Académique Documents
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Participants
Na Initials Department Position Risk assessment role
me
Jean-Ann Carminade FRJAC R&D Risk Management Specialist Risk Management
Specialist/Responsible
Pascale Holliday- FRPHO Clinical Clinical Scientist Medical Expert
Bonnard
Stphane Bouch FRSBU RA Regulatory Affairs Manager RA
Approvers
Documented in Document Management System
Product variants (items) covered by this assessment:
Extractible New
REF Detail Ch Wires IFU
basket products
Is the medical device intended to be routinely No single use. Dormia can be re-inserted several times, but
8
cleaned and disinfected by the user? only during the same procedure.
After identifying the characteristics related to safety it is possible to define the situations of use. The situations of use can
be defined for an individual product or product family. The situations of use describe the scenario and context in which
the device is applied.
The characteristics related to safety combined with the defined situations of use form the basis of deriving hazards and
hazardous situations. The situations can both reflect the intended use and reasonably foreseeable misuse. Many of the
hazards the user can experience originate from various sources/causes and can be introduced throughout the product life
cycle.
The hazard type refers to the hazard types defined in the the FMECA sheet (biological, chemical etc.)
Situations of use:
Product variant: Specific Hazards for Dormia Stainless Steel
Describe situation of Describe situation of use Describe situation of use # Describe situation of use # 4: Describe situation of use #
use # 1: # 2: 3: 5:
Preliminary Preparation and Injection of contrast Use of device: Removal and reassembling
medical Insertion of device: medium: - Dormia shall be easily handled of device:
precautions - Dormia shall be - Dormia injector/re- with one hand to open the basket - Dormia shall be
compatible with introducer shall be easily #1 withdrawn from the
endoscope #1 connected to syringe or to - Dormia basket shall open patient #1
- Dormia shall slide sheath #1 #2 correctly #2 #3 - for filiform tip: Dormia
easily to position the - Dormia shall allow contrast #4 shall keep the access path
basket over the stone #2 liquid injection - Dormia basket shall dilate to the ureter #2
- Dormia shall be visible #3 ureter or choledoc canal when - Dormia shall be dismantled
(ORX or marking) - Metallic part shall be re- opening #5 in case of stone not going
#3 #4 introduced in the sheath - - Dormia basket shall trap stones through the endoscope #3
- Dormia shall not release See Situation of use #5 - by closing - for DOR7: Dormia shall
PTFE particles in patient Situation #6 be cuttable with tools #3
body #5 #4 - Dormia shall withstand - Dormia shall be
several cycle of basket reassembled outside the
opening/closing #7 #8 #9 #10 patient #4
- Dormia shall not be used
together with a fragmenting
device #11
- Dormia shall be atraumatic #12
Hazardous situation # Hazardous situation # 1: Hazardous situation # 1: Hazardous situation # 1: Hazardous situation # 1:
1:
Off label use of product Dormia is not Dormia injector/re- Dormia handle cannot be Dormia withdrawal is
compatible with introducer cannot be manipulated with one hand (or impossible
endoscope connected to the sheath with difficulty) (or with difficulty)
Hazard type: Hazard type: Hazard type: Hazard type: Hazard type:
Use of product Physical Physical Physical Use of product
Hazardous stituation # Hazardous stituation # 2: Hazardous stituation # 2: Hazardous stituation # 2: Hazardous stituation # 2:
2:
Contrast medium side Dormia cannot pass the Syringe cannot be connected Basket cannot be opened (or with Dormia filiform tip
effect calculus to the Dormia injector/re- difficulty) cannot maintain the
introducer ureteral path
Hazard type: Hazard type: Hazard type: Hazard type: Hazard type:
Use of product Use of product Physical Physical Production
Hazardous stituation # Hazardous stituation # 3: Hazardous stituation # 3: Hazardous stituation # 3: Hazardous stituation # 3:
3:
The patient is allergic Dormia radio opacity Contrast medium cannot Opened basket comes only Dormia cannot be dismantled
to device materials (ORX) is out of be injected partially out of the sheath
specifications
Hazard type: Hazard type: Hazard type: Hazard type: Hazard type:
Use of product Chemical Physical Physical Physical
