Abstracts

INTRODUCTION

Healthcare-associated infections (HAI) were first diagnosed during the so-called “Pasteur revolution” by investigators including Ignaz Semmelweis, Florence Nightingale, and Joseph Lister.⁶6 Larson E. Innovations in health care: antisepsis as a case study. Am J Public Health. 1989;79(1):92-9. DOI:10.2105/AJPH.79.1.92 During the 21^st century, because of the development of increased life support and immunosuppressant therapies, the need to control hospital-acquired infections became apparent. Therefore, hospital-acquired infections have been systematically addressed in developed countries.¹⁰10 Nogueira Jr C, Mello DS, Padoveze MC, Boszczowski I, Levin AS, Lacerda RA. Characterization of epidemiological surveillance systems for healthcare-associated infections (HAI) in the world and challenges for Brazil. Cad Saude Publica. 2014;30(1):11-20. DOI:10.1590/0102-311X00044113^,1515 Selwyn S. Hospital infection: the first 2500 years. J Hosp Infect. 1991;18 Suppl A:5-64. Since the mid-1990s, the term “hospital infection” was replaced with the term “HAI”; the latter designation is a broad concept that incorporates infections that are acquired and associated with healthcare activities in any given environment.⁴4 Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008;36(5):309-32. DOI:10.1016/j.ajic.2008.03.002

HAI have a great impact upon hospital mortality, duration of hospitalization, and costs. The growing number of conditions that lead to hospitalization of individuals presenting with increasingly severe clinical conditions and immunosuppression, in addition to the increased resistance to antimicrobial agents, indicates the importance of HAI in public health management. In addition, developing countries suffer from a large number of HAI, which can be 20 times larger than that observed in developed countries.²2 Allegranzi B, Bagheri Nejad S, Combescure C, Graafmans W, Attar H, Donaldson L, et al. Burden of endemic health-care-associated infection in developing countries: systematic review and meta-analysis. Lancet. 2011;377(9761):228-41. DOI:10.1016/S0140-6736(10)61458-4^,1313 Pittet D, Allegranzi B, Storr J, Bagheri Nejad S, Dziekan G, Leotsakos A, et al. Infection control as a major World Health Organization priority for developing countries. J Hosp Infect. 2008;68(4):285-92. DOI:10.1016/j.jhin.2007.12.013 The factors associated with the lack of qualified human resources, along with an inadequate physical structure for healthcare services and limited knowledge of HAI control measures, contribute to this scenario.

After acknowledging that HAI are a public health problem, the World Health Organization (WHO) recommended that health authorities designate an agency to manage a nationwide healthcare program, which should be aligned with other healthcare goals.^aa World Health Organization. Practical guidelines for infection control in healthcare facilities. Geneva; 2004 [cited 2012 Dec 4]. Available from: http://www.wpro.who.int/publications/docs/practical_guidelines_infection_control.pdf In Brazil, the discussions on programmatic actions are essential to acknowledge the advances made to date, identify challenges, and propose strategies to amplify the potential of these actions.

The present study aimed to investigate the historical and regulatory milestones for the prevention of HAI, to recognize the magnitude of the problem, and to make a critical assessment of the challenges and needs for the prevention of HAI in Brazil.

Historical and regulatory milestones related to HAI in Brazil

Although the first HAI Prevention and Control Committee (HAIPCC) appeared in the 1960s, the programmatic and governmental actions only began at the end of the military dictatorship by norms established by the Brazilian Ministry of Health (MoH).^bb Brasil. Lei nº 9.431, de 6 de Janeiro de 1997. Dispõe sobre a obrigatoriedade de manutenção de programas de controle de infecção hospitalar pelos hospitais do país. Diario Oficial Uniao. 7 jan 1997:265. In the 1980s, several national technical guidelines involving the assessment of healthcare facilities were published, when the use of epidemiological methods to deal with HAI was still in its infancy. In addition, in this period, this subject was discussed among various health authorities, and MoH implemented a training program focused on the training of 14,000 healthcare professionals.⁵5 Lacerda RA, coordenador. Controle de infecção em centro cirúrgico: fatos, mitos e controvérsias. São Paulo: Atheneu; 2003. However, the impact of this initiative was not assessed, and the project was discontinued. This initiative was followed by a gap in terms of government training activities, and only in 2004, new training programs were offered to health surveillance professionals via distance learning.³3 Guerra CM, Ramos MP, Penna VZ, Goto JM, Santi LQ, de Andrade Stempliuk V, et al. How to educate health care professionals in developing countries? A Brazilian experience. Am J Infect Control. 2010;38(6):491-3. DOI:10.1016/j.ajic.2009.09.015

