T-013-003 Risk management report
Intended use and identification of the qualitative and quantitative characteristics
The following questions, extracted from Annex A.2 of UNE-CEN ISO/TR 24971:2020, help us identifying all the characteristics of the medical device manufactured that could affect its safety and performance. The list is neither exhaustive nor representative and must be appropriate to the medical device in question, and we will skip the questions that are not relevant to it.
| # | Characteristics of the medical device that could affect safety | Applicable? (Y/N) | Justification | Risk identified |
|---|---|---|---|---|
| 1 | What is the intended use and how is the medical device to be used? | |||
| 2 | Is the medical device intended to be implanted? | |||
| 3 | Is the medical device intended to be in contact with the patient or other persons? | |||
| 4 | What materials or components are utilized in the medical device or are used with, or are in contact with, the medical device? | |||
| 5 | Is energy delivered to or extracted from the patient? | |||
| 6 | Are substances delivered to or extracted from the patient? | |||
| 7 | Are biological materials processed by the medical device for subsequent reuse, transfusion or transplantation? | |||
| 8 | Is the medical device supplied sterile or intended to be sterilized by the user, or are other microbiological controls applicable? | |||
| 9 | Is the medical device intended to be routinely cleaned and disinfected by the user? | |||
| 10 | Does the medical device modify the patient environment? | |||
| 11 | Are measurements taken? | |||
| 12 | Is the medical device interpretative? | |||
| 13 | Is the medical device intended for use in conjunction with other medical devices, medicines or other medical technologies? | |||
| 14 | Are there unwanted outputs of energy or substances? | |||
| 15 | Is the medical device susceptible to environmental influences? | |||
| 16 | Does the medical device influence the environment? | |||
| 17 | Does the medical device require consumables or accessories? | |||
| 18 | Is maintenance or calibration necessary? | |||
| 19 | Does the medical device contain software? | |||
| 20 | Does the medical device allow access to information? | |||
| 21 | Does the medical device store data critical to patient care? | |||
| 22 | Does the medical device have a restricted shelf life? | |||
| 23 | Are there any delayed or long-term use effects? | |||
| 24 | To what mechanical forces will the medical device be subjected? | |||
| 25 | What determines the lifetime of the medical device? | |||
| 26 | Is the medical device intended for single use? | |||
| 27 | Is safe decommissioning or disposal of the medical device necessary? | |||
| 28 | Does the installation or use of the medical device require special training or special skills? | |||
| 29 | How will information for safety be provided? | |||
| 30 | Are new manufacturing processes established or introduced? | |||
| 31 | Is successful application of the medical device dependent on the usability of the user interface? | |||
| 31.1 | Can the user interface design features contribute to use error? | |||
| 31.2 | Is the medical device used in an environment where distractions can cause use error? | |||
| 31.3 | Does the medical device have connecting parts or accessories? | |||
| 31.4 | Does the medical device have a control interface? | |||
| 31.5 | Does the medical device display information? | |||
| 31.6 | Is the medical device controlled by a menu? | |||
| 31.7 | Is the successful use of the medical device dependent on a user’s knowledge, skills and abilities? | |||
| 31.8 | Will the medical device be used by persons with special needs? | |||
| 31.9 | Can the user interface be used to initiate unauthorised actions? | |||
| 32 | Does the medical device include an alarm system? | |||
| 33 | In what ways could the medical device be misused (deliberately or not)? | |||
| 34 | Is the medical device intended to be mobile or portable? | |||
| 35 | Does the use of the medical device depend on essential performance? | |||
| 36 | Does the medical device have a degree of autonomy? | |||
| 37 | Does the medical device produce an output that is used as an input in determining clinical action? |
List of generic hazards applicable to this product family
| Associated with energy sources | Applicable (Y/N) | Justification |
|---|---|---|
| Electricity | ||
