November 15, 2010
Dear External Defibrillator Manufacturer:
FDA’s records have identified you as the “Official Correspondent” for the Medical Device Manufacturer stated above. Please ensure that the following message is relayed to the most responsible individual at the Medical Device Manufacturer.
The Food and Drug Administration (FDA) is notifying you of our concerns relating to serious adverse events noted in Medical Device Reports (MDRs) associated with the use of external defibrillators and a large number of recalls of external defibrillators. As a result, FDA may, in the future, take regulatory steps to improve the current premarket and postmarket regulatory processes associated with external defibrillators. The FDA believes that improvement in the regulatory processes will help mitigate current risks and reduce future risks associated with external defibrillators.
External defibrillators are important, life-saving devices. However, over the past five years we have seen persistent safety problems with all types of external defibrillators, across all manufacturers of these devices. From January 1, 2005 to July, 10, 2010, there were 68 recalls, exhibiting an increase from nine (in 2005) to 17 (in 2009, the last complete year for which data are available). During this period, the FDA received over 28,000 medical device reports (MDRs), which also exhibited an increase from 4,210 (in 2005) to 7,807 (in 2009, the last complete year for which data are available). The FDA conducted multiple inspections of all external defibrillator manufacturers throughout this time period.
Many of the types of problems we have identified are preventable, correctable, and impact patient safety. We have concluded that there are numerous problems with industry practices for designing and manufacturing defibrillators, handling user complaints, conducting recalls, and communicating with users. Our analysis demonstrates that there are problems with how well firms control how they purchase and accept components used in the manufacture of external defibrillators. The analysis also demonstrates problems with how changes to the device are evaluated before being implemented.
We strongly recommend external defibrillator manufacturers meet with the Agency early in the device development process to discuss submissions regarding new external defibrillators or changes to existing external defibrillators that require significant engineering testing, animal or clinical studies. Such meetings could include discussions of any studies or testing necessary to support the submission, and any other premarket data needs. For further information, please contact Mitchell Shein at (301) 796-6363, or email@example.com.
We also recommend early discussions with FDA’s Office of Compliance regarding the development and implementation of adequate design and purchasing controls. FDA also may conduct pre- or post-clearance inspections in certain circumstances, in accordance with its statutory authority. For further information, please contact Anastacia Bilek, at (301) 796-5588, or firstname.lastname@example.org.
On December 15-16, 2010, FDA is hosting a public workshop to address external defibrillator innovation and to discuss FDA’s current areas of concern regarding these devices. We look forward to your participation.
FDA believes these actions, early communication between the FDA and external defibrillator manufacturers, and additional actions being announced by the Agency today will result in safer and more effective external defibrillators. We look forward to working with you on this important public health issue.
Jeffrey Shuren, M.D., J.D.
Director, Center for Devices and Radiological Health
Food and Drug Administration