Principled Device and Vendor Selection

Originally published in EP Lab Digest May 2017

Those of us who choose and implant medical devices shoulder responsibilities that extend well beyond typical patient care. Device implant decisions carry lifelong impact for our patients, but they also have major implications for our staff, hospitals and the vendors with whom we partner. Doctors need to use a principled approach to get these decisions right. Given the stakes involved, there are few areas in doctor/industry relations that carry more meaningful impact than pacemaker and ICD selection.

Early in my career as an electrophysiologist implanting cardiac rhythm devices, I developed a set of principles in vendor and model selection, and these have served me well in almost 20 years of practice. I’ve also learned that it is critical for us to fight to retain control of these implant decisions, and make them in a disciplined and ethical fashion. We, the front line caregivers, are uniquely qualified to best serve our patients’ interests. By responsibly taking charge of vendor selection, we are best suited to maximize benefit and value to both our patients and the healthcare system.

Device selection must carry an inviolable first principle — the patient gets the appropriate device for his or her indications and specific circumstances. All negotiation occurs in the gray areas in which there are alternatives. Pacemakers and ICDs should never be treated as interchangeable commodities supplied to us by the directives of hospital purchasing departments. Doctors, for their part, should not make implant decisions based on personal whims, friendship-based loyalty or self-serving deals.  For these complex devices, doctors should fight for multi-vendor arrangements with MD control over the decision. Healthy competition elevates service and promotes innovation. Using multiple vendors also amortizes risk of product recalls across the practice, and gives our patients a broad array of options. How many vendors should serve us? That’s a question worthy of discussion, but I’d argue “one” is the wrong answer.

At the point of product decision, a doctor should consider four principles before choosing the device or vendor: product, technical support, price, and value-added service. The device decision hinges upon a balance of these factors.

Product:

It is intuitively obvious and principled that MDs should implant the best product for their patient’s needs, but that need not always be the top tier model from the doctor’s “favorite” vendor. Given the complexity of pacers and ICDs, model selection can prove to be a challenging decision fraught with tradeoffs. Each patient has unique needs. One patient’s priority may be a particular diagnostic tool; another may most benefit from maximal battery longevity or ease of remote follow-up. Reliability is important to all, but difficult to predict. The “perfect” device today may be next year’s recall. By rotating among vendors, the doctor reduces overall risk to their patient population. Doctors need to work hard to educate themselves on all of these tradeoffs and choose responsibly. Vendors need to know that if they create great products, this will influence their share of the business.

Technical Support:

The requirement for lifelong technical support distinguishes cardiac rhythm from most other other medical devices. Healthy MD/vendor relations are critical for optimal patient care, even in hospitals without direct in-hospital rep support. Many industry models exist for device technical support in the office and hospital. Each of these models has merits, but all must be handled within ethical and legal bounds. Other expensive medical devices such as coronary stents or valves do not have this lifelong support need, and hospital purchasing departments need to appreciate this critical distinction as they consider the value of their purchases. If a doctor makes it clear to the vendor that they must earn their business each day, they will be rewarded with exemplary service. Doctors who treat their reps as “box openers” will have their negative expectations reinforced with substandard support. In our system, we treat industry reps as partners, and consider them as part of the hospital implant and support team. The quality of their work becomes a factor in device implant decisions. The vendors’ rational response is to compete on these terms, and our patient’s realize this benefit.

Price:

Simply stated, we doctors need to seek the best value for our patients. Because device price decisions typically do not impact the MD or patient directly in the US health system, it has been historically tempting for doctors to ignore cost. Doctors do this at their own peril. If a vendor recognizes this blind spot, the MD may be leveraged into an arrangement unfavorable to the hospital. This will not be sustainable. Hospitals will protect their financial interests and seize control from price-insensitive physicians. To maintain choice, MDs need to directly insert themselves into hospital pricing discussions, and also make it clear to the vendors that price is important to them. We need to have the discipline to walk away from unfair arrangements favoring the vendor. On the other hand, doctors who are complicit with aggressive purchasing departments and consultants in a “we win/you lose” race to the bottom will eventually find they get what they pay for in loss of product, support, and/or service. They will also find those unhappy vendors less receptive at next contract negotiation.

Value-added Service:

Value-added service that deserves vendor recognition benefits our patients, not the doctor’s wallet or ego. The key here is for all to understand this distinction. When an industry rep goes the extra mile to support the healthcare mission, these actions should be noted. Examples might include patient counseling, office staff education, and MD access to experts. Indirect benefits such as research and consulting opportunities might benefit the overall mission, and could be considered in proportional terms, strictly adhering to ethical and legal standards. Doctors need to guard against being “bought” by industry. Nothing a vendor does to earn business should be construed as an overt or potential quid pro quo.

Key to making all of these vendor relations work is transparency and consistent follow-through. Vendors need to know the rules, and doctors need to enforce them. If a vendor slips in their service responsibility, they need to understand this may affect their share of the business. If a vendor has an exciting new product, the alternative vendor may be able to compete on price or support. The doctor needs to respond to these levers in a predictable fashion.

