Navigation Links
Unprecedented international effort to improve safety of orthopedic devices
Date:12/21/2011

NEW YORK (Dec. 21, 2011) -- Responding to a need for better post-market surveillance of orthopedic devices, the U.S. Food and Drug Administration (FDA) established the International Consortium of Orthopaedic Registries (ICOR) in October 2010.

As outlined in a Dec. 21 special online supplement in the Journal of Bone and Joint Surgery, ICOR is in the process of developing a collaborative process for improving the safety of orthopedic devices using outcomes registries from the U.S. and other countries. The combined ICOR registries may include data on millions of orthopedic surgical procedures and all implantable devices on the market.

More than 700,000 joint replacement devices are implanted in patients in the U.S. every year, and this volume is projected to increase twofold for hip-joint replacements and sevenfold for knee-joint replacements, to a total of more than 3 million annually, in the 20 years.

While there have been dramatic advancements in orthopedics, including new devices and improved surgical techniques, the value of many of these devices has not been established using large studies in real-world settings. The FDA chair of the meeting Dr. Danica Marinac-Dabic and ICOR meeting co-leads Dr. Art Sedrakyan (NewYork-Presbyterian/Weill Cornell and Hospital for Special Surgery) and Elizabeth Paxton, M.A., (Kaiser Permanente) believe that the consortium will help ameliorate this problem.

Unlike drugs, devices have a different path of approval that may not require conduct of clinical trials in the United States. Furthermore, adverse outcomes reporting for devices is voluntary, and the resulting data are often incomplete or inaccurate. While there is currently an effort by the American Academy of Orthopedic Surgeons to develop a large national registry, the midterm follow up will likely take several years or more, says Dr. Sedrakyan, who coordinated the supplement for ICOR and is directing the Patient-Centered Comparati
'/>"/>

Contact: Linda Kamateh
lib9027@med.cornell.edu
212-821-05FDA-initiated60
New York- Presbyterian Hospital/Weill Cornell Medical Center/Weill Cornell Medical College
Source:Eurekalert

Page: 1 2

Related medicine news :

