separation between the clean and dirty areas of MSC, the use of the technical barrier should be established to impede the contact between the health care products from the different areas. Technical barrier are considered to be behavioral measures by health professionals to prevent crosscontamination between both areas (1) . The application of this concept was not identified at most of the services studied, whose flow of health care products did not follow a one-way sense.
As observed in this study, a research developed at four MSC in hospitals from Salvador -BA found no resources on site for hand washing (2) , influencing the prevention of recontamination of already processed products (16) by collecting them from the autoclave before the storage.

Compliance of health care product processing as a process
Departing from the manual execution of product cleaning at all services that participated in the research, the use of steel sponges was observed for this practice, differently from the standards in force in the country (1) .
The indicator related to cleaning obtained the lowest CI (Table 2), which can deeply compromise the final quality of the process (17) .
As regards the inputs used for cleaning, the inappropriate use of enzymatic detergents was observed. The range of products of this type that exist in the market and the different usage orientations can justify difficulties in training professionals in the area (17) .
Concerning the solutions used for chemical disinfection, the use of sodium hypochlorite was observed, a substance summarily used to disinfect nebulization products in PHC in Brazil (5,18) .

Aspects of concentration and immersion time are
linked to the quality of the disinfection and product integrity, such as the presence of toxic residues on the product that was disinfected, particularly inhalation material (3) . sodium hypochlorite for disinfection (78.50%) (18) .
According to the legislation in force, the gravitational autoclaves are permitted when their capacity is inferior to 100 l, the situation found in the study context. The same legislation is not complied with, due to the absence of reports to support the water quality and records of preventive maintenance of the autoclaves (1) .
What the inappropriate arrangement of the products inside the autoclaves is concerned and the lack of awaiting the cooling time, this practice compromises the circulation of the steam and lukewarm or hot packages should not be placed on surfaces with a temperature inferior to their own, as this can cause humidity in-and outside the packages, compromising the protection barrier properties of the packing (16) .
Nevertheless, an experimental study to identify the maintained sterility of health care products in case of presence of moisture due to steam showed that, when the conditioning and storage conditions were appropriate, the inside of the sterilized boxes was not contaminated after they were withdrawn while not cooled yet and stored for 30 days (19) . Nevertheless, this cannot be extrapolated to other types of packaging nor to a lack of inappropriate manipulation, like without hand washing for example.
Biological indicators were not used as frequently as recommended by the assessment tools used and chemical indicators were the most used, similar to a study developed in cities in Goiás, in which the chemical indicator was the most used test in 83.8% (20) . This scenario compromises the confidence that the autoclaves available for the processing of health care products are used for the sterilization at these places.

Preservation of packing of sterilized products
For the storage of the products processed, a consensus exists that it should at least guarantee the integrity of the packing, avoiding tears, dirt or wetting, which was not found in this study. More controlled situations such as air humidity, temperature and specific storage places (such as cupboards or plastic boxes) do not seem to interfere in the maintenance of their sterility (21)(22) .
Although inappropriate, the use of Kraft paper is still a reality in PHC (4) , as verified in this study.
Although the study comes with limitations, as it does not permit the establishment of cause-and-effect relations among the findings or the generalization of results, it is extremely relevant, as it presents measurable and standardized data.

Conclusion
The diagnosis of compliance of health care product processing at the services assessed indicates the commitment of the process quality, as the CI obtained was not close to ideal levels at any service. In addition, there was no statistically significant difference in the quality indicators of structure, process and outcome between the UBS and the USF investigated, as opposed to the initial research hypothesis.
Cleaning indicators obtained worse CI, for structure as well as for process (L.1 < 40% L.2 CI 20%, respectively), which is undoubtedly a source of concern as it seriously compromises the subsequent steps.
This study joins important systemized information on the panorama of health care product processing in PHC, contributing to the expansion of knowledge on one of the pillars of healthcare-related infection control in this environment.