Meeting Announcement -The Adequacy of Assisted Reproductive Technology Oversight

Posted on November 24, 2009 by Steven F. Palter, MD

I received this comunication from the American Society for Reproductive Medicine

MEETING ANNOUNCEMENT —The Adequacy of Assisted Reproductive Technology Oversight

Monday, December 14, 2009

8:30 am – 3:00 pm

Mandarin Oriental Hotel

Washington, DC

Given the rather high profile incidents in infertility therapies that came to light in 2009, the leaders in reproductive medicine are asking questions about how best to prevent such incidents from occurring again. While little factual information is available on the specific incidents, we can and should assess where general oversight of the field is, and seek ways to improve it, if necessary

Accordingly the American Society for Reproductive Medicine is convening a meeting in Washington, DC to gather input on this important topic. Information will be exchanged between government agencies, patients, physicians, leading academic experts, and others.

Featured speakers will include:

Maurizio Macaluso, MD, DrPH, Centers for Disease Control and Prevention
James Goldfarb, MD, President, Society for Assisted Reproductive Technology
Jake Mayer, PhD, the Jones Institute, Eastern Virginia Medical School
Stuart S. Howards, MD, American Board of Urology

Barbara Collura, RESOLVE, The National Infertility Association

Susannah Baruch, JD, Generations Ahead

Liza Mundy, author

Judith Daar, JD, Whittier Law School

For more information or to register send an email to ekramer@asrm-dc.org.

New Program for Centers of Excellence in Minimally Invasive Gynecologic Surgery Launched at International Congress of the AAGL

Posted on November 23, 2009 by Steven F. Palter, MD

BREAKING NEWS: First description- full free slideshow with audio of project and podcast

I am honored to share with you on docinthemachine.com my Presidential Report from the CGE of the launch of the Center of Excellence Program of the AAGL CGE. With 38 years leadership in Gyn Minimally Invasive Surgery the AAGL is uniquely qualified to share its educational mission by verifying those Centers that meet these standards.

The AAGL Global Society for Gynecologic Minimally Invasive Surgery Launches Center of Excellence in Minimally Invasive Gynecologic Surgery Program at Annual Meeting November 16-20, 2009 in Orlando, Florida —dedicated to establish and verify standards at surgical facilities and hospitals.

(click green play arrow to hear presentation audio and automatically advance slides)

The primary objective of the AAGL and its professional interest partner the Council of Gynecologic Endoscopy (CGE) is to promote the adoption of minimally invasive gynecologic surgery with its reduced morbidity, shorter post-operative recovery time, less invasiveness, and reduced costs.

Our Analysis of patient and provider needs worldwide showed that there are widely divergent qualities of practice and that patients and providers have difficulty in identifying excellence. There is a lack of national standards to improve outcomes. While payors seek to control costs/outcomes patients lack access to the educational resources to direct them to the appropriate center to meet their needs in many cases. As I stated in my address:

We recognize in the modern era of health care we have a unique opportunity as well as an obligation to use our educational resources and multidisciplinary expertise to help promote those systems and procedure which can improve patient outcomes in women’s health while reducing costs to both patient, payor, and society as a whole.

The CGE has therefore launched two new programs to address these needs.

First is an individual registry of physicians based upon peer review of operative experience and complications. The CGE, founded in 1996 has over 1100 individual gyn surgeons who have meet its standards. The new program integrates an evaluation based on today’s complexity of procedures in minimally invasive surgery. It is a tiered system with 3 levels of practice (based on procedure complexity) and 4 areas of proactive experience and specialization (General Gynecology Procedures, Fertility Enhancement Surgery Procedures, Repair of Pelvic Floor Defects & Urogynecology Procedures, Gynecologic Oncology Procedures)

Second is a Center of Excellence Program In Minimally Invasive Gyn Surgery. This is in recognition of the modern notion that to achieve best-in classs surgical outcomes requires not only an expert surgeon, but an integrated multidisciplinary surgical facility with systems and procedures in place to maximize quality cost effective safe outcomes for patients.

9 Requirements: Areas of Review To Qualify as a COEMIG:

Institutional Commitment to MIGS
Director of Division
Medical Staff Physician Qualifications
-Dedicated Educational Program
-Formalized Credentialing Guidelines & Systems to Introduce New Procedures
-Procedures for Minimizing Complications
Sufficient Experience with Procedures
A Full Complement of required Non-Surgeon Consultative Staff
Ancillary Staff
-Dedicated Team-Based Concept
-Dedicated non-physician Educational Program
Equipment Guidelines
-Availability & maintenance
Treatment pathways
-Linked to Peer reviewed Practice Guidelines
HIPAA Compliant prospective Outcomes Data Tracking

In my presentation launching this program at the AAGL annual meeting I shared

The AAGL is extremely excited and totally committed to the concept of Gynecologic Minimally Invasive Surgery Centers of Excellence. It represents a unified vision for women’s health that integrates our entire educational mission and expertise over the past 38 years.

