Faulty Defibrillators and Broken Hip Implants: A Terrible Case of Déjà vu

My blogging has been a little on the lighter side of late, since I’ve recently been focused on learning about some unfamiliar but fascinating topics on the business of health care through my new job at the Advisory Board. But I came across a highly relevant news article today, and decided to take the opportunity to share about what I think is a dangerous and often-overlooked problem in our health care system.

The Wall Street Journal today reported on device manufacturer St. Jude Medical Inc., which recalled its Riata defibrillator in 2010 after reports that the defibrillator cables were breaking through their insulation from the inside out. However, documents collected by the FDA reveal that they had known about the problem as early as 2005, and even received reports from physicians between 2006-2009 of the problems. Later in the day, my work-related literature search led me to a 2008 New York Times article reporting on a two other devices that were recalled due to defects: Zimmer Holdings’ Durom cup, a socket used in hip replacements, and Sulzer Orthopedics’ hip implant. The stories outlined in the two articles sound strikingly similar: a few doctors noticed problems early, sounded the alarm, were notified by the company that they were isolated incidents or due to poor surgical technique…and no one could provide systematic evidence suggesting otherwise.

They could have, if the U.S. had a device registry. A device registry is essentially a surveillance system that tracks every device model implanted into every patient, along with the name of operating surgeon and the technique used. The aggregate data can provide early alerts on particular devices that are exhibiting abnormal rates of problems. National registries have been set up in other countries, including Australia, Sweden, Norway, and Britain, where the risk of revision surgeries (repeat surgeries due to device failures or improper technique) is less than half as high as the risk in the U.S. Despite scattered efforts in the U.S. to set up device registries by systems such as Kaiser Permanente and the Hospital for Special Surgery in New York, efforts to set up a national registry have failed for a myriad of reasons such as low physician participation, lack of legal governance, and potentially insidious relationships between orthopedists and device manufacturers.

There is an additional benefit to having a device registry beyond having an early warning alert system to defective devices: having such a large data set may help us take much-needed steps toward evaluating the clinical effectiveness of devices. As Ventola reviews in this 2008 article, we currently face huge challenges in trying to understand and compare just how effective different medical devices are. Although the FDA has rigorous testing requirements for drugs (that’s why it takes an average of 12 years for an experimental drug to go from lab to market), its process for medical devices is a bit more…lax. Basically new devices fall into one of three categories:

1. Low risk products (e.g. bandages, splints, drapes): No premarket review requirements at all;
2. Moderate risk products (an incremental change to an existing product): Requires a premarket notification process where “you provide notice to the FDA that your product is substantially equivalent to a product they’ve already seen.” (Yeah, think about that for a second. This is the route that 95-98% of devices take.)
3. High risk products: Requires clinical trials.

Source: Ventola, C.L. 2008. Challenges in evaluating and standardizing medical devices in health care facilities. P&T 33(6):348-359.

It’s no wonder that very few clinical trials exist on the effectiveness of devices, and the majority of those that do are shoddy-quality studies conducted by the device manufacturers themselves. When you consider that next to the findings of a landmark 2008 CBO study that roughly half of the growth in health care spending over the past several decades can be attributed to new technology, you start to wonder why we don’t more rigorously evaluate whether new, expensive devices actually give us more bang for our buck, as the UK does through their ironically named “NICE” (National Institute for Health and Clinical Excellence), which evaluates the cost-effectiveness of all new technologies.

(Incidentally, it appears that even with this guidance, physicians will still be physicians and refuse to listen to NICE’s recommendations.)

However, I’m of the optimistic opinion that physicians WILL listen to evidence that their particular device of choice is harming their patients. And so a device registry, whether national or private, seems like a much-needed solution to a currently overlooked problem.

“He has been at it for three decades,” the 2008 Times article writes of veteran orthopedic surgeon Dr. Dorr, “long enough to say that history is repeating itself because this country does not gather evidence of how patients fare.”

Tragically, four years later, it appears that history is still repeating itself.