field action
English translation: corrective action
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| 22:27 Feb 13, 2014 |
| English language (monolingual) [PRO] Medical - Medical: Instruments | |||||
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|  Selected response from: Yvonne Gallagher Ireland Local time: 09:03 | ||||
Grading comment
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| SUMMARY OF ALL EXPLANATIONS PROVIDED | ||||
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| 4 | product recall (strategy/plan) |
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| 3 | What to do with the product in the field |
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| 3 | field action/advisory" = "product recall" |
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| Summary of reference entries provided | |||
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| product advisory/ field advisorY |
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| Discussion entries: 2 | |
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Answers
5 hrs confidence: 
What to do with the product in the field Explanation: It means, "what to do with the product in the place where it is supposed to be used. |
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11 hrs confidence:
product recall (strategy/plan) Explanation: http://www.fda.gov/Safety/Recalls/ucm231855.htm http://www.cfpie.com/showitem.aspx?productid=091 "Field actions are a difficult yet necessary aspect of the medical device marketplace. The various stakeholders: regulatory agencies, physicians, users, patients, organizations and personnel are all affected but in different ways, having different requirements to be satisfied. Balancing these different requirements - some documented in regulation, others based on simple human need - creates challenges for those responsible for deciding and implementing field actions. Managing the impact of globalization and the inter-relationships between regulatory agencies, distribution, language, cost consciousness and culture influence the management of actions and determine field action ‘success’... or otherwise." http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc... -------------------------------------------------- Note added at 13 hrs (2014-02-14 11:52:25 GMT) -------------------------------------------------- Hi DDG, I though it was product recall in your context since that is what you suggested to spielenschach1 below. But it can mean any of the following corrective actions 9taken from my last link Definitions Correction means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location. Market withdrawal means a firm's removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc. Recall means a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery. Recall strategy means a planned course of action to be taken in conducting a specific recall, which addresses the depth of recall, need for public warnings, and extent of effectiveness checks for the recall. Recalling firm means the firm that initiates a recall or, in the case of a Food and Drug Administration-requested recall, the firm that has primary responsibility for the manufacture and marketing of the product to be recalled. Removal means the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection. Risk to health means (1) A reasonable probability that use of, or exposure to, the product will cause serious adverse health consequences or death; or (2) That use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences, or an outcome where the probability of serious adverse health consequences is remote. Routine servicing means any regularly scheduled maintenance of a device, including the replacement of parts at the end of their normal life expectancy, e.g., calibration, replacement of batteries, and responses to normal wear and tear. Repairs of an unexpected nature, replacement of parts earlier than their normal life expectancy, or identical repairs or replacements of multiple units of a device are not routine servicing. Stock recovery means the correction or removal of a device that has not been marketed or that has not left the direct control of the manufacturer, i.e., the device is located on the premises owned, or under the control of, the manufacturer, and no portion of the lot, model, code, or other relevant unit involved in the corrective or removal action has been released for sale or use. -------------------------------------------------- Note added at 13 hrs (2014-02-14 11:54:03 GMT) -------------------------------------------------- oops, typos start of 13 hrs note thoughT ....taken (no 9) -------------------------------------------------- Note added at 13 hrs (2014-02-14 11:55:45 GMT) -------------------------------------------------- so perhaps a more general term to suit all cases would be "field corrective action" -------------------------------------------------- Note added at 15 hrs (2014-02-14 14:27:43 GMT) -------------------------------------------------- Great! Glad to have helped! |
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1 day 12 hrs confidence:
field action/advisory" = "product recall" Explanation: v. ref comments |
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Reference comments
35 mins peer agreement (net): +4 |
| Reference: product advisory/ field advisorY Reference information: ‘product advisories’ or ‘field advisories’ - ‘product advisories’ or ‘field advisories’ explained what recalls, product advisories and field actions really mean - http://attorneypages.com/hot/understanding-recalls-product-a... Recalls - same link Product Advisories & Field Actions - same link They always referred to it as a ‘Medtronic Field Action.’ - mesmo link |
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Note to reference poster
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