English (United Kingdom)

https://curated-unify.zendy.io/wp-json/zendy-region/v1/featured_content/oa?rat=en

https://curated-unify.zendy.io/wp-json/zendy-region/v1/highlighted_journal/

Global: Zendy Plus annual

Presents the access of premium content as premium feature

Premium Content

Presents the keyphrase highlighting as premium feature

Keyphrase Highlighting

Presents the summarisation as premium feature

Summarisation

Insights

Presents the pdf analysis as premium feature

PDF Analysis

Presents the zaia usage as premium feature

ZAIA

Global: Zendy Plus monthly

Global: Zendy Tools annual

Global: Zendy Tools monthly

Global: Zendy Free Plan

Over a million prosthetic joints are placed in patients in the United States annually. Of those that fail, 25% will be due to infection, with an estimated cost approaching 1 billion dollars. Despite the clinical and economic importance of these infections, the techniques for their detection are relatively insensitive. An innovative method for detecting these infections by using blood culture bottles (BCB) to culture specimens of periprosthetic tissue (PPT) was described in a recent article [T. N. Peel, et al., mBio 7(1):e01776-15, 2016, doi:10.1128/mBio.01776-15]. There are two potential stumbling blocks to the widespread implementation of this innovation. First, the FDA judges such an application of BCB as an "off-label use" and as such, a laboratory-developed test (LDT). LDTs are coming under greater scrutiny by the FDA and may require extensive, costly validation studies in laboratories that adopt this methodology. Second, the Center for Medicare and Medicaid Services has established a Hospital Acquired Condition Reduction Act under which institutions performing in the lowest quartile forfeit 1% of their Medicare reimbursement. Hospital-acquired infections are an important component of this quality metric. Although prosthetic joint infection (PJI) rates are not currently a hospital quality metric, given their cost and increasing frequency, it is reasonable to expect that they may become one. Will those with financial oversight allow an innovative technique that will require an expensive validation and may put the institution at risk for loss of CMS reimbursement?

Will Regulatory and Financial Considerations Dampen Innovation in the Clinical Microbiology Laboratory?