The first part of risk management, as mentioned, is to assess all the potential threats of a device by formulating a list of risks associated with its use. Each risk is then individually analyzed so that all potential hazards can be addressed and managed. According to lecture, there are four methods for managing risk: avoidance, mitigation, acceptance, transferance. Low-risk devices should be handled under acceptance and transferance procedures while high-risk devices should prioritize avoidance and mitigation to prevent such hazards from occurring. Avoidance of a high-risk device can be related to an antibiotic-releasing hip stem that presents the risk of infection if the body’s own bacteria develops a resistance against the antibiotic. In this case, avoidance would require the hip stem to be coated in an alternate antibiotic unfamiliar to the body, or to remove the antibiotic component altogether and instead change the material of the hip stem to one that is more biocompatible. If this is not feasible, then applying mitigation should also suffice, such as increasing the dosage/quantity of antibiotic coating to overcome the bacterial resistance.

A consecutive factor of risk management is the use of a risk matrix, which measures any specific risk of a device by the level of its severity and its frequency of occurrence. What would be the risk management route if a design matrix for a hip stem stated that the device had a high level of severity but a low chance of occurring (i.e. transferance or mitigation)? Are there any other risk-measuring techniques that can sketch out which risks in a device are acceptable or falls under acceptance?