A Regional Conference on Prevention and Control of HAI was held in 1990 and emphasized the need to implement national HAI prevention and control committees.^cc Santos AAM. O modelo brasileiro para o controle das infecções hospitalares após vinte anos de legislação, onde estamos e para onde vamos? [master’s dissertation]. Belo Horizonte: Faculdade de Medicina da UFMG; 2006. In Brazil, this committee was established by the implementation of the National HAI Prevention and Control Program (NHAICP),^cc Santos AAM. O modelo brasileiro para o controle das infecções hospitalares após vinte anos de legislação, onde estamos e para onde vamos? [master’s dissertation]. Belo Horizonte: Faculdade de Medicina da UFMG; 2006. which resulted in the creation of the Divisão Nacional de Controle de Infecção Hospitalar (National Division of HAI Control).¹1 Agência Nacional de Vigilância Sanitária. Anvisa intensifica controle de infecção em serviços de saúde. Rev Saude Publica. 2004;38(3):47-8. DOI:10.1590/S0034-89102004000300022 A few reports on the effective actions performed by this division are available, and a new national committee was implemented only 20 years later (Table). The following other directives were created during this regional conference: (a) binding hospital accreditation to the establishment of HAI programs; (b) inclusion of the topic in the health sciences curriculum and in continued education programs; (c) cooperation between state institutions and universities for the development of epidemiological research; (d) identification of regional reference microbiology laboratories; and (e) implementation of working groups focused on the use of antimicrobial agents and microbiological diagnosis of HAI. Despite the many advances in this sector, the recommendations established in this conference were not achieved.

At present, the legislation that determines the general guidelines for the prevention and control of HAI are Law 9,431 (1997),^bb Brasil. Lei nº 9.431, de 6 de Janeiro de 1997. Dispõe sobre a obrigatoriedade de manutenção de programas de controle de infecção hospitalar pelos hospitais do país. Diario Oficial Uniao. 7 jan 1997:265. Ordinance 2,616 (1998),^dd Ministério da Saúde. Portaria nº 2.616, de 12 de maio de 1998. Diario Oficial Uniao. 13 maio 1998;Seção1;133. and Resolution RDC 48 (2000).^ee Agência Nacional de Vigilância Sanitária. Roteiro de inspeção do programa de controle de infecção hospitalar. RDC nº 48, de 2 de junho de 2000. Diario Oficial Uniao. 6 jul 2000;Seção I:1415. The key element of these guidelines is the requirement to implement HAIPCC in hospitals. Ordinance 2,616 introduced the proposal to develop structured programs at the federal, state, and municipal levels. However, there was heterogeneity in the state coordination for the control of HAI, and improvement in this scenario was one of the main proposals of NHAICP since the beginning of 2000.^ff Sociedade Brasileira de Infectologia. São Paulo; 2014 [cited 2012 Nov 5]. Available from: http://www.sbinfecto.org.br

From 2000, PNCIH linked with the National Health Surveillance Agency (ANVISA), which promotes the interface with other health surveillance (Table). The transfer of the National HAI Program to ANVISA was an emblematic hallmark and indicated that at the federal government level, the management of HAI should be maintained within the sphere of sanitary audit. Unlike other public health problems, HAI have been perceived as a problem that requires normalization and auditing. The results of this approach were ambiguous. On one hand, there was a notable improvement in the legislation applied for the prevention of HAI and increased health surveillance. On the other hand, the control of HAI was perceived as an activity focused on compliance to standards and solely related to the attitude of individual healthcare services under the law. This weakened the perception of HAI control as a public health problem or shifted the collective perspective about the problem. This factor partly contributed to the initial failure of the attempts made to quantify the impact of this strategy nationwide.

