Recall Notice: Dirty Words for Medical Devices

October 1st, 2010. By Hunter West

There are people walking around with faulty hip implants. If they can even walk at all. This month DePuy Orthopaedics, a division of the giant Johnson & Johnson family of companies, finally recalled troublesome hip implants after removing them from the market last year. DePuy undertook the latter response amidst a hail of criticism that the metal-on-metal implant featured a flawed design.

Okay, so recalls are nothing new. Cars and appliances are recalled all the time. But hip implants, and heart defibrillators are not cars and appliances. They are devices implanted in a patient’s body and not easily resolved. 

Who could forget the pacemaker lead from a few years ago that was recalled? The device, which made fans of surgeons who liked the ease and flexibility of the new, thinner leads that proved easier to thread to the heart, was initially hailed as a breakthrough. 

And then they started to break. Fracture, really. Hairline fractures. But just enough to affect the performance of the device. Patients who required life-giving shocks to keep their hearts going weren’t getting them; while others were injured or killed when a properly performing heart was suddenly hit with a rogue electric shock because the fractured lead impeded the flow of information from the heart to the pacemaker. Believing the heart to be failing (it wasn’t), the device went into action to re-engage a heart that in reality had not failed—often with tragic consequences. 

Which begs the question—why does this keep happening? 

Johnson & Johnson has been under siege of late, with a spate of recalls from the DePuy hip, to artificial knee joints, to medication such as Motrin. The company has had to shut down one of its manufacturing facilities due to a departure from GMP (good manufacturing practices), and there have been questions raised about the behemoth company’s oversight. The management and conduct of J&J has been the subject of congressional investigation. 

But a larger question remains, and it is one not tied to any one company—but any company that manufactures any component or medical device destined for implantation into the human body. 

The quality, durability, viability and sustainability of implanted medical products should be beyond reproach. Beyond questions. While there can never be guarantees in life, medical devices should come pretty damn close. 

How can a medical device that was cited as flawed in the first place, find acceptance for approval? And why is a new medical device similar to an existing approved device, allowed to be spared from full and unbiased testing? The way it is now, if a new medical device up for approval remains similar to an existing device already on the market, it’s fast-tracked through the approval process. 

True, there will always be lemons. That’s a fact of manufacturing life. But there can be no allowance—not even to a fraction of a degree—for the possibility of an overall design flaw in a device that finds its way into the human body. 

In fact, the term ‘recall’ should not even be used when it comes to medical devices. How the hell can you recall something that is implanted inside someone—something that is controlling a person’s heart, or allowing them to walk? 

Recalls are for cars, boats and appliances. Take them back to the store for a replacement, or get your money back. Take the car to the dealer, to be fixed. 

But you can’t yank out your artificial hip and return it to Customer Service, maybe leaving it with them and coming back at 4 o’clock. You can’t take your pacemaker, or defibrillator back to the store. As it is, with the faulty defibrillator leads of a few years ago, surgeons were reluctant to remove them unless absolutely necessary—attaching a lead is a lot easier than removing one, a process that could potentially tear the heart muscle. 

So you are left in the hands of a surgeon who has to evaluate whether, or not it’s better to replace the defective product, or leave well enough alone. If it’s the latter, then you’re walking around with a recalled hip, pacemaker or defibrillator lead in your body wondering with every waking minute if the device that keeps you alive or allows you to walk is going to keep going, or fail. 

Imagine the emotional toll. 

Along with an overhaul of the US Food and Drug Administration (FDA), its policies and its power, there needs to be a complete re-think of the medical device industry to ensure ALL products are properly tested and vetted before allowed for widespread use. 

The word ‘recall’ should not even be a part of the medical device vocabulary. But it will take congressional, and Presidential power to make that happen. 

Tags: Defective Products, medical devices, Recall

This was posted on Friday, October 1st, 2010 at 12:30 pm and is filed under Defective Products, Drugs/Medical . Feel free to respond, or trackback. Read our comments policy.