by Gus Iversen, Editor in Chief DOTmed In a setback for improved cooperation between different medical equipment service stakeholders, two of the leading manufacturer trade groups, the Medical Imaging & Technology Alliance (MITA) and AdvaMed, have announced they will no longer be participating with in-house and independent service organizations in FDA-recommended Medical Device Servicing [...]

IAMERS continues its role, albeit virtually, as an official observer to the European Commission Medical Device Coordination Group. IAMERS has been participating in the MDCG Subgroup on the MDR regulations on Post Market Surveillance and Vigilance. Under these regulations, manufacturers will be furnishing to member country regulators no less than annually reports on the safety [...]

IAMERS has joined on behalf of its members the Healthcare Sector Coordinating Council. The HSCC is a private-sector organized and managed council created to establish a process to coordinate improvements to the security of critical infrastructure. The U.S. Department of Homeland Security is required to engage and consider the advice of the Sector Coordinating Councils. [...]

As many of you know we are continuing our advocacy (albeit virtually) with the Congress, EU and others. We wanted to bring to your attention, IAMERS latest efforts to advocate for greater access to service access information. Read more about our efforts here.

April 29, 2020 An editorial by Robert J. Kerwin Originally publish on DOTMed Health Care Business NewsWith a big tip of the hat to Captain Obvious, our hospitals and health delivery organizations are heroically dealing with a terrible pandemic the likes of which we have no real comparison for in our lifetime. As Healthcare Business News [...]

Here are some of our members enjoying Madrid.Download

GE chairman and CEO Larry Culp said in light of its just-announced deal with Danaher, the IPO for its healthcare division may be delayed. Read more here.

Cuts of up to $112 million in Medicare ultrasound reimbursements have organizations like the American College of Radiology calling for radiologists to clarify the actual costs of purchasing and servicing ultrasound equipment. Read more here.

Read more here. “Nowhere in the white paper does MITA provide support for its claim of an increased "risk to the public health." As MITA once acknowledged in its previous submission to the FDA it is impossible to provide a statistically valid analysis of the extent of problems.”

While current FDA standards regulate the remanufacturing of medical devices, regulation of servicing is not a requirement. In addition, few safeguards exist to prevent the crossover of servicing activity with that of remanufacturing, creating increased risks to public health, the safety of patients and providers who use the technology. These risks are elaborated on in [...]