aatb-accred-instfda-logo-trans

OSSIF-i sem™ Allograft Safety

Surgical Esthetics™ has an exclusive distribution agreement with Pinnacle Transplant Technologies™ (PTT) in the dental market.

Pinnacle Transplant Technologies™ products are produced in a state-of-the-art facility in Phoenix, Arizona.

pinnacle-small

Safety of any allograft material can be broken down into four areas:

  • Screening
  • Testing
  • Sterilization
  • Quality Systems

A Statement from our exclusive distribution partner, Pinnacle Transplant Technologies:

“At Pinnacle Transplant Technologies™, safety is job one.  PTT takes every precaution, from recovery through processing and distribution to ensure safety for our employees and our transplant recipients. We accept full accountability to the thousands of families who generously participate in the donation process as we strive to safely fulfill the donation cycle.

Product Safety: Screening

Pinnacle Transplant Technologies quality systems and validated processes ensures patient safety from the initial donor consultation to the surgeon’s transplantation of a PTT allograft.

Comprehensive medical and social histories are thoroughly reviewed by trained, qualified personnel on every donor.

All donations are reviewed and accepted by PTT’s Medical Director.

Pinnacle Transplant Technologies’ donor acceptance criteria are established and maintained by a Medical Review Board.

Recovery technicians are trained by their respective agencies, receiving continuing education to assure the consistent knowledge and application of Pinnacle Transplant Technologies’ strict donor acceptance standards.

Pinnacle Transplant Technologies has strict standard operating procedures and protocols. Our Quality Systems personnel routinely audit our recovery partners, ensuring compliance.

PTT only receives cadaveric tissue from not-for-profit OPOs and recovery agencies.

Product Safety: Testing

All tissue and blood samples are tested for infectious diseases, including testing for AIDS with Nucleic Acid Testing (NAT by TMA) — the newest and most reliable test to confirm the presence or absence of HIV and HCV early following exposure.

Our comprehensive battery of testing also includes: HIV-1*, HIV-2*, HB Core, RPR, HCV-Ab, HBs Ag*, NAT HIV-1/HCV/HBV.

As an accredited member of the American Association of Tissue Banks (AATB), all of our testing and processing of donated tissue meet or exceed all AATB standards and FDA regulations. All test results are evaluated by a team of specialists and physicians from the infectious disease, pathology and tissue banking fields.

* Tested using FDA required test kits

Product Safety: Sterilization

PTT allografts are terminally sterilized via low dose gamma irradiation. The dose used to sterilize all tissue was determined by performing a VDMAX* validation and is re-validated on a quarterly basis.

All allograft tissue has a Sterility Assurance Level (SAL) of 10 ^-6

* VDmax method validates a 15.8 kGy minimum sterilization dose. This method is limited to a maximum bioburden of 1000 colony-forming units (CFU) per device for VDmax 25. VDmax calculates the highest verification dose possible, which results in a reduced risk of failure. The 15.8 kGy VDmax dose method is for sensitive products that can be successfully sterilized at 15.8 kGy.

Product Safety: Quality Systems

Pinnacle Transplant Technology’s quality departments meet or exceed all FDA regulations, AATB standards and federally mandated Current Good Tissue Practice guidelines. Our allografts are processed under strict aseptic practices and subject to continuous inspections, measurements and packaging reviews to insure the quality and safety of our products. Our Quality Systems personnel are highly educated, experienced and knowledgeable of the tissue banking industry.  We promote attendance at AATB sponsored meetings and seminars. PTT encourages all of our personnel to achieve the status of Certified Tissue Banking Specialist (CTBS).”