Adverse Events and Technical Complaints of Technologies for the Management of Elimination Ostomies in Brazil
Abstract
Objective: To describe adverse events and technical complaints involving technologies for the management of elimination ostomies reported in Brazil. Method: This cross‑sectional descriptive study used secondary data recorded in the Notivisa system. The data encompass adverse events and technical complaints reported from January 2007 to August 2023. Descriptive statistical tools were used for the analysis. Results: A total of 2,812 notifications were identified, of which 101 (3.6%) were adverse events, and 2,711 (96.4%) were technical complaints. The state of São Paulo accounted for 884 (31.4%) notifications. Collection bags were the most frequently reported products, with 2,688 (95.6%) notifications, including 84 (3.1%) adverse events and 2,604 (96.9%) technical complaints. Regarding outcomes, 2,718 (96.7%) notifications lacked information, 19 (0.67%) reported urinary retention, 13 (0.46%) reported dermatitis, and 9 (0.32%) reported skin injury. Conclusion: The number of notifications has continued to rise in recent years; however, the quality remains low, as evidenced by the high rate of omitted information. Technical complaints about collection bags represent the largest number of notifications in Brazil. The description of outcomes in the use of products for ostomy management is unclear and may lead to the underreporting of significant adverse events such as dermatitis.
Downloads
References
Oliveira DAL, Silva MST, Silva RK, Cintra TD, Medeiros RR. Enfermagem e tecnovigilância na assistência segura. Vigil Sanit Debate. 2019;7(1):48-52. https://doi.org/10.22239/2317-269X.001171
Lee SE, Dahinten VS. The enabling, enacting, and elaborating factors of safety culture associated with patient safety: a multilevel analysis. J Nurs Scholarsh. 2020;52(5):544-52. https://doi.org/10.1111/jnu.12585
Villar VCFL, Martins M, Rabello ET. Incidentes e eventos adversos de segurança do paciente notificados pelos cidadãos no Brasil: estudo descritivo, 2014-2018. Epidemiol Serv Saúde. 2021;30(4):e2021005. https://doi.org/10.1590/S1679-49742021000400007
Lemos GC, Azevedo C, Bernardes MFVG, Ribeiro HCTC, Menezes AC, Mata LRF. A cultura de segurança do paciente no âmbito da enfermagem: reflexão teórica. Rev Enferm Cent-Oeste Min. 2018;8:e2600. https://doi.org/10.19175/recom.v7i0.26000
Merhy EE. Micropolítica del trabajo en salud: teoría, métodos y aplicaciones. Nicaragua: Editora Rede Unida; 2023.
Oliveira DAL, Silva MST, Silva RKS, Cintra DT, Medeiros RR. Enfermagem e tecnovigilância na assistência segura. Vigil Sanit Debate. 2019;7(1):48-52. https://doi.org/10.22239/2317-269x.001171
Brasil. Agência Nacional de Vigilância Sanitária. Manual de tecnovigilância: uma abordagem sob ótica da vigilância sanitária [Internet]. Brasília: Agência Nacional de Vigilância Sanitária; 2021 [acessado em 25 out. 2023]. Disponível em: https://www.gov.br/anvisa/pt-br/centraisdeconteudo/publicacoes/monitoramento/tecnovigilancia/manual-tecnovigilancia-2021-v4.pdf/view
Paula MAB, Moraes JT. Consenso Brasileiro de cuidado às pessoas adultas com estomias de eliminação 2020. São Paulo: Segmento Farma; 2021.
Brasil. Ministério da Saúde. Secretaria de Atenção à Saúde. Portaria no 400, de 16 de novembro de 2009 [Internet]. Brasília: Ministério da Saúde; 2009 [acessado em 23 out. 2023]. Disponível em: https://bvsms.saude.gov.br/bvs/saudelegis/sas/2009/prt0400_16_11_2009.html
Bavaresco M, Manfredini GMSG, Moraes CM, Lima RS, Fava SMCL, Dázio EMR. Complications of ostomy bowel and peristomal skin: evidence for nursing care. Rev Enferm UERJ. 2019;27:e45758. https://doi.org/10.12957/reuerj.2019.45758
Carneiro MLO, Milagre ST. Eventos adversos e queixas técnicas notificados ao sistema Notivisa na área de tecnovigilância: levantamento das tecnologias mais incidentes no período de 2013 a 2018. Revista Sítio Novo. 2020;4(4):284-99.
Ribas MA, Almeida PHRF, Chaves GA, Lemos GS. Eventos adversos e queixas técnicas notificados a um núcleo de segurança do paciente. Revista de Atenção a Saúde. 2019;62(17):71-80. https://doi.org/10.13037/ras.vol17n62.6184
Wagner J, Perfoll R. Características e indicações clínicas dos dispositivos para estomia padronizados pela secretaria de Saúde do Estado de Santa Catarina-SES-SC. Revista Inova Saúde. 2023;15(1):51-72.
