Page 263 - Assurance of Sterility for Sensitive Combination Products and Materials

Path forward 241

10.3.1 Sterility assurance risks in health-care facilities
To reduce the risk of infection around the world, the greatest need for pa-
tients is increased focus on and innovation in reducing health-care associ-
ated infections (HAI). As highlighted in Chapter 6, the realities of 2%–30%
infection rates in health-care facilities is a staggering risk to patients and
families and financial burden to health-care systems. Ongoing focus on
basic controls related to hygiene, good hospital practices, and consistent
long-term wound care continue to be critical. Discerning analysis and col-
laborative solutions are required.
Directly related to HAI is sterilization within the health-care facilities in
central sterilization departments, and in particular, sterilization of reprocessed
devices. Reusable devices such as endoscopes can be challenging to disassem-
ble, clean, and sterilize with tragic results when operational pressures lead to
poor practices (e.g., insufficiently trained sterility assurance staff succumbing
to time pressures from overbooked operating theaters). There has been signif-
icant focus and progress related to device design and process standardization
in this area [4], and ongoing diligence in this complex area is critical.
These compelling concerns need to get framed appropriately in order
to pave the way for what could be a new wave of very valuable products
for patients that could be manufactured directly in health-care facilities—
regenerative medicinal biologic products. This opportunity also frames the
need for innovation in the broader product development and regulatory
paradigms being developed. There is a compelling need for clarity and
thoughtfulness for sterility assurance professionals.

10.3.2 Sterility assurance risks related to single-use products
Moving out of the health-care facility, the sterility assurance professional
needs to put the risks related to terminal sterilization and aseptic processing
into broad perspective. When validated and controlled appropriately, termi-
nal sterilization provides reproducible and validated logarithmic reduction
of product microbial load while being contained in sterile barrier systems
that prevent further contamination. This provides very high confidence
in robust sterility assurance. It is the preferred approach to provide sterile
product [5].
As discussed in Chapter 3, established moist heat, ethylene oxide, and
radiation sterilization technologies have served the terminal sterilization
industry well for decades. The industry has significant innovation within
these established options as well as a growing array of technology options
for terminal sterilization [6].