Hospital device and equipment safety this ppt touches the important points in concern to Nurses..

1. HOSPITAL DEVICE
AND EQUIPMENT
SAFETYP R E S E N TAT I O N B Y:
R E B E C K A T H A N A N A K I
T U T O R
A I I M S PAT N A .

2. WHAT ARE CONSIDERED AS HOSPITAL
DEVICE AND EQUIPMENT:
Medical device” means any instrument, apparatus, implement, machine, appliance, implant,
in vitro reagent or calibrator, software, material or other similar or related article, intended
by the manufacturer to be used, alone or in combination, for human beings for one or more
of the specific purposes of:
• Diagnosis, prevention, monitoring, treatment or alleviation of disease or compensation for
an injury.
• Investigation, replacement, modification, or support of the anatomy or of a physiological
process.
• Supporting or sustaining life
• Control of conception
• Disinfection of medical devices
• Providing information for medical purposes by means of in vitro examination of
specimens derived from the human body and which does not achieve its primary intended
action in or on the human body by pharmacological, immunological or metabolic means,

3. WHY EQUIPMENT SAFETY?
• Era of cost intensive medical care.
• Demand for improving diagnostic facilities.
• Sophisticated equipment’s with modern technology.
• Progress in surgical procedures
• Physicians becoming more investigation oriented
• Introduction of computer science and robotics in medicine
• Use of medical instruments in specific procedures, diagnostic evaluation, treatment and
rehabilitation.
• These devices/ equipment’s might directly affect the lives of patients.
• Equipment maintenance keep the equipment’s/devices reliable, safety and available for use
when needed.
• It increases the life of the equipment/ device and makes it cost effective.

4. WHO IS RESPONSIBLE FOR THE
SAFETY OF PATIENT?
Equipment
&device safety
Manufacturer
Vendor
User (Medical
professional/
patient)

5. ROLES OF EACH STAKEHOLDERS TOWARDS
SAFETY OF EQUIPMENTS/DEVICE:
• The Manufacturer, as the creator of the device, must ensure that it is manufactured to meet or
exceed the required standards of safety and performance. This includes the three phases
(design/development/testing, manufacturing, packaging and labelling) that lead to a product
being ready for the market.
• The Vendor provides the interface between the product and the user. He/she should ensure that
the products sold comply with regulatory requirements. They should be careful to avoid making
misleading or fraudulent claims about their products or issuing false compliance certificates.
Medical devices often require specialized training from the manufacturer for proper use and
service; therefore, the vendor should make training a condition to the manufacturer or importer
in accepting to sell the device
• The User should make sure that he/she has qualifications and training in the proper use of the
device, and is familiar with the indications, contra-indications and operating procedures
recommended by the manufacturer. It is crucial that experience gained with medical devices be
shared with other users, the vendor and manufacturer to prevent future problems. This can be
done by reporting any incidents to a coordinating centre from which warnings can be issued as
the user could be a layman when the device is used homebased.

6. OBJECTIVES:
•To optimize utilization of the equipment/
device i.e Cost effective & efficient.
•Qualitative patient care and satisfaction.
•Prevention from patient and user safety
hazards.
•Optimal patient handling

7. SCOPE TOWARDS DEVICE SAFETY:
• Planning and implementation of a maintenance program in
the facility.
• Optimal operational efficiency.
• Maintaining an up-to-date inventory of each and every
equipment, their distribution in the facility.
• Anticipating the requirement of commonly required spare and
arranging for their adequate stocking. Ensuring break down
maintenance to promote uninterrupted services.
• Ensure safe and hazard free working place.

