Posted by From AHRA Regulatory Affairs Committee, with permission by Tom Greeson/Reed Smith
In April, GE Healthcare issued an alert to its customers that due to a supply chain issue in Shanghai, China, its iodinated contrast agent used to enhance many CT scans, Omnipaque, is in scarce supply. GE’s production facility there is shut down during the COVID-19 lockdown in that city. GE said it expected the shortage to be in effect for at least the next two months, until the end of June. The shortage will threaten the ability of many hospitals and imaging centers to perform medically necessary CT with contrast studies. Omnipaque is now on the US Food & Drug Administration’s drug shortage list.
The Committee on Drugs and Contrast Media of the American College of Radiology (ACR) issued a statement on May 6th that recommends considerations for imaging facilities operating during this time of iodinated contrast media shortage. The committee recommends that facilities attempt to utilize alternative studies to answer the clinical question such as non-contrast CT, MR with or without gadolinium-based contrast media, ultrasound with or without ultrasound contrast agents, nuclear medicine, or PET/CT, when feasible. See the short blog article about the shortage.
The blog article notes that facilities considering alternatives to CT contrast studies need to be mindful of Medicare’s ordering test rules [found at 42 CFR § 410.32(a)] which require that, in a non-hospital setting, only the patient’s treating physician can order diagnostic tests. In a hospital setting, for tests orders for Medicare patients, one should be guided by Medicare’s conditions for participation for hospitals which state that,
“Radiologic services must be provided only on the order of practitioners with clinical privileges…authorized by the medical staff and the governing body to order the services.” (See 42 CFR § 482.26(b)(4))
It is essential that the patient’s treating physician be very much in the center of decision- making on what test is to be performed and the parameters of those tests.
A key question has been how to make use of all contrast and how to avoid discarding residual contrast found in single patient use vial. ACR recommends that facilities’ institutional pharmacies be contacted to determine if it is possible to repackage those vials in smaller aliquots to reduce waste at the institution level.
On Friday May 6, 2022, ACR updated the committee statement.
Among the considerations, ACR advised, “In the setting of severe shortage, institutions can explore developing their own guidelines for the safe use of single-use vials for more than one patient following proper infection control guidance and ensuring institution approval since this would deviate from medication and regulatory guidelines.”
Some facilities are reported to be considering repackaging options; others are considering safe ways to convert the use of single use vials into multi-dose containers.
The American Hospital Association (AHA) is hosting a members-only webinar tomorrow at 3PM ET.
AHA members who want to participate in the webinar, must register by 6 p.m. ET on Tuesday, May 17. Registration information will be reviewed and confirmations with access information will be sent to your registered email in advance of the webinar. If you have not received your access information by May 18, 10 a.m. ET, please contact AHA at 800-424-4301 for assistance. The webinar will not be recorded and a webinar replay will not be available.
Please visit AHRA Advocacy for more information on regulatory issues, legislation, AUC, and more!
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GE did not inform their customers in April. At least not my hospital and when I asked our rep why the response was “it was too difficult to provide notice to all customers so they sent notice to the GPOs”. Pretty disappointed about GEs lack of communication on this.