Regulatory Focus™ > News Articles > French Regulators find Cardiology Manufacturer Non-Compliant with Regulations, Withdraw Devices

French Regulators find Cardiology Manufacturer Non-Compliant with Regulations, Withdraw Devices

Posted 15 May 2013 | By

French regulator ANSM has announced yet another problem-the second in as many weeks following a major scandal in 2012-this time with the Jarvik 2000 heart device due to violations of French laws and regulations by a manufacturer in the country.

Background

ANSM-Agence nationale de sécurité du médicament et des produits de santé, for those who prefer the full title-is a recent addition to the world regulatory stage, having only been created on 29 April 2012. Prior to its creation as ANSM, it was known as Afssaps. But thanks to the deluge of scandals facing the agency, including one involving the manufacture and sale of defective breast implants, most of the leadership of that agency was thrown out, leaving French officials to reconstitute the agency with new leadership and a new mission: Keep patients safe.

But the regulators' perceived failings haven't strayed far from the public eye. Just a month ago, one of the largest-ever trials in French history got underway, with plaintiffs looking for redress against PIP, whose faulty implants have been associated with revision rates that are higher than necessary. Notably, the implants were reported to have been manufactured with a substandard, non-medical grade silicone product that some had believed might cause cancer. Those concerns have not been substantiated.

However, if regulators hoped to move past the breast implant scandal of 2012 and subsequent questions regarding its ability to regulate, recent weeks have put its efforts back in the spotlight, and not in a flattering light. In early May 2013, ANSM announced that an inspection of implant manufacturer Ceraver had found the company to be marketing its product without meeting CE marking standards. The company noted in a statement, however, that its products did not pose a risk to human health-something conceded by ANSM regulators.

Another Device Puts Regulators Back in the Spotlight

Now a second device has been identified by ANSM regulators as having skirted French laws and regulations. In a 15 May announcement, ANSM said an inspection of IST Cardiology found that the company had not followed proper procedures for re-labeling, sterilization, storage, tracking, claims management or organization.

While regulators said that they had "no indications" that the devices had in any way been linked with adverse events, they were suspending the company's market authorization and withdrawing "certain medical devices" distributed by the company due to its lack of compliance.

According to ANSM's website, the company markets the JARVIK 2000 system, a ventricular assist device (VAD) that helps the heart to pump blood throughout the body when a heart is too weak to do so on its own.  Nearly all of those devices and their related components will be withdrawn from the market, French regulators said in addition, all other medical devices manufactured by IST Cardiology will be suspended in light of the compliance issues.

The company did not have a statement available at the time of press.


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