BMD Plan Azizia 2024

This document is a controlled document.
Facility reserves the right to amend or terminate any of its content at any time
without prior notice. The information should only be used for internal use.
DEPARTMENT Maintenance Department ISSUE DATE

PROCESS OWNER Facility Management January 1, 2020
REVISION DATE
TITLE/DESCRIPTION Medical Equipment Management plan
November 15, 2023
EXPIRY/NEXT REVIEW DATE
PLAN NO. AMB-FMS-PL-05 Version #: 05
November 15, 2024
Facility Name/Stamp
Plan #: AMB-FMS-PL-05
Page 1 of 15 Medical Equipment Management plan
This document is a controlled document. Facility reserves the right to amend or terminate any of its content at any time
TABLE OF CHANGES
Section Change Explanation
Overall Issued on January 1, 2020 Version 01 – New
Overall Issued on January 1, 2021 Version 02 – Updated Approval Section
Overall Reviewed on January 1, 2022 Version 03 – Updated Approval Section
Overall Reviewed on January 1, 2023 Version 04 – Updated Approval Section

Version 05- Title page: added version number to the
Title page,
page,
footer and
Reviewed on November 15, 2023 Footer: removed dates from the footer, added policy tit
approval
Approval section: removed preprinted names and add
section
section for handwriting the approvals names
Note: this section lists the latest changes in this document only. For detailed revisions, please refer
to the sections referenced on this list.
TABLE OF CONTENTS
NO. TITLE PAGE NO.
1 PURPOSE 3
2 SCOPE 3
3 GOALS 3
4 DEFINITIONS 3 -5
5 POLICY 5
6 PROCEDURES
7 PLANNING & ASSESSMENT 6
8 BUDGETING & FINANCING 6-7
9 TECHNOLOGY ASSESSMENT & SELECTION 7
10 PROCUREMENT & LOGISTICS 7
11 INSTALLATION & COMMISSIONING 7
12 TRAINING & SKILLS DEVELOPMENT 7–8
13 MAINTENANCE & REPAIRS 9 - 10
14 DECOMMISSIONING & DISPOSAL 10
15 INVENTORY & RECORDS 10 – 11
16 RESPONSIBILITIES 11
17 REFERENCES 11
18 APPROVALS 12
1. PURPOSE
1.1. The purpose of this policy is to guide the facility regarding the management of medical
devices/equipment to ensure that medical devices/equipment is managed in a way
which complies with the requirements of regulation and best practice.
1.2. The Facility Medical Equipment Management Plan is designed to assess and control the
physical and Facility risks of all equipment used in the diagnosis, treatment, monitoring
and care of patients.
2. SCOPE
2.1. This policy applies to all departments of the facility using medical equipment.
2.2. It also applies to companies who are contracted by the facility to provide services in
relation to any aspect of the management of medical devices.
3. GOALS
3.1 The goals of the facility Medical Equipment Management Plan include the following:
3.1.1 To minimize the operational and physical risks of equipment use through
inspection, testing and regular maintenance;
3.1.2 To establish criteria for identifying, evaluating and inventorying equipment
used.
3.1.3 To provide education to personnel on the capabilities, limitations and special
applications of equipment. These include but not limited to:
3.1.3.1 Operating the equipment including knowledge of alarms
3.1.3.2 How to use operation and service manuals
3.1.3.3 safety and emergency procedures for ensuring proper functioning of the of
equipment
3.1.3.4 the procedures to follow when reporting equipment management
problems
3.1.3.5 troubleshooting failures and user errors
3.1.3.6 The skills and/or information to perform maintenance activities.
4. DEFINITIONS
4.1 Medical Device (Equipment): Any instrument, apparatus, appliance, material or other
article, whether used alone or in a combination, including the software necessary for its
proper application intended by the manufacturer to be used for human beings for the
purpose of:
4.1.1 Diagnosis, prevention, monitoring, treatment or alleviation of disease.
4.1.2 Diagnosis, monitoring, treatment or alleviation of or compensation for an
injury or handicap.
4.1.3 Investigation, replacement or modification of the anatomy or of a

