Mike Barbella09.29.10
Add the Advanced Medical Technology Association (AdvaMed) to the growing number of defenders of the U.S. Food and Drug Administration’s premarket device review process.
A study recently released by AdvaMed found that less than 1 percent of all medical devices cleared through the FDA’s 510(k) review process have been involved in serious product recalls over the last 12 years. Conducted by Cambridge, Mass.-based research firm Battelle Memorial Institute, the study analyzed public data from both the FDA and companies with recalled products to reach its conclusion.
Battelle unearthed 77 Class I recalls (the most serious kind) among the roughly 47,000 medical devices cleared through the 510(k) process since 1998, giving the FDA a 0.16 percent recall rate for that time period. Even fewer devices (0.08 percent) were recalled for design reasons that may have been caught during the premarket review process. Twenty-nine percent of the recalls were traced to manufacturing deficiencies and 6 percent resulted from labeling mistakes, according to the report. Another 15 percent were recalled for “design or manufacturing” reasons (meaning data were not available to help officials pinpoint the cause of the recall.
“If you look at the data, you’ll see a situation where it’s hard to imagine any other regulatory process that will have as good a record at weeding out unsafe products before they reach patients,” AdvaMed Vice President David Nexon said during a conference call discussing the 14-page study.
Battelle’s report complements the results of two other studies released earlier this year that reaffirm the effectiveness of the FDA’s 510(k) review process. University of Minnesota professor Ralph Hall, Ph.D., determined the rate of Class I recalls for 510(k) products to be less than 0.2 percent while William H. Maisel, M.D., of Beth Israel Deaconess Medical Center in Boston, Mass., put the recall rate in the range of 1.0 to 1.5 percent.
The quantitative nature of Battelle’s report could prove helpful to the FDA as it attempts to overhaul the premarket approval process. In early August, the agency released a blueprint for improving the process, detailing its plan in a 172-page report that calls for increased reviewer training, development of additional guidance, and greater communication of reviewers’ decision rationale. But AdvaMed executives are wary of many of the more than 70 changes proposed by the FDA; they argue that changes to the 510(k) process could significantly disrupt the program and delay patients’ access to technological advancements. AdvaMed officials also cite the three industry studies as proof that additional premarket review requirements will not considerably improve device safety.
“Reform of the 510(k) program is appropriate, but you need a scalpel, not a meat axe,” Nexon said. Added Stephen J. Ubl, AdvaMed president and CEO: “These studies reinforce the fact that the basic structure of the 510(k) process is sound. We believe the FDA’s recommendations should be targeted, focusing on a small number of specific device types where changes will result in a clear public health benefit without creating new hurdles for the vast majority of 510(k) cases.”
Internal evaluations by the FDA have shown frustration within the industry about the efficiency of the 510(k) process. Last year, the Center for Devices & Radiological Health (CDRH) received a record number of calls, according to a report from the FDA’s ombudsman. The CDRH experienced a dramatic, 45 percent increase in complaints in 2009, logging a record high of 1,333 in 2009.
The FDA is gathering public input on its proposed changes to the 510(k) program through Oct. 4.
A study recently released by AdvaMed found that less than 1 percent of all medical devices cleared through the FDA’s 510(k) review process have been involved in serious product recalls over the last 12 years. Conducted by Cambridge, Mass.-based research firm Battelle Memorial Institute, the study analyzed public data from both the FDA and companies with recalled products to reach its conclusion.
Battelle unearthed 77 Class I recalls (the most serious kind) among the roughly 47,000 medical devices cleared through the 510(k) process since 1998, giving the FDA a 0.16 percent recall rate for that time period. Even fewer devices (0.08 percent) were recalled for design reasons that may have been caught during the premarket review process. Twenty-nine percent of the recalls were traced to manufacturing deficiencies and 6 percent resulted from labeling mistakes, according to the report. Another 15 percent were recalled for “design or manufacturing” reasons (meaning data were not available to help officials pinpoint the cause of the recall.
“If you look at the data, you’ll see a situation where it’s hard to imagine any other regulatory process that will have as good a record at weeding out unsafe products before they reach patients,” AdvaMed Vice President David Nexon said during a conference call discussing the 14-page study.
Battelle’s report complements the results of two other studies released earlier this year that reaffirm the effectiveness of the FDA’s 510(k) review process. University of Minnesota professor Ralph Hall, Ph.D., determined the rate of Class I recalls for 510(k) products to be less than 0.2 percent while William H. Maisel, M.D., of Beth Israel Deaconess Medical Center in Boston, Mass., put the recall rate in the range of 1.0 to 1.5 percent.
The quantitative nature of Battelle’s report could prove helpful to the FDA as it attempts to overhaul the premarket approval process. In early August, the agency released a blueprint for improving the process, detailing its plan in a 172-page report that calls for increased reviewer training, development of additional guidance, and greater communication of reviewers’ decision rationale. But AdvaMed executives are wary of many of the more than 70 changes proposed by the FDA; they argue that changes to the 510(k) process could significantly disrupt the program and delay patients’ access to technological advancements. AdvaMed officials also cite the three industry studies as proof that additional premarket review requirements will not considerably improve device safety.
“Reform of the 510(k) program is appropriate, but you need a scalpel, not a meat axe,” Nexon said. Added Stephen J. Ubl, AdvaMed president and CEO: “These studies reinforce the fact that the basic structure of the 510(k) process is sound. We believe the FDA’s recommendations should be targeted, focusing on a small number of specific device types where changes will result in a clear public health benefit without creating new hurdles for the vast majority of 510(k) cases.”
Internal evaluations by the FDA have shown frustration within the industry about the efficiency of the 510(k) process. Last year, the Center for Devices & Radiological Health (CDRH) received a record number of calls, according to a report from the FDA’s ombudsman. The CDRH experienced a dramatic, 45 percent increase in complaints in 2009, logging a record high of 1,333 in 2009.
The FDA is gathering public input on its proposed changes to the 510(k) program through Oct. 4.