First Ever Global Opportunity for Standards of Excellence:I was equally excited to present the concept to the Affiliated Societies of the AAGL which is made of representatives of National Minimally Invasive Gyn Societies from around the World. Our dedication to this concept and recognition of its value was shared by representatives of Partner Societies from South America, Europe, and Asia. We agreed to work together collaboratively to establish a shared Global Standard and to establish a shared program to advance Women’s health under the AAGL CGE COEMIGS program in cooperation with each Nation’s Society.

I will share further details of the program with you here as they are released!

Details of the society are are on the website of the AAGL

Information on the CGE

Information and Applications for the COEMIG Program

AAGL CGE COEMIGS Program Launch Information [ 10:57 ] Play Now | Play in Popup | Download

New Endometriosis Fertility Scoring System Predicts Fertility: Exclusive Podcast With Author

Posted on November 20, 2009 by Steven F. Palter, MD

In a docinthemachine exclusive first I am excited to share with you a new endometriosis scoring staging system that is the first ever to predict a patients chance of getting pregnant without IVF.

The EFI or endometriosis fertility index was just presented by Dr David Adamson, a fertility specialist at the 38th annual Global Congress on Gynecologic Minimally Invasive Surgery– the annual meeting of the AAGL in Florida. As a fertility specialist and surgeon myself it was starred on my agenda not to miss as a highlight of the entire congress. Here’s all the details of his presentation and the scoring system.

Here’s my podcast interview with the lead author Dr Adamson just after he gave his talk at the 38th AAGL Global congress in Orlando

Dr David Adamson Endometriosis Fertility Index Podcast with Docinthemachine.com [ 17:12 ] Play Now | Play in Popup | Download

New Groundbreaking Endometriosis Staging System Presented is 1st to Predict Fertility- First Anouncement

Posted on November 19, 2009 by Steven F. Palter, MD

BREAKING NEWS

Why Its Important: Every staging system up to now were made by committee trying to guess what would be an important factor– but none have ever directly predicted a patient’s chance of pregnancy– they main thing they need to know. This study was mathematically devised and DOES the allow a patient to know her direct chance of having a baby after surgery!!!

In this post I’ll review his findings and share the scoring forms and data. My next post will be an exclusive podcast interview I just did with the author of the importance of this major breakthrough. The paper is being released today as “in press” in the journal “Fertility and Sterility” of the ASRM (here’s the link) — but you’ll need a membership to access it. I’ll post the final pubmed links when it comes out in print.

Background- What’s endometriosis? Endometriosis is a devastating disease where the cells that normally line the uterus and grow each month in preparation for a baby grow abnormally outside the uterus on it surface or on the tubes ovaries or other internal organs. These cells bleed cyclically each month internally an cause inflammation resulting in pain, infertility , and damage to other organs. It affects 5% of the population who have no symptoms but up to 25-33% of women with infertility or pelvic pain. A valuable resource is the endometriosis association who I work with frequently.

Lead Author–is my friend collegue and mentor from a distance Dr David Adamson. He’s and ob gyn fertilit specialist who is on the faculty of both UCSF and Stanford and who specializes in both fertility and reproductive surgery — he’s served as president of both our fertility society ASRM and our surgical society AAGL.

The Results– Predicting Fertility: Chances of pregnancy by Stage

Breaking News: New Recommendations for Women’s Health To Be Released 11/16/2009

Posted on November 12, 2009 by Steven F. Palter, MD

I Just received notifiction from the American College of Ob Gyn that new recommendations for women’s health care will be released on Monday, November 16, at 5 pm EST. The recommendations are under embargo until then. At that time the college will issue a “response” so sounds like we don’t agree with them! I’ll post the recommendation as soon as it comes out (or sooner if its leaked) — until then here is the office ACOG email

Office of the President
Gerald F. Joseph, Jr., MD, FACOG

Dear Colleague:

The College is providing you with advance notice that new recommendations for women’s health care will be released on Monday, November 16, at 5 pm EST. The recommendations are under embargo until then, but we will share them with you as soon as the embargo expires. Please visit www.acog.org after 5 pm EST Monday, November 16, for the new recommendations and the College’s response.

