1.Definition of reportable incident

 

One of the time- and cost consuming activities after approval of medical device in each market is incident reporting by normally quality management department at manufacturer.

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Normally reportable incident is anonym of serious adverse event and recall is in some markets called Field Safety Corrective Action (FSCA). It means that authority want to be informed only about serious adverse event and recall which happens during the post market stage of approved medical device.

 

The definition of these 2 terms in each market has not the same wording globally however very similar meaning based on termination of IMDRF

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​Serious Adverse Event:

Adverse event that:

a) led to a death;

b) led to a serious deterioration in the health of the subject that either

1) resulted in a life-threatening illness or injury, or

2) resulted in a permanent impairment of a body structure or a body function, or

3) required in-patient hospitalization or prolongation of existing hospitalization, or

4) resulted in medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function;

c) led to foetal distress, foetal death or a congenital abnormality or birth defect.

 

Field Safety Corrective Action (FSCA): A field safety corrective action is an action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device. Such action should be notified via a field safety notice.

 

By the way reportable incidents could come from complaint reporting and customer feedback too if the adverse events impact patient safety seriously.

 

2.Who is responsible?

 

Legal manufacturer is for approved medical device over the world responsible and more important primary liable. Normally there are other 2 stakeholders outside home country: legal representative and distributor.

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General speaking, all three parties should contribute to incident reporting. This is in most laws worldwide regulated that legal representative in subject market has liaison role between overseas manufacturer and local authority, and has indirect liability of product too.

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Below are typical activities of three roles about incident reporting:

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Legal manufacturer: receive, analysis, report and file incidents, post-report of incidents in each market

Legal representative: support incident communication and submit final incident report to authority

Distributor: receive, co-analysis and file incident

 

Manufacturers must be surprised that many regional incidents are turned up by being reported by other stakeholders as users, importers or facilities. Unfortunately it is true that almost all persons with access of incident could register an adverse event which is not always a serious incident.

In this case legal manufacturer and other 2 main stakeholders have to cooperate to complete incident report.

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3.Reporting incident outside subject market?

 

Only some countries are interested about reportable incident outside own market. Let us take MDSAP countries as example. Canada and Australia don’t require it however Brazil, Japan, US and Europe ask for reportable incidents outside subject market.

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4.Which essential elements are for reportable incident?

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We recommend manufacturer to have incident matrix with following contents. These are more or less essential parts covering global incident requirements.

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• Applied regulation

• Deadline of registering incident

• Deadline of reporting incident

• Language and format of incident report

• Content of report

• Database to submit report

 

5.Which language of report is needed?

 

Normally the language of incident report is country specific and not English. It makes time adjustable translation from draft, revision and final version of details of incident difficult. At least legal manufacturers have to file the final investigation of incident after approval of authority with own language.

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6.Procedure and related to international QM and TD

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The procedure of incident in MDSAP countries is common session for inspection. Actually the procedure of incident and recall in Taiwan is obligatory document during application of quality system documentation (QSD) which should be written separately.

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Nevertheless the definition of vigilance terms, applied regulation, workflow of incident reporting (Deadline) in critical markets should be studied and maintained.

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From our regulatory experience, information of reportable incidents and recalls is input in many markets` quality system report regularly. In EU info at vigilance system is great part of Post-market surveillance. Very often for product registration, a list of reportable incident as well is to submit.

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For whole lifecycle of medical device, risk management should be updated to corresponding incident and recall.

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Contact us as interim manager of international vigilance activities.