Supply Chain/Technology

Latest Issue of OR Manager
August 2018
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Study: Residual moisture, waterborne pathogens found inside flexible endoscopes

Editor's Note Inadequate reprocessing and insufficient drying contributed to retained fluid and contamination found inside flexible endoscopes in this study led by noted epidemiologist Cori L. Ofstead. Of 45 endoscopes analyzed at 3 hospitals, fluid was detected in 49%, and the prevalence of moisture varied significantly by site (5%, 83%,…

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By: Judy Mathias
April 19, 2018
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FDA issues letter to healthcare providers on risks of endoscope connectors

Editor's Note The Food and Drug Administration (FDA) on April 18 alerted healthcare providers and facilities about the risk of cross-contamination with 24-hour, multipatient use connectors used in gastrointestinal (GI) endoscopy. Endoscope connectors are small accessories used to connect the auxiliary water channel to a water source and irrigation tubing.…

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By: Judy Mathias
April 19, 2018
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Report predicts growth for spinal fusion devices

Editor's Note A Coherent Market Insights report predicts the global market for spinal fusion devices is set to grow at a 4.6% compound annual growth rate through 2025, after hitting $7.5 billion in 2016, according to the April 17 Becker’s Spine Review. The increasing incidence of spinal deformities will boost…

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By: Judy Mathias
April 19, 2018
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FDA approves firmware update for Abbott ICDs, CRT-Ds

Editor's Note The Food and Drug Administration (FDA) on April 17 announced that it had approved a firmware update that is now available for certain Abbott (formerly St Jude Medical) implantable cardiac devices (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The update is a corrective action (recall) to reduce the…

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By: Judy Mathias
April 18, 2018
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FDA alert: Coastal Meds recalls all sterile products

Editor's Note The Food and Drug Administration (FDA) on April 13 announced the recall by Coastal Meds (Biloxi, Mississippi) of all nonexpired products marketed as sterile because of visible particles in some of the drug vials for injection and poor sterile production practices. The FDA on April 5 requested the…

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By: Judy Mathias
April 16, 2018
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FDA: Premier Pharmacy Labs recalls certain sterile injectable products

Editor's Note The Food and Drug Administration (FDA) on April 12 announced the recall by Premier Pharmacy Labs (Weeki Wachee, Florida) of certain lots of sterile injectable products because of a potential lack of sterility assurance. The products include morphine sulfate (2 mg/mL and 3 mg/mL), hydromorphone HCL 1 mg/mL,…

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By: Judy Mathias
April 16, 2018
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FDA: Recall of Acrodose Plus and PL systems by Haemonetics

Editor's Note The Food and Drug Administration (FDA) on April 13 announced the recall by Haemonetics (Braintree, Massachusetts) of certain lots of its Acrodose Plus and PL Systems because the company has received reports of low pH readings for platelets stored in CLX HP bags. In some instances the drop…

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By: Judy Mathias
April 13, 2018
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ECRI Institute announces new Culture of Safety Assessment for Health IT Companies

Editor's Note The ECRI Institute and the Partnership for Health IT Patient Safety (ie, a multistakeholder collaborative convened and operated by the ECRI Institute) announced April 10 the new INsight® Culture of Safety Assessment for Health IT Companies. The new program allows health IT developers to assess safety culture with…

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By: Judy Mathias
April 11, 2018
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FDA announces AccessGUDID data update

Editor's Note The Food and Drug Administration announced that new data elements will be available on AccessGUDID, in the download files and in the APIs, as of April 2. Data for FDA Premarket Submission Number and FDA Premarket Supplement Number will not be provided until this summer. The FDA is…

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By: Judy Mathias
April 9, 2018
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EHRs hinder ability to report quality measures

Editor's Note The poor design of electronic health records (EHRs) poses challenges for primary care practices to generate the required reports for federal value-based payment programs, this study finds. An analysis of survey responses from 1,492 practices in 12 states, found that the reports generated for meaningful-use participation, which requires…

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By: Judy Mathias
April 6, 2018
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