physiological process.
4.1.4 Control of conception and which does not achieve its principle intended
action in or on the human body by pharmacological, immunological or
metabolic means, but which may be assisted in its function by such means.
4.1.5 Medical equipment excludes implantable, disposable or single-use medical
devices.
4.2 Single use device: A medical device that is intended for only one episode of use on one
patient only.
4.2.1 the international symbol, which is a figure 2 with a diagonal line drawn
through it may be used on medical device packaging to indicate ‘Do Not
Reuse’ and may replace any wording.
4.2.2 There are instances where the department may decide to use a ‘Single Use
Only’ item on more than one occasion on the same patient, in such
circumstances a risk assessment will be undertaken and a local guideline
developed to ensure that the patient is not put at risk.
4.2.3 Single use devices should never be used for multiple uses (e.g. Hypodermic
needles). Once used these devices should be disposed of in line with the
Infection Control Policy.
4.3 Single patient use device: A medical device that is intended for more than one episode of
use on one patient only, the device may go through some sort of processing between each
use.
4.4 Re-usable medical device: A medical device that may be re-used on either the same or
different patient after it has been through decontamination processing or reprocessing.
4.4.1 Some accessories of reusable medical devices may be either for single use or
single patient only.
4.5 SFDA: Saudi Food and Drug Administration: The Saudi Food and Drug Authority (SFDA) was
established as an independent body corporate that directly reports to The President of
Council of Ministers. The Authority objective is to ensure safety of food and drug for human
and animal, and safety of biological and chemical substance as well as electronic products.
4.6 Assessment Testing: is the testing of a medical device prior to its first use in a Facility area.
This does not include all devices and in most cases refers to electrical medical devices (e.g.,
Pulse oximeter), or medical devices that require a moving mechanism to function (e.g.,
wheelchairs).
4.7 Pre-purchase questionnaire/ Product feedback form: is a full assessment of functionality
and technical specifications of a new medical device before purchase any devices in Facility.
This is usually used to define a product used for demo/ experimental services. It may also be
used to evaluate an equipment already being used and may help in the decision to rebuy it.
4.8 PPM, Planned Periodic Maintenance: is "a routine for periodic inspection" with the goal of
"noticing small problems and fixing them before major ones develop." This is to prevent any
equipment from breaking down.
4.9 Corrective maintenance: maintenance which is carried out after failure detection and is
aimed at restoring an asset to a condition in which it can perform its intended function
4.10 BME: Biomedical engineering (BME) or medical engineering is the application of
engineering principles and design concepts to medicine and biology for healthcare purposes
(e.g. diagnostic or therapeutic). This field seeks to close the gap
between engineering and medicine, combining the design and problem solving skills of
engineering with medical biological sciences to advance health care treatment,
including diagnosis, monitoring, and therapy.
4.10.1 Also included under the scope of a biomedical engineer is the management
of current medical equipment within the facility while adhering to relevant
industry standards. This involves equipment recommendations,
procurement, routine testing and preventative maintenance, through to
decommissioning and disposal. This role is also known as a Biomedical
Equipment Technician (BMET) or Facility engineering.
4.11 BME/ BMET: Biomedical Engineer: A biomedical engineering/equipment
technician/technologist ('BMET') or biomedical engineering/equipment
specialist (BES or BMES) is typically an electro-mechanical technician or technologist who
ensures that medical equipment is well-maintained, properly configured, and safely
functional.
4.12 BMD: Biomedical Department
4.13 VFM: Value for money. Is in the perception of the buyer or receiver of goods and/or
services. Proof of good value for money is in believing or concluding that the goods/services
received was worth the price paid.
4.14 FDA: Food & Drug Administration
5. POLICY
5.1 It is the facility policy to ensure that a formal system to manage medical devices is established in
Facility.
5.2 The plan assures that a dedicated and coordinated approach for the procurement, maintenance
and functioning of Medical Devices / Equipment throughout the facility is taken.
5.3 This will ensure patient safety via Facility and social care governance, risk management and
quality assurance of Medical Devices/Equipment.
5.4 The policy aims to:
5.4.1 Minimize related hazards by implementing training for staff using equipment and ensuring
that the equipment is maintained and kept in working order at all times.
5.4.2 To ensure that employees are properly trained and competent in the use of Medical
Devices/Equipment including recognizing alarms and troubleshooting
5.4.3 All devices are maintained in a safe and reliable condition via periodic PPM
5.4.4 All devices and medical equipment are subjected to asset/ inventory management that is
inclusive of device history and tracking. This will ensure tracking of the productive life of the
machine throughout its installation including PPM, equipment failures and corrective
actions.
5.4.5 These will play a strong role in deciding whether to rebuy/ replace an equipment
5.5 Good equipment management will involve all aspects of the lifecycle of medical
devices/equipment to include:
5.5.1 Department scope of Need
5.5.2 Affordability
5.5.3 Scope of Need Approval
5.5.4 Confirmation of Specification
5.5.5 Trials of proposed equipment
5.5.6 Selection of equipment
5.5.7 Commissioning and Installation
5.5.8 End user Training
5.5.9 Inventory management
5.5.10 Equipment Maintenance
5.5.11 Equipment Malfunction management
5.5.12 Capital Development Projects
5.5.13 Infection Prevention and Control
5.5.14 Decontamination and Cleaning
5.5.15 Disposal/ condemnation
6. PROCEDURES
6.1 The equipment management for each facility is dependent on the need assessment
and the life cycle of the equipment. In general; the below cycle will be followed to
procure, maintain, commission and disposal of any equipment.
6.2 Phase 1: Planning and assessment:
6.2.1 Each department in collaboration with the BMD will plan an annual equipment
plan depending on the existing and next year scope of services.
6.2.2 The facility BMD will do an assessment of each department’s plan and send the
verified plan to the facility head and will be discussed and approved in the facility
executive committee for discussion and budgeting approval.
6.2.2.1 The verification/ needs assessment done by the facility BMD for new or re-buy
equipment will include but not limited to:
 Reason/ need of the equipment if a new one is required e.g., increase in services,
new technology etc.
 For existing equipment, the end user feedback will be included.
 Frequency of failures or unplanned shutdown for existing equipment
 Cost of repairs or maintenance of existing equipment
 Equipment company response and ability to solve issues and repairs.
 Any other relevant details

