Safety & Quality

HIGHEST SAFETY STANDARDS
Skye premium biologic allografts adhere to the strictest quality and safety standards to provide surgeons with the highest quality tissues to assist in successful patient outcomes.

TISSUE RECOVERY AND DONOR SUITABILITY

  • All tissues are recovered and processed according to the industry’s highest and most current standards and regulations.
  • Donors are only released to processing after comprehensive medical and social histories are cleared by the Medical Director.
  • All Skye allografts are processed only once by state-of-the-art donor tissue screening. FDA-licensed NAT and PCR tests are also completed.
  • For FDA and various other certificates please click here

PREMIUM PROCESSING

  • Skye allografts are processed using the industry’s most innovative methods to ensure the very highest in processing standards and biologic integrity.
  • All allografts are minimally processed to acheive the highest standards in tissue quality and patient safety.

SAFETY

  • Our comprehensive battery of testing includes: HIV-1*, HIV-2*, NTLV-1, HTLV-2, HBCore, RPR, HCV-Ab, HBsAg*, HIV-1 NAT, NCV-NAT. *Tested using FDA required test kits.
  • All processing steps are validated and performed in Class 1000 Clean Rooms to ensure sterility and prevent contamination or cross-contamination of human tissues.
  • Every Skye allograft undergoes extensive quality controls before being released.
  • Each tissue is electronically tracked from recovery through implantation.

STERILITY

  • Tissues are sterilized with a minimal dose of irraditation to ensure safety and maintain performance.
  • All tissues are validated by the industry’s highest standards to be sterile prior to release.