Description of Event or Problem · 1
THE PURPOSE OF MY SUBMISSION IS TO REQUEST THAT THE U.S. FOOD AND DRUG ADMINISTRATION -FDA- TAKE ACTION AGAINST MEDTRONIC CORP OF REDMOND, WASHINGTON, TO COMPEL MEDTRONIC TO PROVIDE THE SOFTWARE UPGRADES NECESSARY TO MAKE ALL OF ITS LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATORS -AEDS- COMPLIANT WITH THE 2005 AMERICAN HEART ASSOCIATION GUIDELINES FOR CPR AND EMERGENCY CARDIAC CARE. THESE GUIDELINES, ISSUED ON 11/28/05, RECOMMEND SIGNIFICANT CHANGES IN THE TECHNIQUES OF CPR, INCLUDING THE WAY IN WHICH AEDS ARE INTEGRATED INTO THE CPR PROCESS. THEY ARE BASED ON EXTENSIVE MEDICAL RESEARCH, AND REPRESENT A CONSENSUS AMONG CARDIAC ARREST RESEARCHERS THROUGHOUT THE WORLD. FULL IMPLEMENTATION OF THESE NEW GUIDELINES HOLDS THE PROMISE OF SUBSTANTIALLY INCREASING THE RATE OF SURVIVAL FROM SUDDEN CARDIAC AREST. COMPLIANCE WITH THESE NEW GUIDELINES WITH RESPECT TO THE USEOF AEDS, HOWEVER, IS COMPLETELY DEPENDENT UPON THE WILLINGNESS OF THE MFR OF EACH MODEL OF AED TO PROVIDE UPDATED SOFTWARE FOR IT, SINCE AEDS ARE COMPUTERIZED DEVICES WITH THEIR TREATMENT PROTOCOLS COMPLETELY SOFTWARE-DRIVEN. PRACTICALLY ALL AED MFRS HAVE PROVIDED THE NECESSARY SOFTWARE UPGRADES FOR THEIR PRODUCTS CURRENTLY IN USE. ONE VERY GLARING EXCEPTION TO THIS, HOWEVER, IS THE CASE OF MEDTRONIC CORP WITH RESPECT TO THE EARLIER VERSIONS -GENERALLY MANUFACTURED PROR TO 5 YRS AGO- OF ITS POPULAR LIFEPARK 500 AED. THESE AEDS ARE VERY EXTENSIVELY USED BY BOTH EMS AGENCIES AND PUBLIC ACCESS DEFIBRILLATION -PAD- PROGRAMS THROUGHOUT THE UNITED STATES. IN OUR THREE-COUNTY REGION ALONE, THERE ARE WELL OVER ONE HUNDRED CURRENTLY IN USE. IN THE SPRING OF THIS YEAR, MEDTRONIC RELEASED INFO ON HOW ITS AED PRODUCTS COULD BE UPDATED TO COMPLY WITH THE NEW GUIDELINES. INCLUDED IN THIS INFO WAS THE STATEMENT "MONOPHASIC LIFEPAK 500 AEDS ARE NOT UPGRADEABLE." "MONOPHASIC" REFERS TO THE ELECTRICAL WAVEFORM USED IN THE SHOCKS DELIVERED BY THE EARLIER VERSIONS OF THE LIFEPAK THUS, NO OPTION WAS GIVEN TO BRING THESE DEVICES INTO COMPLIANCE WITH THE NEW GUIDELINES, OTHER THAN TO REPLACE THEM WITH NEW EQUIPMENT -MEDTRONIC'S STATEMENT CAN BE FOUND ON-LINE AT HTTP//72.5.51.168/_DWN/PWN/LP500.PDF-. I IMMEDIATELY MADE CONTACT WITH MEDTRONIC CORPORATION, IN THE PERSON OF THE MEDTRONIC SENIOR SALES REP SERVING OUR REGION-, DURING WHICH I EXPRESSED MY DISAGREEMENT AND DISMAY WITH MEDTRONIC'S UPGRADE POLICY REGARDING MONOPHASIC LIFEPAK 500S. WHILE EXPRESSING UNDERSTANDING OF AND SYMPATHY FOR MY CONCERNS, AND PROMISING TO ESCALATE THEM TO HIGHER LEVELS OF HIS CO, HE NONTHELESS AFFIRMED THE POLICY, AND HELD OUT LITTLE HOPE THAT IT WOULD CHANGE. IN THE ENSUING WEEKS, I WOULD HAVE FURTHER TELEPHONE COVNERSATIONS WITH HIM, AND WITH HIS REGINAL SALES MGR. FINALLY, ON JULY 17, I REC'D A LETTER FROM MEDTRONIC'S VICE PRESIDENT FOR GLOBAL MARKETING AND SOLUTIONS, AFFIRMING THE NON-UPGRADE POLICY AND RESTATING THE SUGGESTION THAT THE OLDER EQUIPMENT BE REPLACED WITH THEIR NEWER PRODUCTS. AT THIS POINT, IT IS APPARENT TO US THAT OUR EFFORTS TO PERSUADE MEDTRONIC TO CHANGE ITS NON-UPGRADE POLICY FOR OLDER LIFEPAK 500S HAVE FALLEN ON DEAF EARS, AND WE ARE NOW APPEALING TO REGULATORY AUTHORITY TO ASSIST US WITH WHAT HAS BECOME A SIGNIFICANT PUBLIC HEALTH CONCERN. IN PARTICULAR, WE ARE CONCERNED WITH THE CONFLICT BETWEEN WHAT IS NOW TAUGHT BY ALL OF THE MAJOR NATIONALLY-RECOGNIZED CPR TRAINING PROGRAMS -AMERICAN HEART ASSOCIATION, AMERICAN RED CROSS, NATIONAL SAFETY COUNCIL, AMERICAN SAFETY AND HEALTH INSTITUTE-, AND THE WAY IN WHICH THESE OLDER AEDS PERFORM WITHOUT THE NEEDED UPGRADES. THE USE OF AN AED IS A LOW-USE SKILL, ESPECIALLY FOR LAY PAD RESPONDERS AND EMS PROVIDERS IN LOW-VOLUME -RURAL- EMS SYSTEM, AND THE CONFUSION CREATED BY THIS DISCREPANCY MAY WELL RESULT IN INEFFECTIVE ACTIONS OR A HESITANCY TO ACT ON THE PART OF THESE RESPONDERS WHEN FACED WITH A CARDIAC ARREST EMERGENCY. CERTAINLY, FOR MOST OWNERS OF OLDER LIFEPAK 500 AEDS, THEIR REPLACEMENT WITH NEW EQUIPMENT IS NOT A VIABLE OPTION. MANY OF THESE AEDS WERE PURCHASED WITH FUNDS DONATED BY THE PUBLIC -AT A COST OF UP TO $3,500 EACH, WITH NO SUCH FUNDING AVAILABLE OR OBTAINABLE FOR THEIR REPLACEMENT -ESPECIALLY AFTER SUCH A SHORT SERVICE LIFE FOR THE INITIAL UNITS.- WE STRONGLY BELIEVE THAT IT IS IN THE BEST INTEREST OF THE PUBLIC THAT MEDTRONIC BE REQUIRED TO PROVIDE THE SOFTWARE UPGRADES NECESSARY TO BRING ALL OF ITS LIFEPAK 500 AEDS IN COMPLIANCE WITH THE CURRENT INTERNATIONAL GUIDELINES. THERE WOULD SEEM TO BE NO BARRIER TO MEDTRONIC PROVIDING THESE UPGRADES OTHER THAN ITS DESIRE TO PROFIT FROM THE SALE OF NEW EQUIPMENT.