Sousa AS, Sousa BS, Melo MLJ, Santana JD, Gois YDC, Carregosa KRS, Albertoni AL, Silva HSVB, Rego Neto FF, Batista JFC. Subnotificação de eventos adversos ocasionados por medicamentos. Res Soc Dev. 2023;12(6):e26912642376. https://doi.org/10.33448/rsd-v12i6.42376
Mascarenhas FAS, Anders JC, Gelbcke FL, Lanzoni GMM, Ilha P. Facilities and difficulties of health professionals regarding the adverse event reporting process. Texto & Contexto Enferm. 2019;28:e20180040. https://doi.org/10.1590/1980-265X-TCE-2018-0040
Moraes JT, Santos VLCG, Dantas SRPE, Paula MAB. Cursos de estomaterapia acreditados para uma formação de excelência. Estima. 2020;18:e0420. https://doi.org/10.30886/estima.v18.866_PT
Hey AP, Nascimento LA. A Pessoa com estomia e o fornecimento de equipamentos coletores e adjuvantes pelo Sistema Único de Saúde. Estima. 2017;15(2):92-9. https://doi.org/10.5327/Z1806-3144201700020005
Burch J. Stoma product selection: a guide for community nurses. Br J Community Nurs. 2022;27(1):20-4. https://doi.org/10.12968/bjcn.2022.27.1.20
Silva IP, Sena JF, Lucena SKP, Xavier SSM, Mesquita SKC, Silva VGF, Costa IKF. Autocuidado de pessoas com estomias intestinais: implicações para o cuidado de enfermagem. REME Rev Min Enferm. 2022;26:e1425. https://doi.org/10.35699/2316-9389.2022.38661
Goldstine J, van Hees R, van de Vorst D, Skountrianos G, Nichols T. Factors influencing health-related quality of life of those in the Netherlands living with an ostomy. Br J Nurs. 2019;28(22):S10-7. https://doi.org/10.12968/bjon.2019.28.22.S10
Down G, Vestergaard M, Ajslev TA, Boisen EB, Nielsen LF. Perception of leakage: data from the Ostomy Life Study 2019. Br J Nurs. 2021;30(22):S4-12. https://doi.org/10.12968/bjon.2021.30.22.S4
Silva FMV, Morato JEM, Silva LSR, Barros AWMS, Jatobá JAVN, Pereira EBF. Fatores associados à dermatite em pacientes estomizados. Enfermagem Brasil. 2022;21(4):482-94. https://doi.org/10.33233/eb.v21i4.4887
Shiraishi T, Nishizawa Y, Nakajima M, Kado R, Ikeda K, Tsukada Y, Sasaki T, Ito M. Risk factors for the incidence and severity of peristomal skin disorders defined using two scoring systems. Surg Today. 2020;50(3):284-91. https://doi.org/10.1007/s00595-019-01876-9
D’Ambrosio F, Pappalardo C, Scardigno A, Maida A, Ricciardi R, Calabrò GE. Peristomal skin complications in ileostomy and colostomy patients: what we need to know from a public health perspective. Int J Environ Res Public Health. 2022;21;20(1):79. https://doi.org/10.3390/ijerph20010079
Zelga P, Kluska P, Zelga M, Piasecka-Zelga J, Dziki A. Patient-related factors associated with stoma and peristomal complications following fecal ostomy surgery: a scoping review. J Wound Ostomy Continence Nurs. 2021;48(5):415-30. https://doi.org/10.1097/WON.0000000000000796
Voegeli D, Karlsmark T, Eddes EH, Hansen HD, Zeeberg R, Håkan-Bloch J, Hedegaard CJ. Factors influencing the incidence of peristomal skin complications: evidence from a multinational survey on living with a stoma. Gastrointestinal Nursing. 2020;18(Sup4):S31-8. https://doi.org/10.12968/gasn.2020.18.Sup4.S31
Cressey BD, Belum VR, Scheinman P, Silvestri D, McEntee N, Livingston V, Lacouture ME, Zippin JH. Stoma care products represent a common and previously underreported source of peristomal contact dermatitis. Contact Dermatitis. 2016;76(1):27-33. https://doi.org/10.1111/cod.12678
Barbosa SLES, Carvalho FO, Souza IES, Lima LS, Aragão NRO, Ribeiro CJN, Santos VLCG, Abud ACF. Intervenções de enfermagem para prevenção de dermatite periestoma em estomas intestinais: revisão sistemática. Res Soc Dev. 2021;10(7):e48110716740. https://doi.org/10.33448/rsd-v10i7.16740
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2024 Claudiomiro da Silva Alonso, Amanda Borba Barbosa, Fernanda Passos Silva, Ieda Gomes Rios, Maria de Lourdes de Freitas Gomes, Eline Lima Borges
This work is licensed under a Creative Commons Attribution 4.0 International License.
Português (Brasil)
English
