MDR Terms Flashcards
What is an Adverse Event?
Any incident where, regardless of dose, the use of a medical product [drug or biologic, including human cell, tissue, or cellular/tissue-based product {HCT/P}] or medical device [including in vitro diagnostic products] is suspected to have resulted in an unwanted/unexpected adverse outcome in a PT.
What is a Product Quality Problem?
Any report regarding the performance, quality, or safety of any medical product. This category is selected when reporting a medical device or product that has a defect/malfunction that could result in serious injury or death if it were to occur [e.g. defects/malfunctions]
What is a theraputic failure?
Therapeutic failures problems can include when a medical product does not seem to work as well when you switch from one generic to another.
What constitues a Malfunction?
A Malfunction occurs when a device fails to perform as intended, or fails to meet its performance specifications [including all claims made in the labeling for the device].
What is considered a medical device’s intended performance?
The intended performance of a device refers to the intended use for which the device is labeled or marketed, as defined in 801.4 of this chapter.
What is an HCT/P?
Human cells, tissues, and cellular/tissue-based products (HCT/Ps) consist of human cells or tissues intended for implantation, transplantation, infusion or transfer into a human recipient.
What is a Device User Facility?
A “device user facility” is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician’s office.
How is the term “Serious Injury” referred to in EU/Australia, and in Canada?
- Serious Injury is referred to as “serious deterioration in health” in the EU and Australia, and
- as a “serious deterioration in the state of health” in Canada.
What constitues a serious injury, as defined in 21 CFR 803.3?
A serious injury or illness, as defined by 21CFR 803.3, meets one of these criteria:
- Is life-threatening
- Results in permanent impairment or damage of a body function or structure
- Necessitates medical or surgical intervention to preclude or correct any permanent damage or impairment of a body function or structure.
What is a disability?
A Disability is defined as a substantial disruption of a person’s ability to conduct normal life functions.
What does ISO stand for?
International Organization for Standardization
What does CFR stand for?
Code of Federal Regulation
Define a Complaint
a complaint, as defined by both ISO 13485 and 21 CFR 820.198, is any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it has been released for distribution (post-market survaillance).
