MDM PROTOCOLS

Protocol for Commissioning of Medical Devices

AUGUST 8, 2022
DEBREBIRHAN COMPREHENSIVE SPECIALIZED HOSPITAL
Ethiopia, Amhara, Debre-birhan town
PURPOSE AND SCOPE .................................................................................................................................................. 2
1. THE PURPOSE ...................................................................................................................................................................2
2. THE SCOPE.......................................................................................................................................................................2
PROCEDURES TO BE FOLLOWED ............................................................................................................................ 3
MONITORING AND EVALUATION ............................................................................................................................ 3
ANNEXES ........................................................................................................................................................................ 4
1. ACCEPTANCE AND TESTING REPORT FORM .............................................................................................................................4
3. RISK ASSESSMENT FORM ....................................................................................................................................................6
2. MD SOP TEMPLATE .........................................................................................................................................................7
3. TRAINING VERIFICATION FORM............................................................................................................................................8
4. MD REGISTRATION BOX ....................................................................................................................................................8
5. MEDICAL DEVICES INVENTORY DATA COLLECTION FORM ...........................................................................................................9
DETAILS FOR THIS STRATEGIC PROCEDURE .................................................................................................... 10

1|Page
 Purpose and scope
1. The purpose
The purpose of this Protocol is, to ensure that all medical devices in the hospital are properly and
rightly commissioned and recorded.
Obedience to this procedure will ensure compliances with Standards intended to make sure the Devices
that are used to deliver care and treatment:
 Have protocol for commissioning
 Are properly availed, and commissioned
 Have relevant documents recorded

2. The scope
Who does the  Authorized DBCSH Staff on purchase, commissioning and record of
Protocol apply to? monitoring, diagnostic, therapeutic and miscellaneous medical devices
 MEMU coordinator
 Ward/Department Managers
 MEC and SMT/DBCSH Administration
When should the When:
Protocol be  Commissioning of medical device and spares/accessories/consumables is
applied? required

2|Page
 Procedures to be followed
 Any new medical device entering into the hospital whether through purchase (planned or
emergency) or donation undergoes acceptance test. (Annex 1)
 If Acceptance test ends with rejection, the device returns to the owner OR the supplier corrects
the problem if possible.
 If Acceptance test ends with acceptance, Inventory Number1 is allocated to the device and
Registration box (Annex5) filled and attached to it using a water proof PVC sticker.
 After registration box attached, inventory data collection form (Annex 6) is filled for the device,
risk assessment done (See annex2), SOP (Annex3) prepared, training verification form
(Annex4) filled and all stored in newly opened history file with other relevant documents.
 Then only can the device be used and other wise prohibited.

Monitoring and evaluation

The hospital MEMU follows the commissioning implementation and timely reports to MEMC and SMT/plan
program

Reportable variables Frequency of report

# Medical devices delivered Quarterly
# Medical devices not installed/commissioned Monthly
# Medical Devices Rejected Quarterly
# Medical Devices under formal compliant Quarterly
# Medical devices with SOP Quarterly

1
Presented in ‘Protocol for inventory of Medical Devices’

3|Page
Annexes
1. Acceptance and testing report Form

4|Page
5|Page
 3. Risk Assessment Form

6|Page
 2. MD SOP Template

7|Page
 3. Training Verification Form

4. MD Registration Box

8|Page
 5. Medical Devices Inventory data collection form

9|Page
 Details For this Strategic Procedure
Title of The Procedure Protocol for Commissioning of Medical Devices
Unique Identifier DBCSH-MEMU-PRO3-2022

State (New or Revised) New

Previous Title where applicable -

Category Health Technology Management

Executive Director Chief Clinical officer

Lead/Author Job titles only Bio-Medical Engineer

Committee/Group responsible for the

Hospital Senior Management Team
approval
Chairman print name Hospital stamp

Month/year consultation process completed June-2022

Month/year procedure approved

Month/year ratified and issued

Next review date June-2024
can be disclosed to suppliers of medical devise and the
Disclosure status
public HC sectors
Medical device, commissioning, acceptance, risk
Key Words assessment, SOP, Inventory Data Collection, Training
verification

10 | P a g e