Serious Adverse Events Triple in Three Years: Is Risk or Reporting to Blame?

By Nora Iluri, founder and CEO, Clarimed and DeviceMatters

Doubling during the past three years, more than 400,000 medical device adverse event reports were submitted to FDA in 2011, according to healthcare rating agency DeviceMatters. Perhaps even more shocking, however, is the 45% annual growth rate and more than 50,000 reported serious patient outcomes--defined as hospitalization or worse--associated with medical device malfunctions or defects in 2011. But is this rapid rise in recent adverse events indicative of riskier medical devices entering the market, or is the industry just becoming more diligent about reporting them?

Key Drivers of Adverse Event Growth

Adverse event reports are filed when a patient has been injured or could have been injured while using a particular medical device. While these reports do not necessarily prove that a medical device caused an injury, they do provide a means of assessing the risk involved in using the product.

On occasion, multiple reports can be filed for the same adverse event. Some adverse events, however, will not involve a patient report. As such, patient outcomes are considered to be a more-accurate measure of the real patient impact of adverse events. In reviewing this data, DeviceMatters found that the top five device categories with the most adverse events (AEs) in 2011 were:

  1. Needles, Syringes, and Infusion Supplies: 53,500 AEs; 3400 serious AEs
  2. Pacemaker and Defibrillator Pulse Generators: 35,100 AEs; 16,600 serious AEs
  3. Sugar (Saccharide) Test Systems: 30,300 AEs; 5700 serious AEs
  4. Pacemaker and Defibrillator Electrodes: 23,500 AEs; 9700 serious AEs
  5. Hip Implants: 25,200 AEs; 2300 serious AEs

These statistics might, at first glance, appear alarming. However, there are four key drivers for the growth in adverse event reports that may justify the jump and even reflect positively on the industry.

Driver 1: Improved Reporting Compliance 
Many experts believe that adverse events are vastly underreported and that much of the growth observed in recent years is simply indicative of improved reporting. Thus, the case may be that the number of people experiencing adverse events is not increasing, but rather that these events are more likely to be reported when they do occur. If the increase in adverse events is purely attributed to improved reporting, then consumers have nothing to worry about.

Driver 2: More Devices in Use Means More Adverse Events 
Medical device prevalence has also grown significantly faster than the healthy 6 to 9% CAGR of the medical device market because products such as pacemakers, defibrillators, and hip implants are expected to have a lifetime ranging from 10 to 20 or more years. Unfortunately, we do not centrally track devices in use--not even for high-risk devices. Therefore, we cannot calculate the normalized adverse event rate for each device category.

Driver 3: Increased Complexity Leads to Errors 
Medical devices are becoming increasingly complex, and complexity spawns errors. This notion is particularly evident in the increased use of electronics and software in recent years as well as in the associated threats, such as malware, that are growing exponentially each year. 

Driver 4: Higher-Risk Patient Groups and Procedures Result in Increased Adverse Events 
Finally, as medical device manufacturers continue to innovate, they often target patients that were previously considered too frail or unsuitable for other medical devices or procedures. Percutaneous heart valves, for example, were introduced specifically for use in some of the most vulnerable patients. If the patient is very sick or the procedure is especially risky, adverse events are more likely to occur. Nevertheless, the benefits might still be worth the risk for those patients.

Regulatory Red Flags

Taking these four factors into account, it is difficult to determine whether overall medical device safety across the industry is actually improving or declining. Nevertheless, the data provides us with ways to evaluate the impact of some of these drivers and gain a better understanding of which categories deserve more or less regulatory attention.

It is interesting to note, for example, that the majority of adverse events hail from a very small number of product groups. We at DeviceMatters have classified medical devices into almost 600 product groups; five of these product groups (listed previously) were responsible for 50% of all adverse event patient outcomes in 2011.

In terms of the growth seen in adverse event outcomes from 2010 to 2011, the same five groups are responsible for 80% of the growth. But if we exclude these five product groups, adverse events for the rest of the medical device industry are pretty much in line with industry growth.

Upon reviewing this data, the question becomes: Are adverse event reports a self-fulfilling prophecy of media and regulatory attention, or can they be used as a predictive measure by which the report numbers tend to skyrocket once issues are reported?

To determine the answer, we need to compare when adverse events began to rise with the timing of a media and regulatory attention-grabbing event such as a major recall. As one example, we examined the adverse event reports filed for Medtronic's pacemakers and defibrillators prior to the recall of the Fidelis lead in 2007.

