Tutogen Medical Responds to Sterility Claims by Regeneration Technology
Friday February 7, 11:17 am ET
WEST PATTERSON N.J.--(BUSINESS WIRE)--Feb. 7, 2003--Tutogen Medical Inc., the only biological implant device company whose complete product line of sterile biological implants meets or exceeds requirements sterility assurance level (SAL) of 10-6 per AAMI and ISO Standards and FDA guidelines for labelling a product sterile.
Tutogen has been delivering sterile biological medical device implants for over 30 years. To date well over 1,000,000 sterile biological implants have been successfully used in patients worldwide providing a complete and permanent lifelong surgical solution. Regeneration Technologies has yet to label and distribute any biological implant as sterile. With the gestation period of many pathogens extending well beyond five years, (Microbiologic Screening of Cadaver Donors and Tissues for Transplantation: Octavio Martinez, MD AATB 26th Annual Meeting August, 2002; cdc.gov the brief history of Regeneration Technologies, or the 300,000 non-sterile implants processed to date does not align well with the bold claims made at the current meeting of the American Academy of Orthopaedic Surgeons recently held in New Orleans, Louisiana.
The suggestion made by RTI, that current methods of sterilization such as gamma irradiation, (http://www.fda.gov/cdrh/ode/guidance/361.pdf) may not be effective is an affront to the scientists and staff of the FDA and leads to the suggestion that the products of companies such as Tutogen may in fact not be sterile. Such scare tactics may undermine the judgement of medical professionals and the publics understanding of the biological implant industry as well as there confidence in time proven methodologies for producing sterile biological implants.
With the recent history of production and processing problems experienced by RTI, Tutogen believes that the public statements made by RTI must be taken in the full context of the history of the biological implant industry. Only time will tell whether or not the biological implants produced by RTI will hold up over the life of the patient.
With over 30 years of experience, and over 1,000,000 STERILE biological implants successfully healing patients, and a completely STERILE product line, Tutogen remains the leader and most experienced manufacturer of STERILE biological medical devices. |
