10 Causes of Medical Device Failure

  • 1. Insufficient Testing

    Going about electrostatic discharge testing (ESD) in the wrong way can be perilous, as a popular YouTube video titled “Don't worry, it's just ESD!” points out.  

    Not doing any kind of requisite testing for that matter can be problematic, of course.

    Evidently, HeartWare (Framingham, MA) made that mistake when developing controllers for a clinical trial of its implantable heart pumps. The older controllers, used by about 120 U.S. patients, exhibit a higher susceptibility to electrostatic discharge (ESD) than the company’s newer, commercial controllers.

    Such an ESD could cause the pump to stop, leading to serious injury or death, the company said. Since a voluntary Field Safety Corrective Action in 2013, HeartWare has received reports of one additional death and one additional serious injury in which ESD may have caused or contributed to a pump stop.

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  • 5. Having Inadequate Alarm or Warning Technology

    False alarms are commonplace in hospitals, where patient monitors, infusion pumps, and other devices sound alarms when there is in fact no problem.

    Recent recalls of infusion pumps as well as 13,000 MRI systems, however, point to the opposite problem: devices that lack a sufficient warning system.

    A Class I recall last year of the Hospira Plum A+ and Plum A+3 Infusion Systems was announced because the devices sometimes fail to sound an alarm tone when a therapy is interrupted.

    Similarly, the recalled MRI machines from from GE Healthcare apparently did little to warn users when the systems’ magnet rundown units (MRU) were disabled. The MRUs offer a method of turning off the MRI system’s powerful magnetic field during an emergency. Such an emergency can occur when a large metallic (ferrous) object is placed within the unit’s magnetic field, potentially causing life-threatening injuries to any people who happen to be in the area.

    The MRUs could apparently be switched off by service personnel or by equipment users. This prompted GE to release a voluntary field corrective action report that recommends users of the devices to do a diagnostic test to determine whether the MRI’s MRU is disabled.

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  • 4. Ignoring Negative Data

    Metal-on-metal hip implants were supposed to last longer than their metal-on-poly counterparts. The DePuy Articular Surface Replacement (ASR) device, for instance, was expected to stand up to 15 years of use. Marketed to orthopedic surgeons because of its durability, the cobalt-chrome-molybdenum device was designed to have minimal friction between the ball and socket joint and the surfaces within the joint were exceptionally smooth. In addition, designers expected a thin layer of bodily fluid to fill the joint, minimizing friction further.

    An internal groove on the cup of the ASR device was designed to provide space for an orthopedic surgeon to use a tool to position the implant within a patient’s hip. The groove, however, limited the surface area of the cup, making it more likely that the ball would rub up against the edge, generating significant friction and metallic debris in the process.

    The ASR implant, however, did not perform as intended, and last year, it was revealed that the implant failed an internal test in 2007 that pit the device against other Johnson & Johnson hip implants.

    While we don’t know the specifics of what happened there, the example does illustrate the importance of learning from negative data—whether it be less than stellar testing data or complaints from your users.

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  • 7. Improper Labelling or Instructions

    Mentioned earlier, the Olympus TJF-Q180V duodenoscope also illustrates another pitfall: marketing a device without inadequate operating instructions.

    Lawsuits filed against Olympus allege that the TJF-Q180V was redesigned, but the cleaning instructions packaged with the device referenced an older model.

    In March, the company released new instructions that call for several changes in how the devices are cleaned, including the use of a smaller cleaning brush and additional recess flushing and forceps elevator raising and lowering steps.

    In a similar vein, there were three serious recalls in the United States last year related to confusion over which electrodes to use on certain Philips automated external defibrillators.

    The Dutch multinational made changes to the connector design of its FR3 and FRx AEDs, according to the FDA. But health providers and other users apparently did not understand that the changes meant that the Philips AEDs should only be used with the Philips brand electrodes specified in equipment manuals.

    The misunderstanding over the ramifications of Philips’ change meant that hundreds of thousands of other electrodes were involved in three Class I-level recalls. Companies with recalled electrodes including Heart Sync Inc., CONMED Corp., and Covidien.

    Both Heart Sync and CONMED said they had not received any reports of deaths or injuries. But Covidien had two reports of a mismatch that delayed resuscitation. One of the cases may have contributed to a death, according to the company. 

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  • 6. Ignoring Appropriate Regulatory Requirements

    Two medical devices have received attention recently for marketing products without the appropriate regulatory stamp of approval.

