Medical Device Risk Assessment - Environmental Contamination

M

MarkinCalifornia

#1
The company I work for was recently asked by our notified body to assess the acceptability of all the residual risks that we categorized as ALARP (as low as reasonably possible) in our risk management document. One of the potential hazards in our document assigned a residual risk of ALARP is environmental contamination (our device is an active implantable with external hardware components that are RoHS compliant). My question is: What does environmental contamination mean in terms of harm?
 
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M

MIREGMGR

#2
Re: Risk Assessment (Medical Device)-Environmental Contamination

An example: The implantable device, after cleaning and before packaging, moves through an environment that is contaminated with a transferable non-biocompatible material. Some contamination transfers to a device, which subsequently is implanted. An adverse reaction or other negative health issue ensues, and the device has to be explanted.
 
M

MarkinCalifornia

#3
Re: Risk Assessment (Medical Device)-Environmental Contamination

Thanks for the reply. I realize my question needs clarification. I am trying to assess the harmful impact of the device through improper disposal, not the impact of the environment on the device. For example, a battery that is not disposed of properly could emit toxic fumes that could result in severe injury (and possibly death). This example has well understood implications. And in this particular case, the residual risk was not deemed acceptable requiring us to perform a risk benefit analysis. What I am trying to assess is the other presumably lesser harms associated with the improper disposal of the device in the enviroment.
 
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