Charles Sternberg, Associate Editor02.23.23
The notified body for certification services, DEKRA, has temporarily suspend the CE-certificates for Getinge’s HLS and PLS sets from March 1, 2023. Getinge is in dialogue with authorities and working urgently to minimize the impact on patients.
Getinge previously identified and announced potential breaches in sterile packaging of the HLS and PLS sets used for extracorporeal respiratory and/or cardiovascular support. Getinge has since then reported progress to relevant authorities on a number of initiatives, such as package design improvements and advanced testing of the packaging to ensure that the products are protected by a sterile barrier according to the applicable standards and requirements.
According to DEKRA, the documentation related to the initiatives submitted from Getinge does currently not demonstrate compliance with the essential requirements according to the Medical Device Directive and applicable standards. As a result, DEKRA will temporarily suspend the certificates for the HLS and PLS sets from March 1, 2023.
Getinge says it is aware of the severe situation this suspension puts on healthcare and critically ill patients. The company is in dialogue with authorities and working urgently to minimize the impact on patients. All affected customers will receive communication from Getinge.
The financial impact is not expected to be material.
Getinge previously identified and announced potential breaches in sterile packaging of the HLS and PLS sets used for extracorporeal respiratory and/or cardiovascular support. Getinge has since then reported progress to relevant authorities on a number of initiatives, such as package design improvements and advanced testing of the packaging to ensure that the products are protected by a sterile barrier according to the applicable standards and requirements.
According to DEKRA, the documentation related to the initiatives submitted from Getinge does currently not demonstrate compliance with the essential requirements according to the Medical Device Directive and applicable standards. As a result, DEKRA will temporarily suspend the certificates for the HLS and PLS sets from March 1, 2023.
Getinge says it is aware of the severe situation this suspension puts on healthcare and critically ill patients. The company is in dialogue with authorities and working urgently to minimize the impact on patients. All affected customers will receive communication from Getinge.
The financial impact is not expected to be material.