The traceability of medical devices plays an important role in enhancing patient safety. Through effective traceability medical devices can be easily and promptly identified and located to allow actions that may be required to reduce the safety risks to patients to be carried out in a timely manner.
Spineart spinal implants arrive at the operating theatre sterile, bar-coded and individually packaged thus providing unprecedented levels of implant traceability.
Spineart implants are bar-coded by lot number to guarantee efficient traceability for patients and to provide hospitals with the means to be able to respect and implement traceability compliance at all times.
At point of use in the operating theatre the bar code on every individual Spineart implant can be scanned directly into the hospital system guaranteeing accurate tracking of the implants.
All Spineart implants come with a minimum of 4 traceability labels. This allows labels to be attached to the operation note, patient care plan and an implant register plus others, for example internal hospital tracking. The use of such record ensures compliance with pending European legislation regarding traceability of all surgical implantable devices.
Good practice and pending EU legislation sees pre-sterilized individually packaged implants as being the means of addressing the issues of:
Spineart’s sterile and individually packaged implants completely eliminate these risks and can decrease the risk of infection and contamination in the operating theatre.
The use of Spineart products ensures that patients receive pristine implants in every case, unlike loose implants in trays, which have been repeatedly reprocessed (cleaned and sterilised) by Central Decontamination Units.
For theatre personnel, setting up the operating room is easier and faster and the risk of hand picking the wrong implant is eliminated, often the implant size/type is not immediately obvious leading to potential time consuming delays in selecting and presenting the implant at operation. All Spineart implants are packaged with easy to read product descriptions.