NORTHWESTERN UNIVERSITY: DEPARTMENT OF RADIOLOGY
CENTER FOR TRANSLATIONAL IMAGING (CTI)
MRI RESEARCH FACILITY
MRI SAFETY: POLICIES AND OPERATING PROCEDURES
TITLE: CONTRAST POLICY
PAGES: 7
EFFECTIVE: 4/01/2019
POLICY_______________________________________________________________________________
Contrast media is administered to enhance the diagnostic potential of imaging. Intravenous contrast can be administered by registered nurses, radiologic technologists and radiologists. Subjects are observed and monitored to minimize clinical risks. It is the policy of the Radiology department to provide appropriate and safe care to all subjects.
PURPOSE_____________________________________________________________________________
The purpose of this policy is to ensure the appropriate and safe use of intravascular contrast media in the performance of radiology research procedures. Gadolinium-based contrast agents (GBCA’s) have been associated with Nephrogenic Systemic Fibrosis (NSF), a rare but serious systemic disease that is characterized by fibrosis of the skin and other tissues throughout the body in renal impaired individuals. The policy takes safe practice measures to prevent NSF due to the administration of GBCA’s by following recommended guidelines. In an event of a reaction or extravasation to contrast media, a protocol is in place to take immediate response to treat subjects.
PERSONS OR AREAS AFFECTED___________________________________________
This policy applies to all personnel of the Department of Radiology, principal investigators (PI) and research affiliates, researchers, and research subjects involved in the injection or monitoring of subjects receiving intravascular contrast media.
PROCEDURE___________________________________________________________________________
A. Contrast media shall be selected, prepared, and administered with the following guideline considerations:
• According to manufactures’ recommendations and study protocol.
• Institutional Review Board (IRB) approved study protocol.
• U.S. Food and Drug Administration (FDA) medication guides
• According to appropriate sterile procedures.
• Emergency contrast reaction drug box located in the radiology department areas utilizing contrast media.
• Access to 911 for offsite facilities
B. Administration of intravenous contrast:
1. Gadolinium-based contrast agents (GBCAs).
2. Some studies may use Feraheme (ferumoxytol injection) as part of an NU approved IRB.
• ***Feraheme has a black box warning which is the strongest warning that the FDA provides, signifying that medical studies indicate that the drug caries a significant risk of serious or even life-threatening adverse effects.
• Feraheme should be administered as an IV infusion in 50-200ml of 0.9% sodium chloride or 5% dextrose over a minimum period of 15 minutes following dilution.
• Closely monitor subjects for signs and symptoms of hypersensitivity reactions, including monitoring blood pressure and pulse rate, during administration and for at least 30minutes following each infusion of Feraheme.
• Studies requesting the use of Feraheme as a contrast agent will be reviewed by the Clinical Research Unit (CRU) prior to approval by CTI management to ensure safe conditions are in place.
3. Studies requesting to use Feraheme (ferumoxytol injection) as part of an NU approved IRB must use the Center for Clinical Research for assistance from the Clinical Research Unit (CRU) for the administration of Feraheme (ferumoxytol injection).
• To submit a study to the CRU, please complete the CCR intake form: http://bit.ly/CCRIntake
• Be sure to NMH CRU as a service requested
• Questions about the CCR intake form or charges for the CRU services please email the CRU directly in regards to your study:centerforclinicalresearch@northwestern.edu@northwestern.edu
C. Prior to injecting intravenous contrast media, the radiologist, radiology nurse, and technologist shall do the following:
1. Conduct a subject pre-exam inquiry, complete a MRI safety questionnaire and take a subject history that includes:
• Indications and contra-indications of contrast administration
• Method of administration and dosing
• Possible adverse reactions and/or complications
• Reactions to previous injections of diagnostic contrast media
• Current medication list pertinent to contrast administration
• Presence of loose teeth and/or removable dental fixtures
2. Confirm that the emergency drug boxes containing medications to treat contrast reactions are immediately available in the treatment area. These are checked daily in all radiology departments where contrast is administered.
3. For subjects receiving intravenous gadolinium based contrast media, an estimated glomerular filtration rate (eGFR) will be obtained on the day of the exam using a point of care testing (defined as within 24 hours).
4. A point of care creatinine result will be obtained prior to exam. A creatinine greater than 2.0 will verified through laboratory services and communicated to the ordering physician and principal investigator. The added cost is the PI’s responsibility. The results will be reviewed by the radiology nurse and or radiologist. An eGFR value less than 30mL/min/1.73m should not receive contrast. See IRB eGFR approved values for each study. If the values are outside IRB approved values the study will be canceled.
• Radiology nurse to ensure point of care encounter in EIC is linked to the study.
5. Research participants at high risk for low GFR < 30mL/min/1.73m values include those with:
• Renal disease (including solitary kidney, renal transplant, renal tumor)
• Age over 55
• Diabetes
• Hypertension
• Severe hepatic disease, liver transplant, pending liver transplant.
6. Pregnant women should not receive intravenous contrast media in research studies.
7. Research participants with a history of allergy to GBCA’s should not receive contrast media.
8. Only radiology nurses, Clinical Research Unit nurses, and radiologists will insert and assess peripheral intravenous catheters.
