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Risk control can involve changes to production processes to reduce or eliminate hazardous waste products that may damage the environment.
False
From a hazard identification standpoint, information on the compounds released from the medical device can be used to focus the biological testing strategy to address the most clinically relevant endpoints.
True
Risk evaluation builds upon the risk analysis, taking the next step of evaluating the risks defined in the risk analysis for their significance and identifying requirements and opportunities for mitigation (risk control).
True
The biological safety of a medical device shall be evaluated by the manufacturer over the whole life-cycle of a medical device.
True
Tests that employ cell culture techniques can be used to determine cell death, the inhibition of cell growth, colony formation, and other effects on cells caused by medical devices, materials, and/or their extract.
True
All known possible biological hazards shall be taken into account for every material and final product, but this does not imply that testing for all possible hazards will be necessary or practical.
True
For medical devices that have known leachable chemical mixtures, potential interactions between the leachables should be considered.
True
When developing test procedures, the ratio of device surface area to recipient body size and mass should be taken into account.
True
It is necessary to identify additional reasonably and practicably obtained data or testing needed to complete the data sets required to perform the risk assessment.
True
If extracts of the medical device are prepared, the solvents and conditions of extraction used should be appropriate to the nature and use of the final product.
True
The biological risk assessment of materials or final products shall be re-evaluated if the cost of the materials sharply increases.
False
In general, in order to be able to support biological safety, materials testing should be carried out on material test samples that have been processed in equivalent ways to the materials included in the final medical device in question. Otherwise, a justification is required as to why the differences are not significant to the determination of biological safety.
True
Degradation information shall be provided for any medical devices, medical device components, or materials remaining within the tissue, that have the potential for degradation within the human body.
True
Following risk analysis and evaluation and the implementation of risk controls, it is necessary to review the findings of these preceding activities and to document the residual risk and to decide on any further disclosure of such residual risk, for example through appropriate labeling, cautions, or warning.
True
In vitro test methods, which are appropriately validated, reasonably and practically available, reliable and reproducible, shall be considered for use in preference to in vivo tests.
True
The biological evaluation plan should include a review of marketing plans for the medical device to ensure they are accurate and reflect the actual benefits and risks of the medical device.
False
Consideration of biological risk is only one aspect of the risk assessment of a medical device, which should consider all aspects of risk.
True
Gathering physical and chemical information on the medical device or component is a crucial second step in the biological evaluation.
False
The results of the characterization and in vivo testing should be reviewed before proceeding to in vitro testing.
False
Risk analysis is the process of identifying an effective approach for selling medical devices and securing enough funds for the company to stay in business.
False
User Error
User action or lack of user action while using the medical device that leads to a different result than that intended by the manufacturer or expected by the user.
The manufacturer shall identify and document known and foreseeable hazards associated with the medical device based on the intended use, reasonably foreseeable misuse and the characteristics related to safety in both normal and fault conditions.
True
Most understandings of biocompatibility relate experiences with harmful outcomes. Biocompatibility is often described in contrast to bioincompatibility.
True
Although risk management activities are highly individual to the medical device being considered, there are basic elements that need to be included in the risk management process.
True
The following is the definition of manufacturer: natural or legal person with the responsibility for the design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name, whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person.
True
Toxic effects that are mild or slowly produced may be missed in the direct contact test. Toxic effects that are caused by corrosion byproducts with a short half life may be missed in the extract test.
True
Risk analysis, risk elaboration, and risk control are commonly recognized as essential parts of risk management. The risk management process continues on into the post-production phase.
False
A risk management plan is required because the plan encourages objectivity and helps prevent essential elements from being forgotten.
True
When conducting the risk analysis, physical and chemical material properties that are relevant to biological safety must be identified.
True
The decision to use a medical device take into account the intended use, the circumstances of use, the performance and risks associated with the medical device, as well as the risks and benefits associated with the clinical procedure.
True
The materials must be well characterized to reduce risks of biological harm. The amount of new information needed relates to how much is known about the device and the conditions of human exposure (internal, external, etc). The purpose is to determine what is known and unknown about the device in terms of biological safety.
True
Culturing cells in vitro allows for testing toxic effects of materials on human cells. This is an important early screening process that usually occurs prior to in vivo testing. However, this test can sometimes over estimate the toxicity of materials due to differences in testing conditions from the in vivo environment.
True
Chemical and material characterization is not essential, although its inclusion can support the biocompatibility evaluation of medical devices
True
The biological evaluation process involves the identification of biological hazards, estimation of biological risks, and determination of the acceptability of the risks, which depends upon the expected benefits
Ture
Acceptable risks must be controlled (to reduce risks as close to zero as possible) and the effectiveness of these measures must be verified and recorded.
False
The use of a medical device involves an inherent degree of risk, even after the risks have been reduced to an acceptable level.
True
Risk has two key components: the probability of realizing a return on investment and the opportunity cost.
False
The group of persons performing risk management tasks shall include non-science or medical members of the local community, to ensure diverse perspectives are taken into account when generating the risk management plan.
False
The ISO 14971 document specifies a process through which the manufacturer of a medical device can identify hazards associated with the medical device, estimate and evaluate the risks associated with these hazards, control these risks, and monitor the effectiveness of the controls throughout the life cycle of the medical device.
True
The decision to use a medical device in the context of a particular clinical procedure requires the residual risks to be balanced against the anticipated benefits of the procedure.
True
The manufacturer makes judgements relating to the acceptability of a medical device and its risk from a profit analysis.
False
The implantation of biomaterials and medical devices provokes an unavoidable localized inflammatory response. An acute resolving inflammatory response is desired, and generally minimizing the acute response is an important biocompatibility property for a material or device.
True
The intended use of the medical device is an important aspect and is the starting point of the risk analysis.
True
Obtaining sufficient data and information for risk estimation can be difficult, resulting in uncertainty of the residual risk evaluation. It can therefore be practical for the manufacturer to focus effort on verification of effectiveness of risk control measures to establish a convincing residual risk evaluation.
True
