BUMEDINST 6710.63 Flashcards

Reporting and processing of defective or unsat medical and dental material.

1
Q

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

A

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

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2
Q

CFR, Title 21, Food and Drugs, Part 803

A

Requires the FDA and manufacturer to be notified of all deaths, serious injuries, and illnesses caused by medical devices.

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3
Q

Who is designated as the responsible agent to handle reporting of unsafe and defective medical equipment to the FDA?

A

Defense Supp;y Center, Philadelphia (DSCP)

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4
Q

For thorough investigations of product defect vill require involvement of what several medical facility resources?

A

Risk Management, Quality Assurance, Safety Coordinator, Biomedical engineering, COs, OICs, Dept Heads

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5
Q

What are some types of deficiencies?

A

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

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6
Q

Category I complaints

A

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

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7
Q

Category II complaints

A

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

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8
Q

How should reports be initiated?

A

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

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9
Q

What electronic form is used to submit to DSCP?

A

Product Quality Deficiency Report (PQDR)

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10
Q

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

A

NAVMEDLOGCOM

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