CDC warns open-heart surgery patients on risks of medical-device infection

heatercoolerPost-op heart surgery patients who experience night sweats, muscle aches, weight loss, fatigue, or unexplained fever should contact their doctors, stat, federal officials say. They’re warning that a medical device, designed to keep organs and blood at a constant temperature, was contaminated with nontuberculous mycobacterium (NTM). Officials already have confirmed more than two dozen NTM infections in open heart patients, and thousands more may be at risk.

The federal Centers for Disease Control and Prevention flagged the potential patient risks linked to the Stöckert 3T, temperature-regulating surgical devices made by LivaNova PLC (formerly Sorin Group Deutschland GmbH).

Temperature-regulating devices are common in the 250,000 open heart surgeries performed annually in hospitals, officials say, and 60 percent of the procedures involve the German-made model. NTM infections may not develop immediately, and some cases were confirmed as many as four years after surgery. They typically are not fatal but can be problematic for immune-compromised patients, such as many open heart patients are. They respond well to antibiotics if detected.

Officials tracked the device woes through the “genetic fingerprint” of the bacteria involved, tracing it to the German model and with “strong” suggestion that taint occurred in a plant overseas. The device circulates water in closed tubes to keep constant the temperature of organs and the blood. The water never comes into direct contact with patients. But it is stored in a reservoir, which experts fear over time provides a moist place for NTM to grow. The device has a fan to keep itself cool−and which authorities suspect blew bacteria into the surgical site.

The federal Food and Drug Administration earlier had issued a warning about the 3T and possible infections involving another bug, Mycobacterium chimaera (M. chimaera), an NTM strain.

I’ve written  about the growing risk posed by now ubiquitous medical and other dangerous products and devices, most recently and notably the fatal and disgusting design flaws connected to a dubious maker of scopes used in gastrointestinal exams. A challenge for those seeking to reduce patient harms from medical devices has been tracking them. I’ve written before how reformers want device makers to label their products with distinctive identifying numbers and to create a national tracking registry. This all occurs and has proven beneficial with prescription drugs.

Although the makers of highly lucrative devices have resisted these and other efforts to better protect patients, the Pew Charitable Trusts have reported on the major costs that problem devices can rack up, and, which are difficult to tally without better tracking. Pew says data on just seven heart implants that failed or were recalled cost we taxpayers, via Medicare, an estimated $1.5 billion as officials dealt with device-related problems of 375,000 patients who received them. Patients got stuck with another $140 million in co-pays and other expenses due to these faulty devices.

Pew says Medicare covers 55 million Americans, who are treated with millions of devices. The most common hospital procedure covered involved hip and knee replacements, racking up $7 billion in expenditures. As Pew writes of the proposed device tagging:

The risks and the costs are clear. Most medical devices are safe and effective, but occasionally they do fail, such as the hip joints that sent metal shards into patients’ bloodstreams a few years ago. If the device codes had been recorded, problems would have been far easier to detect. The Medicare claims form could have been used to identify victims more easily, provide remedial treatment quickly, and prevent other patients from receiving the faulty device in the first place.  Saving lives and sparing patients pain and suffering is critical … recording device codes in Medicare claims can also save taxpayers billions of dollars. If the committee fails to act, Congress can and should mandate the change for Medicare.

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