Editorials

New and unproved medical devices

BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f7413 (Published 19 December 2013) Cite this as: BMJ 2013;347:f7413
  1. Aaron S Kesselheim, assistant professor of medicine1,
  2. Jerry Avorn, professor of medicine1
  1. 1Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA 02120, USA
  1. akesselheim{at}partners.org

Enthusiasts need educating about the clinical, ethical, and legal implications of choices supported by limited data

There is a well established nomenclature for describing the uptake of new technologies.1 “Innovators” adopt a novel approach the fastest; they are often mavericks and have personalities that feature a high tolerance for risk. “Early adopters” are the next to take up the new technology. Their behavior, which is only slightly more circumspect, has been described as self conscious experimentation.2 Together, these professionals are one standard deviation greater than average in terms of speed of adoption than their peers and make up about 16% of the relevant population.2

In a linked paper (doi:10.1136/bmj.f6956), Kynaston-Pearson and colleagues show that innovation research would have accurately predicted the proportion of orthopedic surgeons in England and Wales at the vanguard of using new technology.3 The authors examined the National Joint Registry of England and Wales to identify the range of prostheses used in total hip arthroplasty in 2011, and they found that about half of the 261 brands in the database had been on the market for fewer than three years. After conducting a systematic review of the literature, they found that about half of these recently introduced brands had no published evidence of clinical effectiveness. …

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