Procedure For Adverse Events Reporting of Medical Devices

PRO/07
Approved by: Signature:
General Manager
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Original date: Version: Next Review Due on:
25th October 2021 1st 25th October 2022

PURPOSE

 The purpose of this procedure is to describe the sequence of events that take
place when an adverse event is reported, its investigation and the steps taken to
prevent the recurrence of the adverse event in the future.

Definition

 Adverse Events: is an event that causes, or has the potential to cause,

unexpected or unwanted effects involving the safety of device users (including
patients) or other persons.
 Reportable Adverse Events: Adverse event caused by any malfunction or
deterioration in the characteristics and/or performance of a medical device, as
well as any inadequacy in the labelling or the instructions for use should be
reported to NHRA to take the necessary action, for example:
 A patient, user, or professional is injured (Serious / Minor injury) because
of a medical device failure or its misuse.
 A patient’s treatment is interrupted or compromised by a medical device
failure.
 A misdiagnosis due to a medical device failure leads to inappropriate
treatment.
 A patient’s health deteriorates due to medical device failure.
 User error (or “use error”) which means a device-related error or mistake
made by the person using the device. The error could be the main cause
of an adverse event or just a contributing factor. Such errors often reflect
problems with device labeling, the user interface, or other aspects of
device design. Also, may include design; poor user instructions or
training; inappropriate modifications; inadequate maintenance; and
unsuitable storage and use conditions
SCOPE

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  This procedure is applicable to all the adverse events that are reported to the
company “Ammar Optician Company W.L.L”.

RESPONSIBILTIES

 Office department staff is responsible for initiating the investigation as soon as

an end user/client, through any communication channel, reports an adverse
event.
 The adverse event will immediately be logged in the adverse event form, which
will include:
 End user/healthcare facility details
 Date of adverse event occurrence
 Time of adverse event occurrence
 Details of the adverse event
 Details of the person(s) involved in the adverse event
 Details of the medical device/product (Includes manufacturer details)
 Serial Number of the Medical Device
 Batch Number of the Medical Device
 Lot Number of the medical Device
 Expiry
 Corrective action taken.
 Details of the company (Authorized Representative)
 Office department will liaison with the relative departments, particularly
maintenance team, to decide and implement a corrective action plan, and define
a companywide strategy in place to ensure that a recurrence of the adverse
event does not take place in the future.
 The maintenance team will be responsible for the assessment of the returned
goods and the general Manager will give the final call for either its destruction or
repacking, after getting NHRA approval.

PROCEDURE

 An adverse event may be reported via any communication channel from the end
user. The office department staff will receive and initiate the investigation into
the adverse event after logging it in the adverse event reporting form.
 The adverse event complaint will be followed by the following steps:
 When it has been identified that the adverse event is one that needs to
be reported to NHRA, then NHRA will be promptly informed by
submitting “Medical Devices Reporting form” including all details and
information related to it.
 All details relating to adverse event are recorded accurately; including
date, time, and the medical device name, model, serial / lot number.

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  The devices involved in the adverse event would be kept in quarantine in
a separate area in the storage, where practicable, until all involved
parties, including NHRA, have been consulted and the investigation is
completed.
 NHRA and the manufacturer will be informed within the below mentioned
period:
 within 10 working days for Death/Serious Injury
 within 30 working days for minor injury/other problems

 The office department staff , with the assistance of the maintenance team an
branch managers, shall lead the investigation if the adverse event is regarding
medical device failure/breakage/calibration.
 The office department staff, with the assistance of the storekeeper and branch
managers, will lead the investigation of the adverse event if it is related to
faulty or expired products.
 Formation of a committee will take place, comprising of the office staff,
maintenance team and storekeeper where they will discuss the adverse event
occurrence, it’s reason and put forward a suitable corrective action to prevent
repetition in the future.
 At the end of the investigation, a detailed report with the findings, corrective
actions, along with the preventive measures, will be submitted to the end user
and the company will retain its copy.
 All the adverse events will be reported to the National Health Regulatory
Authority (NHRA), along with the necessary documents, pictures and actions
implemented to rectify the situation and to prevent the recurrences.
 A copy of details of the report will be added in the software tool DOTLINE
TECHNOLOGY that can be traced and accessed later on. If it is not the first time
for the same product/device, then the company will report to NHRA to take the
suitable action like recalling the product (Please refer to Recall policy for
further details).
 If NHRA issues a recall notice because of the adverse events, then the company
will issue recall notices to all its end users/customers to whom the
products/devices have been supplied to in the Kingdom of Bahrain
 For returned goods, that have been recalled from the market after the adverse
events reporting, they will be traced and assessed by the storekeeper, by using
DOTLINE TECHNOLOGY, against the batch numbers, serial numbers and expiry
provided by the manufacturer and shipment.
 The recalled devices/products, which will be returned after the adverse event,
will be considered as “Non acceptable returned goods” and a label of “For
Recall- Quarantine” will be affixed to them and they will be moved to an
isolated area in the store so that they are not mixed up with the regular goods.
(Please refer to Policy for Recall for details)

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  Rejected goods shall be destroyed, after the approval of NHRA, in a way it will
not cause any harm to any individual or the environment.
 All records of destruction of goods shall be maintained by the company.

REVIEW

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

ATTACHMENT

 Adverse event form

 Label “Quarantine-Recalled Goods”
 Label “Quarantine-For Destruction”
 Label “Quarantine-Returned Goods”

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 Medical device/Product:

Date of Expiry

Serial Number:

Quarantine- Batch Number:

FSN No.

Recalled Goods Quantity:

Reason:

Medical device/Product:

Date of Expiry

Serial Number:

Quarantine- Batch Number:

Quantity:

For Destruction Reason:

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 Medical device/Product:

Date of Expiry

Serial Number:

Quarantine- Batch Number:

Quantity:

Returned Goods Reason: