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Support of adult urinary incontinence products: recommendations to assure safety and regulatory compliance through application of a risk assessment framework

Urinary incontinence (UI) or involuntary loss of urine is a common chronic medical condition among women. It is estimated that 5%−70% of the population experiences incontinence with most studies suggesting 25%−45% of the population. Varying definitions of UI (e.g., stress, urgency, mixed) exist, and...

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Autores principales: Krause, Edburga L., Hattersley, Anne M., Abbinante-Nissen, Joan M., Gutshall, Denise, Woeller, Kara E.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10285159/
https://www.ncbi.nlm.nih.gov/pubmed/37361342
http://dx.doi.org/10.3389/frph.2023.1175627
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author Krause, Edburga L.
Hattersley, Anne M.
Abbinante-Nissen, Joan M.
Gutshall, Denise
Woeller, Kara E.
author_facet Krause, Edburga L.
Hattersley, Anne M.
Abbinante-Nissen, Joan M.
Gutshall, Denise
Woeller, Kara E.
author_sort Krause, Edburga L.
collection PubMed
description Urinary incontinence (UI) or involuntary loss of urine is a common chronic medical condition among women. It is estimated that 5%−70% of the population experiences incontinence with most studies suggesting 25%−45% of the population. Varying definitions of UI (e.g., stress, urgency, mixed) exist, and inconsistent symptom assessment tools, age, and gender can affect the estimate of incidence. Disposable Adult Incontinence products were first introduced into the market in the late 1970s and initially were used mostly in nursing homes and hospitals. However, during the 1980s, the market for incontinence products via retail outlets dramatically increased as awareness of the benefits of the products grew and stigma about their use declined. Today's products that manage urine loss have an extensive history and have evolved with time. Always products were introduced into the market in 2014 and are designed to meet the needs of women of all ages. Considered medical devices in some countries, regional regulations and global guidelines require clear planning, thorough assessment, and concise documentation of clinical safety. This manuscript will briefly review the regulatory landscape with a specific focus on European Union regulations. As previously published, the iterative, risk assessment framework used to assess the safety of Always incontinence products confirms that these products are compatible with skin and can be used safely. This manuscript will expand on the current literature highlighting additional steps that help assure the safety and compliance of the products from quality assurance programs through comprehensive post-market safety surveillance. Recommendations to help ensure several of the key regulatory requirements are met are outlined in the context of a risk assessment framework used to assure safety.
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spelling pubmed-102851592023-06-23 Support of adult urinary incontinence products: recommendations to assure safety and regulatory compliance through application of a risk assessment framework Krause, Edburga L. Hattersley, Anne M. Abbinante-Nissen, Joan M. Gutshall, Denise Woeller, Kara E. Front Reprod Health Reproductive Health Urinary incontinence (UI) or involuntary loss of urine is a common chronic medical condition among women. It is estimated that 5%−70% of the population experiences incontinence with most studies suggesting 25%−45% of the population. Varying definitions of UI (e.g., stress, urgency, mixed) exist, and inconsistent symptom assessment tools, age, and gender can affect the estimate of incidence. Disposable Adult Incontinence products were first introduced into the market in the late 1970s and initially were used mostly in nursing homes and hospitals. However, during the 1980s, the market for incontinence products via retail outlets dramatically increased as awareness of the benefits of the products grew and stigma about their use declined. Today's products that manage urine loss have an extensive history and have evolved with time. Always products were introduced into the market in 2014 and are designed to meet the needs of women of all ages. Considered medical devices in some countries, regional regulations and global guidelines require clear planning, thorough assessment, and concise documentation of clinical safety. This manuscript will briefly review the regulatory landscape with a specific focus on European Union regulations. As previously published, the iterative, risk assessment framework used to assess the safety of Always incontinence products confirms that these products are compatible with skin and can be used safely. This manuscript will expand on the current literature highlighting additional steps that help assure the safety and compliance of the products from quality assurance programs through comprehensive post-market safety surveillance. Recommendations to help ensure several of the key regulatory requirements are met are outlined in the context of a risk assessment framework used to assure safety. Frontiers Media S.A. 2023-06-08 /pmc/articles/PMC10285159/ /pubmed/37361342 http://dx.doi.org/10.3389/frph.2023.1175627 Text en © 2023 Krause, Hattersley, Abbinante-Nissen, Gutshall and Woeller. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) (https://creativecommons.org/licenses/by/4.0/) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Reproductive Health
Krause, Edburga L.
Hattersley, Anne M.
Abbinante-Nissen, Joan M.
Gutshall, Denise
Woeller, Kara E.
Support of adult urinary incontinence products: recommendations to assure safety and regulatory compliance through application of a risk assessment framework
title Support of adult urinary incontinence products: recommendations to assure safety and regulatory compliance through application of a risk assessment framework
title_full Support of adult urinary incontinence products: recommendations to assure safety and regulatory compliance through application of a risk assessment framework
title_fullStr Support of adult urinary incontinence products: recommendations to assure safety and regulatory compliance through application of a risk assessment framework
title_full_unstemmed Support of adult urinary incontinence products: recommendations to assure safety and regulatory compliance through application of a risk assessment framework
title_short Support of adult urinary incontinence products: recommendations to assure safety and regulatory compliance through application of a risk assessment framework
title_sort support of adult urinary incontinence products: recommendations to assure safety and regulatory compliance through application of a risk assessment framework
topic Reproductive Health
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10285159/
https://www.ncbi.nlm.nih.gov/pubmed/37361342
http://dx.doi.org/10.3389/frph.2023.1175627
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