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32 Cards in this Set
- Front
- Back
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WHAT CLASS OF MEDICAL DEVICE DO THE KCI WOUND V.A.C.S FALL UNDER?
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class ii
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HOW WILL KCI EXCEED CUSTOMER EXPECTATIONS?
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through innovative programs with exceptional service with quality products
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HOW WILL KCI EXCEED FDA QUALITY SYSTEMS REGULATIONS AND THE ISO 13485 QS STANDARDS?
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by establishing and continuously improving our Quality System
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HOW WILL KCI CREATE AN INCLUSIVE AND EMPOWERING WORK ENVIRONMENT?
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by building a foundation of open communication trust training and teamwork
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WHAT IS A COMPLAINT?
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any written electronic or oral communication that alleges deficiencies related to the identity quality durability reliability safety effectiveness or performance of a device after its release for distribution
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WHAT DOES A COMPLAINT EVALUATION PROGRAM DO?
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-evaluates and trends complaints for need to remove or correct
-provides design feedback -reduces risk to the company -assures regulatory compliance |
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WHAT IS CONSIDERED A SERIOUS INJURY?
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an injury that is life threatening or results in permanent impairment of a body function or permanent damage to a body structure or necessitates medical or surgical intervention to preclude permanent impairment or damage
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WHAT DOES 'CAUSED OR CONTRIBUTED' MEAN?
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a death or serious injury was or may have been attributed to a medical device or that a medical device was or may have been a factor in a death or serious injury
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WHAT DOES 'MALFUNCTION' MEAN?
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the failure of a device to meet its performance specifications or otherwise perform as intended
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PERFORMANCE SPECIFICATIONS
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include all claims made in the labeling for a device
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INTENDED PERFORMANCE
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refers to the intended use for which the device is labeled or marketed
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OFF-LABEL PROMOTION
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promotion that consists of making claims for a product which are different than the product claims allowed by the FDA this is a violation of the Food, Drug, and Cosmetic Act
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NON-COMPLIANCE WITH FDA REGULATION CAN RESULT IN WHAT DISCIPLINARY ACTIONS?
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-warning letter and/or
-Dear Dr. letter and/or -discontinuance of the use of the offending marketing materials |
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WHAT CAN WE SAY ABOUT V.A.C. THERAPY?
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-creates an environment that promotes wound healing -reduces edema -may be used on FDA-cleared wound types -promotes perfusion -promotes granulation formation -removes exudate and infectious materials -assists in flap and graft take
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WHAT CANT WE SAY ABOUT V.A.C. THERAPY?
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-accelerates wound healing -safe and effective for venous stasis ulcers -increases blood flow and promotes angiogenesis -increases granulation tissue growth rate -reduces infection -increases flap and graft survival
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WHAT ARE THE 8TYPES OF FDA-CLEARED WOUNDS?
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1. chronic 2. Ulcers (diabetic, pressure, and venous insufficiency) 3. acute 4. partial thickness burns 5. dehisced wounds 6. flaps 7. grafts 8. traumatic wounds
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IN REGARDS TO INTERACTIONS WITH HCPs WHAT GUIDELINES/REGULATIONS DOES KCI FOLLOW?
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-ADVAMED industry guidelines
-state regulations -KCI code of conduct (proper place, proper people, proper payment and/or gifts) |
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WHAT ARE THE THREE MAIN THINGS YOU SHOULD REMEMBER TO DO IN TERMS OF INTERACTING WITH HCPs?
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-bring ideas for marketing to the attention of your manger -use only KCI approved materials -follow KCI Code of Ethics for interactions with healthcare professionals
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WHAT ARE THE 5THINGS YOU SHOULD NEVER EVER DO IN REGARDS TO MARKETING MATERIALS?
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-never make homemade promotional materials! -never make price comparison sheets!! -never make product comparison sheets!!! -never make summaries of journal articles!!!! -never write on, highlight, change in any way, or even put a business card on with a paper clip or staple to ANY piece of clinical literature!!!!!
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WHAT ARE YOUR 3 MAIN RESPONSIBILITIES AS A KCI EMPLOYEE IN REGARDS IN INTERACTING WITH HCPs?
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1. know what's right
2. do what's right 3. tell KCI if something isn't right |
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THE ONLY WAY TO PROMOTE OFF-LABEL USE IS WITH THE UNSOLICITED DISTRIBUTION OF REPRINTS OF ARTICLES THAT ARE PUBLISHED IN PEER-REVIEWED JOURNALS OR INDEPENDENT TEXTBOOKS & MEET THESE 3 CRITERIA...
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1. it is disclosed that the use is not approved by the FDA 2. it is disclosed that there was a financial interest 3. the manufacturer commits to the submission of data to support the off-label claim they cannot be false or misleading claims records must be kept & reported to the FDA cumbersome process that is not often used
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MEDICAL DEVICES ARE DEFINED BY WHAT ACT?
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the Federal Food Drug and Cosmetic Act
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MEDICAL DEVICES ARE REGULATED BY WHAT ORGANIZATION(S)?
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FDA -Food and Drug Administration and also by state laws and regulations
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FROM WHEN TO WHEN ARE MEDICAL DEVICES REGULATED?
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throughout the life of the product - from development through expiration
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A MEDICAL DEVICE IS...
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an instrument apparatus machine implant or other similar or related article including any component part or accessory which is intended for use in the diagnosis of disease or in the cure mitigation treatment or prevention of disease or intended to affect the structure or function of the body OTHER THAN CHEMICAL ACTION OR METABOLISM
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WHAT IS A 510K?
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a pre-marketing submission made to the FDA to demonstrate that a medical device is: -substantially equivalent to a device that is already legally marketed -applicants must compare their device to one or more similar devices currently on the US matket & provide evidence to support the claim of substantial equivalence -if found acceptable, the company can take product to market (they are given permission by FDA)
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ARE 510K PRODUCTS ARROVED?
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no - they are found either acceptable and granted permission to be marketed or not found acceptable
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HOW MANY CLASSES OF MEDICAL DEVICES ARE THERE?
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3
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WHAT IS A CLASS I MEDICAL DEVICE?
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general non-specific controls; may require 510k pre-market notification to FDA
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WHAT IS A CLASS II MEDICAL DEVICE?
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general and specific (specific performance) controls; pr-market 510k notification to FDA required
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WHAT IS A CLASS III MEDICAL DEVICE?
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pre-market approval(PMA) a process that is somewhat like a drug approval requiring clinical trial etc. is required
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WHAT IS A PMA?
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pre-market approval -provides evidence that the device is safe and effective -almost always requires contolled clinical trial data -FDA reviews, approves, inspects manufacturing and quality processes
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