Who Owns Explanted Medical Devices

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Ask HRC: Retaining Explanted Medical Devices - ECRI

https://www.ecri.org/components/HRC/Pages/AskHRC122716.aspx

The generally unpredictable nature of whether or when litigation regarding a device may occur; The guidance article Medical Device Tracking and accompanying List of Tracked Devices contain additional information about FDA requirements. For example, if …

Handling of Explanted Medical Devices Addressed in …

https://ortoday.com/handling-of-explanted-medical-devices-addressed-in-aorns-revised-guideline-for-specimen-management/

By Susan Klacik, BS, CRCST, CIS, CHL, ACE, FCS. On Dec. 14, 2020, the Association of periOperative Registered Nurses’ (AORN’s) Guideline for Specimen …

The “What, What, What” of Medical Device Explants - SpendMend

https://www.spendmend.com/the-what-what-what-of-medical-device-explants/

By Joe Heminger, Business Development Representative The OIG listed on the 2022 workplan that they will be auditing the hospital’s explanted medical device …

Hospitals Hit Snags With Device Credits; Mayo Has …

https://assets.hcca-info.org/Portals/0/PDFs/Resources/Rpt_Medicare/sample-5-15.pdf?ver=2017-05-30-143513-417

the formidable challenge of identifying and tracking explanted medical devices and passing on the credits to Medicare, as required by CMS. Mayo Clinic has …

Implants and Explants - ECRI

https://www.ecri.org/search-results/member-preview/hrc/pages/surgan18

Medical device implants can save or prolong lives or improve quality of life, but they may also be sources of significant risk to patients. Several risk, regulatory, and …

Advice on Explanted Implants - Infection Control Today

https://www.infectioncontroltoday.com/view/advice-explanted-implants

A policy and procedure should be developed and approved by the infection prevention committee. SPD and OR personnel should be in-serviced in the provisions …

Expanded Access for Medical Devices | FDA

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/expanded-access-medical-devices

Expanded access to an investigational device under the emergency use mechanism is intended to provide patients and physicians with access to investigational …

Device Makers Have Funneled Billions to Orthopedic …

https://khn.org/news/article/spine-surgery-implants-device-makers-orthopedic-surgeons-kickbacks/

Orthopedic surgeon-turned-whistleblower Dr. Manuel Fuentes is suing his former employer, Florida device maker Exactech, alleging it offered “phony” consulting …

Managing Medical Devices - GOV.UK

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/982127/Managing_medical_devices.pdf

medical devices are covered in separate documents. Medical devices play a key role in healthcare, vital for diagnosis, therapy, monitoring, rehabilitation and care. Effective …