Biocompatibility Assessments

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

Biocompatibility

Ability of a medical device or material to perform with an appropriate host response in a specific application

Biological Risk

Combination of the probability of harm to health occurring as a result of adverse reactions associated with medical device or material interactions, and the severity of that harm

Biological Safety

Freedom from unacceptable biological risk in the context of the intended use

Chemical Constituent

Any synthetic or natural substance that is used in a process for manufacturing materials and/or medical devices, including the base material(s), additives (antioxidants, UV stabilizers, color additives, dyes, etc.), and processing aids (solvents, lubricants, antifoaming agents, etc.)

Data Set

Information, such as physical and/or chemical characterization, toxicity data, etc. from a variety of sources necessary to characterize the biological response to a medical device

Direct Contact

Medical device or medical device component that comes into physical contact with body tissue

Externally Communicating Medical Device

Medical device or medical device component that is partially or wholly located outside the body but has either direct or indirect contact with the internal body fluids and/or tissue

Final Product

Medical device or medical device component that has been subjected to all manufacturing processes for the "to be marketed" medical device including packaging and if applicable, sterilization

Geometry (Design Configuration)

Shape and relative arrangement of the parts of the medical device

Implant

Medical device which is intended to be totally introduced into the human body or to replace an epithelial surface or the surface of the eye by means of clinical intervention and which is intended to remain in place after the procedure

Indirect Contact

Medical device or medical device component through which a fluid or gas passes, prior to the fluid or gas coming into physical contact with body tissue

Material

Synthetic or natural polymer, metal or alloy, ceramic, including tissue rendered non-viable, used as a medical device or any part thereof

Material Characterization

Broad and general process or collecting existing information about a material's chemistry, structure and other properties, and if appropriate, new data, to facilitate the evaluation of these properties

Medical Device

Any instrument apparatus, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medial purpose

Nanomaterial

Material with any external dimension in the nanoscale or having internal structure or surface structure in the nanoscale

Non-Contacting

Indicates that the medical device or medical device component has neither direct nor indirect contact with the body tissues

Physical and Chemical Information

Knowledge regarding formulation, manufacturing processes, geometric and physical properties and type of body contact and clinical use that is used to determine whether any additional biological or material characterization testing is needed

Risk Analysis

Systematic use of available information to identify hazards and to estimate the risk

Risk Assessment

Overall process comprising a risk analysis and a risk evaluation

Risk Evaluation

Process of comparing the estimated risk against 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

Toxic

Capable of causing an adverse biological response

Toxicological Hazard

Potential for a chemical substance or material to cause an adverse biological reaction, taking into amount the nature of the reaction and the dose required to elicit it

Toxicological Risk

Probability of a specified degree of an adverse reaction occurring in response to a specified level of exposure

Toxicological Threshold

Limit, such as a tolerable intake (TI), tolerable exposure (TE), allowable limit (AL) value, or Threshold of Toxicological Concern (TTC) below which adverse affects are not expected for relevant biological endpoints

Transitory Contact

Medical device or medical device component that has a very brief duration of contact with body tissue

Accompanying Documentation

Materials accompanying a medical device and containing information for the user or those accountable for the installation, use, maintenance, decommissioning and disposal of the medical device, particularly regarding safe use.

Benefit

Positive impact or desirable outcome of the use of a medical device on the health of an individual or a positive impact on patient management or public health.

Harm

Injury or damage to the health of people, or damage to property or the environment.

Hazard

Potential source of harm

Hazardous Situation

Circumstance in which people, property, or the environment is/are exposed to one or more hazard(s).

Intend Use / Intended Purpose

Use for which a product, process or service is intended according to the specifications, instructions, and information provided by the manufacturer.

In Vitro Diagnostic Medical Device / IVD Medical Device

Device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes and including reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles.

Life Cycle

Series of all phases in the life of a medical device, from the initial conception to final decommissioning and disposal.

Manufacturer

Natural or legal person with 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(s).

Medical Device

Instrument, apparatus, implement, machine, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose and which does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

Objective Evidence

Data supporting the existence or verity of something

Post-Production

Part of the life cycle of the medical device after the design has been completed and the medical device has been manufactured.

Procedure

Specified way to carry out an activity or a process.

Process

Set of interrelated or interacting activities that use inputs to deliver an intended result.

Reasonably Foreseeable Misuse

Use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behavior.

Record

Document stating results achieved or providing evidence of activities performed

Residual Risk

Risk remaining after risk control measures have been implemented.

Risk

Combination of the probability of occurrence of harm and the severity of that harm.

Risk Analysis

Systematic use of available information to identify hazards and to estimate the risk.

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 comprising the estimated risk against given risk criteria to determine the acceptability of the risk.

Risk Management

Systematic application of management policies, procedures and practice to the tasks of analysis, evaluating, controlling and monitoring risk.

Risk Management File

Set of records and other documents that are produced by risk management.

Safety

Freedom from unacceptable risk.

Severity

Measure of the possible consequences of a hazard.

State of the Art

Developed stage of technical capability at a given time as regards products, processes and services, based on the relevant consolidated findings of science, technology and experience.

Top Management

Person or group of people who directs and controls a manufacturer at the highest level.

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.

Verification

Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.

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