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

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.