As seen in Figure 2a, the growth rate of adverse events was, in fact, quite significant prior to the recall of the Fidelis lead in 2007, although the recall did accelerate reporting beyond previously seen rates. Likewise, adverse events for DePuy's metal-on-metal hip implants began rising in 2007, a full three years prior to the ASR recalls (Figure 2b). 

Exploiting Adverse Event Data

While adverse event analytics may not be the silver bullet, analyzing adverse event data in a new light can definitely help provide new insights and early warnings for areas that should be further investigated. Reporting and analytics are starting to be mature enough to serve as an early-warning system to signal potential problems, even though understanding underlying drivers and causes will require additional research in each case. Given that these data are the only source of such fact-based statistics, they should be harnessed, used, and improved upon. 

And industry experts and the FDA can all agree upon that final point. As FDA noted in an October 2011 white paper titled "Understanding Barriers to Medical Device Quality:" "Moving toward greater visibility into device quality and properly aligning FDA's regulatory approach will be important to catalyzing industry movement towards improved device quality." 

Nora Iluri is founder and CEO of Clarimed and DeviceMatters, which focus on medical device safety and approvals with the intention of fostering innovation and improvements in quality. Clarimed has partnered with Qmed to offer users exclusive access to download reports by product code, device category, or by manufacturer through the DeviceMatters Web site. Users can find and download free reports on any device category or manufacturer. Full, detailed reports are also available for a fee. DeviceMatters is currently the only Web site that provides adverse event reporting of medical devices based on unbiased and independent FDA data, among other sources. 

MD&M East—The Details

May 21–24, medical device industry professionals will gather in Philadelphia for the 2012 Medical Design & Manufacturing (MD&M) East trade conference and exhibition. The event brings together manufacturers, suppliers, and industry experts for four days of networking and education at the Pennsylvania Convention Center.

The three-day expo will feature qualified suppliers showcasing all the products and services OEMs need to develop innovative medical devices. The four-day conference will feature 16 full-day programs, with tracks on product design and development, regulatory and quality, and hands-on workshops. As an added bonus, an MD&M East badge also gains attendees access to six other collocated events.

For more information:
UBM Canon
Tel: 310/445-4200

MD&M East Session to Address Risk Management

With high-profile failures of products such as metal-on-metal hip implants in the news and consumer advocates clamoring for safer medical devices, risk management is a topic that has been getting a lot of attention from FDA lately.

“At this point in time, FDA is extremely interested in risk management as a technique to better protect the public health,” says Michael Barile.

Barile, the founder and managing partner of Barile & Associates, a consulting firm that provides advice to FDA-regulated industries, is chairing a two-day track on risk management at this year’s MD&M East conference. The two sessions will cover topics ranging from risk management concepts, terminology, and regulatory requirements to supplier and post-production controls.

The first day’s session is a workshop on ISO 14971:2007. It will focus on introducing attendees to the requirements of the standard as well as detail FDA’s expectations for its integration into a quality management system.

“We’ll do real case studies with the group, selecting certain types of devices and walking through preliminary risk assessments, failure mode and effects analysis, fault tree analysis, path sets, and cut sets,” Barile says.

The workshop, he says, will be highly interactive, and attendees are encouraged to come with questions.

“It’s pretty informal,” Barile says. “If you put your hand in the air and I don’t see it immediately, wad up a ball fo paper and just throw it at me.”

The second day will focus on the real-life ramifications of risk management and how to integrate risk managment into a quality system.

Both sessions are geared toward a broad range of job functions, from manufacturing, quality, and design engineers to those working in regulatory and clinical affairs, Barile says. Professionals in engineering-level, supervisory, and senior management positions will come away with knowledge that will help them better do their jobs.

“Risk Management for Medical Devices: Applying 14971 Effectively Using Risk Assessment and Reliability Tools” and “Beyond Basic Risk Management: How Much is Enough?” will take place Wednesday, May 23, and Thursday, May 24, respectively. Both sessions run concurrently from 9 a.m. to 4 p.m.

Jamie Hartford

Delivering What FDA Expects in Human Factors

Traditionally, human factors have not been a large part of FDA regulatory requirements. That’s all going to change in the fall of 2012, when FDA is anticipated to finalize its new guidance on human factors and human usability requirements. In the view of Stephen Wilcox, founder of human factors and usability design firm Design Science (Philadelphia) the new guidelines promise to add important steps to FDA’s approval process and could help to further clarify the process.

