Risk Management Report , Page 1 of 20
Risk Management Report
on
EsCom100
Report # : SPA 009 (Rev.0)
Prepared by: K.H. Beak /QA
Approved by: J.H. Kim /President
SPIDENT CO., LTD.
SPIDENT CO., LTD.
Risk Management Report , Page 2 of 20
Table of Contents
1. Scope
2. Definition
3. General requirements for risk management
3.1 Risk management process
3.2 Responsibilities and authority
4. Risk analysis
4.1 Intended use/ intended purpose and identification of characteristics related to the safety of the
medical devices.
4.2 Identification of hazards
4.3. Estimation of the risks for each hazardous situation
5. Risk evaluation
6. Risk Control
6.1 Risk reduction
6.2 Risk control option analysis
6.3 Implementation of risk control measures
6.4 Residual risk evaluation
6.5 Risk/benefit analysis
6.6 Risk arising from risk control measures
6.7 Completeness of risk control
7. Evaluation of overall residual risk acceptability
8. Risk management report
9. Production and post-production information
SPIDENT CO., LTD.
Risk Management Report , Page 3 of 20
1. Scope
This risk management is carried out for EsCom100 to identify the hazards associated with medical
devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the
effectiveness of controls. This report is applicable to all stages of the life-cycle of a medical
device in accordance with ISO 14971:2007.
2. Definition
○ Harm: Physical injury and/or damage to health or property.
○ Hazard: A potential source of harm
○ Hazardous situation: Circumstance in which people, property, or the environment are exposed
to on or more hazard(s)
○ Risk: The probable rate of occurrence of a hazard causing harm and the degree of severity of
the harm
○ Post-production: Part of the life-cycle of the product after the design has been completed and
medical device has been manufactured.
○ Residual risk: Risk remaining after risk control measures have been taken.
○ Risk Analysis: The investigation of available information to identify hazards and to estimate
risks.
○ Risk assessment: Overall process comprising a risk analysis and a risk evaluation
○ Risk control: Process in which decisions are made and measures implemented by which risks
are reduced to, or maintained within, specified levels
○ Risk estimation: Process used to assign values to the probability of occurrence of harm and the
severity of that harm
○ Risk evaluation: Process of comparing the estimated risk against given risk criteria to
determine the acceptability of the risk
○ Risk management: Systematic application of management policies, procedures and practices
to the tasks of analyzing, evaluating, controlling and monitoring risk.
○ Safety: Freedom from unacceptable risk of harm
○ Severity: Measure of the possible consequences of a hazard
○ Verification: Confirmation, through the provision of objective evidence, that specified
requirements have been fulfilled
SPIDENT CO., LTD.
Risk Management Report , Page 4 of 20
3. General requirements for risk management
3.1 Risk management process
SPIDENT CO., LTD.
Risk Management Report , Page 5 of 20
3.2 Responsibility and authority
3.2.1 Risk Management Plan preparation: J. W. Kim/ QM
3.2.2 Plan approval: G. H. Baek/ QMR
3.2.3 Risk analysis: J. W. Kim/ QM
3.2.4 Risk evaluation: J. W. Kim/ QM
3.2.5 Risk control: G. H. Baek/ QM
3.2.6 Verification: G. H. Baek/ QM
3.2.7 Post-production information feedback: G. H. Baek/ QMR
3.2.8 Control of Risk management file: J. W. Kim/ QMR
3.2.9 Assessment (inspector) : G. H. Baek/ QMR
SPIDENT CO., LTD.
Risk Management Report , Page 6 of 20
4. Risk analysis
4.1 Risk analysis process
Overview of the risk management process including analysis process for medical devices
(Annex B)
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Risk Management Report , Page 7 of 20
4.2 Intended use/ intended purpose and identification of characteristics related
to the safety of the medical devices (Step 1).
1. Overview
Es Fil is light-cured flowable composite resin which makes it ideal for small cavities in
anterior and posterior teeth. It has the characteristics of good flowability, high
compressive strength, and radiopaque
2. Device Name
Proprietary Name; EsCom100
Common Name; Dental Flowable Composite Resin
3. Standards concerned :
ISO 14971:2007 Medical devices - Risk management ISO 4049 [2000-07-15] Dentistry – Polymer-based filing, restorative and luting materials
4. Device Master File : DMR-10(Rev.0)
5. Indication for use :
-
Application of ClassⅢ-Ⅴ cavity
-
As a linear for ClassⅠ-Ⅱ cavity
Restoration of minimally invasive cavity preparations
SPIDENT CO., LTD.
