Principles of Medical Technology Practice 1

Chapter 7 – Biorisk Management  It refers to anything in the environment that

has the potential to cause harm.
Proper Management is necessary to carry out the
Risk
total safety of laboratory workers and patients.
 It is the possibility that something bad or
Biorisk is the risk associated to biological toxins or
unpleasant will happen.
infectious agents.
In performing risk assessment, a structured and
Biorisk Management is the integration of biosafety
repeatable process is followed. It consists of the
and biosecurity to manage risks when working with
following steps:
biological toxins and infectious agents.
1. Define the situation.
According to the CEN Workshop Agreement
2. Define the risks.
(CWA) 15793:2011, Biorisk Management is a
3. Characterize the risks.
“system or process to control safety and security
4. Determine if risks are acceptable or not.
risks associated with the handling or storage and
disposal of biological agents and toxins in Mitigation
laboratories and facilities.”
 These are actions and control measures that
It is divided into three primary components: are put into place to reduce or eliminate the
risks associated with biological agents and
 Assessment
toxins.
 Mitigation
 Performance Elimination
AMP model requires that control measures be  It is the most difficult and most effective
based on a robust risk assessment, and a continuous control measure.
evaluation of effectiveness and suitability of the  It involves the total decision not to work
control measures. It illustrates the balanced role with a specific biological agent or even not
among the components of BRM. doing the intended work.
 It provides the highest degree of risk
A robust risk assessment is the heart of BRM.
reduction.
Identified risks can be either mitigated, avoided,
Substitution
limited and transferred to an outside entity or
accepted.  It is the second control measure.
 It is the replacement of the procedures or
Risk Assessment
biological agent with a similar entity in
 This is the initial step in implementing a order to reduce the risks.
biorisk management process.
Setting of Engineering Controls
 It includes the identification of hazards and
characterization of risks that are possibly  It includes physical changes in work
present in the laboratory. stations, equipment, production facilities, or
any other relevant aspect of the work
environment that can reduce or prevent
exposure to hazards.
Hazard Examples:
1. Installation of biosafety cabinets
 Principles of Medical Technology Practice 1
2. Safety equipment
3. Facility design
4. Enabling proper airflow
5. Ventilation system to ensure directional flow
6. Air treatment systems to decontaminate or
remove agents from exhaust air
7. Controlled access zones
8. Airlocks as laboratory entrances
9. Separate buildings or modules to isolate the
laboratory
Setting of administrative controls
 It refers to the policies, standards, and
guidelines to control risks.
 Proficiency and Competency Training for
laboratory staff is considered an
administrative control.
Examples:
1. Displaying of biohazard or warning signage
2. Controlling visitor and worker access
3. Documenting written standard operating
procedures
Use of Personal Protective Equipment
 These are the devices worn by workers to
protect them against chemicals, toxins, and
pathogenic hazards in the laboratory.
 It is considered as the least effective
measure because it only protects the person
who is wearing it, and only when it is used
correctly.
Performance Evaluation
 The last pillar of the biorisk management.
 It involves a systematic process intended to
achieve organizational objectives and goals.
 The model ensures that the implemented
mitigation measures are indeed reducing or
eliminating risks.
Performance Management
 A reevaluation of the overall mitigation
strategy.