As doctors, our primary mission is to provide high quality healthcare to every patient we see. Responsible device selection must serve this mission.  Vendor selection must be a transparent and principled process. Once it is determined the array of device options available to a given patient, the doctor can apply the four principles discussed to finalize the decision. If the vendors understand the rules of the playing field, natural competition on product, service, price, and support will create the optimal environment for doctors to deliver care.

 

 

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EHR Review Folders – Saving Trees, Improving Care

I'm pretty sure we generate as much or more paper documents on EHR as we did in the paper charts days.

I’m pretty sure we generate as many or more paper documents on EHR as we did in the paper chart days.

On Twitter I’ve shared in many lively discussions about the struggles we have caring for individual patients on EHR systems that aren’t optimized for that purpose. Many better and more prolific writers have done a wonderful job outlining the frustration we front line clinicians face on a daily basis. Still it seems our voices have a hard time being heard.

I really don’t think EHRs really don’t have to be so difficult. Simple changes could radically change the ease of care delivery if the folks designing and implementing these systems prioritized the needs of the end users. Unfortunately, the bulk of development work these days seems to be aimed at satisfying government Meaningful Use requirements and optimizing systems for charge capture and quality metrics. Clearly EHR vendors have their hands full serving their two primary masters – the US government and hospital administrators – and the needs of those seeing actual patients are lost in the shuffle.

A couple of years ago, I hosted a couple of developers from Epic EHR for a day in my office seeing patients. We talked about a lot, but in the end I said I’d put one wish on the top of my list. I called this EHR Review Folders. Here’s a discussion of these concept, adapted from an email that outlines this simple request:

Thank you for your interest in the idea of “review folders.”  This is an old idea or mine, and I still think a good one.  I discussed this with our Epic site visitors, so I’ll include them in my email.  Let me try to describe my idea so we can try to get this promoted and (I hope) implemented

When we physicians see a patient in a new encounter or as a return after a period of time, there is a subset of the medical record that is highly relevant to us.  Most of this is predictable. We need any recent office notes from the referring MD, we need the most recent diagnostic tests.  We might wish to have the history and physical and discharge summary from any recent hospitalizations.  Every doctor has his or her own needs, but the basics are the same for all.  

In my office, our medical assistant does a chart prep prior to each scheduled visit.  She will comb through the EHR to find these relevant records, print them, and collate them into a packet that is then placed on my desk.  Since we may see 20-30 patients a day, this packet gets pretty thick and the assembly of the packet is pretty labor consuming.

It would be great if we could do away with this old process.  Unfortunately, the current EHR is not organized enough for us to quickly find relevant records on the fly.  Getting what we need can be a bit of a crap shoot because the relevant information is mixed with irrelevant information.  Only after we click on the record is it apparent whether we have what we need.  Even after finding all of the “good stuff,” there is no way to quickly go back to this record as it resides “hidden” with the other records.  In a busy office day, it is extremely challenging to click around the EHR to find all of this stuff.  Hard to find records, such as outside MD letters and other scanned documents are very easy to miss.  Most of us get frustrated, and may do an incomplete review on this basis.

My idea of a review folder would be to have a tab in the EHR in which all of the information relevant to the encounter could be collected during or prior to the encounter.  This tab would live in the patent’s EHR for as long as it is needed, and be visible to any who need it when they log in to the record.  I would envision having my MA sort records prior to the office visit by dragging and dropping the relevant records into this folder.  As I do my own prep, I will add and subtract records as well.  Some of this could be automated by having the folder collect specific types of records by date parameters or type.

A great analogy for what I envision is an Apple iTunes playlist.  On my iTunes, I can create a collection of songs into one folder that may be labeling something like “today’s run.”  I might drag and drop songs individually, or I might set up a “smart playlist” in which I specify parameters like “songs added after December 12, 2012” or “songs by the artist Ratatat.”  That list sorts what I need into one easy to find folder.

Uses for review folders could extend beyond what I’ve described.  Recently a interdepartmental complication review meeting was run for the first time in an EHR only format.  In front of a group of doctors and QA personnel, I struggled to find the relevant records in order to present a case.  Had these records been electronically sorted prior to the meeting and available on all parties Epic desktop, the meeting would have gone much better.

I find this idea conceptually logical, but I’m not sure I’ve done an adequate job describing.  I feel strongly that we could enhance patient care and save a lot of time and money if we could get this done.  I’d be more than happy to discuss further.

I’d love to hear other’s thoughts about EHR data organization. We go thorough an enormous amount of paper in my practice, purely to allow clinicians to review relevant data in an easy to access format. If some form of organized, intuitive digital data review is implemented, I could easily envision doing away with most or all of this printing. Going to a two screen solution with review data on a tablet and data entry on a bigger screen and keyboard is really an attractive option to me. Simple programming changes in our system could get us to this point. Does anyone have this sort of clinician data organization implemented in their EHR (Epic or other)? Would you find this useful? Would you help make it happen?

Jay

ICD System High Voltage Component Failure HRS 2014

What an honor it was to speak on ICD high voltage component failure at this year’s Heart Rhythm Society Scientific Sessions. For those interested, I’ve a link to a few slides outlining potential high voltage failure mechanisms in Riata ICD leads. Please feel free to review and comment. I would request attribution for anything you elect to share.

