TY - JOUR AU1 - , AB - Downloaded from http://journals.lww.com/biomedicalsafetystandards by BhDMf5ePHKbH4TTImqenVA5KvPVPZ0P5BEgU+IUTEfzO/GUWifn2IfwcEVVH9SSn on 06/05/2020 Biomedical Safety & Standards Concise, accurate news reports for medical device safety professionals BS&S FEATURE April 1, 2017 Volume 47 Genetic-Based Testing for Opioid Risk and Number 6 Other Profiles Raises Questions IN THIS ISSUE Recalls & Field Angela Starkweather, PhD, ACNP-BC, CNRN, FAAN Corrections—Class II IQon Spectral CT ............. 41 Genetic-based tests are becoming more accessible to health care facilities and the public, but who is responsible for ensuring that the tests are accurate and Philips IntelliVue .............. 43 based on legitimate scientific findings? i.v. Station Onco Compounding System ...... 43 Companies such as 23andMe (https://www.23andme.com) have been Phoenix Hemodialysis delivering direct-to-consumer services on analysis of genetic variants, with a Maintenance Kits ............. 43 disclaimer stating that, “The tests are not intended to diagnose a disease, or tell Unna-Z Unna Boot you anything about your risk for developing a disease in the future.” However, Bandages .......................... 43 other companies are moving forward on marketing genetic tests that claim a Pentax Rigid precise diagnostic value. Laryngostroboscopes ....... 44 Philips Velara Generator ..44 This specific group of diagnostic tests, called laboratory-developed tests Accu-Chek Diabetes (LDTs), is designed, manufactured, and used within a single TI - Symmetry Surgical Sterilization Containers JF - Biomedical Safety & Standards DO - 10.1097/01.BMSAS.0000515026.66706.6b DA - 2017-04-01 UR - https://www.deepdyve.com/lp/wolters-kluwer-health/symmetry-surgical-sterilization-containers-uCI2gADU4n SP - 45 VL - 47 IS - 6 DP - DeepDyve ER -