“It’s been a number of years since the original law, 21 CFR 820.30, came out that required validation research; it wasn’t consistently enforced and it wasn’t completely clear what was required,” Wilcox says. “It used to be that it was never clear what the rules were and [FDA] was relatively inconsistent in what it required.”

Wilcox believes that the new guidelines, currently in draft form, will alleviate these issues. “I think this new draft guidance has made it clearer that you really have to go through a process to obtain [FDA] approval. They’ve raised the bar in terms of eliminating user error, but at the same time they’ve made the whole thing much more transparent and predictable.”

It is because of these changes that Wilcox will be chairing a session, “Integrating Design in Human Factors to Meet Regulatory Requirements and User Needs,” as part of MD&M East. The session will cover general principles for addressing human factors with an emphasis on meeting FDA approval.

“The goal is to provide practical advice that has implications for improving products and also helping with regulatory requirements,” he says.

Human factors professionals working in device design, regulatory people looking to be brought up to speed on the new FDA regulations, and even those just looking to learn more about the usability side of device development will be able to immediately apply the information given in this session, Wilcox says.

Even with the new FDA guidance still in draft form, Wilcox stresses that what’s already in place is still of great value to professionals. “The draft was extremely explicit, and even though it’s not finalized, this represents the FDA’s current thinking,” explains Wilcox, who is in constant communication with FDA through Design Science. “I haven’t seen much or any real contradictions in what they say and what is in the draft. The feedback we’ve been getting is in keeping with draft guidance.”

Those in attendance will also benefit from having Ron Kaye on-hand. Kay leads the FDA Human Factors Pre-Market Evaluation Team, the group responsible for the new draft guidance.

“The primary author of the draft guidance is the first speaker,” Wilcox says. Kaye will provide an overview of the new draft guidelines and what companies can expect in the future. Following Kaye’s talk, William Muto, principal human factors engineer at Abbott, will build on Kaye’s discussion and examine ways companies can address the FDA requirements.

“Aidan Petrie of Ximedica is going to talk about putting standard operating procedures in place to address human factors issues,” Wilcox says. “Following that, Michael Wiklund [of Wiklund Research and Design] is going to talk about using technology to make products more usable.”

Speakers will take audience questions, and case studies will be presented to further attendees’ understanding of the process.

“Our plan is to have case studies from major corporations,” Wilcox explains. “We’ll have case studies in which corporate representatives will walk through examples of their work addressing human factors and integrating human factors into industrial design.” Ethicon, Phillips, and GE Healthcare representatives are among the presenters.

For Wilcox this all ties into the core of creating great products, and he hopes attendees will take from the session practical advice as well as a greater appreciation of human factors and design.

“There’s a kind of magic in the combination of human factors and industrial design. Human factors people come from a scientific perspective, and industrial designers are typically trained in art schools,” he says. “There’s a kind of yin-yang between the two, and the combination is what you need to build products that people like to use and to avoid mistakes.”

The session will take place Monday, May 21.

Chris Wiltz

Can a LinkedIn Group with Over 100,000 Members Help Get the Device Tax Repealed?

Can a LinkedIn Group with Over 100,000 Members Help Get the Device Tax Repealed?

Joe Hage

Earlier this year, Joe Hage, the owner of the “Medical Devices Group” on LinkedIn, published a thread from a medical device professional asking if anything good could possibly result from the “tongue depressor tax.” Comments rolled in decrying the tax and its effect on the industry in the United States.

It eventually became apparent that the device tax was “the single issue that people in the industry are the most vocal about,” he says.

So Hage decided to do something big: Set up a website with the intent of getting 25,000 signatures on a petition to repeal it. “I sought to give my members a more constructive outlet than grousing,” he says. 

At the time of writing, there were nearly 1,500 signatures listed on the site and the number is increasing steadily. The “Medical Devices Group” on LinkedIn, which now has nearly 109,000 members, also continues to grow in size—with as many as 500 new names added on some days. 

Hage says that the website and the movement it is working to engender is an appropriate response to the device tax, which could lead to the elimination of 43,000 U.S. jobs and $3.5 billion in lost wages, according to one study. “Companies that are not even profitable will have to pay the tax, too,” he says.