Hazardous situation # Hazardous situation # 4: Hazardous situation # 4: Hazardous situation # 4:
4:
Patient cannot endure Dormia marking is Opened basket comes out of the Dormia cannot be
stone extraction out of specifications sheath too much reassembled
procedure
Hazardous situation # 7:
Basket cannot be opened/closed
several times - Sheath and handle
are getting disassembled
Hazard type:
Physical
Hazardous situation # 8:
Basket cannot be opened/closed
several times - Metallic part
breaks
Hazard type:
Physical
Hazardous situation # 9:
Basket cannot be opened/closed
several times - Sheath damaged
or broken
Hazard type:
Production
Hazardous situation # 10:
Basket cannot be opened/closed
several times - Handle anomaly
Hazard type:
Production
Hazardous situation # 11:
Dormia is damaged by stone
fragmenting device
Hazard type:
Use of product
Hazardous situation # 12:
Dormia distal tip is traumatic
Hazard type:
Use of product
Defining situations of use, hazards and hazardous situations
After identifying the characteristics related to safety it is possible to define the situations of use. The situations of use can
be defined for an individual product or product family. The situations of use describes the scenario and context in which
the device is applied.
The characteristics related to safety combined with the defined situations of use form the basis of deriving hazards and
haza rdous situations. The situations can both reflect the intended use and reasonably foreseeable misuse. Many of the
hazards the user can experience originates from various sources/causes and can be introduced throughout the product life
cycle.
The hazard type refers to the hazard types defined in the the FMECA sheet (biological, chemical etc.)
Situations of use:
Product variant: Specific Hazards for Dormia Titane-Nickel
Describe situation of use Describe situation of use # 2: Describe situation of use # 3: Describe situation of use # 4:
# 1:
Preliminary medical Preparation and insertion of Use of device: Removal and reassembling of
precautions device: - Dormia shall be easily handled with device:
- Tuohy-Borst Adapter shall be one hand to open the basket #1 - Dormia shall be withdrawn from
easily connected to endoscope - Dormia basket shall open correctly #2 the patient #1
#1 #3 #4 - Dormia shall be dismantled in
- Dormia shall be compatible with - Dormia basket shall dilate ureter when case of stone not going through
Tuohy-Borst opening #5 the endoscope #2
Adapter and endoscope #2 #3 - Dormia basket shall trap stones by - Dormia shall be reassembled
- Tuohy-Borst Adapter shall be closing #6 outside the patient
waterproof #4 - Dormia shall withstand #3
- Dormia shall slide easily to several cycle of basket
position the basket over the stone opening/closing #7 #8 #9 #10
#5 - Dormia shall not be used together
- Dormia shall be visible (ORX) with a fragmenting device #11
#6 - Dormia shall be atraumatic #12
- Dormia shall not release PTFE
particles in patient body #7
Off label use of product Tuohy-Borst adapter cannot be Dormia handle cannot be manipulated Dormia withdrawal is impossible
connected to endoscope (or with with one hand (or with difficulty) (or with difficulty)
difficulty)
Hazard type: Hazard type: Hazard type: Hazard type:
Use of product Physical Physical Use of product
Hazardous stituation # 2: Hazardous stituation # 2: Hazardous stituation # 2: Hazardous stituation # 2:
The patient is Dormia cannot go through Basket cannot be opened (or with Dormia cannot be dismantled
allergic to device Tuohy-Borst adapter difficulty)
materials
Hazard type: Hazard type: Hazard type: Hazard type:
Use of product Physical Physical Physical
After identifying the characteristics related to safety it is possible to define the situations of use. The situations of use can be defined for an individual product or
product family. The situations of use describes the scenario and context in which t he device is applied.
The characteristics related to safety combined with the defined situations of use form the basis of deriving hazards and haza rdous situations. The situations can both
reflect the intended use and reasonably forseeable misuse. Many of the hazards the user can experience originates from various sources/causes and can be introduced
throughout the product life cycle.
The hazard type refers to the hazard types defined in the the FMECA sheet (biological, chemical etc.)
Situations of use:
Product variant: Generic Hazards for Stone Extractor Dormia
Describe situation of Describe situation of Describe situation of use # Describe situation of Describe situation of Describe situation of Describe situation of use #
use # 1: Primary use # 2: Labelling 3: Shelf life use # 4: use # 5: Product use # 6: Re- 7: Disposal
packaging Biocompatibility Sterilisation (EtO) sterilization
Opening of primary Incorrect handling of Shelf-life, storage (end user, Use of biocompatible Use of sterile product Re-packaging of Disposal
packaging and product Post-market sales reps) and distribution device and clean product product before - Hospital
removal of product product identification of product - Before use all materials sterilization - Discontinuation of product
from packaging not possible - Maintain sterile barrier shall be biocompatible - Re-work by Coloplast
Primary packaging - Maintain product (biological / chemical) - Re-use by customer
shall: performance - All materials shall be
- Be easy to open stable for product life in
- Facilitate the removal terms of biocompatibility
of the product (mechanical / biological)
- Maintain clean and
sterile product
- Maintain sterile
procedure, when
required
Hazardous situation # Hazardous situation # 1: Hazardous situation # 1: Hazardous situation # 1: Hazardous situation # 1: Hazardous situation # 1: Hazardous situation # 1:
1:
Difficult to open peel Correct labelling & Product performance not Product not Product cannot be Product re-sterilized too Product discarded as "normal"
pouch/tray product - but user mistake according to specification biocompatible with the sterilized many times waste and not as "hospital"
- dimension problem (i.e. : tissues / mucosa / body (by Coloplast) waste
4Ch instead of 2.5Ch) fluids
Hazard type: Hazard type: Hazard type: Hazard type: Hazard type: Hazard type: Hazard type:
Use of product Use of product Physical Biological Production Production Disposal
Hazardous situation # Hazardous situation # 2: Hazardous situation # 2: Hazardous situation # 2: Hazardous situation # 2: Hazardous situation # 2: Hazardous situation # 2:
2:
Impossible to open peel Inconsistent labelling / Use of unsterile product Product is a vector of Product not sterilized Reuse of a single use Unauthorized use
pouch/tray labelling does not match pathogenic agents according to product - Marketing discontinue
product - dimension specification (EtO) product due to unsafe
problem (i.e. : 4Ch instead performance
of 2.5Ch) or quantity of - Recall of product
products in the packaging
Hazard type: Hazard type: Hazard type: Hazard type: Hazard type: Hazard type: Hazard type:
Use of product Production Distribution Chemical Production Use of product Use of product
Hazardous situation # Hazardous situation # 3: Hazardous situation # 3: Hazardous situation # 3: Hazardous situation # 3: Hazardous situation # 3:
3:
Packaging not opened as Absence or wrong place of Sterility compromised during Degradation of product Products not subjected to Contamination of product
intended IFU / shelf life from exposure to body sterilization cycle during re- work (by
labels or printed environment Coloplast)
information
Hazard type: Hazard type: Hazard type: Hazard type: Hazard type: Hazard type:
Use of product Production Storage Chemical Production Production
Hazardous situation # Hazardous situation # 4: Hazardous situation # 4: Hazardous situation # 4: Hazardous situation # 4:
4:
Product / tray falls out Wrong labelling (old Loss of product performance Degradation of product Excessive bio-burden
version, text mistakes) (due to exposure to from exposure to before sterilization
temperature and humidity accessory product (oil,
outside recommended gels )
storage/distribution
conditions)
Hazard type: Hazard type: Hazard type: Hazard type: Hazard type:
Use of product Use of product Environmental Chemical Biological
Hazardous situation # Hazardous situation # 5: Hazardous situation # 5: Hazardous situation # 5:
5:
Product / tray difficult or Missing required symbols Loss of product performance Inadequate EtO degassing
impossible to access (single (due to exposure to UV light
after opening use, sterile,) outside recommended
storage/distribution
conditions)
Hazard type: Hazard type: Hazard type: Hazard type:
Use of product Production Environmental Chemical
Hazardous situation # Hazardous situation # 6: Hazardous situation # 6: Hazardous situation # 6:
6:
Lack of barrier Wrong or inconsistent Discolouration (due to Unclean product
properties for primary required symbols (single exposure to UV light outside
packaging use, sterile,...) recommended
storage/distribution
conditions)
Hazard type: Hazard type: Hazard type: Hazard type:
Physical Production Environmental Physical
Hazardous situation # 7:
Labelling not
understandable
Hazard type:
Use of product
Hazardous situation # 9:
Inconsistent shelf-life:
- labelling consistent but
differs from the real
product shelf-life
Hazard type:
Production
Hazardous situation #
10:
Inconsistent shelf-
life:
-labelling inconsistent
(shelf-life on pouch label
differs from shelf-life on
box)
Hazard type:
Production
Hazardous situation #
11:
No traceability (for recall
or complaint)
Hazard type:
Distribution
1. Scope
The purpose of this hazard guidance paper is to define what a hazard is, generically, and define the specific types of
hazards that are predefined in the corporate template for product risk assessment.
