Durable Medical Equipment Recall Policy

Medical Device Recalls | FDA

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls

The FDA posts summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health...

Recalls, Corrections and Removals (Devices) | FDA

https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices

What is a Medical Device Recall? | FDA

https://www.fda.gov/medical-devices/medical-device-recalls/what-medical-device-recall

Initiates a recall (through correction or removal) Notifies the FDA. Legally, the FDA can require a company to recall a device. This could happen if a company refuses to recall a …

Durable Medical Equipment (DME) Center | CMS

https://www.cms.gov/Center/Provider-Type/Durable-Medical-Equipment-DME-Center

The Level II codes that have been issued were intended to describe non-implantable CGMs that fall under the Medicare benefit for durable medical equipment. Implantable CGMs …

CLINICAL POLICY Medical Equipment Management …

https://health.uconn.edu/policies/wp-content/uploads/sites/28/2021/07/Medical-Equipment-Management-Plan-11-021.pdf

Any information that comes into the organization regarding manufacturer recalls or warnings about medical equipment is immediately forwarded to the Clinical Engineering Manager. …

MLN905709 – DMEPOS Quality Standards - Centers for …

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/DMEPOSQuality/DMEPOSQualBooklet-905709.html

The DMEPOS Quality Standards have 2 sections and 3 appendices: Section I: Supplier Business Service Requirements focuses on administration, financial management, …

Baystate Health Supply Chain Department Medical …

https://www.baystatehealth.org/-/media/files/about-us/corporate-information/3-2100-product-recall-procedure.pdf?la=en

The following recall information must be received by InventoryControl (IC) from the person notified of the recall: The original document(s), including the original mailing …

Payment Policy | Durable Medical Equipment - BCBSRI

https://www.bcbsri.com/providers/sites/providers/files/policies/2022/02/Durable%20Medical%20Equipment_1.pdf

POLICY STATEMENT Medicare Advantage Plans and Commercial Products Rent-to-Purchase The following guidelines apply to rental items: DME rentals are for a period of …

DMEPOS Templates | CMS

https://www.cms.gov/Research-Statistics-Data-and-Systems/Computer-Data-and-Systems/Electronic-Clinical-Templates/DMEPOS-Templates/DMEPOS-Templates

Templates and Suggested Clinical Data Elements (CDEs) for Durable Medical Equipment, Prosthetics, Orthotics & Supplies (DMEPOS) You can use the printable …

Important Notice on DME Recall | DMAS - Department of …

https://dmas.virginia.gov/news-and-updates/posts/2021/july/important-notice-on-dme-recall/

A Certificate of Medical Necessity (CMN) will not be required at the time of service authorization to streamline the process of getting new CPAP, BiPAP and ventilators out …