EP Perspectives

Editorial: Whose Responsibility Is It?

Neil Sanghvi, MD

Neil Sanghvi, MD

I’ve recently had to manage a run of malfunctioning leads and devices under recall/advisory in my patients. Unfortunately, this has resulted in the need for these patients to undergo surgery in order to address and rectify the problem. The procedure is scheduled, each patient’s insurance company is called, and the pre-authorization (if required) is obtained. The patient is then subjected to a possible copay and co-insurance. Here is where the system breaks. Why should the patient be subjected to a financial burden when the product they have purchased has malfunctioned? 

When probed, the device manufacturing companies state that a rebate is available TO THE HOSPITAL if the device requires replacement within the warranty period. However, this rebate is given TO THE HOSPITAL. The patient and insurers still bear the financial cost of the procedure. That also doesn’t take into account the emotional and physical toll on the patient from the surgery.

Is our industry so different from the auto industry? As a society, we have held auto manufacturers to a higher standard. The auto manufacturer often bears the cost if a recall is issued that may be harmful to the driver. The manufacturer is required to send notices, facilitate for the automobile to be brought into a dealership, PAY the dealership for any diagnostics required, and PAY for the part that is being replaced. So then why is it that we allow implantable device manufacturers to PASS the cost of replacing a malfunctioning device/lead that is under recall/advisory? The recall/advisory is issued when a certain deviation beyond the expected failure rate of a device/lead occurs, which is often due to a manufacturing or engineering error. Therefore, the cost of this error should be borne by the manufacturer, and not by the patient and the greater healthcare system.

I recently came across a patient whose ICD battery has entered an error state that prevents the device from reliably determining its charge, thus preventing reliable defibrillation. This is a life-threatening error that directly places the patient in harm’s way. The device needs to be replaced. Unfortunately, the patient has lost his insurance due to personal circumstances since his device implantation. An appeal to the manufacturer has been made to cover the cost of replacing the device, to which the company has responded that it will DONATE a new device, but that the hospital and the physician must be willing to perform the surgery for free! I was taken aback by the apathy of the company and the inability of the manufacturer to take ownership of a fatal malfunction of one of their devices. 

What if the problem were brakes that were malfunctioning in a car, which prevented the reliable stopping of the car? Furthermore, what if this malfunction was directly attributable to a problem in the manufacturing process? Would we, as a society, accept an automobile manufacturer stating that they will provide the brake parts for free, but that the garage and the mechanic would have to work for free to replace the parts? I highly doubt that.

I ask my colleagues to consider this continued stance of manufacturers not taking full responsibility for errors that occur in the manufacturing process, which may result in faulty devices/leads. I appreciate that a small percentage of failure can occur — any manufactured device has this. However, the manufacturer must be held fully accountable for failures that deviate from the norm. This practice of allowing manufacturers to pass on the cost of their failures to the patient, insurer, taxpayer, and system has gone on long enough.

The views expressed in this editorial are the author’s, and do not represent the views of any organization he is affiliated with.

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