2. Hazards
What is a hazard? A hazard is a potential source of harm. Literature [The Royal Society, 2002] defines three types
of hazards
Natural hazards (volcanoes, virus, bacteria etc.)
Technological hazards (nuclear plants, trains, medical devices etc.)
Social hazards (war, arson, terror etc.)
When talking medical devices the most frequent are natural hazards (bacteria, chemicals, virus etc.) and
technological hazards (the application of the device and its features). A hazard has no relevance (the risk is low) if
you are not in a situation where the hazard can inflict harm on you.
A hazard can appear in many shapes and forms. Normally we regard a hazard as an object or a part of an object
that can harm us directly physically, e.g. a sharp edge on a catheter.
But hazards can also appear more abstract, e.g. a leaky urine bag that can induce a psychological reaction (harm)
on the patei nt. Furthermore software in a pulse sensor, applied on a critically ill patient, that fails and thereby
prevents an alarm form alarming a caregiver when the patients pulse drops. Inthis context the alarm can be defined
as the hazard because its absence can result in serious harm to the patient.
The situation where you are at risk (because the hazard can inflict harm on you) is a hazardous situation.
With respect to medical devices the hazardous situations are often in conjunction with the use of the device. The
use of thedevice is based on the intended use defined. It is important always to bare this in mind.
A more profound definition of these effects is given in DS/EN ISO 10993-1, Table 1. This list is non
exhaustive.
The causes to many of these hazards (if the risk the hazards pose is unacceptable) are identified in the process
risk assessment and often mitigated by process validation and clean room validation.
4. Conclusion
Hazards are the potential source of harm. They can appear concrete or mere abstract. The non-exhaustive list over
specific hazards is only intended as a basis for identifying hazards in association with product risk assessment (some of
which affect the process risk assessment). The objective with the list is not to place a hazard under a correct heading,
but to generate the identification of as many hazards associated with the device as possible.
SEVERI RATING Definition
TY Urology & Continence Care
GROUP
- Death
5
- Irreversible damage to Central Nervous System or Cardio Vascular System
- Untreatable infection/virus (short term life expectance)
2 - Inconvenience for the health care professional and for the patient/end-user
NON-
In the table the probability of harm is determined. This sheet contains two tables - one for low
volume surgical devices and one for the rest of the device portfolio. The probability table for low
volume devices is used for Long-Term Implantable Surgical Devices and Disposable Surgical
Urology devices with projected annual sales <30,000 units.
This includes the following Product Families for Disposable Surgical Urology devices: See
DOCAQ12003 List of Low volume DHFs according to SBA06023
This matrix shows the criteria for risk acceptability. When the individual risks have been estimated the
evaluation is done by plotting the risk into this matrix. Every risk that falls into the red area is unacceptable
and must be controlled. This is done by reducing the "PxD" value in order to "push" the unacceptable risk into
the green area.
Severity
Probability x
1 2 3 4 5
Detectability
21 - 25
16 - 20 (Red)
11 - 15
6 - 10 (Green)
1-5