Risk Management Report , Page 8 of 20
6. Identification of qualitative and quantitative characteristics related to EsCom100
Relations to the lists in ISO 14971 Annex C
(“A” means Applied. “N/A” means Not Applied.)
A or
Relations with
ISO 14971 Lists
N/A
EsCom100
C.2.1 Intended use and how is the medical device to be
used?
1. Intended user
1. Dentist
2. Mental and physical abilities
2. Qualified
3. Skill and training of the user
3. Qualified
4. Ergonomic aspects
4. Qualified
5. The environment in which it is to be used
5. Preferably hospital
6. By whom it will be installed
A
6. N/A
7. Whether the patient can control or influence
7. Actually not
the use of the medical device
8. Special attention should be paid to intended
8. No
users such as the handicapped, the elderly and
children
9. Assistance by another person
9. No
10. Intended to be used by individuals with various
10. Dentist
skill levels and cultural backgrounds
C.2.2 Is the medical device intended to contact the
patient or other persons?
1. Surface, invasive or implant
A 1. Invasive
2. Frequency
2. Once
3. Period
3. Long term (over 30 days)
C.2.3 What materials and/or components are
incorporated in the medical device or are used
with, or are in contact with, the medical device?
C.2.4 Energy delivered or extracted from the patient?
1. Control
2. Quality
3. Quantity
4. Duration
C.2.5 Substances delivered to and/or extracted from the
patient?
1. Single or composite
2. Minimum and maximum transfer rate
3. Control
C.2.6 Biological materials processed by the device for
subsequent re-use?
1. Type of process
2. Substances processed
SPIDENT CO., LTD.
A
Polypropylene
Stainless steel
N/A
A
N/A
The composite resin is delivered
through the Tip.
Risk Management Report , Page 9 of 20
C.2.7 Supplied sterile or intended to be sterilized by the
user, or are other microbiological controls
applicable?
1. By whom it is sterilized
2. Single use or re-use
3. Packaging
4. Shelf life
5. Number of re-use cycles
6. Kinds of sterilization
C.2.8 Is device intended to be routinely cleaned or
disinfected by the user?
1. Types of cleaning
2. Disinfecting agents to be used
3. Any limitations on the number of cleaning
cycles
4. Design of the medical device can influence
the effectiveness of routine cleaning and
disinfections
C.2.9 Device modifies the patient environment?
Temperature, humidity, atmospheric gas
composition, pressure and light
C.2.10 Measurement?
1. Accuracy
2. Precision
C.2.11 Interpretative?
1. Type of output
2. Confidence limit
C.2.12 Related with other drugs or devices?
1. Potential problems
C.2.13 Unwanted outputs of energy or substances?
1. Noise, vibration, heat, radiation, ultraviolet,
infrared radiation
2. Contact temperature, leakage current, magnetic
fields
3. Discharge of chemical
4. Waste
5. Body fluids
C.2.14 Susceptible to environment?
1. Operational
2. During transport
3. Storage
C.2.15 Medical device influence the environment?
1. Power and cooling supplies
2. Emission of toxic or EMI
C.2.16 Consumables or accessory?
1. Restriction of selection
SPIDENT CO., LTD.
N/A
N/A
N/A
N/A
N/A
N/A
N/A
A
Avoid High Temp, Light
N/A
A
Needle
Risk Management Report , Page 10 of 20
C.2.17 Maintenance or calibration?
1. By operator or user or specialist
2. Special substances or equipment necessary?
N/A
C.2.18 Software included?
1. Installed by
2. Modified or exchanged by
N/A
C.2.19 Restricted shelf life?
1. Included in label or indicator
2. Disposal
A
C.2.20 Any delayed and/or long term use effects?
1. Ergonomic effects
2. Cumulative effects
N/A
C.2.21 Mechanical forces?
1. Controlled by user or others
N/A
2 years from manufactured date
on the label
C.2.22 What determines the lifetime?
1. Ageing
2. Battery depletion
A
Ageing
C.2.23 Single use or re-use?
A
Single use
C.2.24 Safe decommissioning or disposal is necessary?
1. Toxic material?
2. Recycled?
C.2.25 Special training for installation or use?
C.2.26 New manufacturing process needs to be
established or introduced?
1. New technology
2. New scale of production
C.2.27 Human factor?
1. Use error
2. Device control?
3. Symbol used?
4. Ergonomic features?
5. Layout?
6. Hierarchy of operation?
7. Menus for software
8. Visibility of warning?
9. Audibility of alarm?
10. Standardized color-coding?
C.2.27.1 Connecting parts or accessories?
1. Wrong connection?
2. Feedback on connection integrity
3. Over or under tightening
SPIDENT CO., LTD.
N/A
A
Dentist.
