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Risk assessment meets biotechnology (ISO 14971)

• Risk Assessment
– Overall process comprising a risk analysis and a risk evaluation
• Risk Analysis
– Systematic use of available information to identify hazards and to estimate the
risk
• Risk Evaluation
– Process of comparing the estimated risk against given risk criteria to determine
the acceptability of the risk
 

-> tool for risk minimization: using natural non-pathogenic MO!?

S1 Biological material, which is non-pathogenic, and consequently unlikely to cause human diseases.
eg. E.coli K-12

S2 Biological material, which can cause human diseases, and
consequently is dangerous for the employees.
Risk of spreading: unlikely
Prophylaxis and therapy: possible
eg. Influenza A Virus

S3 Biological material, which can cause severe human diseases,
and consequently is seriously dangerous for employees.
Risk of spreading : latent
Prophylaxis and therapy : possible
eg. Mycobacterium tuberculosis

S4 Biological material, which can cause severe human diseases, and consequently is seriously dangerous for employees.
Risk of spreading : high
Prophylaxis and therapy : NOT possible
eg. Ebola Virus

 

Medical devices are in vitro diagnostic medical devices (IVDs) if they are reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment, or system, whether used alone or in conjunction with other diagnostic methods.

A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These essential requirements are publicized in European directives or regulations.

A manufacturer can use voluntarily European harmonised standards to demonstrate that a product complies with some (or all) of the EU essential requirements; a notified body can use the same harmonised standards to assess the conformity to these essential requirements. Conformity assessment can include inspection and examination of a product, its design, and the manufacturing environment and processes associated with it. For example, a notified body may designate that a medical device conforms to the Medical Devices Regulation (MDR (EU) 2017/745) which defines the applicable legislation, including the general safety and performance requirements, for medical devices. With this declaration of conformity, the manufacturer can label the product with the CE Mark, which is required for distribution and sale in the EU. Additionally, the EU member state accrediting the notified body will then inform the European Commission that the product complies with set standards (or not).

risks are divided depending on their likelihood & their effects or the extent of damage

-> worst-case scenario can be determined at a glance
-> result of the risk analysis and risk evaluation
     ->important component of project & risk management

A risk matrix is a matrix that is used during risk assessment to define the level of risk by considering the category of probability or likelihood against the category of consequence severity. This is a simple mechanism to increase the visibility of risks and assist management decision making.

Evaluating the risk:
Likelhood
1. Highly unlikely
2. Possibly
3. Quite likely
4. Very likely

Severity
1. Slight harm
2. Injury affecting work
3. Serious injury
4. Possible fatality

╭ᑎ╮ DIC ╭ᑎ╮
• Decide measures to be taken
• Implement them according to priority
• Confirm measures appropriate and work