The regulatory role of ANVISA has been intensive since its inception. The regulation of marketed products such as sanitation and healthcare products (including equipment) is one of the strongest areas, along with the normalization of physical areas for healthcare services (Table). In recent years, the creation of guidelines has intensified; until 2012, 10 guidelines were already available in ANVISA’s website.^gg Agência Nacional de Vigilância Sanitária. Segurança do paciente e qualidade em serviços de saúde. Bol inform Segur Pac Qual Serv Saude. 2011 [cited 2013 Feb 2];I(1):1-12. Available from: http://portal.anvisa.gov.br/wps/wcm/connect/f72c20804863a1d88cc88d2bd5b3ccf0/BOLETIM+I.PDF?MOD=AJPERES

The recent history of HAI control in Brazil has suffered the impact of large-scale epidemics. The outbreaks of rapidly growing mycobacteria in invasive procedures^hh Agência Nacional de Vigilância Sanitária. Relatório descritivo de investigação de casos de infecções por micobactérias não tuberculosas de crescimento rápido (MCR) no Brasil no período de 1998 a 2009. Brasília (DF); 2011 [cited 2011 Nov 25]. Available from: http://www.anvisa.gov.br/hotsite/hotsite_micobacteria/relatorio_descrito_mcr_16_02_11.pdf have shed light on important failures in the reprocessing of articles, aggravated by the detection of resistance of rapidly growing mycobacteria resistant to glutaraldehyde.⁷7 Lorena NS, Pitombo MB, Cortes PB, Maya MC, Silva MG, Carvalho AC, et al. Mycobacterium massiliense BRA100 strain recovered from postsurgical infections: resistance to high concentrations of glutaraldehyde and alternative solutions for high level disinfection. Acta Cir Bras. 2010;25(5):455-9. DOI:10.1590/S0102-86502010000500013

8 Matsumoto CK, Chimara E, Ramos JP, Campos CE, Caldas PC, Lima KV, et al. Rapid tests for the detection of the Mycobacterium abscessus subsp. bolletii strain responsible for an epidemic of surgical-site infections in Brazil. Mem Inst Oswaldo Cruz. 2012;107(8):969-77. DOI:10.1590/S0074-02762012000800002^-99 Monego F, Duarte RS, Nakatani SM, Araujo WN, Riediger IN, Brockelt S, et al. Molecular identification and typing of Mycobacterium massiliense isolated from postsurgical infections in Brazil. Braz J Infect Dis. 2011;15(5):436-41. DOI:10.1016/S1413-8670(11)70224-0^,1111 Padoveze MC, Fortaleza CM, Freire MP, Brandão de Assis D, Madalosso G, Pellini AC, et al. Outbreak of surgical infection caused by non-tuberculous mycobacteria in breast implants in Brazil. J Hosp Infect. 2007;67(2):161-7. DOI:10.1016/j.jhin.2007.07.007 In addition, outbreaks of carbapenemase-producing Klebsiella pneumoniae and Enterococcus spp. resistant to vancomycinⁱi Agência Nacional de Vigilância Sanitária. Investigação e controle de bactérias multiresistentes. Brasília (DF); 2007 [cited 2012 Nov 3]. Available from: http://www.anvisa.gov.br/servicosaude/controle/reniss/manual%20_controle_bacterias.pdf were widely covered by the press, culminating in the prohibition of purchase of antimicrobial agents without medical prescription and the obligatory use of alcohol-based disinfectants in healthcare units (Table). With regard to laboratory support and management of microbial resistance, board committees composed of specialists were created; however, to date, their actions are scarce, considering the extent of the problem (Table).

