MDM PROTOCOLS

Protocol for Medical Device Maintenance

APRIL 26, 2023

DEBREBIRHAN COMPREHENSIVE SPECIALIZED HOSPITAL
Ethiopia, Amhara, Debre-birhan town
Purpose and scope _________________________________________________________________ 2
Work Order Notifications ____________________________________________________________ 3
Transportation ____________________________________________________________________ 6
Decontamination __________________________________________________________________ 7
Preventive Maintenance ____________________________________________________________ 8
Corrective Maintenance _____________________________________________________________ 9
Equipment calibration _____________________________________________________________ 11
Testing Tools calibration ___________________________________________________________ 12
Annexes _________________________________________________________________________ 13
Details For this Strategic Protocol ____________________________________________________ 19

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 Purpose and scope
1. The purpose

The purpose of this procedure to ensure that all medical devices we have are safe to use, in order to
enhance the quality of healthcare services in our hospital.
✓ Obedience to this protocol will ensure compliance with Standards intended to make sure
that the devices that are used to deliver monitoring, diagnostic, therapeutic and treatment
service:
 Have Procedure for work order notification
 Have Procedure for transportation
 Have Procedure for Decontamination, Preventive maintenance and Repair
 Are properly maintained.
✓ All maintenance involvements will be recorded for all devices on the hospital Medical
Devices History file/database.
 This will be audited and verified by the hospital’s MEMU and MDC for
compliance with this and other relevant local and national protocols.

2. The scope

Who does the procedure ✓ Authorized DBCSH Staff on monitoring, diagnostic, therapeutic,
apply to? treatment and miscellaneous medical devices
✓ All DBCSH-MEMU staff
✓ All external contractors on medical device maintenance
activities.
✓ Ward/Department Managers
✓ MDC and SMT/DBCSH Administration
When should the ✓ When medical devices require transportation, preventive
procedure be applied? maintenance, and repair

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 Work Order Notifications
1. Procedures to be carried out

• Whenever there is a need of: medical device acceptance, training, corrective maintenance,
decommissioning, or Preventive maintenance alert; the user or MD Focal person of the room should
report immediately to MEMU using a Work Order Form. (See Annex 1)
o In urgent cases the request for any biomedical services can be made by a phone call or other
means of reporting, however this must always be backed up with Work Order Form.
o Any transport of medical device is performed following transportation procedure below.
• Three copies of the Work Order Form should be filled for one request:
o The first copy, after signed by the receiver, should be kept by the user department and filed
in a ‘Medical Device Maintenance File’ folder which is divided into two halves.
▪ The two halves work as follows:
• The front is the pending section and is a record of all the jobs reported; organized
according to respective dates.
• The back is the completed section and is an ongoing record of all the jobs that have
been completed; organized according to respective dates.
▪ The ‘pending section’ should be checked regularly by users’ Team Head to ensure that
Work Orders are being carried out in a timely manner.
▪ When the work is completed and or the item is re/turned to service, the Form should
be signed by the users’ Team Head or equivalent
▪ It is then moved from the front (pending section) to the back (Completed section).
▪ Users’ Team Head obtains feedback regarding the status of maintenance requests and
monitors progress by reviewing ‘Medical Device Maintenance File’ monthly.
o The second is filed in a ‘Work Order Progress File’ which is divided into two halves.
▪ The two halves work as follows:
• The front is the pending section and is a record of all the jobs requested;
organized according to respective dates.
• The back is the completed section and is an ongoing record of all the jobs that
have been completed; organized according to respective dates.
▪ The ‘pending section’ should be checked regularly by MEMU Team to ensure that
Work Orders are being carried out in a timely manner.
▪ When the work is completed and or the item is re/turned to service, the Form is moved
from the front (pending section) to the back (Completed section).
▪ MEMU Head obtains feedback regarding the status of Work Orders and monitors
progress by reviewing ‘Work Order Progress File’ every week.
o The last copy is used by the service provider technician/engineer as a record of the work
undertaken.
▪ After completion the form then is used to create a service history for the equipment or
item concerned.

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• MEMU will record all service/maintenance undertaken on the national and local history
file/inventory database; and this will be audited and verified by the hospital’s MDC for compliance
with this and relevant protocols in place.

2. Summary of work-order form use

To front

To back

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 3. Monitoring and evaluation

The hospital MEMU follows the implementation of work order procedure and timely reports to MDC
and SMT/plan program

Reportable variables Frequency of report

# Biomedical work orders received Monthly
# Biomedical work orders completed Monthly
# Biomedical work orders pending Monthly
# Biomedical work orders outsourced Monthly

The user team head follows the status of work orders and timely reports to PMT.