    Most prominently is the Olympus TJF-Q180V duodenoscope, which played a role in several hospital-acquired infections—including two deaths. Olympus was able to capture the the lion’s share of the duodenoscope market for a device that had no 510(k) clearance during the outbreak of infections. FDA, however, did not remove the device from the market, explaining that doing so “could lead to an insufficient number of available duodenoscopes to meet the clinical demand in the United States of approximately 500,000 procedures per year.” Instead of pulling the product from the market, Olympus released updated instructions for cleaning the devices.

    Most recently is the recall of the Ebola Virus One-Step Test Kits from LuSys Laboratories, which were marketed without FDA clearance or Emergency Use Authorization for in vitro diagnostic detection of Ebola virus.

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  • 3. Piggybacking onto Questionable Products

    The substantially equivalent doctrine at the heart of the 510(k) premarket notification program means that a chain of devices can reach the market, piggybacking onto products that are all theoretically substantially equivalent. In reality, however, each product in the chain may deviate somewhat from the predicate before it.

    Things can get especially tricky when a product in such a chain turns out not to be as safe as the predicate before it, yet nonetheless makes it to the market. And every couple of years, we get a reminder that just because a device is cleared for sale with the 510(k) pathway doesn’t mean that is safe.

    Such was the case of the ProteGen from Boston Scientific, the first vaginal mesh product to be introduced in the United States. Introduced in 1996, the device received 510(k) clearance on the basis that it was substantially equivalent to cardiovascular grafts already on the market. Its manufacturer tested the device on rats in a 90-day trial, which, along with bench testing data, was sufficient to have it win regulatory clearance. The ProteGen product had not been tested on humans for urologic applications when it was released. After the device was introduced, many patients treated with the device began to complain of severe side effects, prompting Boston Scientific to yank the product from the market in 1999.

    Later, a number of other vaginal mesh products were introduced by piggybacking onto the ProteGen, even though the product was recalled.

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    Image from http://meshmedicaldevicenewsdesk.com

  • 10 Causes of Medical Device Failure

    April 2015

    When medical devices fail, the consequences can be tragic. Here are 10 common reasons they do.

    Learn more about cutting-edge medical devices at MD&M East, June 14–15, 2016 in New York City.

    Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz. Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker

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    Image above inspired by figure from an FDA guidance document.

  • 2. Rushing the Product Development Process

    It is common to have aggressive milestones in the product development cycle. But device developers should be careful that their product development timeline is not unrealistically paced, says Jon Speer, founder of Greenlight.guru (Indianapolis, IN). That can result in sloppiness, which can result in user complaints, 483s, and recalls down the road.

    Early on in product development, at least, complaints are actually good, helping to inform and refine the product development process. Negative feedback in the prototyping stage is much easier to accommodate than complaints received after a product has been released.

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  • 8. Haphazard Design Controls

    Complying with design control process is one of the most common deficiencies at medical device companies. Problems with design controls can sometimes be egregious. “I know of a medical device startup that actually submitted their 510(k) to the FDA that didn’t have any of their product development activities documented outside of what was in the FDA submission,” says Jon Speer, founder of Greenlight.guru. “When I hear that, I think: ‘how can you possibly do that?” The whole premise of the 510(k) is that you document your design controls and prove your product is safe and effective.”

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  • 9. Contamination

    Safeguarding medical devices from contamination can be a challenge. Orthopedic devices, for instance, are often machined by third parties that can be difficult to monitor. The machining process itself can leave metal shavings that are difficult to rinse off in an aqueous or oil-based bath. Those baths can leave their own residue as well as microbiological and particulate debris. Contamination from chemical attack is another common problem for medical devices.

    Such problems can typically be detected with a variety of tests. Chemical attack, for instance, can be recognized using Fourier transform infrared spectroscopy. 

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  • 10. Off-Label Promotion

    The Acclarent Stratus sinus balloon catheter device was reportedly designed to elute drugs through small holes in the balloon, according to an indictment filed in U.S. District Court in Massachusetts. But the makers of the device received 510(k) clearance for the indication of mechanically “maintain[ing] an opening to the sinus for 14 days” and deploying saline to that tissue.

    Two of the company’s former executives have been recently charged with promoting the device for off-label use: delivering a steroid to the sinus mucosa.

    While this example is extreme, off-label “probably happens more where people realize,” says Jon Speer, founder of Greenlight.guru. “You get clearance for certain use but the most common use might be different than what you got clearance for.”

    The risks associated with off-label use can sometimes be extremely high—and in the case of the Synthes Norian product, off-label use can be fatal for some patients.  

10 Causes of Medical Device Failure

April 2015

When medical devices fail, the consequences can be tragic. Here are 10 common reasons they do.

Learn more about cutting-edge medical devices at MD&M East, June 14–15, 2016 in New York City.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz. Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker

Like what you’re reading? Subscribe to our daily e-newsletter.

Image above inspired by figure from an FDA guidance document.

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