9. Contrast administered with a power injector may only be administered through a peripheral intravenous catheter.
10. Only attending radiologists, radiology house staff, approved radiology registered nurses, CRU nurses, and MRI technologists perform the injection of intravenous contrast media. Subjects remain under observation throughout the infusion process.
11. MRI technologists may hand inject a central line (through an established IV infusion line) once the line is accessed by a registered nurse.
12. For every procedure performed involving the injection of intravenous contrast material, the name, administered dose, route must be documented in the scanner log book.
D. Reporting of Contrast Reactions
1. All contrast reactions, including minor reactions, require immediate notification of the attending physician or house staff radiologist in the cardiovascular imaging reading room (6-1838). If appropriate, the order will be given to the radiology nurse to treat the reaction as ordered by the radiologist. The following may be administered but is not limited to: 50mg Benadryl IV or PO, 125mg Solu-Medrol, and Epi IM 0.3mg. If the attending radiologist or house staff radiologist believe the reaction to be serious, they will notify the technologist/radiology nurse to contact 911. If no radiologist can be reached, the technologist/radiology nurse should contact 911, regardless of reaction severity.
2. The radiology nurse will record the subject name, the reaction type, and the treatment administered for each contrast reaction and will document this in the event log. The PI of the study should be notified.
G. Identifying Reactions
1. Reactions to contrast agents are categorized as minor, moderate or severe by the American College of Radiology (ACR) criteria.
2. Severe reactions include severe and prolonged hypertension, coma, convulsion, pulmonary edema, laryngeal edema, severe bronchospasm and arrhythmia.
3. Moderate reactions can be stable but can also progress to a major reaction. These include hypotension or hypertension of short duration, mild bronchospasm, dyspnea, wheezing, or slowly resolving cutaneous reactions such as a rash and urticaria.
4. Minor reactions are often self-limited and treatment is frequently not necessary. Minor reactions include nausea, vomiting, light-headedness, vertigo, dizziness, sweating, itching, urticaria, salivary gland swelling, arm pain, facial edema, chills, and sneezing. With all minor reactions, each case must be reviewed. In some instances, the reaction may be a vasovagal response that is related to the stress of the injection, rather than the contrast material itself. Any cutaneous reactions, such as rash, urticaria and itching, should be considered a true reaction even if mild and not treated. Salivary gland swelling and chills should also be carefully evaluated on a case by case basis. The remainder of the “minor reactions” may well not represent a true allergic reactions to contrast agents.
5. Subjects will be assessed by a nurse who will consult with Dr. James Carr, Dr. Alexander Korutz or designated radiology house staff and will be given a “Subject discharge instructions: Contrast Allergy” sheet. Subjects experiencing a contrast reaction shall be observed by a radiology research or CRU nurse for at least 60 minutes prior to leaving the facility. Subjects will be referred to their Primary Care Physician or the emergency department for post reaction assessment and care, as needed. Follow up patient assessment is made on all subjects (via phone call) by a radiology nurse or CRU within 24 hours and is documented in the CTI event log.
H. Extravasation of Contrast
1. All contrast extravasation events require notification and assessment by the radiology staff (Cardiovascular imaging fellow or nurse). Documentation of extravasation is completed on contrast volunteer record form and a copy is maintained in the CTI event log. Subjects are given a “Discharge instructions: Extravasation of contrast media” sheet. Follow-up assessment on all subjects (via phone call) is made by a radiology nurse within 24 hours and documented in the CTI event log.
RESPONSIBILITIES______________________________________________________________________
A. The Directors of the CTI and the CTI MRI Safety Officer are responsible for the development and implementation of policies and procedures that address departmental issues and ensure compliance with Northwestern University policies.
B. The management team in the CTI research areas are also responsible for ensuring that all employees comply with these policies and procedures.
C. Employees, PIs and research affiliates, personnel of the Department of Radiology, and researchers are responsible for being knowledgeable about and complying with University-wide and department-specific policies.
POLICY UPDATE SCHEDULE_______________________________________________
A. This policy will be reviewed every 4 years or more often as appropriate.
REFERENCES__________________________________________________________________________
ACR Manual on Contrast Media, American college of Radiology, Version 10.3, 2018
https://www.acr.org/-/media/ACR/Files/Clinical-Resources/Contrast_Media.pdf
Kanal E, Barkovich AJ, Bell C, et al. ACR guidance document on MR Safe Practices: 2013. J Magn Reson Imaging 2013; 37: 501–530.
CROSS REFERERENCE __________________________________________________
NMH policy # NMH RAD 17.0007 version 1.0: Contrast administration and reaction management
APPROVAL:____________________________________________________________________________
Effective date: April 1, 2019
Responsible parties: CTI Research Managers:
Donny Nieto and Yu Fen Chen
Reviewed by:
CTI Director of Cardiovascular Imaging:Michael Markl, PhD.
CTI Director of Neuro Imaging: Todd Parrish, PhD.
MRI Safety Officer: Alexander Korutz, M.D.
Approved by: CTI Director: Andrew Larson, PhD.
ADDITIONAL FORMS:
2. CTI-SUBJECT DISCHARGE INTRUCTIONS FORM-EXTRAVASATION OF CONTRAST MEDIA FORM
3. CTI-SUBJECT DISCHARGE INTRUCTIONS-CONTRAST ALLERGY FORM
