Abbott Labs Receives Stern FDA Warning About Heart Devices

Abbott Laboratories recieved a FDA warning letter after failing to investigate and resolve risks related to its implanted heart devices.

In a warning letter, the FDA critiziced Abbott Laboratories for failing to resolve issues related to its  cardiovascular devices.Abbott

Battery and cybersecurity problems with the heart devices seemed to be a dominant issue.

Concerns about the safety of several implantable defibrillators and its Merlin@home monitor, which allows doctors to care remotely for patients with cardiac devices.

In February, we covered complicatipons with the HeartMate PHP catheter. During procedures to unclog blood vessels, the HeartMate PHP is inserted in the heart to keep blood flowing. The device is used inside the heart with no need for open-chest surgery.
The most recent  investigation showed that lithium batteries in the devices weredraining and that the company had “underestimated the occurrence of the hazardous situation.”

As recently as September, the device received praised from the medical community.

Now, the Lab is putting an end to the commercially successful blood pumps use in the United States and Europe after several malfunctions and a patient death.

In late 2016, there were reports that the Merlin@home transmitter used in monitoring certain (then  St. Jude Medical) implant devices could be hacked. These hacks could lead to deadly consequences for  the patient.

The devices in question are several cardiovascular devices acquired in Abbot’s $25 billion purchase of St. Jude Medical.

In an email to the FDA, the company said that it was looking into the matter.

The FDA has publicly noted that Abbott had failed to provide evidence that the actions had actually been implemented.

Software

Medical Device Software Vulnerabilities a Huge Concern

Software vulnerabilities of medical devices may be difficult for health sector officials and manufacturers to manage.

As we reported last week, St. Jude implemented software updates that could protect pacemakers and other medical devices from being compromised by hackers. Oxycontin

Unfortunately, new information suggested that the public is not completely in the clear.

“Software is never perfect and all systems still will have these flaws,” says Joshua Corman, director of the Cyber Statecraft Initiative at the Atlantic Council and an expert on medical device security. “The question is how gracefully and collaboratively and quickly and safely can we respond to these flaws.”

In late 2016, there were reports that the Merlin@home transmitter used in monitoring certain St. Jude Medical implant devices could be hacked. These hacks could lead to deadly consequences for  the patient.

MedSec, a cybersecurity firm,  initially found the problems in the St. Jude devices. After which they “tipped off”- the activist investment firm Muddy Waters, which publicized the flaws and advised clients to bet against the health care firm’s stock.

Ever since the US government and St. Jude confirmed the one flaw, the VA has been “taking steps to be sure all our patients and providers are aware of this issue and take appropriate actions to be sure that all our patients get the update for their monitor,” said Merritt Raitt, acting director of the VA National Cardiac Device Surveillance Program.