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The HCMA is clear in its mission and this mission leaves us in an interesting and perplexing position at this time. We have been working to raise awareness of HCM and assisting those with the condition to get the appropriate level of care for their condition. As 1 in 500 people in the USA have HCM and an estimated 20-25% of them are at elevated risk for sudden cardiac death we need to help these people protect themselves by means of the use of ICD’s. Simply stated the HCMA advocates the use of this important therapy in the appropriate patient population. The HCM community has a great interested in all of the companies that manufacture and develop ICD therapies. Those with HCM and ICD’s know that we are trusting our lives to a manmade device that is susceptible to human error and potential failure. We are also trusting the manufactures to provide timely and accurate information regarding problems, concerns or failures of devices. The recent news of recalls from Guidant have brought up many concerns and worries within the HCM community. While Medtronic and St Jude have also had advisories and programming recalls neither have raised the ethical and moral questions that Guidant’s failure for timely discloser have.
An important question that needs to be addressed is the manner in which the patients were notified of the advisory or recall. The HCMA firmly believe that it is the responsibility of the manufacturer to notify the doctors and patients directly while also advising the media. Many patients have only found out about the recall due to media coverage, which leaves them open to many questions and unnecessary apprehension and fear.
In the case of the Guidant’s Prizm 2 models there is no excuse to have withheld information on potential flaws in the device, which we now know to be responsible for at least 2 deaths. I know as a patient I want all information about my device so the I can discuss it with my doctor and make the best choice for me, I know many within the HCM community share my feelings. If there is a problem with a device patients have a right to expect full and complete disclosure, anything less is criminal. Now that the problem has been exposed the remedy provided by the manufacture was offering a replacement device and a minimal amount of compensation for uncovered medical expenses. Within one week of this offer, Guidant has issued a second advisory and has asked doctors to stop using 5 other ICD’s, thus leaving the question what ICD should patients receive as a replacement? And who is going to pay for these replacements?
The other question that must be asked is who is responsible for the financial aspect of these situations? The patient and or their insurance company have paid for the original surgery and have paid for the original device. Now the manufacture has found an error issued a recall and the question must be who is responsible for the costs associated.
In the end what is important to know is the ICD therapy have saved the lives of thousands of people and will save many more. The questions of how to deal with the reality of flaws in manmade devices and how we a society will deal with them are yet to be determined. I can assure you that the HCMA will be part of finding the solutions to these complex problems.
An important question that needs to be addressed is the manner in which the patients were notified of the advisory or recall. The HCMA firmly believe that it is the responsibility of the manufacturer to notify the doctors and patients directly while also advising the media. Many patients have only found out about the recall due to media coverage, which leaves them open to many questions and unnecessary apprehension and fear.
In the case of the Guidant’s Prizm 2 models there is no excuse to have withheld information on potential flaws in the device, which we now know to be responsible for at least 2 deaths. I know as a patient I want all information about my device so the I can discuss it with my doctor and make the best choice for me, I know many within the HCM community share my feelings. If there is a problem with a device patients have a right to expect full and complete disclosure, anything less is criminal. Now that the problem has been exposed the remedy provided by the manufacture was offering a replacement device and a minimal amount of compensation for uncovered medical expenses. Within one week of this offer, Guidant has issued a second advisory and has asked doctors to stop using 5 other ICD’s, thus leaving the question what ICD should patients receive as a replacement? And who is going to pay for these replacements?
The other question that must be asked is who is responsible for the financial aspect of these situations? The patient and or their insurance company have paid for the original surgery and have paid for the original device. Now the manufacture has found an error issued a recall and the question must be who is responsible for the costs associated.
In the end what is important to know is the ICD therapy have saved the lives of thousands of people and will save many more. The questions of how to deal with the reality of flaws in manmade devices and how we a society will deal with them are yet to be determined. I can assure you that the HCMA will be part of finding the solutions to these complex problems.
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