Page 154 - Assurance of Sterility for Sensitive Combination Products and Materials
P. 154

136   Assurance of sterility for sensitive combination products and materials


          of HAIs. Although single-use medical devices have not traditionally been a
          major source of infection, great strides have recently been made in treating
          and preventing these types of HAIs.


          6.2  Background in HAIs

          HAIs affect patients or staff who are or were in a health-care facility (HCF)
          but the infection was not present or incubating at the time of admission or
          work. These include infections that were acquired at the HCF but that did
          not appear until after discharge. Occupational infections among HCF staff
          are also counted in HAIs.
             HAIs are currently the most common adverse event that occurs in
          health-care delivery worldwide. In developed countries 7 of every 100 hos-
          pital patients will acquire at least one HAI while in the hospital. In devel-
          oping countries, 10 of every 100 patients will get an HAI. Each year in the
          United States, 2 million  people in HCFs  will acquire serious  infections
          from bacteria that are resistant to one or more antimicrobial agents. Of
          these 2 million people, approximately 23,000 people will die as a result of
          these infections. Even more people will die from other conditions that were
          complicated by an HAI [1].
             HAIs are a problem globally in all areas of the hospital. Data from
          2002 show that on average in the European Union (EU) the average HAI
          rate was 7.1% and in the United States the average was 4.5% [2]. The
          rate changes significantly according to the procedure and the condition
          of the patient. ICU patients have the highest incidence of infections and
          are associated primarily with invasive medical devices, e.g., central venous
          lines, urinary catheters, and ventilators. Newborns are another higher-risk
          patient population. Surgical site infections (SSIs) are also a significant
          problem especially in developing countries. Up to 30% of intensive care
          unit (ICU) patients in developed countries will get at least one HAI. The
          rate of infections can jump to 66% of patients with surgery in developing
          countries.
             HAIs are widespread, and events are under reported because many
          countries do not have effective surveillance systems. HAIs are frequently
          hidden from the public’s view except when high-profile incidents occur,
          which capture media attention. The recent duodenoscope infections due to
          re-cleaning challenges and cross infection of Ebola are prime examples of
          this, but even these events quickly lose the public interest. No institution or
          country can claim to have solved the problem of HAIs.
   149   150   151   152   153   154   155   156   157   158   159