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208 Assurance of sterility for sensitive combination products and materials

is extremely unlikely while the potential for new and innovative treatment
options is significant. It seems warranted, therefore, to support the likeli-
hood of innovative new health-care products reaching patients with sterility
assurance innovation. An example of this innovation is the clarification of
the risk-based use of alternative SALs (lower PNSU*s in this chapter) while
maintaining acceptable risk to the patient is discussed in Chapter 9.

References

[1] M.S. Favero, Patient infections: The relevance of sterility assurance levels, in: Sterilization
of Medical Products, Vol. VI, 3, Polyscience Publications, Morin Heights (Canada), 1993,
pp. 156–163.
[2] M.S. Favero, Sterility assurance: concepts for patient safety, in: W.A. Rutala (Ed.),
Disinfection, Sterilization and Antisepsis: Principles and Practices in Healthcare Facilities,
Association for Professionals in Infection Control and Epidemiology, Washington, DC,
2001, pp. 110–119. chapter 12.
[3] Bryans TD, Kimbrell M, Darnell R, Hitchins VM, Lappalainen S, Liu D, and Masefield
J. Sterility Assurance Levels for Terminal Sterilization of New/Emerging Healthcare
Products, CDC Conference, 2010, Poster # 1841.
[4] An example of a legacy paradigm from steam sterilization is addressed in a series of arti-
cles by J.P. Agalloco, Increasing patient safety by closing the sterile production gap, Parts
1–3, PDA J Pharm Sci Tech 71 (2017) 261–278.
[5] S.P. Denyer, R.M. Baird (Eds.), Guide to Microbiological Control in Pharmaceuticals
and Medical Devices, second ed., 2007.
[6] E. Scott, S.F. Bloomfield, The survival and transfer of microbial contamination via cloths,
hands and utensils, J. Appl. Bacteriol. 68 (1990) 271–278.
[7] S.W. Srun, B.J. Nissen, T.D. Bryans, M. Bonjean, Medical device SALs and surgical site
infections: A mathematical model, Biomedical Instrumentation & Technology (2012).
May/June 2012.