FDA Workshop External Defibrillator Improvement Initiative December 15-16, 2010

1. MDR Reporting Factors Over the Past 5 Years Derek Smith Senior Vice President General Manager Therapeutic Care Philips Healthcare FDA WorkshopExternal Defibrillator Improvement InitiativeDecember 15-16, 2010

2. The Population of AEDs Has Increased Significantly Over the Past 5 Years AEDs Worldwide AED Milestones AED Milestones Global Automated External Defibrillators (AED) Market: Demand to Drive Growth; June 2009 U.S., European and Japanese External Defibrillation (PAD) Market Report. Frost & Sullivan. 2000. Valenzuela TD, et al. N Engl J Med. 2000;343:1206-1209. Caffrey S, et al. N Engl J Med. 2002;347:1242-1247.

3. Reporting Regulation (21CFR 803) for External Defibrillators • “…An event that manufacturers or importers become aware of that reasonably suggests that one of their marketed devices: • May have caused or contributed to a death or serious injury, or • Has malfunctioned and that the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.” 3

4. Challenges for External Defibrillator Reporting • In many types of emergencies where an external defibrillator is used, the patient is already severely ill and the likelihood of survival is low. Defibrillation therapy can be highly effective, but only with certain patients suffering from specific conditions. • When Philips investigates events where a patient did not survive, it is often difficult to obtain the information needed to assess whether the patient could have benefited from defibrillation therapy, Because the reporting standard is “may have caused or contributed to death or serious injury, whether an event is reported depends more on how much information we were able collect, rather than on the actual contribution of the defibrillator to the patient outcome. 4 MDR Guidance Document. September 9, 1994.

5. Challenges for External Defibrillator Reporting • If the defibrillator issues an alert that it may need services while sitting on a crash cart, in a wall cabinet or in a closet long before it is needed in emergency,, the conservative approach under the regulations is still to submit an MDR.  However,  should a report be made “in cases where the manufacturer has data showing the issue can be detected prior to emergency use?” • Knowing exactly what to report and what not to report in these situations has led Philips to adopt a conservative interpretation of  “may have caused or contributed to death or serious injury” resulting in an aggressive approach to MDR reporting over the past 5 years 4 MDR Guidance Document. September 9, 1994.

6. Philips Experience with MDR Reporting • The number of MDRs from Philips has increased over the past 5 years • Aggressive reporting and an increased number of units in the field have been significant factors • Philips experience is consistent with published literature on MDRs and lives saved Shah JS, Maisel WH. Recalls and Safety Alerts Affecting Automated External Defibrillators. JAMA. 2006; 296:655-660. 5

7. Our Mission is to Help Improve and Save Lives External defibrillators are doing this 6

8. Recommendations for Moving Forward • Collaborate with clinicians, the FDA, and industry to fully understand how we can further improve outcomes • “We are never satisfied” • Meeting of FDA/manufacturers to update 1994 MDR guidance document that reflects the modern use of external defibrillators so that reporting better reflects field performance and offers better data for dialogue on future generation defibrillator development 7