Medical Device Replacement Program

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Remanufacturing and Servicing Medical Devices | FDA

https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/remanufacturing-and-servicing-medical-devices

Draft GuidanceThe distinction between "remanufacturing" and "servicing" is important to under…Papers and Reports1. Servicing Discussion Paper: Strengthening Cybersecurity Practices A… See more

Total Product Life Cycle Advisory Program (TAP) | FDA

https://www.fda.gov/medical-devices/how-study-and-market-your-device/total-product-life-cycle-advisory-program-tap/

TAP is intended to help ensure that U.S. patients have access to high-quality, safe, effective, and innovative medical devices first in the world for years to …

State Assistance Programs for Durable Medical Equipment

https://www.payingforseniorcare.com/durable-medical-equipment/state-assistive-tech

State-based assistance for durable medical equipment can come from one of three types of program (excluding Medicaid). There are Assistive Technology …

Durable Medical Equipment (DME) Center | CMS

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

Furnish a replacement device as it may take Philips Respironics up to a year to repair or replace the device. Under federal regulations, you must replace the equipment at no …

Healthcare Equipment Planning and Replacement | Strata

https://www.stratadecision.com/article/why-age-is-not-enough-a-better-approach-to-equipment-replacement/

By leveraging existing data, replacement planning can help an organization achieve the following objectives: Reduce costs associated with parts, maintenance, …

Medical Device Recall Information

https://www.usa.philips.com/healthcare/e/sleep/communications/src-update

In most markets, devices currently authorized for repair and replacement include DreamStation CPAP and Bi-level devices, DreamStation ASV devices, and DreamStation ST/AVAPS …

CMS Manual System - Centers for Medicare

https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3181CP.pdf

When a hospital furnishes a device for which it incurs no cost, (these cases include, but are not limited to, devices replaced under warranty, due to recall, or due to …

Sterilization for Medical Devices | FDA

https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices

Sterilization for Medical Devices | FDA Sterilization for Medical Devices Medical devices are sterilized in a variety of ways including using moist heat (steam), …

Medical Equipment Management Plan - Duke …

https://www.safety.duke.edu/sites/default/files/Medical-Equipment-Management-Plan.pdf

All equipment included in the medical equipment management program will receive scheduled maintenance and testing based on manufacturer’s recommendations unless …

Payment Credits for Replaced Medical Devices That …

https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000085.asp

Payment Credits for Replaced Medical Devices That Were Implanted Certain medical devices are implanted during inpatient or outpatient procedures. Such devices may …

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