Reportable variables Frequency of report

# Pending Maintenance of Medical Devices Monthly
# Completed Maintenance of Medical Devices Monthly

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 Transportation
1. Procedure to be followed

1. Before Transportation
a) Responsible staff ensures that the device has been decontaminated as per decontamination
procedure below
b) If the device operates with fluids, these are emptied before transportation.
c) Department managers ensure that risks associated with transporting devices are assessed and
hazards are considered within the department.
d) Always assess the load and the pathway before attempting the move.
 Uneven surfaces are to be avoided. If this cannot be done, seek assistance from another
staff member
e) If a number of devices are to be transported, then a secured transport box should be used.

2. Transportation on site
a) When transporting devices on site, a trolley should be used.
b) Devices with castors/wheels should be pushed and if the device is large, then two members of
staff should maneuver it.
c) Always avoid uneven surfaces. If this cannot be avoided seek assistance from another staff
member

3. Transportation by vehicle
a) Drivers should ensure that they fully understand and carry out their duties relating to the
requirements of this procedure.
 They should: have a valid license; make sure their vehicle is load worthy, safe; and have
appropriate insurance cover.
b) To transport the medical device to the vehicle the staff follows the process above. The device
should be safely loaded and secured.
c) When leaving the vehicle unattended during working hours, all bags, devices and tools should
be stored out of sight to reduce risk of vandalism and theft. Equipment should not be left in the
vehicle overnight.

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 Decontamination
1. Procedures to be carried out

• All re-useable medical devices must be decontaminated according to the following Infection Risk
Classification of Medical Devices after each use and always prior to any kind of repair or final
disposal.

Risk Application Of Devices Decontamination Recommendations

High • In close contact with cut skin or broken mucous • Cleaning followed by sterilization
membranes
• Introduced to sterile body areas
Medium • In contact with mucous membranes • Cleaning followed by sterilization or
• Contaminated with particularly virulent or disinfection
readily transmissible organisms Note: - Where sterilization will damage
• Before use on immunocompromised patients equipment, cleaning followed by high level
disinfection may be used
Low • In contact with healthy skin • Cleaning
• Not in contact with patient

• The ward/department must ensure that decontamination has taken place following the manufacturer’s
recommendations
• A decontamination status label must be attached to the decontaminated device waiting for repair
• After decontamination devices should be stored in accordance with legislation and best practice
requirement
• Once decontamination is complete the item should be labelled as follows accordingly

Date______________
Please tick appropriate box
Decontaminated according to the procedure
Externally cleaned but may require internal
cleaning/decontamination
CAUTION! The device is subject to infectious
contamination!

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 Preventive Maintenance
1. Procedures to be followed

• All medica equipment shall have defined operator and technical PPM1 schedules;
o These will be identified on PPM logs (Annex 3) in dedicated ‘PPM Logbook’ folder and on
‘Devices Status Follow-up form2’ of sophisticated devices (which needs to be availed at user
room and workshop).
▪ In addition, the technical preventive maintenance schedule may be seen on MEMIS
web app, on facility WOT, and in history files.
• Biomedical professionals of the hospital regularly round wards of their divisional assignment and this
shall be clearly posted in Biomedical Workshop and in all other relevant wards/departments.
o This is to oversee user ppm, conduct and or schedule for technical ppm, schedule for-
corrective actions, update labels and history files, and follow up status of their respective
division devices.
o Post round discussion is to be conducted.
• Whether its work order is initiated by schedule automation system or users’ alert, biomedical
professionals must follow procedure for work order notification to take respective ppm actions.
• There shall be Medical Devices Focal person in each ward/department.
o To follow-up PPM Logbook folders, Medical Device Maintenance File folders and status
of devices there; and to accompany biomedical professional assigned there.
o No device shall be in an attempt of any maintenance by any means, without arrangement of
this Focal person or equivalent user;
▪ This will be identified by ‘Devices Status Follow-up form’ ( Annex 4) which shall
be in place at each ward/department with high-risk and or sophisticated devices.
• MEMU will record all preventive maintenance undertaken; on the national and local history
file/inventory database
o And this will be audited and verified by the hospital’s MDC for compliance with this and
relevant protocols in place.

2. Monitoring and evaluation

The hospital MEMU follows the implementation of planned preventive maintenance and timely reports
to MDC and SMT/plan program

Reportable variables Frequency of report

% Of Preventive maintenance schedule conducted Monthly
% Of technical Preventive maintenance schedule conducted Quarterly
% Medical devices with Preventive maintenance schedule Semi-annually

1
PPM consists of cleaning, inspection, testing, parts calibration, servicing (adjustment/replacement of parts)
2
Device’s status follow-up form is for devices needing long-time-maintenance work.

