Knowledge Center

How to write a constructive, information-rich comment that clearly communicates and supports its claims to have an impact on regulatory decision making.

The FDA UDI ruling has finally arrived - the proposed rule has published. Please see the FDA website (www.fda.gov/udi) for a link to the proposed regulation. Highlights include a 120 day comment period to begin shortly, 6 months later a final ruling that will begin with Class III devices within 2 years, possibly sooner. Below is the FDA press release:

On November 21, 2013, AHRMM submitted electronically

The final regulations that provide guidance on the excise tax imposed on the sale of certain medical devices, enacted by the Health Care and Education Reconciliation Act of 2010 in conjunction with the Patient Protection and Affordable Care Act.

An overview of Fiscal Year (FY) 2015 Hospital Value-Based Purchasing (VBP) Program.

AHRMM comments to the FDA regarding an amendment to the UDI proposed rule to address the UDI implementation time frame required by the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA).

As a Leading Practice, the AHRMM Board of Directors adopts that Supply Chain Services be fully integrated into high cost clinical services departments.

The Patient Protection and Affordable Care Act of 2010 (ACA) requires the Secretary of Health and Human Services to establish a VBP program to pay hospitals for their actual performance on quality measures, rather than just the reporting of those measures, beginning in fiscal year (FY) 2013. The VBP program will apply to all acute-care prospective payment system (PPS) hospitals. Read a summary of key provisions of the proposed rule.

In this page, AHRMM recommends these 3 proactive activities in the event of economic downturn.

This Special Fraud Alert focuses on the specific attributes and practices of PODs that OIG believes produce substantial fraud and abuse risk and pose dangers to patient safety.

In 2001 the Institute of Medicine (IOM) published

AHRMM supports the concept and use of Comparative Effectiveness Research (CER) to provide evidence-based data to help inform purchasing decisions. CER is designed to support healthcare decisions by providing objective conclusions after comparing the effectiveness, benefits, and potential harm of various medical equipment, devices, or treatment options for specific episodes of care or states of disease.   By using objective data provided by CER, healthcare supply chain professionals have the ability to:

New Guidance on Humidity Levels in the Operating Room

To provide administrative support to the TCH IDS contracts process.

AHRMM’s Issues & Legislative Committee issued the following Statement on Pricing Transparency approved by AHRMM Board of Directors:

This learning lab covers alarm safety management in the health care supply chain field.

This page provides information about submitting data to the database for device Labelers, entities responsible for providing the data to the GUDID.

This document provides interim guidance for infection control for healthcare facilities (e.g., hospitals, long-term care and outpatient facilities, and other settings where healthcare is provided).

The Strategic Marketplace Initiative (SMI) is a consortium of healthcare supply chain executives united to re-engineer and advance the future of the healthcare supply chain. SMI has provided AHRMM with free supply chain industry resources. To access the resources, visit www.smisupplychain.com or click on the topic below. You will be prompted to register with SMI in order to access the free tools.

Recent Guidance on Meaningful Use of EHRs Makes Compliance More Difficult.