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    Procedure For Alerts and Modifications - AOC

    Uploaded by

    Mohamed Ezzat
    This document outlines a procedure for handling alerts and modifications issued by medical device manufacturers. It describes responsibilities for communicating alerts to regulatory authorities and end users, procedures for recalling affected devices using inventory records, applying quarantine labels, and implementing corrective actions as directed by manufacturers. The purpose is to document actions taken in response to manufacturer notices to ensure safety and compliance.

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

    Procedure For Alerts and Modifications - AOC

    Uploaded by

    Mohamed Ezzat
    87 views4 pages
    This document outlines a procedure for handling alerts and modifications issued by medical device manufacturers. It describes responsibilities for communicating alerts to regulatory authorities and end users, procedures for recalling affected devices using inventory records, applying quarantine labels, and implementing corrective actions as directed by manufacturers. The purpose is to document actions taken in response to manufacturer notices to ensure safety and compliance.

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    Procedure for Alerts and Modifications- AOC

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    This document outlines a procedure for handling alerts and modifications issued by medical device manufacturers. It describes responsibilities for communicating alerts to regulatory authorities and end users, procedures for recalling affected devices using inventory records, applying quarantine labels, and implementing corrective actions as directed by manufacturers. The purpose is to document actions taken in response to manufacturer notices to ensure safety and compliance.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    87 views4 pages

    Procedure For Alerts and Modifications - AOC

    Uploaded by

    Mohamed Ezzat
    This document outlines a procedure for handling alerts and modifications issued by medical device manufacturers. It describes responsibilities for communicating alerts to regulatory authorities and end users, procedures for recalling affected devices using inventory records, applying quarantine labels, and implementing corrective actions as directed by manufacturers. The purpose is to document actions taken in response to manufacturer notices to ensure safety and compliance.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 4

    Procedure For Alerts and Modifications of Medical Devices

    PRO/06
    Approved by: Signature:
    General Manager
    -------------------------------------------
    Original date: Version: Next Review Due on:
    25th October 2021 1st 25th October 2022

    PURPOSE

     The purpose of this procedure is to describe and retain the documentation of the
    actions that take place once an Alert and Modification notice is issued from the
    manufacturer.

    Definition

     Modification from manufacturer can be changes in manufacturing process of the


    medical device or the design, the materials, changes in sterilization that may
    unintentionally affect device performance or software upgrading or releasing a
    new model or updated version of medical device

    SCOPE

     This procedure is applicable to all the medical devices/products delivered by


    “Ammar Optician Company W.L.L” within the Kingdom of Bahrain.

    RESPONSIBILTIES

     The company will depend on the manufacturer/principle to issue the Alert and
    Modification notice.
     Every alert/modification notice issued from the manufacturer/principle for
    existing devices in the Kingdom of Bahrain must be communicated to NHRA by
    the maintenance team, after the approval of the General Manager.
     In the cases, where modification notice of a device/product affects the safety of
    the medical device /product, the company will also submit reasons for
    modification and the details to NHRA.
     Maintenance team must ensure that the end users receive a copy of the
    alert/modification notice.

    1
     Maintenance team will withdraw the affected device from the Bahrain market and
    hand it over to the store for storage until the corrective action is implemented.
     Storekeeper will be responsible for affixing the “For Modification-Quarantine”
    label to each medical device that has been recovered from the market and store it
    in a separate storage area.

    PROCEDURE

     The maintenance team will receive and log the modification/alert notice from the
    manufacturer and communicate it to the storekeeper and the office department to
    verify if the relevant products/devices are in stock.
     The storekeeper will trace the devices from the company’s software DOTLINE
    TECHNOLOGY system (against their serial numbers, lot/batch numbers etc.) to
    recall them for any modification or withdrawal. The details entered into the
    system will be, but not limited to the following:
    1. Medical Device/Product name
    2. Model
    3. Serial Number
    4. Batch Number
    5. Lot Number
    6. Manufacturer details
    7. Country of Origin
    8. Quantity
    9. Price/Cost
    10. End user details
    11. Recall/adverse event/alert and modification record
    12. Service reports/PPM
     The storekeeper will submit a list of the product/device that are already in the
    shelf to the maintenance team.
     Any alert/modification notice received by the company, that could affect
    significantly the safety and effectiveness of a device, or change the device's
    intended use, requires the submission of full details about the medical device and
    reasons of modification to NHRA.
     End users must be notified about the Alert/Modification within:
     02 Working days if alert/modification is categorized as Very High Risk
     05 Working days if alert/modification is categorized as High Risk
     10 Working days if alert/modification is categorized as Medium Risk

     All the goods which are returned from end users or from store shelf will be
    considered as “Non acceptable returned goods” and they shall be placed in a

    2
    separate area in the store with the label fixed to them that reads, “For
    modification –Quarantine” so they do not get mixed with the regular goods.
     Maintenance team will communicate with the manufacturer to determine the
    corrective action plan and, whatever corrective action plan the manufacturer
    shares, will be implemented and the goods will be returned to the end users/
    customers and returned back to the Bahrain market as well.
     After follow up with the manufacturer’s instruction, the goods will be returned to
    end users/customers, and will start to be available again in the Bahrain market.
     In case the modifications of a medical device could affect significantly the safety
    and effectiveness of a device, or change the device's intended use, it would
    require the submission of full details and reasons of modification to NHRA
    through the company.
     Corrective action for the alert/modification should be documented and a closure
    report containing the detailed corrective action taken by the company should be
    submitted to NHRA.

    REVIEW

     This policy shall be reviewed on an annual basis for any modifications and
    iterations in the process.

    ATTACHMENTS

     Alert & Modification Form (separately attached)


     Label Quarantine- Modified Goods (attached below)

    3
    Medical device/Product:

    Date of Expiry

    Serial Number:

    Batch Number:
    Quarantine- FSN No.

    For Modification Quantity:

    Reason:

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