field action

English translation: corrective action

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:field action
Selected answer:corrective action
Entered by: Daniel Grigoras

22:27 Feb 13, 2014
English language (monolingual) [PRO]
Medical - Medical: Instruments
English term or phrase: field action
"When needed, we notify the users of our equipment about important product updates and field actions. There are no active field actions at this time." (http://www.ohiomedical.com/default.aspx?id=9&AspxAutoDetectC...

What exactly is meant by "field action"?
Daniel Grigoras
Romania
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...

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Note added at 13 hrs (2014-02-14 11:52:25 GMT)
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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.

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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!
Selected response from:

Yvonne Gallagher
Ireland
Local time: 11:11
Grading comment
Thanks!
4 KudoZ points were awarded for this answer



SUMMARY OF ALL EXPLANATIONS PROVIDED
4product recall (strategy/plan)
Yvonne Gallagher
3field action/advisory" = "product recall"
José Patrício
3What to do with the product in the field
acetran
Summary of reference entries provided
product advisory/ field advisorY
José Patrício

Discussion entries: 2





  

Answers


5 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
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.

acetran
Native speaker of: Native in HindiHindi, Native in EnglishEnglish

Peer comments on this answer (and responses from the answerer)
neutral  Charles Davis: No, it means product recall. See spielenschach's reference.
5 hrs
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11 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
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!

Yvonne Gallagher
Ireland
Local time: 11:11
Native speaker of: Native in EnglishEnglish
PRO pts in category: 8
Grading comment
Thanks!
Notes to answerer
Asker: "corrective actions" is an excellent synonym for "field actions"; the translation of this synonym into Romanian makes perfect sense

Asker: Thanks a lot! You saved me! "corrective actions" is how I will translate "field actions" into Romanian

Asker: I guess that "field actions" is just a euphemism for "corrective actions," and it's easy to figure out why

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1 day 12 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
field action/advisory" = "product recall"


Explanation:
v. ref comments

José Patrício
Portugal
Local time: 11:11
Native speaker of: Native in PortuguesePortuguese
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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

José Patrício
Portugal
Native speaker of: Native in PortuguesePortuguese
Note to reference poster
Asker: Thanks! You should post this as an answer, i.e. " field action/advisory" = "product recall"


Peer comments on this reference comment (and responses from the reference poster)
agree  DFTGames: Correct, a Field Action is the term used to intend a defective product recall
24 mins
  -> obrigado
agree  Patricia Franco
3 hrs
  -> obrigado
agree  Charles Davis: This should have been posted as an answer.
9 hrs
  -> obrigado
agree  Yvonne Gallagher: I posted an answer to this as other answer is wrong...
11 hrs
  -> obrigado
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