Division Department

Administration FMS
Document: Policy & Procedure Page 1 of 2

Applies to:
Subject Medical Equipment Alert/Recall Bio-Medical Staff

Preparation Date Approval Date Index No.

Kingdom of Saudi Arabia 24/02/1441 H 07/03/1441 H FMS -PP-037
General Directorate of Effective Date Review Date Version
Health Affairs (Al-JOUF) 14/03/1441 H 14/03/1443 H 3
Maternity & Children's Hospital
PURPOSE:]JOUF-MCH[

1. To identify a procedure to remove, repair, or replace products or devices which may be

unsafe for patient or employee use throughout the JMCH.
DEFINITIONS:
NONE
RESPONSIBILITY:
1. Biomedical Department:
1.1 Is responsible for any Alerts Report which contains information on medical devices that
may require action by the user or other department(s).
1.2 Alerts may also be sent directly from the manufacturer/distributor.
2. All department head:
2.1 Sent Alerts Report which contains information on medical devices that may require
action to implement this policy.
2.2 the recall/alert is reviewed by the appropriate departments and actions taken as needed
3. Departmental safety coordinators to implement this policy.
4. FMS Committee: shall oversee this implementation.
POLICY:
1. To ensure that all products or devices are safe for use within JMCH.
PROCEDURE:
1. JMCH Biomedical Department upon notification of a Product Recall or Product Alert will
send a "Product or Device Alert/Recall" form to the applicable department.
2. The responsible individual will determine if their department is in possession of the listed
product or device and return the completed form to the Biomedical Department
indicating the action taken.
3. If the product or device recall is life threatening, i.e. an Urgent recall, the recall form will
be hand delivered by Biomedical Department to the responsible individuals and must be
returned, by hand to Biomedical Department within 24 hours.
4. The following procedure are as follows:
4.1 All Alert or Hazard notifications received are to be forwarded immediately to the
Biomedical Department.
4.2 Any notice received by another department will be immediately forwarded to the
Biomedical Department.
4.3 The Biomedical Engineer will check the clinical equipment inventory for the
equipment matches and will evaluate the severity of the risk.
4.4 The Biomedical Engineer will dispense the notice to any/all appropriate departments
involved by nature of using the material/device.
4.5 The department(s) receiving the Recall Notices will:

TQM-F-005
 Division Department
Administration FMS
Document: Policy & Procedure Page 2 of 2

Applies to:
Subject Medical Equipment Alert/Recall Bio-Medical Staff

Preparation Date Approval Date Index No.

Kingdom of Saudi Arabia 24/02/1441 H 07/03/1441 H FMS -PP-037
General Directorate of Effective Date Review Date Version
Health Affairs (Al-JOUF) 14/03/1441 H 14/03/1443 H 3
Maternity & Children's Hospital
]4.5.1
JOUF-MCH[ Implement the information provided in the Recall Notice.
4.5.2 Place each in their department's under the Recall Notices section.
4.5.3 In the event equipment must be removed from service, the equipment is
replaced with a safe effective substitute.
4.5.4 The Biomedical Department will impound equipment removed from use until it
can be rendered safe for use.
4.5.5 The Biomedical Department is responsible for contacting any/all departments
utilizing the material(s)/device(s) to confirm their compliance with the Recall
Notice.
4.5.6 Biomedical Department reports the following in the monthly safety committee
report:
4.5.6.1 Recall Notices received.
4.5.6.2 Action taken by the departments utilizing the device(s)/ product(s).
FORMS:
APPROVAL:
"Product or Device Alert/Recall

EQUIPMENTS:
Item Name Title Signature Date
NONE

CROSS REFERENCES:
Prepared by Eng. Fatima Aldrioish BMD Supervisor 24/02/1441
NONE
REFERENCES:
Reviewed by Dr. Asaad Hassan FMS Director 24/02/1441
1. CBAHI Resources.
2. KSMC.

Reviewed by Mr. Turky Alfahad Supportive

Services Director 26/02/1441

Reviewed by Ss. Jomol P. A Nursing Director

28/02/1441

Reviewed by Dr. Jamal Abbadi TQM Director 29/02/1441

Approved by Dr. Mohamed Essam Medical Director 02/03/1441

TQM-F-005
Approved by Sp. Nawaf Aljaber Hospital Director 07/03/14341