What is medical device recall

Medical device recall a product after the listing of the main instrument of risk control.

In the recently held its first session China medical device risk management seminar, national ADR is responsible for medical surveillance of the detailed medical device recall status and related regulations.

Recall that not all the return of the original factory

The official said, at this stage, the latest medical device recall is not long ago to seek the advice of the medical device recall management measures "referred to in the paragraph:" medical device recall, refers to medical device manufacturers in accordance with the provisions of the program is on sale of security breaches, according to the rules of procedure, to alerts, inspect, repair, labelling, modify user manual, software, upgrade, replace, recovery, destruction, and other ways to eliminate their product hazards.

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It is understood that the medical device recall different from ordinary product recalls, because of its high frequency, causes are complex, so the recall measures.

Most of the medical device recall can be completed through technical means, you can put the risk control within a reasonable range, not always returned to the manufacturer. Like the in-place modification labels, brochures, upgrades and other recall measures, in any place can be carried out.

In addition, the risk of the medical device control, mainly in the medical equipment of design improvements, warning notices, strengthen the maintenance and use of training.

When all operations are unable to control risks, the product will be city from.

Medical device recall has not been extensive cognitive

According to the official introduction, medical device recall has been commonplace in the world, but in domestic is not widely cognitive and misunderstood.

For example, not long ago the Center made a recall investigation related to the event, a region of the regulatory authorities have to hear that a device, it was decided to recall information storage device immediately. Hospitals have also asked that the equipment is not returned. Enterprises are concerned that their products once publishing recall information, tends to be competitors use various irregularities occurred.

According to reports, FDA since 2003 published medical device recall information, has been played 391, i.e. at the level of recall using the equipment may cause serious health hazards.

Since 2008, the Agency has released the level II, and III recall information from 1347.

What are the recall regulations

It is understood that the China medical device recall legislation is gradually improving.

2007 July 26, the State Council on strengthening the food product safety supervision and management of the special provisions of the law, at the legislative level for all products with the recall of the legal basis.

The special provisions of article 9, paragraph 1, producers found it product security breaches can have on human health and the safety of life, to damage should be made public for information, notify the seller stop sales, informing consumers to stop using.

Sellers discover his sales of products for security breaches can have on human health and the safety of life, to damage should immediately stop marketing the products, inform the manufacturer or supplier, and report to the relevant supervisory authorities.

SFDA 2006 release of the further strengthening of medical device adverse event monitoring related matters notice (i.e., file No. 406), in the territory of China medical device adverse event of suspicious, medical device manufacturers should report in accordance with the relevant requirements, and prompt investigation, analysis of causes and, if necessary, take the initiative to take corrective measures, such as the recall to ensure that patients and personnel of the health and safety.

406 files also submits that the medical device manufacturing enterprises in China for its product recall and other corrective measures taken, including in situ and ex situ, at its option, will repair, modify, adapt, modify the label, manual, destroy, inspection, replacement, and other ways to eliminate their product defects must be made to permit issuing food and drug administration and sibling medical device adverse event monitoring technical agencies report.

The document stipulates that medical device manufacturing enterprises should promptly be listed in China products and similar products in foreign countries and Hong Kong, Macao and Taiwan regions recall events of the situation and progress report to the permit issuing food and drug administration and sibling medical device adverse event monitoring technology sector.

The official said, this is now launching the basis for the medical device recall work.

Describes what you want to report on the situation of the recall, you need to report to the who, what is the content of the report; in addition, more than just selling products, similar products in China and abroad to recall and report to the drug administration departments.

In addition, in September 2005, the State food and drug administration, and other departments to set up the medical device recall management approach ", the drafting group, November 2006, March 2008, the" rules "of two Internet request for comments, is expected to be launched in the near future.

A recall performing undesirable case

The end of 2007, the FDA in the United States issued a class II recall information that an enterprise's digital radiography system camera at the bedside, certain protective devices may fail.

National ADR after obtaining this information, expand the relevant investigate the enterprise according to the report in document 406 domestic situation. Enterprises reported the material that in China the use of a standard set of diagnostic bed so that the device is not like the product abroad, will cause harm to patients. In order to maintain consistency in the device, the enterprise but also in countries outside the United States, the District of equipment upgrades. At the time the equipment in the domestic total of 91 units 81 sets of input use. Used equipment, 47 table has completed the upgrade.

The Centre in June this year launched on this recall event implementation results of the investigation.

The products of 81 users, total reclaim has 68 product survey feedback. Results showed that there were 38 home users do not receive recall issued by the enterpriseNotice or notice of the customer, including 32 home users do not receive the business risk of the product. There are 3 users report having undergone the equipment U-arm and check the collision between adverse events of the bed.

This enterprise is basically the product maintenance upgrade, but there is no risk to inform users on the enterprise product risk awareness is not sufficient, also think China will not take place U-arm collision check deposit.

In addition, enterprises did not recall. A recall action implementation, first of all to inform users of the risk information. Risk information service is a key part of the recall work. The only way to control immediately after the listing.

This event also reflects the company's complaint reporting system and quality control system has failed to effectively run, did not gather to suspect adverse events.

The enterprise in the United States recall doing very norms, but in the country as a whole had undertaken the work of recall is not very satisfactory.

This event also remind the domestic enterprises, should face up to the importance of the recall.

The recall is to control the production of medical risk, promote technological progress, improve product design. The recall also reflect the enterprise's integrity and social responsibility.