• Determination if changes must be made to the original medical device risk assessment;
• A systematic process to evaluate product (not just customer complaints);
• Inclusion of objective evidence in the risk management file;
• Evaluation of any new hazards;
• Determining whether there have been changes in the acceptability of risks as originally defined; and
• Inclusion of feedback and revisions of risk assessment/management as required.5
Medical Safety ensures post market products perform as intended by monitoring and trending on potential risks identified in the product’s risk management process. It captures and investigates data from customer feedback and non-conforming products. Data from customer feedback include: complaints from patients, health care providers, focus groups, published literature, internet blogs, and post market clinical studies. Medical Safety is responsible for comprehensive case management of post market complaints. This entails intake of complaints, recording complaint data, complaint follow-up, providing medical assessments, preparing a regulatory report (if warranted), and closing the complaint file.
In the intake and processing of complaints, Medical Safety reaches out to the source of the complaint and gathers further information on the case. The information gathered provides insight to what product was involved, where the even...
... middle of paper ...
... frequency and warrant further investigation.
Medical Safety assesses the safety impact of non-conforming products. Non-conforming products are products which do not meet manufacturing specifications. This usually results from unforeseen events that occur during the manufacture, storage, transportation, or distribution stages of a product. When a non-conforming product is identified, a team of SMEs is gathered to investigate. This team typically includes representatives from Quality Assurance, Manufacturing, Medical Safety, Regulatory Affairs, etc. This team is tasked to identify the root cause of the issues and eliminate or reduce the hazard and hazardous situation. Medical Safety is responsible for identifying potential safety issues that may warrant manufacturing/product investigation or market action (i.e. placing a product on hold or recalling a product).
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