OncoSil Medical can only authorise a shipment of the OncoSil™ System after:
The license for the treatment facility to receive and hold phosphorous-32 (32P) has been verified by OncoSil Medical
A training visit has been conducted in which individuals permitted to work as an Authorised Dispenser and Authorised User (and other surgical/procedural personnel as required) have successfully completed the OncoSil Medical Training Program
Getting started with OncoSil™
Certification of treatment facilities and personnel
The OncoSil™ System is to be used in a treatment facility which must hold an appropriate license for the isotope phosphorous-32 (32P) and have an appointed radiation safety officer (RSO) / radiation protection officer (RPO) who will be the primary contact for all matters related to radiation safety.
The OncoSil™ suspension should be prepared within the Nuclear Medicine Department or within a licensed radiopharmacy. Only appropriately licensed personnel, who have been trained in the preparation of the OncoSil™ suspension may prepare the product for implantation.
The Authorised Dispenser (AD) is the person who will prepare the OncoSil™ Microparticle suspension (ie radiopharmacist, nuclear medicine personnel) and must successfully complete the OncoSil Medical Training Program and additional training for this role.
The AD must perform at least one cold dose dilution (ie using microparticles that are not radioactive) which is supervised in the physical presence of an OncoSil Medical representative (Authorised Trainer).
The Authorised User (AU) will be the physician physically depressing the syringe containing OncoSil™ Microparticle suspension during the implantation procedure and must successfully complete the OncoSil Medical Training Program and additional training for this role.
The training program is overseen by an OncoSil Medical representative (Authorised Trainer) who will be present for the first patient implantation by the Authorised User before they can be fully accredited.
In some cases, the AD and the AU may be the same person.
Who else should take part in the OncoSil Medical Training Program?
As the implantation and handling of OncoSil™ involves a multi-disciplinary team, the following personnel may be expected to undertake the OncoSil Medical Training Program:
Nuclear medicine personnel (physician, physicists, technologists, radiopharmacist)