Inspiration for the Effort

In setting up the site, one of Hage’s inspirations was the Kony 2012 campaign to hunt down the Ugandan warlord Joseph Kony. “Everything about that effort was spectacularly done,” he says, pointing out that a YouTube video promoting the cause received more 80 million views.

The day the site was launched, Hage received a call from the Office of Congressman Erik Paulsen (R-MN), a vocal critic of the tax. Paulsen's office gave Hage some concrete steps he could take to help shore up support for the device tax repeal in the Senate.

Medical Devices Group
The “Medical Devices Group” on LinkedIn now has nearly 109,000 members. 

Within the first week following the launch of the online campaign, 90% of visitors to the site came from the United States. The site also will have the ability to report who signed the petition based on their state and zip code.

In 2011, Medical Device Manufacturers Association (MDMA) created a petition protesting the tax that received roughly 400 signatures, which they sent to Congress. “That is almost a year ago. I am sure it still has impact but it is kind of old news now,” Hage says. “What if we were to kind of brush it off and say: remember that letter? Well, here is another 25,000 people who feel the same way.”

One of the things that sets the petition apart from the one sponsored by MDMA is that it was borne out of a grassroots movement, Hage says. “This isn’t just at the CEO level. This is the petition where individual families who would be affected adversely by this tax can say, I am your constituent, and I want my voice to be heard.”

The site is now supported by Cook Medical. Hage is currently looking for other companies to join the effort.

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.

Related Content

What Would Warren Do? Repeal the Device Tax

I haven't seen this many double takes since Pat Robertson came out in favor of legalising marijuana. When Massachusetts Senate hopeful Elizabeth Warren came out in favor of a repeal—yes, she used the r word—of the medical device tax in an editorial on, the reaction was swift and perplexed.

In what the Wall Street Journal called an "op-ed piece for the ages," Warren writes:

"When Congress taxes the sale of a specific product through an excise tax, as the Affordable Care Act does with medical devices, it too often disproportionately impacts the small companies with the narrowest financial margins and the broadest innovative potential. It also pushes companies of all sizes to cut back on research and development for life-saving products."

Clearly, this is not the sort of observation that some would expect from a progressive Democrat, especially someone who was a key architect of the Consumer Financial Protection Bureau. Or, as the Wall Street Journal snarkily put it: "So Ms. Warren is conceding that when the government taxes something we get less of it, though you'd have to be a Harvard faculty member to believe otherwise."

But, as the Healthwatch blog points out, "Warren is not the first Democrat — or even the first liberal Democrat — from a device-industry state to criticize the tax. Sen. John Kerry (D-Mass.) fought the proposal during the healthcare debate. But he voted against Brown’s proposal to repeal the policy in 2010. Sen. Al Franken (D-Minn.) has also been critical of the tax."

And so, many in the twitterverse are asking if opposition to the device tax is gaining steam. No question about it,  AdvaMed just tweeted. What do you think?

Norbert Sparrow

New MIT Coating Could Help Reduce Orthopedic Implant Failure

Hydroxyapatite nanoparticles are incorporated into multilayer coatings for faster bone tissue growth. (Image courtesy of the Paula Hammond Lab at MIT)

Everyone gets older, but different medical conditions affect people at different ages. For the huge cohort of baby boomers, orthopedic maladies associated with such parts of the body as hips and knees pose a particular challenge. But at the medical device design and manufacturing end of the spectrum, such orthopedic conditions represent a challenge and an opportunity to develop new implant technologies, new materials, new sensors, and--not least--new coatings.

As the 2010 recall of DePuy's metal-on-metal acetabular head system amply demonstrates, hip implants are susceptible to high failure rates. In fact, in approximately 17% of patients that receive total joint replacements, the implant eventually loosens, requiring explantation and reimplantation. Addressing this issue, chemical engineers at the Massachusetts Institute of Technology (MIT; Cambridge) have developed a new coating that could help adhere the implant to the bone, preventing premature failure. By inducing the body's cells to produce bone that fixes the implant in place, the coating could also be used to help heal fractures.

