Resources

Hospitals not required to inform patients when using reprocessed medical devices:

No state requires hospitals to obtain a patient’s informed consent when using reprocessed medical devices. Over the last several years some original equipment manufacturers (OEMs) orchestrated a number of bills at the state legislative level proposing to require hospitals to obtain a patient’s informed consent (among other things) prior to use of a reprocessed device. To date, every state that has considered such legislation promoted by the OEMs has rejected it.

Daniel J. Vukelich, Esq., President of AMDR

Reprocessing SUDs is Lawful under FDCA

The reprocessing of devices labeled by the original equipment manufacturer (OEM) as for “single-use” (SUDs) is lawful under the Federal Food, Drug, and Cosmetic Act (FDCA), if conducted in accordance with FDA’s medical device manufacturer requirements.

21 U.S.C. §§ 351, 352, 360, and 360c-360e

CMS Reimbursement and Patient Billing for Reprocessed SUDs

Reprocessed SUDs are Eligible for Reimbursement by CMS Just as Non-Reprocessed Devices A reprocessed device that complies with the regulatory requirements enforced by FDA is eligible for payment and coverage by Medicare to the same extent as non-reprocessed devices."

AMDR in the Position Paper/Policy Statement, “CMS Reimbursement and Patient Billing for Reprocessed SUD”, September 2010

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