6.2.3 Once the approval is done at the facility level,the requirements will be
escalated to the corporate senior management and Corporate Risk and
Safety Committee for approval.
6.2.4 The Corporate BMD will do an assessment of the facility’s plan and send the
verified plan to the corporate senior management for discussion and
budgeting approval by the Senior Management.
6.2.5 The results of the budgeting and approval will be relayed to the facility head
and through the management to the department.
6.2.6 In case of any unplanned equipment requirement (in case of unforeseen
failure etc.) the requesting department will request to BMD the need of
equipment through the “Asset request “through C-Med platform
6.2.7 The BMD will assess the need for urgent purchase and get approval from the
facility head, Corporate BME, finance and purchase departments and if
approved proceed to purchase via C-Med platform
6.3 Phase 2: Budgeting & Financing:
6.3.1 Once the Corporate BMD has reviewed and provided the CAPEX for the
required equipment; the facility head will send the requirements to the
senior management via the budgeting committee.
6.3.2 The Senior Management (budgeting Committee) will discuss with the facility
head and BMD and plan the required equipment based on the need and
various costs associated with the equipment.
6.3.3 Based on the assessment the procurement plan will be finalized and
implemented detailing which equipment will be bought at what stage (based
on the facility needs) and when it will be installed and made operational.
6.3.4 Also included will be the terms and condition with the vendor inclusive of
maintenance contracts, periodic training etc to ensure continued running of
the machine.
6.3.5 The plan will also include other requirements e.g. HVAC, construction,
electrical, water ,medical gas etc required for the safe installation and
functioning of the required equipment.
6.3.6 The decision will also include payment terms and duration of installments
etc.
6.3.7 The above process should include the approximate lead time that the
medical equipment company will take to provide the equipment as well as
the time required to complete the pre-installation requirements and the
actual installation & commissioning of the equipment.
6.4 Phase 3: Technology Assessment & Selection:
6.4.1 Based on the plan and the departmental needs the BMD will identify the
requirements and specifications (based on FDA, SFDA and CE rules) of the
equipment needed to perform a certain service in the facility.
6.4.2 Based on the required specifications the BMD will discuss with the purchase
department to identify vendors
6.4.3 The purchase department will arrange for the suitable vendors (at least 3
quotes for one equipment) and the equipment will be placed on trial with
the end users for a define time period. The trial equipment will be handed
over to the department by the BMD via a written delivery note.
6.4.4 The end users will use the equipment for a certain period of time and provide
a product evaluation form regarding the recommendation/ rejection of the
equipment
6.4.5 The BMD will collect this data, negotiate with the end users for the choices
made and provide the list of recommended equipment to the purchase for
procurement.
6.5 Phase 4: Procurement & Logistics:
6.5.1 The purchase department in collaboration with the finance will negotiate the
equipment prices, mode of payment, delivery times, terms & conditions etc.
with the vendors and inform the BMD of the lead time of receiving the
equipment.
6.5.2 During this phase all queries related to safe delivery of the equipment
including the flow chart of the supply chain, associated risks and how they
will be mitigated will be finalized with the vendor
6.5.2.1 Decision whether to place/ not place the equipment on the list of “high
risk” items will be taken at this stage
6.5.3 The BMD will prepare the site in terms of civil works, electrical and other
requirements as informed by the Medical Equipment Company so that the
site is ready for installation
6.6 Phase 5: Installation & Commissioning:
6.6.1 The BMD will perform a Needs Assessment and create a plan (pre-installation
plan) for site preparation
6.6.2 For site preparation cross-department communications and agreement on
who is responsible for which part of the installation and commission is
necessary before starting preparation.
6.6.3 It is the responsibility of the BMD and the company engineers to ensure that
the procured equipment is installed as planned and that it is received by the
BMD and the department in optimum working order.
6.6.4 The BMD will ensure that the warranty commences and payment made only
after successful installation.
6.6.5 The end user should have a copy of the warranty document and should be
well informed of the warranty conditions before commencing use of the
equipment.
6.6.6 The end user departments will also be provided with the commissioning
documents including a copy of the installation report.
6.6.7 The BMD will create an equipment code for the machine and add it to the
assets list. This code will be the identification for the equipment throughout
its life in the facility.
6.7 Phase 6: Training & Skill development:
6.7.1 The BMD staff should work with suppliers to provide training for end users as
well as the BME as below:
6.7.1.1 Include training in tender specifications (described needs), and specify who
should be trained for how many days with what outcomes.
6.7.1.2 Begin by doing an assessment of current knowledge, both for users as
technicians
6.7.1.3 Create training that fits the local needs. The materials and examples used
in the training should resemble reality
6.7.1.4 Identify champions; train the trainer, to guarantee continuation of training
for new staff and repetition for current staff
6.7.1.5 Repeat user training every 6 months and for changing staff
6.7.1.6 The training of the end users by the company staff or the facility BME will
include at least the below:
 Operation of the machine
 Daily checks
 Failure reporting
 Alarm’s recognition
 Trouble shooting
 How to use the end user manuals
6.7.2 Training needs should be addressed by the supplier and should be part of the
contract made with them.
6.7.3 Technical & operation manuals of all equipment used will be placed in the
end user area as well as in the BMD for reference
6.8 Phase 7: Operation & Safety:
6.8.1 The BMD and the HOD/ supervisor should ensure the below once the
equipment is in operation:
6.8.1.1 Staff checks equipment every day before commencing operations. Special
machines e.g. lab equipment/ radiology machines etc undergo the required
daily control/ quality checks before use
6.8.1.2 Do scheduled safety checks e.g. every 3 months, train on awareness and
safety practices. Check personal protection is available (e.g. gloves face
masks and radiation protection items like lead apron)
6.8.1.3 Organize training on sterility and hygiene. Check what products are used to
clean. Do not only focus on the cleaning staff. Hygiene is a basic skill for
everyone working in a healthcare setting especially the personnel using the
equipment
6.8.1.4 Introduce good practice protocols and train the staff how to use them
6.8.1.5 Check if equipment is operational. Bring or report malfunctioning

