Licensing Guidance for Best Vascular, Inc., Beta-Cath IVB System
Licensing Guidance for Best Vascular, Inc., Beta-Cath™ Intravascular Brachytherapy (IVB) System
|Note:||The Novoste Intervascular brachytherapy products were bought by Best Vascular, Inc., and the product name was changed on August 2006 to reflect this.|
Remarks: Certain training and physical presence guidance is included for consideration because IVB is a new technology, and the devices deliver high dose rates (greater than 1200 rads per hour). For license application requirements, see 10 CFR 35.12(d).
Below are some recommended areas that licensees are encouraged to address in order to obtain license authorization for the use of the Best Vascular, Inc., Beta-CathTM IVB System. To facilitate faster processing of the license application, applicants are highly encouraged to address all of the points outlined below.
Authorized users should meet the training and experience requirements in 10 CFR 35.690, "Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.”
The authorized user (AU) and interventional cardiologist/physician should satisfactorily complete the vendor training in device operation, safety procedures and clinical use, or training in the device operation, safety procedures and clinical use supervised by an AU or authorized medical physicist (AMP), as appropriate, who is authorized for the same Beta-CathTM IVB System.
The AMP should satisfactorily complete the vendor training that includes hands- on device operation, safety procedures, clinical use, and the operation of a treatment planning system, or training in the device operation, safety procedures and clinical use supervised by an AMP authorized for the use of the same Beta-CathTM IVB System.
Procedures should be conducted under the supervision of the authorized user, who should consult with the interventional cardiologist/physician and authorized medical physicist before initiating treatment. The procedures should be conducted in the physical presence of the authorized user or the authorized medical physicist.
The written directive should, before treatment, specify treatment site, the radionuclide, and dose.
The authorized medical physicist should perform independent measurement of source output, before the first patient treatment, using a dosimetry system that meets the requirements of 10 CFR 35.630(a).
The licensee should develop, implement, and maintain written emergency procedures for both stuck and detached sources, including the provision of appropriate emergency response equipment and any appropriate surgical procedures.
The licensee should survey the patient and IVB treatment catheter immediately following source retraction or removal to confirm complete retraction of the source(s) as specified in 10 CFR 35.404.
For the radiation safety of patients and to reduce the risk of a medical event, an introducer sheath should be used unless such use is contraindicated for an individual patient.
For the radiation safety of patients and to reduce the risk of a medical event, a dual syringe system should be used.
"Source stepping" is permitted, if the licensee establishes appropriate procedures in writing. Source stepping procedures are not covered by the manufacturers’ instructions.
The licensee should commit to locked storage of the storage container in a secure location.
The device should be inspected and serviced at intervals recommended by the manufacturer, and maintenance and repair should be performed only by the manufacturer or persons specifically licensed by NRC or an Agreement State to perform such services.
- License authorizations should read as follows:
Authorization 6: Strontium-90
Authorization 7: Sealed sources (BEBIG Sr0.S03, AEAT SICW.2)
Authorization 8: 5 mCi per source; 800 mCi total
Authorization 9: For use in Best Vascular, Inc., A1000 Series models for intravascular brachytherapy
The license/amendment issuance cover letter should state that source separations during treatment should be evaluated as possible medical events.
Shielding calculations are not necessary for areas outside the treatment room and device storage areas, because Sr-90 is a pure beta emitter.
Revision of the Best Vascular, Inc., Beta-Cath™ IVB System radiation safety programs to conform to changes in this licensing guidance.
The above licensing guidance may be revised as additional experience is gained regarding the medical use of the Best Vascular, Inc., Beta-Cath™ IVB System. A licensee already authorized to use this product that is committed by license condition to following provisions in this guidance existing at the time of commitment must apply for and receive an amendment to its license in order to make changes to conform with the revised provisions.
An applicant initially applying for authorization for the medical use of Best Vascular, Inc., Beta-Cath™ IVB System, or a licensee applying for an amendment to conform with revisions in this guidance, may request authorization to allow future changes to its radiation safety program, provided the following conditions are met:
(1) the revision is in compliance with the regulations;
(2) the revision is based upon NRC's current guidance for the Best Vascular, Inc., Beta-Cath™ IVB System 35.1000 use posted on the NRC Web site;
(3) the revision has been reviewed and approved by the licensee’s radiation safety officer and licensee’s management;
(4) the affected individuals are instructed on the revised program before the change is implemented;
(5) the licensee will retain a record of each change for five years; and
(6) the record will include a copy of the appropriate Web site guidance, the old procedure, the new procedure, the effective date of the change, and the signature of the licensee management that reviewed and approved the change.
If this authorization is approved, these conditions will be incorporated as license conditions in the licensee's license.