BUMEDINST 6710.63 Flashcards Preview

ADVANCEMENT BIB > BUMEDINST 6710.63 > Flashcards

Flashcards in BUMEDINST 6710.63 Deck (10):
1

What must all Naval Medical Department personnel report to their supervisor?

Personnel are responsible for reporting potential hazards of defective med/den materials.

2

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.

3

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)

4

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

5

What are some types of deficiencies?

Systemic equipment failures, Incorrect labeling, faulty calibrations, poor quality products

6

Category I complaints

Most serious item of materiel or an event that could cause or resulted in serious injury, illness, or death.

7

Category II complaints

All other complaints that don't meet the severity level of Category I will be at Category II

8

How should reports be initiated?

Online using the electronic link est. through DSCP;s DMMonline protal: https://dmmonline.dscp.dla.mil

9

What electronic form is used to submit to DSCP?

Product Quality Deficiency Report (PQDR)

10

What command monitors all complaints involving standard and nonstandard med/den materials?

NAVMEDLOGCOM

Decks in ADVANCEMENT BIB Class (64):