In 2007, in line with the development of global strategies for the prevention of HAI, MoH officially engaged in the Global Patient Safety Initiative proposed by WHO. However, most of these actions have been implemented by ANVISA, with the recent involvement of MoH.^gg Agência Nacional de Vigilância Sanitária. Segurança do paciente e qualidade em serviços de saúde. Bol inform Segur Pac Qual Serv Saude. 2011 [cited 2013 Feb 2];I(1):1-12. Available from: http://portal.anvisa.gov.br/wps/wcm/connect/f72c20804863a1d88cc88d2bd5b3ccf0/BOLETIM+I.PDF?MOD=AJPERES

Magnitude of the HAI problem in Brazil

To date, the only known national assessment performed in Brazil is that by Prade et al (1995), wherein a HAI prevalence of 15.0% was found in 99 tertiary hospitals.¹⁴14 Prade SS, Oliveira ST, Rodriguez R, Nunes F, Netto EM, Félix JQ, et al. Estudo brasileiro da magnitude das infecções hospitalares em hospital terciário. Rev Contr Inf Hosp. 1995;2(2):11-24.

After 2001, ANVISA started assessing situation of HAI programs in Brazilian hospitals.^jj Agência Nacional de Vigilância Sanitária. Diagnóstico do controle de infecção hospitalar no Brasil. Brasília (DF); 2005 [cited 2013 Feb 2]. Available from: http://www.anvisa.gov.br/servicosaude/controle/Infectes%20Hospitalares_diagnostico.pdf The findings underscored structural fragilities in HAI control: 1/3 of the hospitals did not have microbiology laboratory support. This fragility in the Northeast (46.0%) was accentuated compared with that in the Southeast (24.0%).^cc Santos AAM. O modelo brasileiro para o controle das infecções hospitalares após vinte anos de legislação, onde estamos e para onde vamos? [master’s dissertation]. Belo Horizonte: Faculdade de Medicina da UFMG; 2006. Furthermore, essential requirements were not met by all institutions, such as the accreditation of CCIH (76.0%) and performance of epidemiological surveillance (77.0%). In 2002, a national survey was conducted to assess the suitability of microbiology laboratories in Brazil and helped to identify pertinent fragilities in this area.^kk Agência Nacional de Vigilância Sanitária. Análise do Inquérito Nacional sobre infra-estrutura, recursos humanos, equipamentos, procedimentos, controle de qualidade e biossegurança nos Laboratórios de Microbiologia. Brasília (DF); 2007.

Moreover, it is acknowledged that only an effective nationwide epidemiological surveillance system could define the real magnitude of the HAI problem in Brazil.¹⁰10 Nogueira Jr C, Mello DS, Padoveze MC, Boszczowski I, Levin AS, Lacerda RA. Characterization of epidemiological surveillance systems for healthcare-associated infections (HAI) in the world and challenges for Brazil. Cad Saude Publica. 2014;30(1):11-20. DOI:10.1590/0102-311X00044113 The first surveillance systems created at the governmental level that achieved concrete results occurred in the states of Sao Paulo and Paraná.¹²12 Padoveze MC, Assis DB, Freire MP, Madalosso G, Ferreira SA, Valente MG, et al. Surveillance Programme for Healthcare Associated Infections in the State of Sao Paulo, Brazil. Implementation and the first three years’ results. J Hosp Infect. 2010;76(4):311-5. DOI:10.1016/j.jhin.2010.07.005^,1616 Toledo PV, Arend LN, Pilonetto M, Costa Oliveira JC, Luhm KR. Surveillance programme for multidrug-resistant bacteria in healthcare-associated infections: an urban perspective in South Brazil. J Hosp Infect. 2012;80(4):351-3. DOI:10.1016/j.jhin.2012.01.010

From 1998, the overall understanding of programmatic actions began to incorporate the epidemiological management of HAI. In 2010, ANVISA implemented the surveillance of primary bloodstream infections associated with central venous catheters. The 2012 data on 1,128 hospitals identified an incidence of 5.5 and 2.0 for primary bloodstream infections per 1,000 central venous catheters per day using laboratory and clinical data, respectively. These data were collected at adult intensive care units (ICU), and coagulase-negative Staphylococcus strains were the most common etiological agents.^gg Agência Nacional de Vigilância Sanitária. Segurança do paciente e qualidade em serviços de saúde. Bol inform Segur Pac Qual Serv Saude. 2011 [cited 2013 Feb 2];I(1):1-12. Available from: http://portal.anvisa.gov.br/wps/wcm/connect/f72c20804863a1d88cc88d2bd5b3ccf0/BOLETIM+I.PDF?MOD=AJPERES In 2013, the National HAI Prevention and Control Program was launched.^ll Agência Nacional de Vigilância Sanitária. Programa Nacional de Prevenção e Controle de Infecções Relacionadas à Assistência à Saúde. Brasília (DF); 2013 [cited 2014 Jun 24]. Available from: http:// http://portal.anvisa.gov.br/wps/portal/anvisa/anvisa/home/servicosdesaude

