Scribd Logo
Upload

Welcome to Scribd!

  • 108 views

    Who Reuse Single Use

    Uploaded by

    nonanovi
    This document summarizes a presentation on single-use medical devices given at an international conference. It begins with the harmonized definition of a medical device from the Global Harmonization Task Force. It then discusses the characteristics and classification of medical devices. The document outlines the reuse of single-use devices and the risks associated with reprocessing single-use devices for additional uses. It notes that reprocessing single-use devices is a regulated manufacturing activity and that these devices are designed and validated for only one use. The risks of reusing single-use devices include unknown effects on device materials from cleaning and sterilization processes and lack of validation for additional uses.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Who Reuse Single Use

    Uploaded by

    nonanovi
    108 views13 pages
    This document summarizes a presentation on single-use medical devices given at an international conference. It begins with the harmonized definition of a medical device from the Global Harmonization Task Force. It then discusses the characteristics and classification of medical devices. The document outlines the reuse of single-use devices and the risks associated with reprocessing single-use devices for additional uses. It notes that reprocessing single-use devices is a regulated manufacturing activity and that these devices are designed and validated for only one use. The risks of reusing single-use devices include unknown effects on device materials from cleaning and sterilization processes and lack of validation for additional uses.

    Original Description:

    re use single use

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    This document summarizes a presentation on single-use medical devices given at an international conference. It begins with the harmonized definition of a medical device from the Global Harmonization Task Force. It then discusses the characteristics and classification of medical devices. The document outlines the reuse of single-use devices and the risks associated with reprocessing single-use devices for additional uses. It notes that reprocessing single-use devices is a regulated manufacturing activity and that these devices are designed and validated for only one use. The risks of reusing single-use devices include unknown effects on device materials from cleaning and sterilization processes and lack of validation for additional uses.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    108 views13 pages

    Who Reuse Single Use

    Uploaded by

    nonanovi
    This document summarizes a presentation on single-use medical devices given at an international conference. It begins with the harmonized definition of a medical device from the Global Harmonization Task Force. It then discusses the characteristics and classification of medical devices. The document outlines the reuse of single-use devices and the risks associated with reprocessing single-use devices for additional uses. It notes that reprocessing single-use devices is a regulated manufacturing activity and that these devices are designed and validated for only one use. The risks of reusing single-use devices include unknown effects on device materials from cleaning and sterilization processes and lack of validation for additional uses.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 13

    Single-Use Medical Devices

    Reuse and Reprocessing


    (Reference number 168862)
    Presented by: Mario Castaneda
    Prepared by: Antonio Hernandez

    International Conference Center (CICG)


    Geneva, Switzerland.
    November 22-24, 2013.

    GHTF* - Harmonized Definition of the


    Term Medical Device
    Medical Device' means any instrument, apparatus, implement,
    machine, appliance, implant, in vitro reagent or calibrator, software,
    material or other similar or related article:
    a) intended by the manufacturer to be used, alone or in combination, for
    human beings for one or more of the specific purpose(s) of:
    
    
    
    
    
    
    

    diagnosis, prevention, monitoring, treatment or alleviation of disease,


    diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
    investigation, replacement, modification, or support of the anatomy or of a physiological process,
    supporting or sustaining life,
    control of conception,
    disinfection of medical devices,
    providing information for medical or diagnostic purposes by means of in vitro examination of
    specimens derived from the human body; and

    b) which does not achieve its primary intended action in or on the human
    body by pharmacological, immunological or metabolic means, but
    which may be assisted in its intended function by such means.
    * Global Harmonization Task Force for Medical Device

    GHTF - Harmonized Definition of the


    Term Medical Device
    Note 1: The definition of a device for in vitro examination includes, for example, reagents,
    calibrators, sample collection and storage devices, control materials, and related instruments or
    apparatus. The information provided by such an in vitro diagnostic device may be for
    diagnostic, monitoring or compatibility purposes. In some jurisdictions, some in vitro
    diagnostic devices, including reagents and the like, may be covered by separate regulations.
    Note 2: Products which may be considered to be medical devices in some jurisdictions but for
    which there is not yet a harmonized approach, are:
    
    
    
    
    

    aids for disabled/handicapped people,


    devices for the treatment/diagnosis of diseases and injuries in animals,
    accessories for medical devices (see Note 3),
    disinfection substances,
    devices incorporating animal and human tissues which may meet the requirements of the above
    definition but are subject to different controls.

    Note 3: Accessories intended specifically by manufacturers to be used together with a parent


    medical device to enable that medical device to achieve its intended purpose should be subject
    to the same GHTF procedures as apply to the medical device itself. For example, an accessory
    will be classified as though it is a medical device in its own right. This may result in the
    accessory having a different classification than the parent device.
    Note 4: Components to medical devices are generally controlled through the manufacturers
    quality management system and the conformity assessment procedures for the device. In some
    jurisdictions, components are included in the definition of a medical device.

    Outline
     Medical Device Definition
     Medical Device Characteristics & Classification
     Reuse of Single-Use Devices (SUD)
     Reprocessing & Risk
     Final Considerations

    Medical Devices
     Characteristics
     Efficacy
     Safety
     Quality

     Classification
     Risk
     Four Levels

     Standards
    
    
    
    
    
    
    

    ISO
    IEC
    ITU
    IEEE
    IHE
    AAMI
    Country Specifics

    Medical Devices

    Single-Use Devices
    Multiple-Use Devices
     Life cycle
     Reprocessing protocols
     Performance evaluation
     Maintenance routines

    Reuse of Single-Use (SUD)


    Background
     It is a growing practice
     Due to limited resources
     Limited or no access to devices
     Economic benefit
     Public concern
     Legal and ethic issues
     Policies and standards
     Patient consent
     Minimal evidence of problems does not mean the current
    practice is safe and effective

    Reprocessing of SUD
     Reprocessing is Manufacturing
     Reprocessing is a Regulated activity
     Conducted by third party or hospitals
     SUD are designed and validated for one use
     Materials selected for one use
     Biocompatibility ensured for intended environment
     Validation and performance test limited for the initial failure

     Reprocessor should know materials and manufacturing


     Reprocessor is responsible for adverse events

    Risk of Reuse SUD


    Technical Issues
    Control of Raw Materials
    Design specifications of the device
    Identification of changes to original device
    Unknown effects of cleaning, disinfecting and
    sterilization
    Validation
    Variation on functionality
    Traceability of reprocessed devices

    Risk of Reuse SUD


    Operational Issues
     Risk classification of the device
     Reprocessing protocols
     Quality Systems
     Number of reprocessing per device
     Labeling
     Recall and retirements of products
     Risk for patients
     Risk-Benefit of this practice

    Final Considerations
     Primary goal is to protect public health
     In most countries Reprocessing of SUD is a regulated activity
    (manufacturing)
     If there are Reprocessed SUDs, these devices should be as safe and
    effective as new SUDs
     FDA research shows reprocessing may be feasible, but IS Difficult and
    Possibly Dangerous
     Reuse of SUD should consider:
     Effectiveness, safety and quality of the devices
     El cost-benefice
     Risk
     There is available information on Reuse of SUD

    Technology appropriately deployed and used


    is a contributive factor to equity in health
    A. Hernndez - 2004

    You might also like