Orthopedic implants are typically secured using bone cement, a polymer that resembles glass when it hardens. However, this cement can crack, causing the implant to detach from the bone and producing chronic pain and loss of mobility. Consisting of a very thin film ranging in thickness from 100 nm to 1 µm, the MIT researchers' coating is composed of layers of materials that help promote rapid bone growth. One of the materials, hydroxyapatite, is a natural component of bone. Made of calcium and phosphate, this material attracts mesenchymal stem cells from the bone marrow and provides an interface for the formation of new bone. The other layer releases a growth factor that stimulates mesenchymal stem cells to transform into bone-producing cells called osteoblasts.

Once the osteoblasts form, they start producing new bone to fill in the spaces surrounding the implant, securing it to the existing bone and eliminating the need for bone cement. Having healthy tissue in that space creates a stronger bond and greatly reduces the risk of bacterial infection around the implant.

"When bone cement is used, dead space is created between the existing bone and implant stem, where there are no blood vessels," explains Nisarg Shah, a graduate student involved in the MIT research. "If bacteria colonize this space they would keep proliferating, as the immune system is unable to reach and destroy them. Such a coating would be helpful in preventing that from occurring."

Previous efforts to coat orthopedic implants with hydroxyapatite have been less than satisfactory because these films have been thick and unstable, causing them to separate from the implant, Shah notes. While other researchers have experimented with injecting the growth factor or depositing it directly onto the implant, most of it drains away from the implant site, rendering it largely ineffective. In contrast, the MIT team can control the thickness of its film and the amount of growth factor released by using a method called layer-by-layer assembly, in which the desired components are laid down one layer at a time until the desired thickness and drug composition are achieved.

The Most Common Resume Mistakes in Medical Device Jobs | Medical Device Podcast

Sue Sarkesian

These are all nice accomplishments. But not the right answers. The hiring manager is thinking, "What is this person going to do for ME and MY team." In this interview with Sue Sarkesian, we learn the myths and mistakes you need to avoid as well as the key tips and tricks you need to include on your resume when looking for your next medical device or medtech job.

Who is Sue Sarkesian? She's the cofounder of The Resume Group. Sue has more than 16 years of experience in guiding and coaching individuals through the search process. Working with Sue, candidates learn ways to focus their job search, develop comprehensive search strategies, and execute a targeted plan for a successful job search. Sue holds a Master’s degree with an added concentration in Career and Transition counseling.

Here's What You Will Learn

  • Why you shouldn't use an "objective" on your resume. Instead, you should use what Sue likes to call "the hook".
  • Are you focusing too much on your past responsibilities? Instead, you need to learn how to effectively quantify your accomplishments.
  • If you state it on your resume, you need to be able to prove it. Better yet, there better be a compelling story behind every point you make.
  • What email address are you using for contact purposes? Sue hopes it's NOT an AOL email address.
  • Should you include the statement "references available upon request"?

Learn Sue's technique for matching key phrases on your resume with the hiring company's challenges.
Have you heard of the ATS (Applicant Tracking System)? Find out why this is a BIG deal.

Listen to the "The Most Common Resume Mistakes in Next Medical Device Jobs" podcast (right click and select "Save Link As" to download the podcast).

Download the PDF action points of the "The Most Common Resume Mistakes in Next Medical Device Jobs" podcast.

Value Plastics introduces user-friendly, single-use sanitary clamp

Value Plastics recently announced the PharmaLok Series, a new line of ergonomic, single-use sanitary clamps for securing fittings to bag ports and filters in the biopharmaceutical market. According to the company, PharmaLok clamps provide an advancement for the industry, as a number of existing solutions either require tools for closure or consist of multiple components, turning what should be a simple operation into a difficult and awkward process. Easily operated with one hand, PharmaLok’s patent pending design allows easy attachment of fittings to bag ports and filters. The user simply rests the fitting in the PharmaLok’s regulation-sized slot, lightly grips the surrounding handles, and listens for the sound of three clicks to confirm a secure connection. The hygienic clamps are made of a glass-filled nylon material that is both USP Class VI and ISO 11137 certified, and ASME BPE 2009 DT-5-3 compliant.

Richard Nass

Weekly Vitals: St. Jude Down in Q1, FDA Rips European Approval System, and More

St. Jude reported an unsurprising 9% drop in Q1 earnings this week attributed to weak heart-rhythm sales in the wake of image woes and skepticism following the Riata lead recall in December. Also this week, the Minneapolis Star Tribune ran an interesting story highlighting FDA's view of Europe's medical device approval process while medical device hacking once again nabbed headlines. Read these and other top stories of the week in our weekly roundup below.