With medical scope-related infection outbreaks making national headlines, the safety of such devices has been called into question. AAMI’s paper aims to provide a “shared understanding” of risk principles and improve interactions between manufacturers and regulators regarding postmarket activities.
“If industry and [the Center for Devices and Radiological Health] have a shared view based on a common risk management process, then less time should be lost resolving differences in understanding between CDRH and industry,” reads the paper.
According to the AAMI, there are six risk principles that should be considered for medical devices in a postmarket setting. They are:
- Informed judgment in risk and benefit evaluations
- Loss-of-benefit assessment
- Populations
- Use environment and clinical assessment
- Communication
- Risk control and recovering loss of benefit
Each principle and its potential application are described further in the full whitepaper, which can be accessed here.
More articles on medical devices:
Device may cut UTI detection time from 24 hours to 70 minutes
High-risk medical devices may not be backed by enough clinical research
FDA releases new guidance for cleaning ‘unsafe’ scopes
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