Clarimed’s Research Finds 230,000 Medical Device Adverse Event Reports in 2010

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Are devices becoming riskier, with a reported 24% annual rise in serious adverse event reports, or are we just getting better at reporting serious adverse events?

Clarimed, the first healthcare rating agency of its kind, has recently uncovered that over 230,000 medical device adverse events were reported to the FDA in 2010 alone. This is a sharp increase from only 3 years ago. Adverse event reports are filed when somebody has been injured or could have been injured while using a medical device. These reports do not prove that a device caused the injury, but it does provide a sense for how much risk is involved in using medical devices.

About 30,000 of the 230,000 medical device adverse events reported in 2010 had very serious outcomes resulting in hospitalization or worse. This included about 5,300 deaths. These statistics are not only alarmingly high today, but serious adverse events have been growing by 24% each year since 2007. That means 90% more adverse event reports in 2010 than in 2007.

The top 5 device categories with the most adverse events (AEs) in 2010 were:
1.    Needles, Syringes and Infusion Supplies: 23,000 AEs, 4,200 serious AEs
2.    Pacemaker & Defibrillator Pulse Generators: 20,000 AEs, 3,500 serious AEs
3.    Sugar Test Systems: 19,000 AEs, 3,600 serious AEs
4.    Pacemaker & Defibrillator Electrodes: 13,000 AEs, 2,700 serious AEs
5.    Implanted Spinal Cord Stimulators: 9,000 AEs, 500 serious AEs

“Science has evolved, the FDA is constantly improving requirements and manufacturers are continuously releasing patches and newer models to fix problems. Shouldn’t we be safer today than 3 years ago?” asked Dr. Nora Iluri, founder and CEO of Clarimed. The data and trends are definitely painting a bleak picture for medical device safety, but even the FDA is unclear on what drives the rapid increase in adverse event reports, and whether consumers should be concerned.

There are generally 4 reasons given for the increase, some are purely book-keeping effects, and some are highly concerning trends:

Reason 1: Improved Reporting Compliance
Experts believe that reporting compliance has been improving. This means that it is not necessarily that more people are getting hurt by medical devices, but that people are more likely to report it when they are hurt. Experts believe there is a long way to go to achieve good compliance as providers tend to be too busy to file reports and patients often do not know enough to file them. If the issue is only that reporting compliance is improving, then consumers have nothing to worry about.

Reason 2: More Devices in Use Means More Adverse Events
Medical device prevalence has grown significantly faster than the healthy 6-9% CAGR of the medical device market, as many devices remain in use for 10-20+ years. Unfortunately we do not centrally track devices in use, therefore we cannot calculate the true adverse event rate per device.

Reason 3: Complexity Leads to Errors
Medical devices are becoming increasingly complex. Complexity spawns errors. This is especially true with the increased use of electronics and software in medical devices and new threats, like malware, that are growing exponentially each year.

Reason 4: Higher Risk Procedures Result in More Adverse Events
As companies continue to innovate, they often target patients that were considered too frail for other procedures or devices earlier. A good example is the introduction of percutaneous heart valves, which are used on some of the most vulnerable of patients. If the patient is very sick and/or the procedure is more risky, adverse events are more likely to occur. Nevertheless, the benefits might still be worth the risk for those patients. Unfortunately it is not known whether the same procedure and situation using medical devices are riskier today or not.

One thing is for sure that experts and the FDA all agree on: “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.” quoted from the FDA.

To learn more about medical device safety and approvals, please visit Clarimed at

About Clarimed
Clarimed is a first-of-its kind healthcare ratings agency and reference site empowering consumers and professionals with fact-based information to make informed decision about their healthcare. Clarimed’s core analytics and ratings are based on official government data, among others, to provide the most helpful insights into healthcare product quality and performance. Founded by Dr. Nora Iluri, a Ph.D. from MIT and a former McKinsey consultant, Clarimed is headquartered in Silicon Valley. Follow Clarimed on Facebook at, Twitter @ClarimedInc or visit the website at:


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