| Heat, surface temperature | ||
| Mechanical strength | ||
| Ionizing radiation | ||
| Electromagnetic fields | ||
| Moving parts (motorized) | ||
| Suspended masses | ||
| Failure of patient support system | ||
| Pressure | ||
| Sound pressure (noise) | ||
| Vibrations | ||
| Magnetic fields |
| Biological | Applicable (Y/N) | Justification |
|---|---|---|
| Biological overload | ||
| Incorrect release of substances or energy | ||
| Incorrect formulation (chemical composition) | ||
| Biocompatibility and toxicity | ||
| Infection and biological contamination | ||
| Difficulty in maintaining hygienic safety | ||
| Degradation |
| Associated with the environment | Applicable (Y/N) | Justification |
|---|---|---|
| Electromagnetic interference | ||
| Inadequate supply of energy or cold | ||
| Restriction of ventilation, perspiration | ||
| Probability of operation in adverse environmental conditions | ||
| Incompatibility with other devices | ||
| Accidental mechanical damage to the product | ||
| Pollution (waste and removal) | ||
| Corrosion | ||
| Flammability |
| Relative to the use of the product | Applicable (Y/N) | Justification |
|---|---|---|
| Inadequate label | ||
| Inadequate instructions for use | ||
| Inadequate specification of accessories | ||
| Inadequate specification of pre-use checks | ||
| Complicated instructions for use | ||
| Instructions for use not available or separate from the product | ||
| Use by untrained personnel | ||
| Reasonably foreseeable misuse | ||
| Inadequate warning of adverse effects | ||
| Inadequate warning of possible hazards in case of reuse of single-use products | ||
| Incorrect measurement and other metrological aspects | ||
| Incorrect diagnosis | ||
| Wrong data transfer | ||
| Misinterpretation of results | ||
| Incompatibility with consumables, accessories or other devices | ||
| Forces, inadequate contact pressures | ||
| Imprisonment of parts of the human body | ||
| Non-functional edges, surfaces or cutting edges | ||
| Discomfort of use and handling (ergonomics) |
| Associated with functional failure, maintenance and aging of the product | Applicable (Y/N) | Justification |
|---|---|---|
| Inadequate to the planned functions | ||
| Inadequate or absent maintenance specifications, including performance checks | ||
| Inadequate maintenance | ||
| Absence of limitation of product lifetime | ||
| Loss of mechanical integrity | ||
| Inappropriate packaging (loss of sterility, contamination or deterioration of the product) | ||
| Incorrect reuse | ||
| Cutting edges due to breakage |
Benefit/Risk ratio acceptability
The benefit/risk analysis is based on global and individual risks considerations:
-
Global: it is assessed in consideration of the product features and its
T-015-003 Clinical evaluation report (CER). Global benefit/risk ratio is acceptable, according to the CER conclusions: TO INCLUDE -
Individual: when a risk is evaluated as “ALARP” it requires minimization measures of the residual risks. The following risks have been evaluated as "ALARP":TO INCLUDE
If measures to minimize residual risks considered "“ALARP”" have not been implanted, it will be required a specific analysis on the T-013-002 Risk Management Record, being the benefit/risk ratio unacceptable during this evaluation until it is acceptable.
Control state of the risks
The current state of risks control verifies that ALL FORESEEABLE RISKS ARE CONTROLLED according to T-013-002 Risk Management Record Include version/date.
All risks are in an acceptable risk zone, but the individual risks mentioned below, are defined as AFAP risk level.
| Hazard # | Hazard and hazardous situation | Additional control measures |
|---|---|---|
| # | ||
| # | ||
| # | ||
| # | ||
| # | ||
| # |
These risks require an individual benefit/risk analysis which is conducted as specified at the T-013-001 Risk management plan, and it is confirmed by the global benefit/risk ratio analysis performed and documented at the T-015-003 Clinical evaluation report (CER). All of them are currently controlled, but PMS and PMCF data will confirm a minimization.
Record signature meaning
- Author: JD-004 Author name
- Review: JD-003 Reviewer name
- Approval: JD-005 Approver name
Template signature meaning
Delete this section when you create a new record from this template.
- Author: JD-004 María Diez
- Review: JD-005 Mr. Alfonso Medela
- Approval: JD-001 Andy Aguilar