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 Corrective Maintenance
1. In-house Corrective Maintenance

Procedures to be followed
a. It is the responsibility of the user when alerted, to remove the device from use and make available to
MEMU for repair/service according to ‘Work Order Notification’ procedure.
b. Users must clean/decontaminate the equipment in line with ‘Decontamination procedure’ and attach
a Decontamination Status Label to all equipment requiring service or maintenance. Unless this is
completed and work order is correctly reported, service or maintenance will be delayed or not
undertaken.
o MEMU reserves the right to return any medical device found to be contaminated back to the
users for cleaning/decontamination before any repairs/maintenance is carried out.
c. Technicians/engineers carry out the repair utilizing relevant tools and PPEs onsite or off site as
possible.
d. Once Repair is carried out, the medical device is tested in accordance with relevant standard and
o The last part of work-order form is completed and signed by the repairing personnel.
o Then the item/device is cleaned and returned to the relevant Department/Ward.
e. MEMU will record all Repairs undertaken on the history file/inventory database.
f. For Devices which cannot be maintained in-house; ‘Procedure For Outsourcing Repair’ and
‘Procedure For Outsourced repair’ must be followed.

2. Outsourcing Corrective Maintenance

Procedures to be followed
a. Medical Equipment Committee establishes a register of all potential individuals and companies that
can be considered as a supplier of maintenance services
o This is based on a list of requirements that individual or company should meet in order to be
contracted by the hospital.
 This list should be prepared by MDC or its subcommittee!
o A team of suitable staff chosen to visit these registered suppliers, when possible, shall ensure
that the suppliers meet the requirements and are qualified to provide the services they offer.
b. Once the appropriate companies or individuals have been identified and registered, the MDC
determines the type of arrangement they would like to have with the particular organization.
c. Whenever a repair requiring external support becomes necessary, the Head of MEMU refers to the
registered list of companies and follows national guidelines:
o Staff from the maintenance department must accompany the Contractor at all times
o Contractor provides feedback on progress of job.
o Contractor sign-in and sign-out after each service visit.
o Contractor provides a report at the completion of the service.
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 3. Outsourced Corrective Maintenance

Procedures to be followed
a. This will be arranged and undertaken by MEMU in conjunction with MDC, the device user,
manufacturer/supplier and or approved contractor for the job.
b. Prior to being handed to any approved contractor for repair, all patient identifiable data must be
securely and correctly removed/deleted from the equipment.
o Whenever possible, Repair of devices carrying patient identifiable data is carried out in
hospital premises.
o Where removal/deletion of patient identifiable data is not possible, approved hospital agent
is involved in the whole process until the device returns to use or be disposed according to
‘Protocol for Decommissioning and Disposal of Medical Device’.
c. If sent to manufacturer/supplier for repair (Stock Dispatch procedure of GOFAMM must be followed
here); any costs incurred, including labor, as a result of user damage or missing parts will be charged
back to the hospital and then to the user related.
d. If outsourced to any other approved contractor, the whole process follows agreements in contract.
o ‘Outsourcing Enrollment form’ (Annex 5) shall be filled and signed by both parties before
the start of the job.
o Maintenance progress shall be followed by ‘Device Status Follow-up form’ until the end of
the job. (Annex 4)
e. At the end, the last part of work-order form is completed and signed by the repair personnel.
o The item/device is cleaned and returned to the relevant Department/Ward.
f. After all, MEMU shall make two copies of completed work-order form
o Issues one Copy to the maintenance personnel and the other to the hospital finance head.
o Then only can the payment process start.
g. Any medical device deemed beyond economical repair shall be decommissioned, and for this end a
‘Condemnation Certificate’ (Annex 6) will be issued to the owner department. The receiver then can
issue the device to ‘used-stock store’ where it stays until disposal.
h. If decommissioned device must be replaced, Department/Ward head must complete section A of the
‘Emergency MD Purchase Request’ Form (Annex 7) and forward to MEMU, then adherence to
‘protocol for procurement’ ensured.