equipment to the BMD department via “Equipment failure form”. Remove
faulty equipment from the workspace or “Lock out / Tag out”.
 Train staff on lock out/ tag out procedure for medical
equipment.
6.8.1.6 Teach technicians or sterilization staff how to clean, disinfect and sterilize
devices, and to verify whether autoclaves are working (measure pressure
and Temperature cycles)
6.9 Phase 8: Maintenance & Repair:
6.9.1 Prepare for environmental challenges, e.g. humidity, dust and heat
6.9.2 In case of a lack of technical staff, see if there is a way to create contractual
obligations to support maintenance
6.9.3 Identify the technical staff, get an idea of their skills and knowledge and
encourage/organize training
6.9.4 Corrective Maintenance: in the case of an unexpected failure or equipment
failure leading to harm to patient or employee; the below procedure will be
followed:
6.9.4.1 End user shall raise a maintenance request to BMD including an incident
report will be completed describing the failure.
6.9.4.2 BMD engineers shall arrange the maintenance in house or through
contracted services as appropriate.
6.9.4.3 When an equipment is waiting for corrective maintenance, it shall be
removed from service and sent for maintenance, if not possible the
equipment shall be tagged under maintenance and not used till
maintenance is completed.
6.9.4.4 Once repairs are done the BME will commission the equipment in the
department and hand over the machine to the staff after ensuring their
satisfaction with its working.
6.9.4.5 If an equipment is out of service; the relevant HOD & the operations need
to be informed so that proper measures e.g. substitution with another
equipment on temporary basis or procuring the required services from
other sources etc can be planned.
6.9.4.6 Investigation and reporting of equipment management problems and user
errors:
 All equipment failures and user errors will be investigated
and reported. Included in the report will be the error/failure
date, location of the equipment, cause & effect on the area
using the equipment, resolution and follow-up. In the event
the equipment problem was caused by user error, the user(s)
will be trained on the operation and use of the equipment.
 All equipment related incidents will be added to an

