Getinge’s 2023 has started on a rocky note as its years-long process to rectify potential breaches in the sterile packaging of its life support systems continues. The company, in December 2022, put out a field safety notice announcing that it had placed a voluntary shipping hold on its Heart-lung support (HLS) Set Advanced and permanent life support (PLS) set which are sold through its Maquet subsidiary.
The hold happened in response to the company stating it had addressed all possible nonconformities with its sterile packaging. An unnamed regulatory body, however, disagreed and determined that tests of the updated packaging had been inadequate. The company also issued an Urgent Medical Device Correction in February 2023 about potential problems with packaging sterility for the HLS, and FDA released a Letter to Healthcare Providers on the matter on March 1. To date, there have been no reports of adverse events due to this issue.
To add salt to those wounds, Getinge was hit with a particularly heavy penalty recently when DEKRA, a German-based notified body, announcing that, as of March 1, the CE certificates for the HLS and PLS systems would be suspended, preventing the company from shipping out any unsold systems in Europe.
“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,” Getinge wrote in a release announcing the suspension. “As a result, DEKRA will temporarily suspend the certificates for the HLS and PLS sets from March 1, 2023.”
The company’s Cardiohelp system together with HLS is intended to be used in hospitals and outside the hospital environment, like hospital transport, for up to six hours. The system is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for either circulatory support, pulmonary support, or both. HLS is a disposable part of the Cardiohelp system that contains the oxygenator, heat exchanger, and integrated centrifugal pump.
In late 2020, Getinge started a voluntary recall of its HLS devices after discovering that “a limited number” of more than 58,000 systems distributed worldwide since October 2018 could have arrived with damage to its sterile packaging. However, in July 2022, the company expanded the recall to cover additional product codes and lot numbers of the HLS systems, growing the number to 67,000 devices. In the field safety notice, Getinge described how an “absence of labeling” on the outer packaging of the devices could result in rough or improper handling, like the potential for the venous probe holder inside to punch holes through the packaging. The damage could occur if one of the machines was transported upside down or dropped from carrying height, causing a non-sterile environment. Use of the systems in this case could, in a worst-case scenario, expose patients to inflammation, infection, and sepsis, among other sickness.
Of note, all HLS devices manufactured after the initial recall — as of September 2021 — were shipped with more durable packaging, according to Getinge.
The company says it’s working diligently to complete additional testing requested by the unnamed regulatory body — likely DEKRA, based on the subsequent CE mark suspension. The testing will require an assessment of the devices’ sterility in worst-case conditions.
Getinge noted that results from the additional testing won’t be available until, at earliest, April.
“Getinge is aware of the severe situation this suspension puts on healthcare and critically ill patients,” the company wrote. “The company is in dialogue with authorities and working urgently to minimize the impact on patients. The extensive work is continuing to secure compliance with essential requirements.”