Evento Sterility relacionados – Estéril & Departamento de Processamento de Materiais – Universidade de Rochester Medical Center

 

Evento Sterility relacionados

I. Introdução

  1. Sterility Event-Related Política de Manutenção define os procedimentos destinados a manter a esterilidade de pacotes até que sejam usados. Este documento centra-se na manutenção da esterilidade relacionada com o caso de pacotes preparados-hospitalares contendo suprimentos estéreis envolto em uso único ou materiais reutilizáveis. Uma vez que algumas fontes têm datas de expiração e degradar ao longo do tempo, este documento abrange apenas os suprimentos para o qual o fabricante ou o distribuidor não fornece expiração namoro na forma de rotulagem, instruções de uso, ou outras declarações.
  2. Por anos, objecto de expiração namoro tem gerado debate considerável. Muitos hospitais têm considerado 30 dias para ser o período de tempo padrão para namorar hospitalares envolto suprimentos estéreis, principalmente por causa da 1971 (1) e 1973 (2) estudos prazo de validade realizados pela Centro de controle de doenças. Esses resultados indicaram que os itens double-envolto em musselina teve uma vida útil de três semanas, e que as embalagens armazenadas em capas de poeira foram considerados estéreis, pelo menos, nove meses. Estudos recentes sugerem que os padrões atuais para testes de esterilidade pode ser melhorada pela adição de testes relacionados com o evento, e que a contaminação de tabuleiros com cobertura pode ocorrer dentro de alguns dias, em vez de semanas.(3)Novas e melhoradas materiais de embalagem, juntamente com uma maior compreensão dos fatores (4)afetando a esterilidade, têm alimentado o debate sobre a validade namoro. Mudanças no JCAHO acreditação Standards (5) refletir a premissa de que a contaminação é “evento-relacionado” e não “relacionados com o tempo”, and recognize the hospital’s expertise in maintaining and delivering sterile products.

While the new standard provides new freedom, it also puts new responsibility on the hospital professional. The major difference in the new standard is that a specific date is no longer required. Hospitals must now establish written policies based on their unique internal practices. The impact of this can be substantial, representing savings in both reprocessing and labor costs. The timely and costly practice of reprocessing is greatly reduced and staff is free to spend time in more productive job functions (ou seja, pack preparation, not pack reprocessing).

With the change in accreditation standards, hospitals are now able to develop procedures that more accurately reflect their sterile containment needs.

II-Justification

Rationale for changing to an Event-Related Sterility Maintenance Policy

    1. Studies published by the Center for Disease Control in the early 1970’s on safe storage times for sterile packs were conducted on materials prevalent at that time. Contudo, materials other than 140-count muslin and crepe paper are widely used today. Portanto, these studies conducted 20 years ago do not provide information on safe storage times for the sterile packs used currently in hospitals.

  1. Patient-care items purchased from manufacturers as sterile typically use “evento-relacionado” labels (6) tais como “Sterile unless the package is opened or damaged”.
  2. The following professional organizations recommend practices that do not require time-related expiration dating:
    • AAMI Draft, 1993 (7)
      • Shelf-Life– “The shelf-life of a packaged sterile item is event-related and depends on the quality of the wrapper material, the storage conditions, the conditions during transport, and the amount of handling. There should be written policies and procedures for how shelf-life is determined and for how it is indicated on the product.
      • Expiration Dating– “Each item intended for use as a sterile product must be labeled with a lot control number, a control date for stock rotation, and the following statement: ‘Product is not sterile if packaging is open, damaged, or wet. Please check before using.'
    • JCAHO(8)There are written policies for the shelf-life of all stored items.IC.5.1.2
    • AORN, Recommended Practice VIII (9)Shelf-life of a packaged sterile item is event-related,…”
  3. Cost of reprocessing items due to Expiration dates vs. Actual compromise of package sterility.

III-Implementation

  • Define goals for the policy.
  • Develop proposal for Infection Control Committee
  • Develop a cost benefit analysis
  1. Cost of sterilization materials
  2. Time spent repackaging
  3. Staff salary costs
  4. Anticipated annual savings
  • Review technical documentation on barrier quality of packaging materials.
  • Review current practices to establish compliance with:
  1. Local and state lawsconsult your hospital’s Infection Control and Risk Management departments.
  2. AAMI
  3. AORN
  4. JCAHO
  5. CDC
  • Develop and implement initial and on-going quality assurance testing protocol.
  • Develop a policy:
  1. Define labeling policy
  2. Define events that would require reprocessing of packages
  3. Determine which items need to be dated
  4. Determine rotation policy
  5. Define how to monitor compliance
  • Develop and implement training programs.
  • Monitor infection rates before and after implementation of new policy. Document other changes in hospital practices that could impact infection rates to be able to identify the potential cause of a change in infection rates.

através da Evento Sterility relacionados – Estéril & Departamento de Processamento de Materiais – Universidade de Rochester Medical Center.

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