Can you Understand your ICD Safety Alerts or Recalls?

Saw this today and thought would be good to share. Most educational materials are aimed at an 8th grade reading level, however this doesn’t hold true for pharmaceuticals and medical devices. Then to top it all off when patients hear about the problems and call their cardiologist, for the most part it seems to tick of the MD, because it takes up considerable amounts of their precious time to discuss. I brought up a recall alert once as a teaching opportunity, posted the notice, informed the clients to call their cardiologist and then got my rear end chewed off as the cardiology office didn’t want to have to deal with it. They eventually drafted a letter of their own and sent to all pacemaker/ICD patients to notify them.  What has been your experience?

Rochester and St Paul, MN – Those letters in which companies inform patients about “recalls” or “safety alerts” that involve their implanted pacemakers or defibrillators? They are written at such a complex level that they “may be incomprehensible for most patients,” according to researchers who rated the readability of such letters from one device company [1].

In 2006, the Heart Rhythm Society (HRS) recommended that device manufacturers communicate with patients affected by their safety advisories with a letter that should also be posted on the company’s website, observe Luke A Mueller (Mayo Clinic, Rochester, MN) and associates in their report published online January 2, 2013 Heart Rhythm.

But in their analysis of 25 such “Dear Patient” letters issued by Boston Scientific (including Guidant) from 2005 to 2011, their readability as measured by standard software was found to be at median grade level of 12.8, or college level in the US. Their reading levels were consistent over the six-year period.

None of the company letters, they note, met the National Working Group on Literacy and Health‘s recommendation of a fifth-grade level of readability for healthcare materials (p<0.001) or even the average US reading level corresponding to eighth grade (p<0.001). A sample letter devised by the HRS didn’t fare much better, coming in at a 12.5-grade level.

According to Mueller et al, who note that “patients affected by [implantable-device] advisories may experience psychological distress” and that poor communication can make that distress worse, “Device manufacturers should ensure advisory letters are comprehensible to most patients. Such letters may serve as a springboard for clinician discussions with patients of all reading skill levels about advisories and help the clinicians discern whether patients understand the clinical implications of the advisories affecting them and correct misinformation.”

Neither lead author Mueller nor coauthor Abigale L Ottenberg (Mayo Clinic) had disclosures. Coauthor Dr Arjun Sharma is the senior medical director at Boston Scientific. Senior author Dr Paul S Mueller (Mayo Clinic) is a member of the Boston Scientific Patient Safety Advisory Board.

Readability of “Dear Patient” device advisory notification letters created by a device manufacturer

New medical device, ECG on IPhone

Would you as a heart patient consider this device? One of the issues to understand is how a 12 lead ECG works vs. a single lead ECG. To understand this, pick up a piece of paper, look at it from every conceivable angle…front, back, top, bottom, side views. This gives a one directional view of the heart, so it really depends on where the issue lies if you are trying to pick up ischemia…lack of blood flow to heart muscle. An ECG has limited ability to diagnose heart attacks, that is why we use serial blood tests to measure enzyme troponin release to diagnose. Now don’t get me wrong, in many heart attacks there are EKG changes, but they don’t always show in a single lead ECG.

I think this tool is beneficial, especially for capturing arrhythmias or irregular heart rhythms. The second issue is if you use this device, who will read the data and what action will they take? Do you download and send to your cardiologist, your primary care physician, or the ER. Then who is responsible, and from their perspective who gets paid for reviewing. Many physicians are overworked and to add interpreting medical device data to their day won’t go over well in today’s environment. I perceive the future will have more devices like this, but the medical community needs to change current practices, and change is slow.

A new device and app is taking the mhealth capabilities of the iPhone to a whole new level.

San Francisco-based AliveCor announced Monday that it has received clearance from the U.S. Food and Drug Administration to market its heart monitor. Now, U.S. users of the iPhone 4 and iPhone 4S can shell out $199 (taxes and shipping are extra) to preorder the device, which begins shipping in January. Oh, and in case anyone was wondering, the iPhone does not come included, the company’s website notes handily. (Looks the like final device ended up costing more than the $100 that founder and physician David Albert at one time envisioned.)

So how does it work? The small wireless device comprising two electrodes can snap on to the back of an iPhone and then the souped-up iPhone can be placed next to the heart, against the skin to deliver clinical quality electrocardiograms. It functions like any iPhone cover intended to protect the smartphone.

Before the FDA clearance, prominent cardiologist Eric Topol used the device on an air plane to determine that a fellow traveler was having a heart attack, ordering the plane to land.

While interest in mhealth is exploding, this device appears to be mhealth on steroids, given that it is actually a physical device aiming to give medical data. The device has been eagerly anticipated by mhealth watchers and it will be interesting to see how well the product is adopted.

Perhaps this is the beginning of what Silicon Valley VC and provocateur Vinod Khosla proclaimed when he said that machines will one day replace 80 percent of middling doctors. No surprises that Khosla Venture, his VC firm, is an investor in AliveCor.

In June, the company raised $10.5 million in a series B round from Khosla Ventures as well as existing series A investors like Burrill & Company, Qualcomm Ventures and Oklahoma Life Sciences fund.

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