Page 225 - Assurance of Sterility for Sensitive Combination Products and Materials

204 Assurance of sterility for sensitive combination products and materials

7.4.3 Comparison to real-world infection rates
This clause puts the statistically quantifiable portion of patient risk from
terminal sterilization, as discussed above, into the perspective of real-world
health-care infection rates. As seen in Chapter 6, Review of Current Practice in
Preventing Health-care-Associated Infections, neither packaging, aseptic process-
ing nor terminal sterilization is significant contributors to real-world in-
fection rates. Basic hygiene; standard procedural precautions; good practice
with long-term access products, for example, urinary tract catheters, venti-
lators, and central lines; and reprocessing of complex devices in overworked
central sterilization service departments are the focus of infection control.
A comparison of the potential for infection based on sterilization of
−4
health-care products, even at a PNSU* of 10 , to real-world infection
rates reveals that medical devices are not the prevalent source of infection.
As described in Chapter 6, a variety of sources contribute to the infection
rates experienced by the patient, and thus rates may vary by hospital, region,
and the type of devices used for treatment. As reported in Chapter 6, aver-
age HAIs are 4.5% in the US and 7.1% in the European Union. Rates in
developing countries may be up to 30% and up to 66% in underdeveloped
countries. It is estimated that half of HAIs are related to long-term use
devices, for example, catheter-associated urinary tract infections (CAUTI).
Fig. 7.15 shows a comparison of hospital infection rates by source com-
pared to the expected medical device infection rate based on the assump-
tions above. The data demonstrate the probability of patient infection due
to device sterilization is orders of magnitude lower than those real-world
rates experienced by the patient. A related analysis of the Center for Disease

Fig. 7.15 Hospital infection rates vs medical device. Key: (1) Medical Device sterilized at
1
−4
PNSU* of 10 ; (2) Estimated US HAI rate attributable to medical device ; (3) Estimated
1
EU HAI rate attributable to medical device ; (4) Estimated HAI rate in developing coun-
1
tries due to medical device ; (5) Estimated HAI rate in underdeveloped countries due to
1
medical device . Note 1: literature rate divided by half to reflect the estimated long-term
use device rate.