Heart of Health Policy | FDA News and Updates; Making the Most of MOC

Updates on Health Policy News Affecting Practice.

ACC Offers Principles for Reducing FDA Regulatory Burdens

In a recent comment letter to the U.S Food and Drug Administration (FDA), the College submitted a set of principles intended to serve as a guide to reduce unnecessary regulatory burdens. Among the included principles:

  1. Ensure regulatory decisions are patient-centered and based on scientific merit
  2. Balance industry flexibility with safety and effectiveness
  3. Allow for necessary therapeutic innovation
  4. Collaborate with other federal agencies and professional medical societies
  5. Ensure protection of the public health

The ACC supports the FDA’s efforts to help reduce administrative and regulatory burdens that affect patients’ timely access to new therapies and will continue to engage with the FDA throughout the process.

Class I Recall for Sterilmed Reprocessed Agilis Steerable Introducer Sheath

The FDA has issued a Class I Recall for the Reprocessed Agilis Steerable Introducer Sheath by Sterilmed due to improperly sealed sheath hubs. An improper seal can allow blood to leak through the hub, which may cause the cap to detach during the procedure or create a change in pressure that lets air into the circulatory system. Use of affected products may cause serious health consequences, including death. The recall includes all product lots for model numbers STJ408309, STJ408310 and STJG408324 manufactured and distributed Jan. 1 – May 5, 2017.

The FDA recommends health care facilities and providers examine their inventories and stop using affected products immediately. Providers should continue to monitor patients treated with the Sterilmed Reprocessed Agilis Steerable Introducer Sheath as normal.

 

New Class Warnings For GBCAs

Cardiology Magazine Image

The FDA recently issued a drug safety communication requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI).

Earlier, the Agency determined the benefits associated with approved GBCAs outweighed any potential risks, as it has not been directly linked to any adverse health effects. However, following additional review with the Medical Imaging Drugs Advisory Committee, the FDA will now require manufacturers to take additional actions to notify health care providers and patients about gadolinium retention and preventative actions.

Health care professionals are encouraged to weigh the retention characteristics of each agent when selecting a GBCA for patients with a higher risk for gadolinium retention and to reduce repeated GBCA imaging studies when possible. GBCA manufacturers are also required to conduct additional human and animal studies to further evaluate the safety of these contrast agents.

Making the Most of MOC

ACC members choosing to participate in the American Board of Internal Medicine’s Maintenance of Certification (MOC) program have access to free resources designed to help seamlessly meet requirements. Among the resources, the following MOC modules provide opportunities for users to earn both MOC and continuing medical education (CME) credits:

MOC Guidelines Module: Management of Heart Failure
CME: 2.5 MOC: 2.5 COP: 2.5
Receive one new question a day or wait and answer all at once as part of the ACC’s MOC Guidelines Module 5 focused on the 2017 ACC/AHA/HFSA Focused Update for the Management of Heart Failure.

MOC Collection in General Cardiology Module - 15
CME: 1.5 MOC: 10 COP: 1.5
Users can answer questions and assess their current level of general cardiology knowledge. Detailed commentary accompanies each question explaining why the right answer is the best choice and why other answer choices may be suboptimal.

ACCF MOC: Medical Professionalism Module
CME: 1.5 MOC: 10 COP: 1.5
This module features 30 multiple-choice questions related to medical professionalism. Questions address topics like integrity and accountability; fair and ethical stewardship of health care resources; self-regulation; and commitment to excellence.

For more information on these and other CME and MOC opportunities, search the online Education Catalogue. Among the tools, certified patient case quizzes, regular JACC Journals activities and more. Visit: ACC.org/education-and-meetings/products-and-resources.

Clinical Topics: Heart Failure and Cardiomyopathies, Noninvasive Imaging, Acute Heart Failure, Magnetic Resonance Imaging

Keywords: ACC Publications, Cardiology Magazine, Gadolinium, Contrast Media, Education, Medical, Continuing, Professional Role, Advisory Committees, Public Health, Pharmaceutical Preparations, Coat Protein Complex I, Education, Distance, United States Food and Drug Administration, Certification, Internal Medicine, Societies, Medical, Health Policy, Social Responsibility, Health Personnel, Magnetic Resonance Imaging, Heart Failure, Cardiovascular System


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