Challenges for the future of HAI prevention and control in Brazil

HAI monitoring by ANVISA implies a different approach from that used for the management of other health problems that are currently under the competence of the National Surveillance Department at MoH. In practice, there is a lack of human resources in this area, and no specific funding has supported the National HAI Prevention and Control Program.

Some major challenges include the large territory, presence of difficult-to-access regions, large number of healthcare institutions (particularly in the larger states and municipalities), large number of small-sized hospitals (≤ 50 beds) with difficulty in implementing CCIH, heterogeneity of healthcare services, and insufficient number of ICU. In addition, economic and cultural differences and distinct political views regarding HAI occur in distinct regions and hinder the establishment of homogeneous normative standards in Brazil. For example, CNES (National Registry of Health Institutions)^mm Ministério da Saúde. CNES: Cadastro Nacional dos Estabelecimentos de Saúde. Brasília (DF); 2000 [cited 2014 Jun 24]. Available from: www.cnes.datasus.gov.br listed 6,266 hospitals in June 2012, distributed in a heterogeneous manner throughout the Brazilian territory, and more than 50.0% of them were located in the Southeast and South regions.

The Brazilian constitution acknowledges that healthcare is a right of every citizen and a state responsibility; however, it does not prohibit the creation of private healthcare services.ⁿn Conselho Nacional de Secretários de Saúde. Legislação do SUS. Progestores 2003 - Programa de Informação e Apoio Técnico às Novas Equipes Gestoras Estaduais do SUS de 2003. Brasília (DF); 2003. The Brazilian Unified Health System functions at the municipal, state, and federal levels by directly management or agreements or contracts with private healthcare units. On the other hand, the private sector (supplementary healthcare services) organizes itself by healthcare plans or by direct reimbursement of healthcare costs to the users. Therefore, important factors such as the dual healthcare system, implementation of alternative health management strategies, and decentralized management model indicate that many interlocutors will need to discuss prevention strategies.

The lack of reference laboratories to adequately provide healthcare support and the growing need of microbiological research, particularly that aimed at providing a rapid response to outbreaks, are challenges that urgently need to be overcome. Considering that high-level microbiological research is being conducted at Brazilian universities, it is a paradox how most of these results are not being directed toward public health priorities in the country.

The growing health costs and limited availability of material resources and skilled labor involved in the control of HAI are relevant adversities. With regard to professional health training, academic courses that provide training in this area are rare. Regardless of academic training, providing permanent in-service professional education is essential and is a challenge for governments, health institutions, and healthcare workers, who should be proactive and constantly trained. The managers of institutions sometimes underestimate the magnitude of the problem, and the support for preventive measures is not always robust.

Despite some positive initiatives,^oo Silva PF, Padoveze MC. Infecções relacionadas a serviço de saúde - orientações para público geral. Conhecendo um pouco mais sobre as precauções específicas. São Paulo: Centro de Vigilância Epidemiológica; 2012 [citado 2013 Fev 02]. Available from: http://www.cve.saude.sp.gov.br/htm/ih/pdf/IRAS12_LEIGOS_PRECAUCAO.pdf citizens have limited access to information on HAI, including the role of patients and family members. The press is generally sensationalist and frightening when addressing the issue of HAI. It is necessary to stimulate community representation on advisory committees to government institutions and health.

It is urgent to hold a thorough nationwide discussion about what should be the concrete manifestation of the State regarding HAI prevention in Brazil. The dialogue between the segments of representative government, health institutions, health workers, and users of the system is a key element to overcome these challenges.

REFERENCES

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