Digital Pathology Blog

A Move by the FDA Signals Possible Classification for Patient Safety and Industry Collaboration

On Jan. 14, 2016, the Digital Pathology Association (DPA) issued a press release suggesting “digital pathology manufacturers currently interested in marketing whole slide imaging (WSI) devices for primary diagnosis in the United States submit de novo applications to the Food and Drug Administration (FDA).”

What exactly does this mean?

The press release goes on to say, “The FDA had previously stated it considered WSI for primary diagnosis to be a Class III medical device. However, FDA had never formally

There is a decades-old theorem first derived at the Mayo Clinic that although based on little actual data has been popularized over the years stating:

• 70% of patients in a hospital have laboratory data.
• 70% of clinical data points (objective information) come from laboratory data.
• 70% of clinical healthcare decisions result from laboratory tests.
• These data account for less than 5-10% of healthcare costs.

This is a lot of bang for the buck. Imagine 70% of objective information assisting in 70% of healthcare decisions for as little as 5% of total healthcare expenditures.

Almost 3 years ago I wrote a piece for Advance for Administrators of the Laboratory in their "Perspectives in Pathology" entitled Death of the General (Surgical) Pathologist.

This piece discussed the issues surrounding what is perceived by many as the increasing (and necessary) sub-specialization in pathology.  The model of "everybody doing everything” has evolved into “everybody doing one thing".

Historically, practicing pathologists were solid general surgical pathologists, often times with their own expertise/interest in a particular area, but they prided themselves on being "surgical pathologists" rather than "liver", "hemato-" or "dermato-" pathologists as in today’s world. A number of factors have driven and resulted in this trend.  

First and foremost, the needs of the market.  Dedicated specialists in breast or gastrointestinal diseases are commonplace in medicine including the radiologist, surgeon, oncologist and radiation therapist.  Pathology appropriately responded accordingly. Secondly, pathologists have driven some our own marketing and needs.  The resulting potential problems are paramount and based on many fallacies.

Dr. Keith Kaplan, Chief Medical Officer for Corista, LLC, offers his thoughts on “The State of Pathology Today” and some strategies for facing today’s challenges. 

Today, the state of pathology, along with our national leadership and organizations, seems fragmented and without direction. I attended the College of American Pathologists (CAP) and House of Delegates meetings earlier this month, and there seem to be a few issues which we cannot deal with as a group:

• Needs of academics vs. community-based hospitals: From the need for AP/CP generalists in some settings to the need for sub-specialists in others, how do we best practice our specialty? We seem to be an increasingly heterogeneous group with loss of identity.  

As I was trying to sleep, sitting upright in seat 11C, this question came over the public address system. 183 of us were traveling from LA to Boston and it was 4 AM, in whatever time zone is home to Kansas. This was the final leg of a quick halfway around the world trip. Our itinerary started in Charlotte on Friday, then to Shanghai, and finally to Boston by Monday morning. We had already traveled nearly 15,000 miles by car, bus, train and air. Now, just a few hours from completing 6 flights in less than 3 days, we may have hit a snag in our travel plans.

Several years ago Tiger Wood’s former golf coach wrote a book with the above title. Among providing glimpses of Tiger’s personal life, his work ethic, practice routines, diet, interaction with his wife, etc… the author of course talks about Tiger’s presence on the golf course, his swing mechanics and level of focus on the course.

News of Rita Wilson’s announcement that she had breast cancer and underwent a double mastectomy has been spreading across media and social media outlets. Anytime a celebrity, vis-à-vis Angelina Jolie or Suzanne Summers or Edie Falco (who played the fictional wife to Tony Soprano) makes public their diagnosis and treatment, the popular media has an opportunity to share their stories with millions of women. Their support promotes breast cancer awareness and early diagnosis and treatment via their publications or on air.

As a medical student/intern/resident in the early to mid-1990s, most of the pathologists I was exposed to in a university/medical center setting were pathologists who were-first and primarily-general pathologists, general surgical pathologists and clinical pathologists. Everyone did everything in terms of surgical pathology subspecialties, with a few notable exceptions (bone marrow examinations and liver biopsies, depending on the nature of the case and the particular pathologist assigned the case). In addition, the staff pathologists I worked with also covered some area of the clinical laboratory and were responsible for any issues referred from house staff during evening and weekend call.

Ever had a good idea that you wanted to see implemented in your organization? Ever had that idea actually implemented and succeed and make a difference? Or have some of those ideas been criticized by personal attacks, death by delay, folks making excuses that the problem that needs to be fixed does not exist or that the solution was tried before and did not work?