Short Answer
What notable adverse event was associated with Rely tampons?
Toxic shock syndrome
Why does FDA require identification and traceability during manufacturing?
To prevent mix-ups.
How does a document differ from a record?
A document is prescriptive (it tells us what to do), whereas a record is merely descriptive (it tells us what was done).
What does quality mean?
The totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance
What needs to be recorded when changing a controlled document?
-description of change
-identification of affected documents
-signature of approving individuals
-approval date
-effective date
What does DMR stand for and what does it represent?
DMR (device master record) It's the recipe
- all device specifications
- all production specifications
- All QA specifications (for testing)
- Packaging and labeling specifications (Installation, maintenance, and servicing specifications)
What information must be included in product identification?
Unique company name
Unique product name
Lot number
What kind of documents need to be controlled?
Any documents that affect the quality of a finished medical device.
What aspects of medical device manufacturing do Good Manufacturing Practices govern?
Methods
facilities
controls for design
manufacture
packaging
labeling
storage
installation
servicing
List some process and production controls
-SOPs to describe processes that can affect specifications
-Monitoring and control of processes and device characteristics during
-Production
-Compliance with standards and/or codes
-Approval of processes and process equipment
-Personnel: training, health, clothing, etc.
What does DHF stand for and what does it represent?
DHF (Design history file)
All design changes and rationale (how we made the recipe)
At what points in manufacturing is acceptance testing required?
Receiving
In-process
Final
What is controlled in a controlled document?
Approval
changes
distribution
To what type of products do Good Manufacturing Practices apply?
All finished (medical) devices intended for human use
What does FDA require manufacturers to do with complaints?
Receive, review, and evaluate all complaints.
Investigate complaints that may relate to a failure to meet specifications.
When necessary, report complaints to FDA.
What does DHR stand for and what does it represent?
DHR (device history record)
This is the record of a lot manufacturing (proof that we followed the recipe)
What does FDA require that manufacturers control regarding non-conforming product?
Identification
Documentation
Segregation
Disposal
What do purchasing controls address, and what do they require?
They address procedures to ensure that products and services received in the context of manufacturing medical devices conform to specified requirements.
They require that we:
1. Establish requirements to evaluate suppliers
2. Keep records of purchasing data
What is a CAPA?
Corrective and Preventive Action. It is an investigation into the circumstances surrounding some failure to:
1.Reduce or eliminate the consequences of the failure and
2.Prevent recurrence of the failure
What does QSR stand for and what does it represent?
QSR (Quality system record)
Everything not specific to a device, but relevant to the quality of devices
In what cases would a foreign medical device manufacturer (e.g. based in Switzerland) have to be compliant with FDA Quality Systems Regulations?
When they make a product intended for marketing within the U.S.
Why would you use an uncontrolled copy of a controlled document?
If the document could be used to manufacture a finished medical device but is being used for some other purpose at present.
What kinds of problems are we trying to avoid by means of handling controls?
Mix-ups
Damage
Deterioration/degradation
Contamination