APH/7.1.

0/F03/R0

APH MEDICAL SYSTEMS

ANALYSIS OF RISK MANAGEMENT
SURGICAL INSTRUMENTS
Product:-

Sn Hazardous Problem create due to Critical Very high High Low Action Taken Action
this hazards Yes No Detail
1 ENERGY
a) Electricity No
b) Heat No
c) Mechanical Force No
d) Ionizing radiation No
e) Non- ionizing radiation No
f) Moving parts No
g) Unintended motion No
h) Suspended masses No
i) Failure of pertinent- support No
device No
j) Pressure No
k) Acoustic pressure No
l) Vibration No
m) Magnetic Fields (MRI) No

2 BIOLOGICAL
a) Bio- Contamination No
b) Bio- incompatibility No
c) Incorrect formulation (Chemical No
composition) No
d) Toxicity No
e) Allergenicity No
f) Mutagenicity No
g) Oncogenicity No
h) Teratogenicity No
i) Re-and/ or cross- infection No
j) Pyrogenicity No
k) Inability to maintain hygienic Yes Yes Yes Rustless
safety steel is
l) Degradation No used .
Sn Hazardous Problem create due to Critical Very high High Low Action Taken Action
this hazards Yes No Detail
3 ENVIRONMENTAL
a) Electromagnetic fields No
b) Susceptibility to electromagnetic No
interface No
c) Emissions of electromagnetic No
interface No
d) Inadequate supply of power No
e) Inadequate supply of coolant No
f) Storage or operation outside No
prescribed environmental conditions No
g) Incompatibility with other devices No
with which it is intended to be used No
h) Accidental Mechanical damage No
i) Contamination due to waste
products and / or medical device No
disposal

4 INCORRECT OUT PUT OF ENERGY

a) Electricity No
b) Radiation No
c) Volume No
d) Pressure No
e) Supply of medical gases No
f) Supply of anaesthetic agents- No

5 USE OF MEDICAL DEVICES

a) Inadequate labeling No
b) Use by unskilled/ untrained misuse Yes Yes Yes Training.
c) Reasonably foreseeable misuse No
d) Insufficient warning of side effects No
e) Inadequate warning of hazards No
likely with re-use of signal- use No
medical devices No
f) Incorrect measurement and other No
metrological aspects No
g) Incompatibility with consumables / No
accessories/ other medical devices No
h) Sharp edges or points Yes Yes Yes Training
i) Inadequate operating instructions
such as_
Sn Hazardous Problem create due to Critical Very high High Low Action Taken Action
this hazards Yes No Detail
5  Inadequate specification of No
accessories to be used with the
medical device.
 Inadequate specification of pre- use No
check
 Over- complicated operating No
instructions
No
 Inadequate specification of service
and maintance.

6 INAPPROPRIATE, INADEQUATE OR
OVER- COMPLICATED USER
INTERFACE (MAN/MACHINE
COMMUNICATION
a) Mistake and judgement errors No
b) Lapses and cognitive recall errors No
c) Slip and blunders (Mental or No
physical)
d) Violation or abbreviation of No
instructions, procedure
e) Complex or confusing control No
system
f) Ambiguous or unclear presentation No
of settings, measurements or other
information
g) Misrepresentation of results No
h) Insufficient visibility, audibility or No
tactility
i) Poor mapping of controls to action,
or of displayed information to actual No
state
j) Controversial modes or mappings as
compared to existing equipment. No
Sn Hazardous Problem create due to this Critical Very high High Low Action Taken
hazards Yes No
7 FUNCTIONAL FAILURE,
MAINTENANCE AND AGEING
a) Erroneous data transfer No
b) Lack of, or inadequate specification
for maintenance including No
inadequate specification of post
maintenance functional checks
c) Inadequate maintenance Yes Yes Yes Training
d) Lack of adequate determination of No given
the end of life of the medical device
e) Loss of electrical/ mechanical No
integrity
f) Inadequate packaging No
(Contamination and / deterioration of
the medical device)
g) Re use and / or improper re use No
h) Deterioration in function ( Gradual
occlusion of fluid/ gas path, or change
in resistance to flow, electrical No
conductivity) as a result of repeated
use

Date: 03.08.21 Prepared by