Adaptation and validation of indicators concerning the sterilization process of supplies in Primary Health Care services1

OBJECTIVES: to adapt and validate, by expert consensus, a set of indicators used to assess the sterilization process of dental, medical and hospital supplies to be used in PHC services. METHOD: qualitative methodological study performed in two stages. The first stage included a focal group composed of experts to adapt the indicators to be used in PHC. In the second stage, the indicators were validated using a 4-point Likert scale, which was completed by judges. A Content Validity Index of ≥ 0.75 was considered to show approval of the indicators. RESULTS: the adaptations implemented by the focal group mainly referred to the physical structure, inclusion of dental care professionals, inclusion of chemical disinfection, and replacement of the hot air and moist heat sterilization methods. The validation stage resulted in an index of 0.96, which ranged from 0.90 to 1.00, for the components of the indicators. CONCLUSION: the judges considered the indicators after adaptation to be validated. Even though there may be differences among items processed around the world, there certainly are common characteristics, especially in countries with economic and cultural environments similar to Brazil. The inclusion of these indicators to assess the safety of healthcare supplies used in PHC services should be considered.


Introduction
The quality of sterilization and disinfection is critical for the control and prevention of Health-Associated Infections (HAIs), since infections can be acquired due to poor processing. Studies show the need for appropriate disinfection and sterilization of medical equipment and instruments (1)(2)(3) .
Even though the actions performed within Primary Health Care (PHC) services employing sterilizable devices are not technically complex, the disinfection of these devices in PHC services is a very complex activity, the main objective of which is to avoid adverse events related to the use of these devices. Disinfection requires operational ability and expertise on the part of the professionals involved (4) . The risks inherent to inappropriate processing are related to the potential transmission of microorganisms that cause infection, to the toxicity of the disinfectant products used in the process, and potential adverse events related to residue from immunological material transmitted from one patient to another (5) .

The prevention and control of infection in PHC units have been overshadowed by news highlighting
HAIs in hospital facilities, in addition to the few studies addressing this topic in extra-hospital environments (6) .
Nevertheless, the same criteria and training required in the Sterile Processing Departments (SPDs) of hospital facilities should be followed at the PHC level (7) .
Due to the increase and diversification of extrahospital care services and to the pressing need to establish HAI control practices in different environments, it is essential to provide a standardized procedure to assess the quality of processing in SPDs.
Therefore, this study's objective was to adapt and validate a set of indicators to assess the sterilization processing of dental and medical articles through expert consensus, to be used within PHC services (8) .

Method
This is a methodological study of adapting and validating an instrument, conducted with experts to assess measures in the health field (indicators of quality of processing). The validation of an instrument through the analysis of its psychometric qualities aims to objectify and improve its use (9) , because it strengthens the reliability of results. The object of study is a set of indicators developed and validated to assess the processing of dental, medical and hospital devices within hospital facilities. This is the first instrument developed for this purpose with methodology available both in Brazil and outside of Brazil (8) . It contains ten indicators addressing the stages of sterilization processing in the health field, including structure, process and result.
Each indicator contains components to be assessed and presents how to make the assessment (inspection, record, and interviews), as well as a formula to calculate compliance. The indicators are numbered according to the type of process to which they are related: cleaning, preparation/packaging, and sterilization (8) .
In the first stage, the study's population was composed of six experts and the second stage included 11 judges, who assessed content validity.

First stage -Adaptation of indicators for PHC
This stage was implemented using a focal group.
Each item of the original instrument was presented and discussed and after consensus was reached among the experts, the instrument would be: maintained as it was; content would be maintained though with new redaction; the item would be excluded; or a new item would be Board (RDC) (10) was published after the focal group had been conducted; some adaptations were required afterwards.

Second stage -Indicators' content validity
This stage included consensus on the part of experts (judges). When these judges were selected, their experience and high level of knowledge regarding the subject was considered. The judges were chosen so that there would be representatives of both the processing field and from PHC. A total of 11 judges participated in this stage. They were 49.9 years old on average and six (54.5%) had more than 30 years of experience. All of them were experts in nursing; seven (63.6%) had a Master's degree and six (54.5%) a Doctoral degree.  addresses the attribute. In the case where there was some item for which minimum agreement was not reached after the judges' assessments, we considered the possibility of adjusting the item based on the judges' suggestions. A Content Validity Index (CVI) of 0.75 was considered in order to attain 75% consensus (11) . Options

First stage -Adaptation of indicators for PHC
In the phase of the instrument adaptation, the indicators concerning physical structure showed a need for adaptations concerning the physical area; that is, the judges did not consider it mandatory that there be two isolated areas per physical structure (dirty and

Second stage -Indicators' content validity
The mean CVI concerning the instrument's general assessment was 0.96. Among the 101 components assessed, 96 obtained satisfactory CVI (≥0.75) in assessment criteria 3 and 4. (Table 1).
Some components obtained a CVI below 0.75 and a new version of these components was proposed, taking into account the judges' suggestions. The initial and final redactions of these components, including the judges' suggestions, are presented in Figure 1.