equipment failure log which will be reviewed in the facility
executive committee and will be part of the FMS reports
 Incident history is documented and maintained in the
Biomedical Engineering section. Equipment displaying
unusual repair history or unusual incidence of injury to staff
or patients will be evaluated for necessary
changes/replacement.
6.9.5 All equipment should have a validation sticker denoting the date on which
the equipment was validated and that it is fit for use. Equipment that fails
electrical safety tests shall not be approved for use until the deficiencies have
been corrected.
6.9.6 Preventive Maintenance:
6.9.6.1 The BMD should have a PPM plan for each equipment of the Facility based
on the medical equipment company/ manufacturer’s recommendations
and/or the SFDA.
6.9.6.2 BMD is responsible for the completion of the regular PPM whether done by
the department’s engineers or as an outsourced service by the equipment
company.
 The BMD shall maintain contracts for preventive
maintenance of all equipment that requires PPM that is not
done by the department engineers.
6.9.6.3 The PPM schedule for all equipment in the department should be shared in
advance with the HOD by the BMD. There should be mutual agreement and
if any changes required should be accommodated. Once finalized the BMD
will plan the PPM accordingly
6.9.6.4 1 week before the PPM date, the BME should relate with the department
head so that the equipment is made free on the day of PPM. This should be
done via official communication (memo, emails etc.) including the
operations & Medical Director as necessary.
 If there is any reason for delay, rush of patients for the said
service etc.; there should be a unanimous decision for
delaying the PPM by the HOD/ MD and Operations Manager.
The delay should be for a short time only and the PPM will
not be cancelled.
6.9.6.5 All equipment should mandatorily have a PPM sticker denoting:
 The equipment identification
 Date of last PPM
 Date of next PPM.
6.9.6.6 The data for the PPM is used for upgrading/ replacement of current
equipment based on the cost of the maintenance, cost of parts replaced,
technical support by the equipment company, availability of parts etc.
6.10 Phase 9: Decommissioning & Disposal:
6.10.1 The BMD should have information regarding the life of the equipment (as per
manufacturer’s recommendations). Based on the maintenance& PPM
history, life and history of unscheduled repairs; the equipment will be
planned for disposal/ replacement
6.10.2 The department where the equipment is used should be informed about the
disposal well in advance e.g. at least 3 months so that a replacement can be
arranged. This period may also be conditional to the availability of the
substitute or replacement.
6.10.3 BMD will follow manufacturer’s guidelines regarding disassembling and
discarding parts of the equipment.
6.10.4 The asset code of the equipment will be marked as “condemned” and not
used again.
6.10.5 The information will be updated in the asset list of the Facility. This list will be
maintained by and sole responsibility of the BMD with a copy to the HOD,
accounts and operations.
6.11 Inventory and Records: BMD shall maintain a current inventory of all equipment at
Facility. BMD shall also maintain equipment record including:
6.11.1 Date of purchase
6.11.2 Commissioning documents and evidence of testing, including electrical safety
6.11.3 Asset codes
6.11.4 PPM schedule& records
6.11.5 Corrective maintenance records
6.11.6 End user training records
6.11.7 Date of decommissioning and records
6.11.8 BMD shall analyze critical equipment records on annual bases for possible
upgrades and replacement based on the equipment performance and
breakdown history.
6.12 Plan review: The Facility equipment management plan will be reviewed annually by the
BMD, FMS Manger and the facility executive committee for appropriateness and editions
that may be required before implementation.
6.12.1 The reviewed pan will be sent for review and approval to the Corporate Risk
and Safety Committee.
6.12.2 The recommendations of the corporate committee will be included in the
plan before implementation
7. RESPONSIBILITY
7.1. BMD: the department manager is responsible for maintaining the Medical Equipment
Management Program
7.2. FMS Manager: ensures that the plan is implemented via BMD and reviews details of
equipment periodically and includes the details in the periodic reports
7.3. Head of Departments: Each department director /head is responsible for orienting
new staff members to the capabilities, limitations, special applications of equipment,
basic operating and safety procedures, emergency procedures if failure occurs,
maintenance responsibilities, if applicable, and the reporting procedures for
equipment problems, failures and user errors.
7.4. Facility head and Operation Manager: involved in planning equipment and budgeting
7.5. Finance manager: involved in planning equipment and budgeting
7.6. Purchase department: planning, budgeting, demos, and procurement of equipment.
7.7. Corporate Risk and Safety Committee: review and recommend changes to the plan.
Ensure that the plan is implemented in the facilities as intended
8. FORMS
8.1. Asset Request Form in C-Med

