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 Comparative Effectiveness Program. He is associate professor of public health at Weill Cornell Medical College.

For the time being, the most reliable data on devices come from large registries in the U.S. such the Kaiser Permanente Implant Registries and international registries such as those in Australia, the U.K. and Scandinavian countries that track 100 percent of device implants in those countries. While these data are complete, each registry takes a unique approach to monitoring safety.

As a result, ICOR is bringing together orthopedic surgeons, scientists and other stakeholders to establish a unified method for analyzing and reporting multinational registry data. "The result will allow us to find important differences among implants -- and thus provide important evidence to inform decision-making by physicians, hospitals and patients," say ICOR researchers.

"This collaboration provides a unique opportunity to improve patient safety worldwide by identifying the best implants for our patients," says Ms. Paxton, supplement co-author and director of Kaiser Permanente's Implant Registries, which has more than 130,000 implants registered in it.

The Journal of Bone and Joint Surgery supplement summarizes the inaugural ICOR meeting held May 9 and 10 at the headquarters of the FDA in Silver Spring, Md. A total of 14 papers (including a summary paper) report on a variety of the meeting's topics such as implant safety and methodology. Conference invitees included 73 stakeholders from 29 registries representing 14 nations. In addition, more than 25 non-registry stakeholders represented the medical device industry, the Agency for Healthcare Research and Quality, the National Institutes of Health, Centers for Medicare & Medicaid Services, academia, device regulatory agencies, device cataloging experts, insurers and other payers. The Hospital for Special Surgery was an important partner in organizing the meeting.


'/>"/>

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

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:1/17/2017)... ... , ... SC&H Group, a leading audit, tax, and consulting firm, announced that ... Services practice . Rossi is the third technology consulting leader to join SC&H Group’s ... and the practice continues to expand.     , Bringing more than 25 years of business ...
(Date:1/17/2017)... ... January 17, 2017 , ... Physicians Education Review®, LCC ... keynote speaker for the 34th Annual Miami Breast Cancer Conference®, on March 9-12, ... president, Phil Talamo, said, “We are delighted to have Sandra Lee join us ...
(Date:1/17/2017)... ... ... make New Year’s resolutions or renew their commitment to better health with the start of ... want to kick off 2017 with better smiles. Dr. Mondavi is offering several promotions for ... , , A new patient package for just $49, which can ...
(Date:1/16/2017)... Boston, MA (PRWEB) , ... January 17, 2017 ... ... winter season, Au Bon Pain, an internationally recognized leader in the fast-casual category, ... new items such as the Good Egg Breakfast Sandwich, Turkey Mash-Up Sandwich, Cranberry ...
(Date:1/16/2017)... ... 2017 , ... Gym Source, America’s leading retailer of premium residential and commercial ... Jersey. , “We are elated to be opening this new showroom,” explains Tom Richard, ... give clients a seamless and motivating shopping experience.” , Every fitness journey is unique, ...
Breaking Medicine News(10 mins):
(Date:1/17/2017)... NEW YORK , Jan. 17, 2017 ... USD 8.02 billion by 2021 from USD 6.35 billion ... major factors driving the growth of this market are ... increasing demand for minimally invasive surgeries. The ... type, procedure, application, and region. On the basis of ...
(Date:1/17/2017)... , Jan. 17, 2017  Jazz Pharmaceuticals plc (Nasdaq: ... patient has been enrolled in a Phase 3 clinical ... best supportive care (BSC) in the prevention of hepatic ... hematopoietic stem cell transplant (HSCT) who are at high ... The defibrotide clinical trial will be conducted across approximately ...
(Date:1/17/2017)... 17, 2017  Market Research Future published a Half Cooked Research ... expected to reach USD 33.6 million during the period 2016 to ... ... Devices Market has been examined as a swiftly growing market and ... demand for endoscopy device in various regions.  The increasing growth in ...
Breaking Medicine Technology: