Understanding Barriers to Medical Device Quality is the name of an FDA report issued October 31 by the Center for Devices and Radiological Health (CDRH) and the Food and Drug Administration (FDA) in an attempt to get a handle on why the medical device industry is putting out poorly made, defective medical devices that are injuring patients.
See the report here.
In 2001 medical devices were a $73.6 billion industry. By 2009, that had grown to $147.6 billion. And while the medical device industry has seen tremendous growth in the last several years, the FDA report says the complication rate from those devices has outpaced the growth of the industry.
During those years more than 30,000 medical devices were cleared through the 510(k) process, a fast track approval for marketing procedure where the manufacturer claims the device is substantially similar to a medical device already on the market despite rapid advances in technology and innovation in materials.
At the same time there were 303 new devices that were required to undergo premarket approval (PMA), the closer scrutiny for safety and efficacy.
No surprise then that serious adverse event reports have outpaced the industry’s growth by 8% a year every year since 2001.
Hospital/ surgical devices and cardiovascular devices account for nearly 60% of those complications, the report says.
Failures in the design of the product and in manufacturing caused more than half of medical device recalls.
The volume of adverse events as measured on the MAUDE database (Manufacturer and User Facility Device Experience) are on the rise about 15% a year. With 1.2 million records on MAUDE from 1998 to 2009, the adverse events sharply increased to 22% a year from 2005 to 2009. Life-threatening or death, disability and hospitalization rose 17% during that time.
In 2009, there were 28,000 serious complications from U.S. medical devices
Editors Note – The MAUDE database is thought to reflect a serious under-reporting of complications because consumers don’t know MAUDE exists and it is not terribly user-friendly requiring detailed information about a medical device many patients do not have.
Doctors may be reluctant to report complications, though under the Medical Device Reporting regulations of the FDA they are supposed to. See here.
Recalls have not kept up with the adverse event reports. For example in 2003 there were 540 recalls, in 2009 there were 763 recalls with an annual increase of 6%.
Class III are high risk devices generally considered essential for sustaining life. Class III devices in 2003 were responsible for 27% of adverse event reports and by the year 2009, responsible for 40% while recalls shrank from 17% in 2003 to 7% in 2009.
Surgical mesh is a Class II moderate-risk medical device and that is the class responsible for 52% of complications in 2009.
Synthetic surgical mesh is in the Top 20 product codes for serious adverse events, though at 1,311 events far behind 14,016 for an insulin pump or 10,917 for a coronary drug-eluding stent. Many devices that have caused serious harm have been recalled while most types of polypropylene surgical mesh products remain on the market.
The FDA tracks “problem codes” that is the Top 20 device product codes to determine the most serious adverse events with 11 of the 20 associated with cardiovascular devices (stents, grafts, defibrillators). The FDA does not correlate codes to the specific description of a problem such as death.
The medical device industry says it resents what it perceives to be the “policeman mentality” of regulators driven by negative PR while the European Union is seen as being more “collaborative” and friendly, says the report.
Correlating the 989 product codes with patient outcomes would “enhance transparency” as the FDA likes to say and give the agency a better handle on what’s going on with a problematic device.
With so many patients suffering from adverse events due to medical devices, the authors of this report said they wanted to get a better handle on lapses in safety and quality and so they interviewed medical device “thought leaders” and FDA leadership as well as analyzed FDA adverse event reports and data.
Here are the participants - Heather Howell- moderating; Jeff Shuren, Dir. CDRH, Steve Silverman, Dir. Office of Compliance, CDRH; Donna Godward Chief Quality Officer Medical Devices, Johnson & Johnson; Ted Fuhr, McKinsey and Co.; Luann Pendy, PhD Medtronic; Liz Blackwood, GM GE Healthcare; David Elder, Dir. Office of Regional Operations, FDA.
The exchange can be seen on an FDA Webcast here.
Editors Note * There were no injured patients present to add their point of view and perspective to adverse events!