Sincerely,
Gerald F. Joseph, Jr, MD
President
American College of Obstetricians and Gynecologists

UPDATE here’s the news about new reduced screeing recs for breast cancer

DITM Podcast on Future of Video for Entertainment & Medicine With Sony Exec

Posted on November 12, 2009 by Steven F. Palter, MD

I have been getting great feedback on my DITM medical technology podcast which starts the podcast series I’ll be doing regularly. Several people wrote to ask if I could post a version with just the interview since they loved it so much and wanted to share that segment. The original podcast starts with FDA approvals then has an interview with Sony Exec Bob Ott on the future of video technology in entertainment and medicine that we did a the NAB broadcast meeting in Vegas.

Here’s an edit version with just the interview enjoy and share with your friends!

Standard Podcast [ 15:35 ] Play Now | Play in Popup | Download

Docinthemachine MedTech Podcast!

Posted on November 10, 2009 by Steven F. Palter, MD

Here’s the latest installment of the docinthemachine podcast. In this installment I review new FDA device approvals and then present an interview about HD technology for entertainment and medicine with Bob Ott (vice president of broadcast and professional audio/video products for Sony Electronics) recorded at the National Association of Broadcasters (NAB).

docinthemachine november 2009 [ 19:35 ] Play Now | Play in Popup | Download

Docinthemachine Expands Fertility Analysis and Reporting

Posted on October 29, 2009 by Steven F. Palter, MD

Since its inception docinthemachine has focused on sharing a vision of how technology can transform medicine. I am excited to expand my postings and analysis of all things related to fertility diagnosis and treatment. As most of you are aware I am a board certified reproductive endocrinologist — which is an Ob Gyn with addition training and expertise in infertility. i am currently the Medical and Scientific Director at Gold Coast IVF in Syosset, NY. When I first started DITM I planned on setting up a second blog solely focused on infertility. With the efforts required to post here and continue my clinical practice and research that idea sat on my “to do” list. I have frequently posted on fertility topics here nonetheless.

After some sould-searching and planning and discussions with my good friends and fellow med bloggers Nick Genes and Gene from Medgadget I have decided to jut add all that content here to docinthemachine. While it does not have a sexy-fertility name its a part of me that has a fantastic group of readers… Everyone I spoke with unanimously agreed to just expand the content here!

So stay tuned for more fertility related posts in the days to come.

First Ever Surgical Video in 4k Ultra High Def- Hollywood and Doctor Team Up for Revolutionary Projects on Future Visualization in Medicine

Posted on November 4, 2008 by Steven F. Palter, MD

our digital cinema control room- Sony controls

For the first time ever Hollywood’s digital vanguard has teamed up with a surgeon to use tomorrow’s cinematic tools to revolutionize visualization in the operating room. We successfully filmed produced and played a 4k digital cinema movie of a live human surgery. This was an amazing collaboration between a fertility surgeon, the AAGL endoscopy society, Sony Medical & Broadcast divisions, Red Digital Cinema Camera Company, FotoKem, Vincent Pace films, USC professor Richard Weinberg, and the NBA just to name a few! We also showed the largest medical 3d displays ever.

The AAGL reported on this groundbreaking session today . Further details are here and here.

Dual Sony SXRD 4k projectors in 3D scaffold

New cinematic technologies are transforming the film business today. The two major revolutionary developments are 1) ultrahigh definition “4k” technology – which brings resolution to 4 times that of HD and 2) realistic immersive high definition 3D. I set out to introduce these technologies to the medical world and to see if we could for the first time apply them to surgical practice- setting the goal to once again use technological innovation to improve our patient outcomes.

Virtually all of my surgery is endoscopic- performed through tiny telescopes and viewed on a TV monitor. In 2001 I performed the world’s firs HDTV surgery and demonstrated how increased resolution improved the surgeon’s visualization and performance of procedures. For those interested in the history of HDTV surgery and the details of its development further details of my work are here from the New York Times and here from Science Daily and here from MIT Technology Review. Over the past two years I refined this work with even better performing camera systems and this work was featured on 20/20 and on the National Geographic Channel’s first ever HD medical show – Inside the Living Body.