Discussion
The construction and validation of indicators, as well as an assessment of practices to control HAIs through the use of indicators, has increased; however, research addressing this subject in Brazil is still incipient and not homogenous (12) .   air in processing rooms within Brazilian PHC services is still a challenge. Sodium hypochlorite is still the most commonly used disinfectant in PHC, especially due to its low cost, despite controversy in the literature regarding its indication and, if indicated, the concentration to be used (3,14) .
It is also important to assess the integrity of how items are packaged that were already processed, because they should be individually wrapped in sealed plastic after drying. Packaging is intended to avoid recontamination during storage and the handling of disinfected items before reuse (14) .
The restricted use of hot air sterilization is provided in the Brazilian guidelines (10) . It is believed that this specification was restated in accordance with the literature that shows that the use of ovens is still very common in healthcare services. One study reports that 15 out of 44 hospitals in Goias, Brazil still use Pasteur ovens for sterilization. Such a method has fallen into disuse due its operational difficulty and technological advancements beyond it (2) . Most hospitals did not apply physical, chemical or biological controls for the sterilization cycles. Another study, performed in cities in the interior of São Paulo, reports its use in dental care facilities, in which only 6% of the ovens indicated the temperature that was attained inside the equipment and had thermostats to maintain the desired temperature (15) .
Most comments and suggestions were incorporated in the validation phase.
Change of redaction concerning the qualification of professionals processing items in the SPDs of PHC services was necessary to comply with RDC No.15 (10) , which provides that all processing activities be performed by professionals whose activity is regulated by professional councils.
There are oral care professionals (oral care technicians and auxiliaries) processing items in PHC services. One study conducted in PHC units in a city in the interior of the state of São Paulo, Brazil, shows that the nursing staff was responsible for the processing of items in almost all the units (97%); only in one unit (2.9%) was the professional responsible for this task a dental professional (7) . Another study shows that for most of the services in the city of Goiania, GO, Brazil, the professionals responsible for the processing of dental items were oral health auxiliaries (48%) or dental hygiene technicians (21%), while in the remaining services, this task is performed by workers without specific training in the health field (21% were auxiliaries with practical experience and 10% were general services assistants (16) .
The processing of items performed by personnel without technical qualification may compromise the quality of care delivery (2) .
The same study reports that the dental office's environment was used to process the items in 55% of the cases. It is ideal that both the nursing and dental staff are connected, so that processing is centralized.
There is greater rationalization of work, optimization of human resources and material, in addition to greater safety for both patients and workers, when there is a centralized system (17) .
Publications addressing the processing of items in the dental field have advanced, which shows a concern with the topic (16,18) . There is a need, though, for further studies so that these processes may be standardized.
Recommendations concerning replacing the enzymatic detergent used in cleaning items state that the detergent must be replaced frequently so that the solution does not become saturated with organic matter, which decreases its efficacy (19)(20) . In this study, the recommendation is to follow the manufacture's specifications because, in Brazil, enzymatic detergent manufacturers must comply with RDC No. 55 (21) , indicating on the product's label that reusing the solution may impair its cleaning efficiency.
The quality of the water used in autoclaves was questioned. According to the manufacturers, potable water is not indicated to supply autoclaves.
This water contains organic and inorganic particles, some pesticides and disinfectant that may impair the equipment (19) . Current Brazilian drinkability standards do not ensure the removal of such particles. Therefore, the recommendation is to follow manufacturer specifications (10) . The use of distilled water or water purified by reverse osmosis filters is suitable to avoid the use of water containing undesirable elements.
The judges questioned the suggestion to use non-  (5,19) . One study verified that, after two years, 100% (152) of the sterilized and stored packages, which suffered no adverse events, were sterile (22) .
Another study concluded that even after exposure to the microorganism Serratia marcescens, an item with a safe microbial barrier remained sterile after 180 days (23) .
Event-related sterility is safe and should, therefore, replace time-related expiration (22) .

Conclusion
The instrument was satisfactorily adapted and