Dive Brief:
- The notified body DEKRA is temporarily suspending the CE certificates for Getinge life support sets because of noncompliance with the Medical Device Directive (MDD).
- Getinge reported potential breaches in the sterile packaging of its heart lung support (HLS) set last year and expanded its existing global medical device field action.
- The company has since tried to improve the design of its packaging but DEKRA, after reviewing documentation related to the improvements, has ruled Getinge is noncompliant with the directive’s essential requirements.
Dive Insight:
Getinge has run into a range of regulatory problems in recent years, overseeing three Class I recalls of its intra-aortic balloon pumps and publishing urgent field safety notices related to its HLS set in 2018, 2021 and 2022. The notice published last year described complaints that a cover was damaged and the device could therefore expose patients to pathogens.
In response, Getinge worked to improve the packaging of its HLS and permanent life support sets, which are used for extra-corporeal respiratory and cardiovascular support. It also ran tests to ensure “the products are protected by a sterile barrier according to the applicable standards and requirements.”
Along the way, the company has reported its progress on the initiatives to “relevant authorities.” DEKRA, a notified body based in Germany, is among the organizations that have reviewed Getinge’s progress and identified problems. According to Getinge, the notified body found the documentation related to the initiatives does not “demonstrate compliance with the essential requirements” of the directive.
DEKRA is temporarily suspending the CE certificates of the life support sets from March 1. Getinge said it is “aware of the severe situation this suspension puts on healthcare and critically ill patients,” adding that it “is in dialogue with authorities and working urgently to minimize the impact on patients.”