Hollywood is embracing its digital future by adopting (with $1 billion in financing and a follow-up deal by Sony) planned conversion of 20,000 theaters to ultrahigh definition 4k (4096x 2048) video. The revolutionary Red One camera is one of the few that can natively record this type of file. Having heard about it I went to vegas for NAB in April and saw with my own eyes the amazing realistic movies being made with it. While there I met with Ted Schilowitz, Red’s “Leader of the Rebellion” and was ecstatic with his desire to help with with a proof of concept- to film surgery with a 4k camera. I also partnered with Sony’s Medical and Broadcast Divisions who eagerly helped me set up a 4k and 3dHD digital cinema in an international medical conference hall in the Las Vegas Paris Hotel. The theme of my Keynote lecture was “Film and Medicine: From the Past to the Future- Through the 4th Wall.” In this, I traced how cinematic film technology has transformed the teaching and performance of surgery- and how the future will again have revolutionary changes in physician visualization. Our Hollywood partners allowed me to first show jaw-dropping pro-sports and theatrical demos of the technology.

Sony’s digital cinemas allow the next generation of film to be projected at these previously impossible resolutions. We used dual SXRD 4k projectors with linear polarizing filters for 3D HD then went to a single projector for the 4k. 4k footage has to be played off a dedicated media block digital server and we used an LMT-100 like a movie theater would and FotoKem converted the 4k files into a DCP digital cinema package that can be played. For 3d footage we played off an HD SR tape dual stream deck. I’ll post a follow-up explaination of each of these technologies in detail.

By increasing resolution to this level we allow the surgeon to be actually immersed in images that surpass the live surgical experience. The progress from regular surgical film technology is like comparing sitting in an HD home theater to watching a video on a cell phone.

Ultra high resolution digital cameras are transforming the art of cinema. Leading Hollywood directors such as Peter Jackson and Stephen Soderbergh today have just started filming the next generation of cinema blockbusters using cameras with “4K” resolution, four times the resolution of High Definition (HD) with 4096 lines of resolution to give audiences unprecedented realism. The Red One digital cinema camera is the at the forefront of the revolution. Director Soderberg previously described this technology as “This is the camera I’ve been waiting for my whole career: Red is going to change everything….Shooting with Red is like hearing The Beatles for the first time. Red sees the way I see.”

Amazingly, the surgeons in the conference were able to visualize the surgery they were watching better than if they had been in the operating room live. If it can transform the immersive experience of the movies with unprecedented realism wouldn’t you want that degree of vision in your surgeon’s hands? By combining unprecedented resolution and magnification the surgical images were beyond what a surgeon would have standing live in the operating room. Those in the audience predicted this technology would further revolutionize minimally invasive surgery as it becomes incorporated into the OR of the future.

We then projected the largest high definition (HD) 3d surgical images ever. Wearing glasses reminiscent of today’s 3d Hollywood blockbusters U23D and Journey to the Center of the Earth a standing-room only crowd of 1600 surgeons felt as if they could “reach out and join the operation”. These images were enabled by converting Sony’s ultrahigh definition and 3d theatrical systems to show medical footage in what the AAGL called the “Theater of Tomorrow.” A Vince Pace 3D demo reel showed where Hollywood is going as well with Gwen Stefani concert footage, underwater vistas, and movie clips.

Since laparoscopic surgery is performed by a surgeon watching on a video monitor making the images “better than live” may facilitate teaching and procedures in the future.

The 4K system, manufactured by RED Digital Cinema Camera Company, was used to film Jumper, Crossing the Line, and The Argentine. This recording represents its first use for medicine and biology in the world. In addition to a surgery we showed the first ever 4k microscopy images of single cell organisms ever recorded (from USC).

Stay tuned a for a series of posts coming up this week that will review the session, how we managed the collaborations, the difficulty in executing each of the technologies, and where I predict this is going in surgical visualization.

FDA Ob/Gyn Update: Panel Meeting to Review New Female Condom

Posted on April 2, 2008 by Steven F. Palter, MD

I will be posting an ongoing series on FDA reviews and decisions on new devices focusing on minimally invasive surgery, future medical technologies, and Ob/Gyn devices. What better way to start off the series then with the latest announcement of the FDA Gyn device review panel (Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee) notice of meeting.

The panel will meet May 16, 2008, from 8 a.m. to 5:30 p.m. at the Holiday Inn, Grand Ballroom, Two Montgomery Village Ave., Gaithersburg, MD. to discuss none other than the newest version of the female condom (FC2 by Femalehealth). Hey I wanted my FDA series to satrt off with some new infrared scanner implant but the FDA just gave me a condom. Notice of the FDA meeting is here.

As an aside as an in-trining Ob Gyn resident I remmber calling the company that made the first female condom and requeesting samples for “clinical testing” and “product evaluation” before it got FDA approval.

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