Several years into the process of rectifying potential breaches in the sterile packaging of its life support systems—a process that has been littered with field correction notices and FDA-rated recalls—Getinge has been hit with a particularly serious penalty.
As of March 1, the CE mark certificates for the Swedish devicemaker’s heart-lung support (HLS) and permanent life support (PLS) systems will be suspended, preventing Getinge from shipping out any unsold systems in Europe.
The suspension decision was handed down by DEKRA, a Germany-based notified body, Getinge announced last week. It came after the device watchdog determined that Getinge’s documented efforts to return its sterile packaging to compliance still don’t meet “the essential requirements according to the Medical Device Directive and applicable standards.”
“Getinge is aware of the severe situation this suspension puts on healthcare and critically ill patients,” the devicemaker said in the announcement. “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. All affected customers will receive communication from Getinge.”
In the meantime, it added, the CE mark suspension isn’t expected to have any material impact on the company’s finances.
The HLS and PLS systems are sold through Getinge’s Maquet subsidiary. They’re used in hospitals to provide “extracorporeal respiratory and/or cardiovascular support,” per Getinge, and therefore must be kept in sterile packaging.
The century-old medtech maker’s discovery of potential breaches in that sterility dates back several years. In late 2020, Getinge embarked on a voluntary recall of its HLS Set Advanced devices after discovering that “a limited number” of the more than 58,000 systems distributed worldwide since October 2018 could have arrived with damage to their sterile packaging. No injuries or deaths had been reported in conjunction with the recall at the time, and the FDA gave the safety action a medium-severity Class II rating.
Last July, Getinge expanded that recall as it discovered the possible breaches in sterility stretched to additional product codes and lot numbers of the HLS Set Advanced systems—though all devices manufactured after the initial recall, as of September 2021, have been shipped with “more durable” packaging, per the company.
The company still reported no injuries or deaths associated with the potential non-sterility, and the expanded recall once again landed a Class II rating from the FDA. According to entries in the agency’s recall database, the updated action had grown to cover more than 67,000 devices.
In an urgent field safety notice (PDF) sent to healthcare providers last summer, Getinge described how an “absence of labeling” on the outer packaging of the devices could result in rough or improper handling. If one of the machines is transported upside down and dropped from carrying height, for example, the venous probe holder of the device inside could punch holes through the packaging.
In a worst-case scenario, according to the notice, use of non-sterile life support systems could in turn expose patients to unwanted pathogens, leading to inflammation, infection or sepsis.
Getinge said that it had already introduced new labeling for the packaging and was working on implementing instructions for healthcare providers to inspect all systems for damage before use, as well as narrowing the “logistics conditions” for proper shipment of the machines.
Last month, Getinge put out another field safety notice (PDF) announcing that it had placed a voluntary shipping hold on its HLS and PLS sets in December. The hold came after Getinge said it had addressed all possible nonconformities with the sterile packaging, but an unnamed regulatory body—likely DEKRA, based on the subsequent CE mark suspension—determined that tests of the updated packaging hadn’t been adequate.
Getinge said it was “working with all possible urgency” to complete the additional testing—which required assessment of the devices’ sterility in worst-case conditions—but noted that the results wouldn’t be available until April at the earliest.
“Thereafter, we will reassess whether further measures need to be taken to ensure patient safety,” the company said at the time, adding, “Based on the preliminary test results under market configuration, we are confident to confirm the conformity of the affected products.”