Medical Equipment Management Checklist

Facility name
Physical Location
Facility hours
License No.
Date & Time
Audit Type: Renewal Concise/Follow up Adhoc
Name Title/License no. Name Title/License no.

HAAD Auditor HAAD Auditor

Name: Name:
Division: Division:
Auditor No.: Auditor No.:

International Patient Safety Goals

1. Improve the accuracy of patient identification

2. Improve the effectiveness of communication among care givers and care recipients
3. Improve the safety of using medications and medical devices
4. Reducing the risk of healthcare associated infections
5. Ensuring correct site, correct procedure, correct patient for all procedures
6. Accurately and completely reconcile medications across the continuum of care
7. Encourage patients active involvement in their own care as a patient safety strategy
8. Improve recognition and response to changes in a patient’s condition
9. Reducing risk of patient harm resulting from falls
10. Reduce the risk of hospital fires

P = PRIORITY PSG = PATIENT SAFETY GOALS

No. Ref Auditor Tasks Yes Partial No PSG Comments

A. The Organization has a medical
P equipment management program/plan
which takes into account the components
of this checklist.
A.1 JCI-FMS 8 Policies and procedures for management 3
P of all stages of equipment life cycle
(Equipment appraisal to disposal) are
available.
A.2 WHO,ECRI All incoming Equipment is appraised 3
P based on technical features, regulatory
compliance(FDA,CE marking etc) and

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 vendor support etc. before purchase.
A.3 FDA If equipment is not appraised prior to 3
P (21 CFR purchase , there must be evidence that
Part 820) the equipment performance was
validated before it is put into use..
A.4 JCI-FMS 8 Medical equipment inventory is available.

A.5 JCI-FMS 8 Amount of equipment is sufficient to

JCI-FMS meet the scope of service
8.1
A.6 ECRI,FDA Critical equipment is identified, listed and
updated.
A.7 There is provision for backup/alternative 2, 3
P in case of failure of the critical
equipment.
A.8 Provision for emergency supply of 3
P utilities (electricity, water, pressure,
medical air etc) for the critical
equipment.
A.9 AAMI,FDA Utilities, accessories, consumables and
,ECRI supplies are aligned with the equipment
functions and as per manufacturer
recommendations
A.11 JCI-FMS 8 Planned preventive maintenance (PPM) 3
P schedule for medical equipment
according to type, use and
manufacturer's recommendation.
Equipment has PPM records and
labels/stickers as evidence of the
schedule being followed.
A.12 FMS 8, Medical equipment is tested for electrical 3, 10
P IEC62353 safety upon installation, during PPM and
after major repairs.
A13 AAMI & New medical equipment receives safety 3, 10
P ECRI and proper performance assurance
inspection prior to its use.

A.14 JCI-FMS 8 All service records, test results

( functional and safety),calibration ,
adjustment and QA /QC reports are
documented and maintained for each
piece of equipment
A.15 JCI-FMS 8 Equipment is maintained by qualified and
trained staff.
A16 JCI FMS 8 An ongoing training programme is
conducted/arranged by the biomedical

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 department for the relevant hospital staff
on safe operation and routine
maintenance of critical medical
equipment
A.17 ECRI All test tools used for maintenance of
medical equipment are calibrated.

A.18 JCI-FMS 8 System is place for monitoring of

vendors/contractors for equipment
under warranty, placement and contract
A.19 JCI-FMS An equipment replacement plan in place.
8.1
A.20 WHO An Equipment disposal plan and process
in place
B. The organization has product/equipment 3, 10
P recall system

B.1 FMS 8.2 There is a product /equipment recall 3, 10

P system in place.

B.2 FMS 8.2 Policies and procedures address removal

from service of any product/equipment
under recall, and the use of any recalled
equipment
B.4 FMS 8.2 The policy or process on recall is 3, 10
P implemented.
Total Met Partially Met Not Met NA
Priority

Non
priority

Medical Equipment Management HAAD Auditor

Name: Name:
Signature: Signature:
Date: Date:

Section Head Comments: ………………………………………………………………………………………………………

………………………………………………………….……………………………………………………………………………………

Name: …………………………………………… Signature: ……………………………………. Date ……………….………

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