# Construction and validation of an instrument for event-related sterility of processed healthcare products

## TL;DR

This paper describes the creation and validation of a tool to assess events affecting the sterility of processed healthcare products.

## Contribution

A new validated instrument was developed to evaluate sterility-related events in healthcare product packaging.

## Key findings

- The instrument was validated with a Content Validity Index and Ratio ≥ 0.80 and modified Kappa ≥ 0.74.
- The final instrument has five dimensions and was deemed good and understandable by 86.67% and 90% of participants, respectively.
- The tool follows literature recommendations and is available for use in healthcare.

## Abstract

To construct and validate an instrument to assess events related to maintaining the sterility of processed healthcare products.

This methodological study developed the instrument through analysis by a panel of experts, focusing on the integrity of commonly used packaging: spunbond-meltblown-spunbond and medical-grade paper. The instrument was analyzed using the Content Validity Index and Content Validity Ratio (≥ 0.80) and modified Kappa (≥ 0.74). The instrument underwent pre-testing.

Six experienced professionals participated in the expert panel. After two rounds, the final version of the instrument contained five dimensions. In the pre-test, 30 nursing professionals participated, of whom 86.67% considered the instrument good, and 90% found it understandable.

The construction and validation followed literature recommendations. The instrument is available, aiding in the safe use of processed healthcare products.

Construir e validar instrumento para avaliar evento relacionado à manutenção da esterilidade de produtos para saúde processados.

Estudo metodológico para desenvolver instrumento mediante análise por comitê de juízes. Considerou-se como aspecto norteador a integridade das embalagens mais utilizadas na prática: a de não tecido e a de papel grau cirúrgico. A análise foi realizada pelo Índice de Validade de Conteúdo, Razão de Validade de Conteúdo ≥ 0,80 e Kappa modificado ≥ 0,74. Submeteu-se o instrumento ao pré-teste.

Participaram do comitê de juízes seis profissionais experientes na temática. Após duas rodadas, chegou-se à versão final do instrumento, contendo cinco dimensões. No pré-teste, participaram 30 profissionais de enfermagem, dos quais 86,67% consideraram o instrumento bom; e 90%, compreensível.

A construção e validação seguiu as recomendações da literatura. O instrumento está disponível para ser utilizado, auxiliando no uso seguro do produto para saúde.