8.2. Annual equipment plan format
8.3. Recommendation/ rejection form
8.4. Equipment failure form
8.5. Equipment failure log
9. ATTACHMENTS
9.1. None
10. REFERENCE
10.1. THET_Managing_the_medical_equipment_lifecycle_HIGH%20RES.pdf.
http://www.thet.org/
10.2. John Denis Enderle; Joseph D. Bronzino (2012). Introduction to Biomedical Engineering.
Academic Press. pp. 16–. ISBN 978-0-12-374979-6.
10. FACILITY LEVEL APPROVALS
DESIGNATION NAME, SIGNATURE & DATE
PREPARED BY Biomedical Engineer
FMS Manager
REVIEWED BY
Assistant TQM Director
Operation Manager
APPROVED BY Medical Director
Facility Head

BMD Plan Azizia 2024

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DEPARTMENT Maintenance Department ISSUE DATE

Overall Issued on January 1, 2020 Version 01 – New

Overall Issued on January 1, 2021 Version 02 – Updated Approval Section

Overall Reviewed on January 1, 2022 Version 03 – Updated Approval Section

Overall Reviewed on January 1, 2023 Version 04 – Updated Approval Section

NO. TITLE PAGE NO.

7 PLANNING & ASSESSMENT 6

8 BUDGETING & FINANCING 6-7

9 TECHNOLOGY ASSESSMENT & SELECTION 7

10 PROCUREMENT & LOGISTICS 7

11 INSTALLATION & COMMISSIONING 7

12 TRAINING & SKILLS DEVELOPMENT 7–8

13 MAINTENANCE & REPAIRS 9 - 10

14 DECOMMISSIONING & DISPOSAL 10

15 INVENTORY & RECORDS 10 – 11

4.1.3 Investigation, replacement or modification of the anatomy or of a

 Any other relevant details

6.8.1.5 Check if equipment is operational. Bring or report malfunctioning

 All equipment related incidents will be added to an

8.1. Asset Request Form in C-Med

10. FACILITY LEVEL APPROVALS

DESIGNATION NAME, SIGNATURE & DATE

PREPARED BY Biomedical Engineer

Assistant TQM Director

APPROVED BY Medical Director

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