Flashcards in BUMEDINST 6710.63 Deck (10)
What must all Naval Medical Department personnel report to their supervisor?
Personnel are responsible for reporting potential hazards of defective med/den materials.
CFR, Title 21, Food and Drugs, Part 803
Requires the FDA and manufacturer to be notified of all deaths, serious injuries, and illnesses caused by medical devices.
Who is designated as the responsible agent to handle reporting of unsafe and defective medical equipment to the FDA?
Defense Supp;y Center, Philadelphia (DSCP)
For thorough investigations of product defect vill require involvement of what several medical facility resources?
Risk Management, Quality Assurance, Safety Coordinator, Biomedical engineering, COs, OICs, Dept Heads
What are some types of deficiencies?
Systemic equipment failures, Incorrect labeling, faulty calibrations, poor quality products
Category I complaints
Most serious item of materiel or an event that could cause or resulted in serious injury, illness, or death.
Category II complaints
All other complaints that don't meet the severity level of Category I will be at Category II
How should reports be initiated?
Online using the electronic link est. through DSCP;s DMMonline protal: https://dmmonline.dscp.dla.mil
What electronic form is used to submit to DSCP?
Product Quality Deficiency Report (PQDR)