Knowledge Center

A panel of provider thought leaders as discusses the ISO 80369-3 (ENFit) small bore connector conversion successes, lessons learned and implementation processes.

Supply chain attributes inform critical supply availability and alignment with internal and external needs, integral to meeting pressures to deliver safe care.

The AHRMM LUC members submitted comments and recommendations to the FDA's Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices. They recommend that information related to all Class I Medical Devices be included in the GUDID without exception.

The AHRMM LUC members submitted public comments and recommendations at the FDA's November 2020 meeting related to the need to include the UDI in the recall process. They highlighted the prototype recall database and electronic submission form, as well as survey data supporting its creation.

AHRMM Issues & Legislative (I&L) Committee identifies, reviews and follows the regulatory, environmental, quality of service and standards matters that impact the health care supply chain field. Each I&L Committee member closely monitors an important topic and compiles an update with useful information to help AHRMM members stay ahead of policy issues that affect their work and health care organization.

In September 2019, FDA announced its Technology Modernization Action Plan (TMAP).  The TMAP describes important near-term actions that FDA is taking to modernize use of technology—computer hardware, software, data and analytics—to advance FDA’s public health mission. The TMAP will provide a foundation for developing a more fluid, agile, and efficient FDA that is scaled to respond to novel technologies and a rapidly increasing workload.