Riata HV Shorts

Edward J. Schloss MD FACC FHRS

 

 

Lessons Learned Part II

One thing I’ve missed since finishing up my formal fellowship training has been the ready opportunity to bounce ideas off people in the lab and fellow’s room.  At Cleveland Clinic in the mid-1990s I had the good fortune to work with a lot of smart EP attendings and fellows.  During cases and in the fellows’ room we’d learn a lot from each other about things that aren’t in journal articles and books:

  • What’s the best way to fashion a pacemaker pocket?
  • How do you do pre-op procedural counseling?
  • What’s the best way to manage lead recalls?
  • How do you access the coronary sinus for LV lead placement?
  • What’s your take on single coil ICD leads?
  • What works for you for getting vascular access?
  • How do decide which device vendors to work with?
  • How do you save money in the EP lab without compromising care?
  • What is the most important attribute in an ICD lead?

Online and social media has been a great new sounding board for these types of interactions.  Last winter when @EPLab Digest invited me to submit an article, I brainstormed a list of tips that I titled Lessons Learned in 18 Years of Device Implant and Followup.  The list probably serves better as a starting point for conversation than as a list of answers.  This month Lessons Learned Part II goes up in the October EP Lab  Digest.  Take a look and let me know what you think.

EJS

October 1, 2013

Left to My Own Devices

September 6, 2013

Welcome to my blog.  Let me introduce myself.

I am Edward J. Schloss MD, but I’ve been called Jay all my life.  Online, I’m @EJSMD, and I work as a clinical cardiac electrophysiologist at The Christ Hospital in Cincinnati, Ohio.  Although my primary professional focus is direct patient care, I also do a lot of clinical research with The Lindner Research Center here at the hospital.  I take care of a variety of patients with electrical disorders of the heart, but in recent years I’ve focused most of my practice on the care of patients with pacemakers and ICDs (implantable cardioverter defibrillators).  I implant and extract devices as well as provide the follow up care of these patients.  We don’t have fellows or residents in our lab, so I am the operator for all of my procedure.  I am fortunate to be surrounded by a remarkable team of physicians, nurse practitioners, nurses, technicians, medical assistants, industry personnel and administrators that keep everything running smoothly.  I am madly in love with my best friend Kendahl, and we’ve been married for over 24 years.  We have three amazing children ages 15, 20 and 21.  I have a bio up on our practice website.

Although this blog is just starting (see my prior two posts), I’ve been actively writing about cardiology and healthcare in online and social arenas for a few years.  I’ve considered starting a blog for a while and jump in now with some degree of trepidation.  Left to My Own Devices will serve as a platform for me to communicate issues primarily affecting my professional world.  As the name implies, expect to hear a lot about pacemakers and ICDs and other issues in cardiology.  I do hope, however, to extend my reach into broader arenas of healthcare in which I have passion, such as healthcare policy and electronic medical records.  I’ve already written a lot on twitter about these issues and done a bunch of long form journalistic pieces on Cardiobrief.org or Forbes.com.  For the blog, I’m hoping to find the sweet spot between 140 characters and 1000 words.

I’d like to recognize a few important people who’ve helped me along the way:

–       J. Rod Gimbel MD single handedly started the Cleveland Clinic Heart Center website from the fellows room back in 1994, just before I started training there with him.  Naturally, all but a few thought he was crazy.  Rod showed everyone that the web is a viable platform to “narrowcast” cardiology content to a specialized audience.  He is still breaking down barriers with his research on MRI of pacemakers and I am proud to be one of his coauthors.

–       Wes Fisher MD is a practicing EP in Evanston, IL and truly is the blogfather of cardiology.  He’s still cranking out regular amazing content at DrWes and on twitter.  Wes hosted my first ever blog comment back in 2008 and has continued to mentor and promote me unfailingly since that time.  He is a bold, entertaining writer who knows just how to skate the line between smartass and wise guide.  He’s the guy shining lights into the blind alleys of health care policy.

–       Larry Husten at Cardiobrief, Forbes.com,  Cardioexchange, and twitter is an first-rate real medical journalist who gave me my first break by posting my summary of the St. Jude Riata Lead Summit back in January 2012.  With that offer, I suddenly felt like a legitimate writer.  With his broad platform and wise editorial guidance, I’ve been able to dramatically expand my reach.  He sets a high bar for excellence, and when I send him content, it still kind of feels like Senior English class back in high school.

–       John Mandrola MD is an electrophysiologist in Louisville, KY who blogs at Dr. John M.  John and I started out as “twitter buddies” and now we’re good friends in real life too.  His humanity permeates all he writes, and if you were sick, this is the kind of guy you’d want as your doctor.  It’s flattering to be supported and promoted by such as great guy and insightful writer.

I finally started the blog this week because I really needed to find a home for the the two posts I just published.  For years I’ve had other ideas bubbling up,  and this forum will allow me to decompress.  Since I don’t really have a roadmap built, it still remains to see exactly where Left to My Own Devices takes me.  I can assure you, though, that what you read will be honest and filled with passion.

EJS

September 6, 2013