Document Detail


The natural history of new orthopaedic devices.
MedLine Citation:
PMID:  16906061     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Each year, hundreds of new devices and implants are introduced for orthopaedic surgeons. However, the proportion of new devices which ultimately will be successful is unknown. We investigated the natural history of new devices introduced to the orthopaedic market. From a list of all devices approved for use by the Food & Drug Administration 5 and 10 years before, a cohort of 100 devices was randomly selected using a random number list. Companies were contacted regarding the safety record and current availability of these devices. The company response rate was 93%. Forty-seven percent of devices approved 10 years ago and 25% of devices approved 5 years ago no longer were on the market. Of the 55 companies studied, 18 (33%) were out of business and their devices no longer were available. Devices approved 10 years ago were more likely to be unavailable than devices approved 5 years ago. Devices introduced by smaller companies were more likely to be unavailable. The majority of unavailable devices were discontinued not for clinical problems, but for poor market performance. Only 2% of devices studied had safety problems. Approximately 50% of devices approved for introduction to the orthopaedic marketplace no longer are available 10 years later. However, major device-related problems seem uncommon.
Authors:
Timothy Bhattacharyya; Ciantel Blyler; Deana Shenaq
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Clinical orthopaedics and related research     Volume:  451     ISSN:  0009-921X     ISO Abbreviation:  Clin. Orthop. Relat. Res.     Publication Date:  2006 Oct 
Date Detail:
Created Date:  2006-10-13     Completed Date:  2006-11-09     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0075674     Medline TA:  Clin Orthop Relat Res     Country:  United States    
Other Details:
Languages:  eng     Pagination:  263-6     Citation Subset:  AIM; IM    
Affiliation:
Massachusetts General Hospital and Brigham and Women's Hospital, Boston MA, USA.
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MeSH Terms
Descriptor/Qualifier:
Device Approval
Equipment Safety
Health Care Sector
Health Services Needs and Demand
Humans
Orthopedic Equipment / statistics & numerical data*,  supply & distribution,  trends
Time Factors
United States

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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