N/A
A
Use error
A
Needle
Risk Management Report , Page 11 of 20
C.2.27.2 Control interface?
1. Spacing
2. Coding
3. Grouping
4. Mapping
5. Modes of feedback
6. Blunders
7. Slips
8. Control differentiation
9. Visibility
10. Direction of activation or change
11. Continuous or discrete control
12. Reversibility of settings or actions
N/A
C.2.27.3 Display information?
1. Visibility in various environments
2. Orientation
3. Populations and perspectives
4. Clarity of the presented information, units,
color coding
5. Accessibility of critical information
N/A
C.2.27.4 Controlled by a menu?
1. Complexity and number of layers
3. Awareness of state
4. Location of settings
5. Navigation method
6. Number of steps per action
7. Sequence clarity and memorization problems
8. Importance of control function relative to its
accessibility
N/A
C.2.27.5 Mobile or portable?
1. Grip, handles, wheels, brakes
2. Mechanical stability
3. Durability
N/A
SPIDENT CO., LTD.
Risk Management Report , Page 12 of 20
4. 2 – Identification of Possible hazards(Step 2)
Possible hazards associated with EsCom100 in both normal and fault conditions in the reflection
of ISO 14971:2007 are as follows;
(“A” means Applied. “N/A” means Not Applied.
“X” means possible to occur)
D.2 Energy hazards
Examples
A or
N/A
1. Electricity
N/A
2. Heat
N/A
3. Mechanical force
N/A
4. Ionizing radiation
N/A
5. Non-ionizing radiation
N/A
6. Moving parts
N/A
7. Unintended motion
N/A
8. Suspended masses
N/A
9. Patient support device failure
N/A
10. Pressure
N/A
11. Acoustic pressure
N/A
12. Vibration
N/A
13. Magnetic field (e.g. MRI)
N/A
Potential hazards
Normal
Harm to user or patient
Fault
D.3. Biological hazards
Examples
A or
N/A
1. Bio-contamination
N/A
2. Bio-incompatibility
N/A
3. Incorrect formulation
A
4. Toxicity
N/A
5. Allergencity
N/A
6. Mutagenicity
N/A
7. Oncogenicity
N/A
8. Teratogenicity
N/A
9. Carcinogenicity
N/A
10. Re-and/or cross-infection
SPIDENT CO., LTD.
A
Potential hazards
Normal
Fault
Harm to user or patient
X
Low efficacy
X
Contaminated device may lead to crossinfection
Risk Management Report , Page 13 of 20
11. Pyrogenicity
N/A
12. Inability to maintain hygienic
safety
A
X
Contaminated
Infection
13. Degradation
A
X
Low efficacy
device
may
D.4 Environmental hazard
Examples
1. Electromagnetic fields
2. Susceptibility to electromagnetic
interference
3. Emissions of electromagnetic
interference
A or
N/A
Harm to user or patient
N/A
N/A
N/A
4. Inadequate supply of power
N/A
5. Inadequate supply of coolant
N/A
6. Storage or operation outside
prescribed environmental
conditions
7. Incompatibility with other
devices
Potential hazards
Normal
Fault
N/A
N/A
8. Accidental mechanical damage
N/A
9. Contamination due to waste
products and/or device disposal
N/A
D.5 Hazards resulting from incorrect output of energy and substances
Examples
A or
N/A
1. Electricity
N/A
2. Radiation
N/A
3. Volume
N/A
4. Pressure
N/A
5. Supply of medical gases
N/A
6. Supply of anaesthetic agents
N/A
Potential hazards
Normal
Fault
Harm to user or patient
D.6 Hazards related to the use of the device
Examples
1. Inadequate labeling
2. Inadequate operating instructions
- Inadequate specification of
accessories
SPIDENT CO., LTD.
A or
N/A
Potential hazards
Normal
Fault
Harm to user or patient
N/A
A
N/A
X
Low efficacy
lead
to
Risk Management Report , Page 14 of 20
- Inadequate specification of preuse checks
- Over-complicated operating
instructions
- Inadequate specification of
service and maintenance
3. Use by unskilled/untrained
personnel
4. Reasonably foreseeable misuse
N/A
N/A
N/A
A
X
Falling off
X
Insufficient warning of side effect may
lead to burn
N/A
5. Insufficient warning of side
effects
6. Inadequate warning of hazards
likely with re-use of single use
device
7. Incorrect measurement and other
meteorological aspects
8.
Incompatibility
with
consumables/accessories/other
devices
9. Sharp edge or points
A
N/A
N/A
N/A
N/A
D.7 Inappropriate, inadequate or over-complicated user interface
A or
N/A
Examples
1. Mistakes and judgement errors
2. Lapses and cognitive recall error
3. Slips and blunders (mental or
physical)
4. Violation or abbreviation of
instructions, procedures, etc.
5. Complex or confusing control
system
6. Ambiguous or unclear device
state
7.
Ambiguous
or
unclear
presentation
of
settings,
measurements
or
other
information
8. Misrepresentation of results
9. Insufficient visibility, audibility
or tactability
10. Poor mapping of controls to
action,
or
of
displayed
information to actual state
11. Controversial modes
mappings as compared
existing equipment
SPIDENT CO., LTD.
or
to
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Potential hazards
Normal
Fault
Harm to user or patient
Risk Management Report , Page 15 of 20
D.8 Hazards arising from functional failure, maintenance and aging
Examples
1.
A or
N/A
Erroneous data transfer
N/A
2. Lack of specification for
maintenance
N/A
3. Inadequate maintenance
N/A
4. Lack of adequate determination
of end of device life
5. Loss of electrical/mechanical
integrity
6. Inadequate packaging
(contamination and/or
deterioration)
Potential hazards
Normal
A
Fault
X
Harm to user or patient
Low efficacy
N/A
N/A
7. Improper re-use
N/A
8. Deterioration in function
N/A
D.9 Other hazards
Examples
A or
N/A
Potential hazards
Normal
Fault
1. Exposure EsCom100 to light
A
X
2. Segregation between needle and
syringe
A
X
3. Ingress of other substance
A
X
Harm to user or patient
Polymerization(hardening)
Segregation between needle and syringe
may lead to burn
Ingress of other substances may lead to
low efficacy
Previously recognized hazards
Not reported until now (Jun 19, 2008).
4. 3 - Estimation of the risks for each hazardous situation(Step 3)
The identified hazards shall be estimated using the criteria below. Reasonably foreseeable
sequences or combinations of events that can result in a hazardous situation shall be considered
and the resulting hazardous situations shall be recorded.
1. Severity
The severity of harm consists of five stages;
SPIDENT CO., LTD.
Risk Management Report , Page 16 of 20
Rating
5
4
Catastrophic
Serious
Critical
3
Minor
2
Negligible
1
Example
public death or damage
death,
Permanent or whole damage to patient
Infection/Contamination
Long term or partial damage
Bio-incompatible, toxic,
Allergy,
Temporary damage
Burn
Actually no damage,
Low efficacy
2. Frequency
The frequency of harm consists of five stages;
Rating
Frequent
5
Probable
4
Occasional
3
Remote
2
Improbable
1
Example
≥10-3
-3
<10 and ≥10-4
<10-4 and ≥10-5
<10-5 and ≥10-6
<10-6
The acceptable region of matrix shall be designated in accordance with manufacturer’s policy.
Qualitative severity levels
Frequent
5
IR
Semi4
quantitative Probable
probability Occasional 3
levels
Remote
2
ALARP
BAR
Improbable 1
Negligible
1
Minor
2
Critical
3
Serious
4
Catastrophic
5
Unacceptable risk [Level 17-25]
Investigate further risk reduction [Level 5-16]
Insignificant risk [Level 0-4]
Where the total value of the risk estimation is Green or Yellow Zone, the risk should be reduced to
the lowest level practicable by appropriate risk control. After the risk reduction measures, the risk
shall be evaluated if the measures produce another risk. Only when the medical benefits outweigh all
the identified and residual risk, they can be accepted. Where it is in Red Zone, it must be diminished
by appropriate measures and re-estimated. Otherwise, it cannot be accepted as a medical device.
SPIDENT CO., LTD.
Risk Management Report , Page 17 of 20
5. Risk Evaluation
Step 4. Risk Evaluation
From the estimated hazard data at step 3, we can decide if risk reduction is needed or not. Where the
level is under 4, BAR or under 16, ALARP, it can go step 9 directly. However, the possible risk
reduction can be adopted.
6. Risk Control
6.1 Risk reduction
When risk reduction is required, risk control activities shall be performed as follows,
6.2 Option analysis (Step 5)
The risk control measures shall be used one or more of the followings in the priority order listed.
1. Inherent safety by design
2. Protective measures in the medical devices itself or in the manufacturing process
3. Information for safety
6.3 Implementation of risk control measures (Step 6)
The risk control measures adopted at stage5 shall be implemented and verified.
6.4 Residual risk evaluation (Step 7)
After the risk control measures are applied, the residual risk evaluation shall be performed in
accordance with the same criteria as in step 3.
6.5 Risk/benefit analysis (Step 8)
Decide if the overall residual risks posed by the medical devices are acceptable.