4. Monitoring and evaluation

MEMU follows the implementation of the procedure and timely reports to MDC and SMT/plan program

Reportable variables Frequency of report

% In house repairs completed Monthly
% Outsourced repairs completed Monthly
% Repairs pending Monthly
# Medical Devices decommissioned Monthly

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 Equipment calibration
1. Procedures to be followed

a. All relevant users of equipment with periodic calibration need 3are required to:
 Check the calibration status of equipment prior to use.
b. MEMU prioritizes and decides on the calibration Frequency based on Manufacturer’s
specifications of equipment with calibration need.
c. MEMU assigned personnel coordinates process of calibration requests, equipment transportation,
and calibration process if calibrator is out of the facility.
d. If calibrator is not available, MDC in conjunction with MEMU selects calibrator considering the
following qualities:
 Technical education and experience in the area of equipment calibration
 Basic knowledge of metrology principles and calibration concepts
 Ability to follow the use of equipment, its maintenance instructions, and quality standards
 Mental attitude which results in safe, careful, and exacting execution of his or her duties.
e. MEMU assigned personnel ensures that selected calibrator:
 Selects suitable equipment to perform the required measurements with accuracy and
precision
 Ensures inspection and test equipment is calibrated in a suitable environment
 Follows all measurement, calibration and maintenance activities in the process.
 Checks for relevant quality standard.
f. Assigned personnel ensure right transportation and storage of calibrated equipment considering:
 The effects of temperature, humidity, vibration, and cleanliness.
 Each equipment is traced through its own Cal record, which contains Identification
number, Manufacturer and model, Cal Frequency, standards used, Validation certificates
and Cal findings.

2. Monitoring and evaluation

The hospital MEMU follows the implementation of Testing equipment calibration procedure and timely
reports to MDC and SMT/plan program

Reportable variables Frequency of report

% Equipment calibrated Yearly
% Equipment calibration reaching due date Bi-annually

3
Examples of equipment with periodic calibration need are Thermometers, hygrometers,

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 Testing Tools calibration
1. Procedures to be followed

g. All MEMU employees are required to:

 Check that inspection and test equipment is not damaged and is fit for purpose
 Check the calibration status of inspection and test equipment prior to use.
h. MEMU head presents a list of testing equipment in need of calibration to MDC.
i. MDC Prioritizes and decides on the Calibration Frequency based Manufacturer’s specifications
and or on how frequently professionals use them.
j. MEMU assigned personnel coordinates process of calibration requests, equipment transportation,
and calibration process if already known calibrator is available.
k. If not, MDC in conjunction with MEMU selects calibrator considering the following qualities:
 Technical education and experience in the area of equipment calibration
 Basic knowledge of metrology principles and calibration concepts
 Ability to follow the use of test equipment, its maintenance instructions, and quality
standards
 Mental attitude which results in safe, careful, and exacting execution of his or her duties.
l. MEMU assigned personnel ensures that selected calibrator:
 Selects suitable equipment to perform the required measurements with accuracy and
precision
 Ensures inspection and test equipment is calibrated in a suitable environment
 Controls all measurement, calibration and maintenance activities in the process.
 Follows relevant quality standard.
m. Assigned personnel ensure right transportation and storage of calibrated equipment considering:
 The effects of temperature, humidity, vibration, and cleanliness.
 Only authorized personnel can access them when needed for calibrating or testing medical
devices.
 Each equipment is traced through its own Cal record, which contains Identification
number, Manufacturer and model, Cal Frequency, standards used, Validation certificates
and Cal findings

2. Monitoring and evaluation

The hospital MEMU follows the implementation of Testing equipment calibration procedure and timely
reports to MDC and SMT/plan program

Reportable variables Frequency of report

% Testing tools calibrated Yearly
% Testing tools with calibration due date reaching Bi-annually
% Availability of Testing tools Bi-annually

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 Annexes
1. Biomedical Work Order Form

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 2. Parts/Accessories/Consumables order Request Form

3. PPM Log-sheet

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 4. Devices Status Follow-up form

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 5. Outsourcing Enrollment form

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 6. Condemnation Certificate

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 7. Emergency MD Purchase Request Form

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Details For this Strategic Protocol
Title of The Procedure Protocol for Medical Devices Maintenance
Unique Identifier DBCSH-MEMU-PRO3-2023

State (New or Revised) New

Previous Title where applicable

Category Health Technology Management (HTM)

Executive Director Chief Clinical officer

Lead/Author Job titles only Bio-Medical Engineer

Committee/Group responsible for the
Hospital Senior Management Team
approval
Committee Chairman print name Hospital stamp

Month/year consultation process completed April-2023

Month/year procedure approved

Month/year ratified and issued

Next review date April -2025
can be disclosed to the public HC sectors and any
Disclosure status
relevant bodies
Medical devices, procurement, emergency medical
Key Words equipment purchase request, spare parts, accessories,
planned purchase, emergency purchase

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