1. Womens Dermatologic Society Marks 35th Anniversary with Release of Unprecedented Book of Wisdom and Inspiration
2. Unprecedented AIUM training guidelines speak to future of musculoskeletal ultrasound
3. Iowan Tackles Everest and More in Unprecedented Adventure
4. Care2Learn Celebrates National Nurses Week with iPad Giveaway, Unprecedented Continuing Education Offer
5. NASAs LRO creating unprecedented topographic map of moon
6. Unprecedented view of protein folding may help develop brain disease therapies
7. Breast health global initiative offers unprecedented tools for developing nations
8. Experimental drug achieves unprecedented weight loss
9. International Diabetes Federation awards $2 million to 9 global diabetes research projects
10. Jion Beijing Great Wall International Travel Agency Immediate Exposure to China Expo 2010
11. H1N1 international symposium to be hosted by Emory-UGA Influenza Center
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/16/2014)... Cliff Lake Dental Care is proud to announce the latest ... to join Dr. Rauchwarter's team. The team at Cliff Lake ... she will bring many benefits to the office as well ... Falls, WI. She finished dental assisting school and graduated ... assisting in the Twin Cities, Milwaukee, California and Virginia. ...
(Date:9/16/2014)... Aspen Advisors, a U.S.-based healthcare IT ... for its high morale and collaborative culture ... Firms to Work For 2014.” Consulting magazine publishes ... 10,000 consultants participating across all major industries, representing more ... conducted, and firms were ranked in six categories - ...
(Date:9/16/2014)... as part of breast conservation is the current ... (HR+) invasive breast cancer. A new study by ... that combination may not be necessary for all ... results, which Fox Chase researchers presented at the ... on Sunday, September 14, suggest that low-risk patients ...
(Date:9/16/2014)... September 16, 2014 Seven heroes who ... world will be honored in New York City on ... ), the only global recognition and funding program that ... by the media as the “Nobel Prize for Child ... created life-changing programs that benefit children in countries around ...
(Date:9/16/2014)... Los Angeles, CA (PRWEB) September 16, 2014 ... the League of United Latin American Citizens (LULAC) will ... California. LULAC’s Feria de Salud will feature free health ... Other free testing includes glucose and cholesterol levels ... screenings will be available for children under 6 years ...
Breaking Medicine News(10 mins):Health News:Cliff Lake Dental Care Announces Newest Team Member 2Health News:Aspen Advisors Earns Recognition in Consulting Magazine’s "Best Small Firms to Work For" 2Health News:Aspen Advisors Earns Recognition in Consulting Magazine’s "Best Small Firms to Work For" 3Health News:Benefit of endocrine therapy in elderly women with low risk hormone receptor positive breast cancer? 2Health News:Benefit of endocrine therapy in elderly women with low risk hormone receptor positive breast cancer? 3Health News:World of Children® Award Announces 2014 Honorees 2Health News:World of Children® Award Announces 2014 Honorees 3Health News:World of Children® Award Announces 2014 Honorees 4Health News:World of Children® Award Announces 2014 Honorees 5Health News:World of Children® Award Announces 2014 Honorees 6Health News:World of Children® Award Announces 2014 Honorees 7Health News:World of Children® Award Announces 2014 Honorees 8Health News:LULAC Hosts Second Annual Latinos Living Healthy Feria de Salud in Los Angeles 2
... BRIDGEWATER, N.J., March 16 Sanofi-aventis U.S. announced ... to Chief Science Officer/Chief Medical Officer, U.S., effective ... sanofi-aventis, U.S. As the company,s Chief Science ... establish a unified medical voice for sanofi-aventis U.S. ...
... Training and Professional Certification ProgramsKERRY, Ireland and ... leading Ireland-based provider of innovative learning solutions, ... eLearning and certification programs for the American ... the Insurance Institute of America (the Institutes), ...
... result, studies find, , , MONDAY, March 16 (HealthDay News) ... can be successfully harnessed to deliver health information to ... encouraging them to stick more closely to the treatments ... suggests. , One study explored giving teens regular ...
... (NYSE: MHS ) Chairman and CEO David ... Luncheon Address to the American Enterprise Institute,s health care ... March 18, 2009, at 12:30 p.m. Through the ... be directed at expanding the use of health information ...
... Vitamin D, but be Careful Not to Burn Cautions Tanning ... Indoor Tanning Association (ITA) is encouraging beach goers to tan ... good health, overexposure to UV light can be a dangerous ... order for tanners to get all the benefits of UV ...
... the NCCN Clinical Practice Guidelines in Oncology(TM) for Thyroid ... 14. Notable updates include a new page on Thyroid ... molecule kinase inhibitors, and revised procedures for evaluating thyroid ... of Texas M.D. Anderson Cancer Center and chair ...
Cached Medicine News:Health News:Paul Chew Appointed to sanofi-aventis U.S. Chief Science Officer/Chief Medical Officer 2Health News:Ireland's PulseLearning Inks Agreement With Leading U.S. Insurance Industry Association 2Health News:Using Music and Sports to Improve Kids' Asthma 2Health News:Using Music and Sports to Improve Kids' Asthma 3Health News:Media Advisory: Medco CEO David B. Snow Jr. To Address American Enterprise Institute: 'Health IT: Empowering Precision Medicine' 2Health News:Indoor Tanning Association Promotes Responsible Tanning for Spring Breakers 2Health News:NCCN Presents Updates to NCCN Guidelines for Thyroid Carcinoma 2Health News:NCCN Presents Updates to NCCN Guidelines for Thyroid Carcinoma 3Health News:NCCN Presents Updates to NCCN Guidelines for Thyroid Carcinoma 4
(Date:9/16/2014)... Wash. , Sept. 16, 2014 /PRNewswire/ ... a late stage development company engaged primarily ... medical isotopes for diagnostic and therapeutic applications, ... for technology related to its brachytherapy products.  ... arise from its license from Battelle, under ...
(Date:9/16/2014)... -- Russia,s pharmaceutical ... Pharma 2020 Strategy provides incentives for local producers to ... foreign markets. These trends, however, were affected by recent ... political and economic sanctions imposed on Russia ... Russia responded to the US ...
(Date:9/16/2014)... Sept. 16, 2014 Surgeons at The Children,s ... a case report the first successful use of a ... year-old boy with failing Fontan circulation to bridge him ... 3 years old, the patient received a Fontan circulation ... single ventricle. "The Fontan operation is the final planned ...
Breaking Medicine Technology:Advanced Medical Isotope Corporation Licensed Brachytherapy Seed Patent Granted 2Advanced Medical Isotope Corporation Licensed Brachytherapy Seed Patent Granted 3Advanced Medical Isotope Corporation Licensed Brachytherapy Seed Patent Granted 4Global Medicines for Russia 213-Year-Old Boy with Failed Fontan Circulation Bridged to Transplant Using the SynCardia Total Artificial Heart, Published in Annals of Thoracic Surgery 213-Year-Old Boy with Failed Fontan Circulation Bridged to Transplant Using the SynCardia Total Artificial Heart, Published in Annals of Thoracic Surgery 3
... and PRINCETON, N.J., Jan. 31, 2011 Qforma, the leading ... health sciences industry, today announced the appointments of Ted Pine ... Michael Murphy as Software Engineer. "As Qforma ... optimize service to our pharmaceutical industry customers, we welcome the ...
... 2011 OXIS International, Inc., (OTC Bulletin Board: ... favorable final results from an initial clinical study to ... joint health formula, launched commercially in December 2010. ... statistically significant after as little as one week of ...
Cached Medicine Technology:Qforma, Leading Provider of Healthcare Analytics, Announces Three New Appointments 2Final Results from ERGOFLEX Study Show Statistically Significant Reduction in Joint Pain in as Little as One Week 2Final Results from ERGOFLEX Study Show Statistically Significant Reduction in Joint Pain in as Little as One Week 3Final Results from ERGOFLEX Study Show Statistically Significant Reduction in Joint Pain in as Little as One Week 4
19 Gauge. Reusable. Block of 4 each....
18 gauge curved. Fine tip. Lightweight design offers precise hemostasis. Pencil design minimizes tissue trauma and induced astigmatism. Knurled handle provides a sure grip and better manipulation....
Set consist of two 23 gauge, stainless steel probes with blunt tips. Probes are 18 cm (7.0 inches) long with 30.5 cm (12 inches) of flexible tubing (O.D. - 0.60 mm, I.D. - 0.30 mm) attached onto the ...
Curved, soft flexible tip allows atraumatic entry through a retinal tear or hole for aspiration of subretinal fluids. 20 gauge x 25 mm cannula attached to 25 gauge x 6 mm tip with 13 mm flexible tubi...
Medicine Products: