The reality of this meeting was that it was convened due to the death of a young man from a faulty defibrillator and the recall of the product and several other products from the same manufacturer. This was the 800 pound gorilla that stood in the room, yet most attempted not to outwardly acknowledge. Instead the focus was on more technical aspects of device surveillance, databases, reporting, analysis, communications and what we believe to be the current state of affairs in these areas.

The term “recall” was discussed at length, the question was raised from multiple parties if in fact this was the proper term to be using in the event of the detection of a flaw, failure or malfunction. The term “recall” makes many think of - removal, which may not be required. Therefore it seems reasonable to suggest a new and more globally understandable term for the events currently defined as “recall”. However, determining if and when a “recall” is required still appears to be the illusive question. The obvious step to determine if a “recall” is warranted is to evaluate the MAUDE database managed by the FDA. From personal experience I can state, without doubt, that the MAUDE database is flawed to a degree that may well be beyond repair. It is easy to cast blame upon a government agency; however I am not sure the blame is theirs to carry. I, myself, was subjected to a device failure in 2001, at the time I was unaware of the MAUDE database. Recently I looked up the report on my device failure (report number 2124215-2001-03138), the “event description” submitted by the manufacturer was not factual and was highly misleading. This error may not have been intentional but it was still an error that misrepresented the event to the manufacturer’s benefit. I also stumbled upon a report in the MAUDE database (report number 2124215-2005-09110) claiming that a patient with an ICD had an “adverse event” the event type was classified as “death”. The “event description” claimed “…the patient was euthanized as a last and necessary resort”. The manufacturer narrative stated the device was not returned, and attempts to get more information were unsuccessful. Could it be true that a human was euthanized in the United States? Or is there a flaw in the reporting? Either way it does not instill a great deal of trust to the accuracy of the system for a myriad of reasons.

A further flaw with the current reporting system is that there is no standard for the collection of data after a death. It is completely understandable that people with devices will, in fact, die at some point, but there is no method of collecting interrogations to ensure the device was working properly at the time of death; and, if not, that the device is returned to the manufacturer for evaluation. If the tool we have to measure device performance is filled with inaccurate and incomplete information how do we know what the real failure rate is and if patients are being warned appropriately in the event of failures?

One of the most unanswerable questions of the day was – where is the line on when to notify physicians about problems with implantable devices? I believe, based on the current inconsistencies in reporting “problems”, “failures” and “concerns” from manufacturer to manufacturer, it is very difficult to know. However, I am reminded of a Supreme Court decision I came upon in my days as a plan administrator for an employee benefits program. In Geissal v. Moore Medical Corporation No. 97-689 Supreme Court of the United States the court justified their decision with the following statement “Do we classify this as an anomaly or merely a necessary consequence of the need to draw a line somewhere? For the sake of argument we might call it an anomaly,” My point here is rather simplistic, if the Supreme Court can choose to draw a line somewhere as a necessary consequence regarding health insurance coverage shouldn’t some step up to the plate and choose where to draw the line with device failure reporting?

At the Policy Conference I was asked to discuss the topic “what do patients want and need to know?” This question is extremely complex and varied; however, in the few minutes I was given at the meeting I tried to convey my thoughts. What is an indisputable fact is that patients want the truth the whole truth and nothing but the truth. The first issue that needs to be determined is if a “recall” is needed, which is completely out of the hands of treating physicians and patients. However, with greater transparency and clarity in reporting this may improve to a point that patient and physician can participate in device choice which may alter which manufacturers’ devices are used based on even and balanced reporting of failures. The next and most obvious question is “who do patients want to hear from?” I believe patients want to hear from multiple sources, starting with their own physician. However, it is not always possible for patients to hear from their physician. I am aware of several patients who were never informed by their treating physicians about the Guidant 1861 recall. Some of those reasons included; the doctor left the state and the patient was unaware, the patient had moved, the doctor did not think it was important for the patient to know, and the patient had been caring for an ill family member and was very involved in the health matters of a gravely ill parent that they did not take the time to return a call from the doctors office because she did not think it was important but stated if someone had mailed her information she would have read it.

For these reasons and others it is imperative that the manufacturers notify their customers directly in the event of a “recall”. I am aware that manufacturers sell the devices to the hospitals, who, in turn sell the devices to the patients. This is much like the automotive industry; cars are sold to a dealership and then resold to the end user. The “recall” notification should be handled the same way, to the customer / user of the product. Once a device is implanted the patient completes a form and receives a card from the manufacturer thus establishing a relationship with each other. In the event the device is still in the hands of the hospital, the notice should be sent out to the hospital for each device in hand. Currently the medical device industry has no method of communicating directly with patients in the event of a “recall”, “alert” or other safety issue. I have searched for any other manufacturer of any other product sold in the USA that does not require notification in the event of a safety hazard and have come up with no such example to offer, therefore why should medical device manufacturers not be held to the same standards as the manufacturers of baby strollers, automobiles, clothing or any other product?

Based on the magnitude of impact a faulty device may have on someone’s life and the fact that the FDA has oversight of this industry, patients should have access to information about the FDA’s findings. In the event of a “recall” patients with devices are often confused about what device is being “recalled” and if it is or is not the one they have implanted in their body. A simple toll free number and or website can be arranged by the FDA where patients can call with their device name, model number and or serial number and they can be advised if the device is involved in the “recall” or not. Surprisingly, some patients get confused as to who manufactured their device and a “one stop shopping” phone number would help to limit concerns. This brings us to the fourth method of communication, the press. The press is important in terms of communicating with the public but mechanisms to minimize panic must be instituted such as the “one stop shopping” mentioned above. Many years ago I was involved in a ‘recall’ for programming reasons but was not informed because my file was in transit. I had been implanted at one hospital in Massachusetts and returned to New Jersey for follow up when a co-worker left a small article on my desk about the recall on the Ventak AV in 1997. If not for that article in my local newspaper I would never have known about the “recall”. I do not think you will find anyone who believes that the most beneficial way for a patient to find out about a recall is by reading the newspaper, but it is far better than not finding out at all; clearly we need to do better in communications.

The question of “what do patients want to know” is simple; we want to know the truth about our devices. Patients have a right to know the status of the devices they have implanted in their bodies. Physicians also have a right to this information as it may well alter the method of treatment he or she may deliver to their patient. One could even argue that failure of the manufacturer to disclose flaws, changes in reliability statistics or any other information about a device alters the informed consent process. Patients may be willing to live with an implantable device if the data proves 99% reliable, however if the device is only 97% reliable it may no longer be of benefit to the patient and they should have the right to choose if the device remains implanted or is simply shut off. Informed consent continues after the original implant and lasts throughout the life of the device.

One issue that was brushed upon in the meeting was the financial implications to the patient. The current system is unfair to the health insurance industry and government sponsored health care programs as they shoulder the financial burden for the “recall” of these devices. The cost of the device is often covered by the manufacturer, IF you agree to have one of their devices as your replacement. I am aware of many people who, due to a lack of trust, could not for psychological reasons re-implant the device of a manufacturer they feel deceived them. Thus they are left having to fight with an insurance carrier to cover a new device to allow them to live in peace with this device they entrust their life to. The fees for implanting, anesthesia, operating rooms, and post implant follow up are left to the burden of the insurance carrier or, if not insured, to the patient. Should it be the burden of the patient or their health care company that a device manufacturer has produced a device with a failure? What other industry is permitted to pass along the cost of their failure onto the consumer?

In the end it will take many more months to see what changes will happen in the industry of implantable devices. Keep your eyes on the next HCMA newletter due out soon - to see what pro-active steps the HCMA is taking to ensure we all have better devices.