8. COMPONENTS OF DEVICE SAFETY
PROGRAMME:
MAINTENANCE
IPM
INSPECTION
PREVENTIVE
MANAGEMENT
CORRECTIVE
MAINTANCE

9. EQUIPMENT LIFE SPAN AFTER
PROCUREMENT:
PROCUREMENT USES CONDEMNATION DISPOSAL

10. EQUIPMENT SAFETY PROGRAMME
ESP
IMPLEMENTATION
PLANNING
MANAGEMENT

11. PLANNING
• PLANNING INVENTORY/ RESOURCES : It includes getting contracts of
devices, financial resourcing and manufacturer, manpower resources
programme, independent services, physical resources organizations.
• FINANACIAL RESOURCES (Initial cost operation): Financial resources
required for Physical resources like space, tools, test equipment, computer
resources, vehicles. Human resources like recruiting, initial training.
• PHYSICAL RESOURCES: Workspace, Tools and test equipment investments
reduce the maintenance cost and increase reliability, Supplies like cleaning
and lubricating supplies, Spare parts and Operation and service manuals.
• HUMAN RESOURCES: Biomedical engineers, Biomedical technicians,
Medical personnel’s and service providers.

12. MANAGEMENT
Financial
management
Operational
management
Performance
monitoring
Performance
improvement
Personnel
management

13. OPERATIONAL MNAGEMENT
Operational
management
IPM Frequency
Use and user
error
Log book
CMMSCommunication
SOP'S
Prioritization

14. IMPLENETATION:
IPM (INSPECTION PREVENTIVE
MANAGEMENT)
CORRECTIVE
MANAGEMENT
ENVIRONME
NTAL FACTOR
REPORTING SAFETY
1.Mostly IPM procedures are
completed by technical
personnel from the clinical
engineering Department.
2.In some cases the simple
routine inspection are done by
the user. This could be like pre-
use or daily checks ex: daily
calibration Of a portable blood
glucose, monitors, daily test of
defibrillators.
3.If during IPM repair or change
of parts is required in any device
it should be informed to the
respective department and to
the co-workorder staff.(as soon
as possible)
1.Ensure if the device
require a repair or a
replacement to
it efficiently.
2. Raise replacement only
if it is cost effective
otherwise send it for
condemnation.
3. Trouble shoot the
duration of replacement
time is comparison of the
requirement of the
in daily basis.
1, Electricity
supply(high
and low
voltage)
2. Inadequate
water supply
3. Ac failure
*They should
also be
streamlined.
1.For a best IPM
the technician or
the user must have
a detailed checklist
of equipment
functioning.
2.This checklist
serves as the
reminder of each
steps and avoid
skipping or
overlooking
specific steps.
1.Safety of
technical
personnel during
performance of
the procedures.
2.Safety of patient.
3.Prevention of
spread of infection
(PPE)
4. Safety from any
type of hazards.

15. CONSTRAINS OF EFFECTIVE MAINTENANCE
• Inadequate training of staff.
• After sales services by supplier is not satisfactory.
• Facilities backup on power supplies is inadequate.
• 24x7 utilization of equipment or wise versa leads to
use co-efficient.
• Patients are less aware of the high tech facilities in the
hospitals.
• Utilization of the special facility or skill requires staff
motivation and cost to the patient.

16. CONSEQUENCES
• Only 50-60% of equipment are in usable condition(according to a
survey done by deptt.of exp)
• High tech equipment worth Rs 50core are lying ideal in government
hospitals.
• Common factors contributing for wastage are
– Purchase of equipment which is never used due to lack of technical
expertise to use and maintain.
– Reduce lifetime due mishandling and lack of maintenance and repair.
– Non availability of spares, accessories.
– Excessive downtime due to lack of preventive maintenance.

17. CONDEMNATION
CONDEMNATIONCRITERIA
1.Electronic
equipment’s (7 to 10
yrs) life span.
2.Beyond economic
repair.
3.Non functional and
obsolete.
4.Functional and
PROCEDURE/DOCUMENT
FORCONDEMNATION
History sheet
Recommendation of
Maintenance committe
condemantion
committee
recommendation to
HOD.

18. SAMPLE EQUIPMENT MAINTENANCE FORMS

19. THANK YOU...