6.6 Other generated hazards (Step 9)
Risk control measures taken in step 5 may have inherent hazard. If any new hazards are introduced
by any risk control measures, the associated risk(s) shall be assessed.
SPIDENT CO., LTD.
Risk Management Report , Page 18 of 20
Step3. Estimation
Category
D.3
Biological
Step2. Examples
Frequ Seve
ency rity
3. Improper formulation
may lead to low
efficacy.
2
10. Contaminated device
may lead to Infection
3
1
Step5. Option
analysis
Step4
Lev Reduction
el
is not
needed?
2
Not
Risk control
measures
Receiving inspection
Step6. Implementation
Result of verification
Receiving inspection record
Step7.
Residual
Step8
Step9
F
S
Unac Other
cepta hazard
L
ble introdu
risk?
ced?
1
1
1
No
No
1
3
3
No
No
1
3
3
No
No
1
1
1
No
No
In-process Inspection Inspection record
3
9
Yes
12. Contaminated device
by inability to
maintain hygienic
safety may lead to
Infection
3
3
9
Yes
13. Degradation
3
1
3
Not
Instruction for use
(Caution-Do not re- SDM-009
use to other patient.)
Labeling (Disposable
Label # TF09-10
tip)
Instruction for use
(Caution-Do not re- SDM-009
use to other patient.)
Design
Shelf life report # SLR-09
(Shelf life 2 years)
Labeling
Label # TF09-10
(Use by date)
2. Inadequate operating
instructions may lead
to low efficacy
-Inadequate
D.6
specification of preHazards
use checks may lead to
related to the
burn.
use of the 3. Use by
device
unskilled/untrained
personnel may lead to
burn
5. Insufficient warning of
SPIDENT CO., LTD.
2
1
2
Not
Instruction for use
(Directions)
SDM-009
1
1
1
No
No
2
2
4
Not
Instruction for use
(Rubber
dam
is SDM-009
recommended…)
1
2
2
No
No
2
2
4
Not
Instruction for use
(Use by trained and SDM-009
qualified dentist.)
1
2
2
No
No
3
2
6
Yes
Instruction for use
2
2
4
No
No
SDM-009
Risk Management Report , Page 19 of 20
side effect may lead to
burn
D.8
Hazards
4. Lack of adequate
arising from
determination of end
functional
of device life may lead
failure,
to low efficacy
maintenance
and aging
D.9
Other hazard
Shelf Life
3
1
3
Shelf life report # SLR-09
Not
2
2
4
Not
Labeling
Label # TF09-10
(Disposable tip)
Instruction for use
(Caution-Do not re- SDM-009
use to other patient.)
2. Segregation between
needle and syringe
may lead to burn
2
2
4
Not
Receiving inspection
SPIDENT CO., LTD.
1
1
No
No
1
2
2
No
No
1
2
2
No
No
1
3
3
No
No
Label # TF09-10
Labeling
1. Exposure EsCom100
to light may lead to
polymerization
(hardening)
3. Ingress of other
substances may lead to
low efficacy
1
Report
Receiving Inspection Receiving Inspection report
2
3
6
Yes
working in
condition
clean
SOP # SVL-602
Risk Management Report , Page 20 of 20
6.7 Completeness of risk evaluation (Step 10)
The risks from all identified hazards have been evaluated and decided to be acceptable.
Hazards
Evaluation
Identified Number of Risk
Number control measures BAR ALARP IR
Acceptable
Unacceptable
Energy
0
0
-
-
-
A
Biological
4
7
4
-
-
A
Environment
0
0
-
-
-
A
Incorrect output of energy and
substances
0
0
-
-
-
A
Use of the device
3
4
3
-
-
A
User interface
0
0
-
-
-
A
Functional failure, maintenance
and ageing
1
2
1
-
-
A
Other generated hazards
3
5
3
-
-
A
SPIDENT CO., LTD.
Risk Management Report , Page 21 of 20
7. Overall residual risk evaluation (Step 11)
No
Decide if the overall residual risk
posed by the medical devices is
acceptable?
Yes
Gather review data and literature on
the medical benefits of the intended
use/ intended purpose to determine if
they outweigh the residual risk.
Evidence;
Does the evidence support the
conclusion that the medical benefits
outweigh the residual risk?
Yes
Step 12
SPIDENT CO., LTD.
No
UNACCEPTABLE
Step 12
Risk Management Report , Page 22 of 20
8. Risk management report (Step 12)
My signature below signifies that I have read to approve the conclusion to this risk analysis
report.
Date :
Signature / Name
Date :
Signature / Name
SPIDENT CO., LTD.