Page 155 - Assurance of Sterility for Sensitive Combination Products and Materials
P. 155
Preventing health care associated infections 137
6.3 Assessment of risk
There are many risk factors that contribute to the development of HAIs.
Prolonged and/or inappropriate use of invasive devices as well as antibiotics
has created a major problem. There is an increased probability that an infec-
tion will occur if there is a breach in the skin barrier or the longer an inva-
sive device is in place. Examples of this are the use of intravenous or urinary
catheters or whenever surgery is performed. With new treatment options
becoming available, procedures today can be more complex, sophisticated,
and use more devices. These factors combine to increase the probability of
an infection occurring. In addition to these factors, treatments are available
for patients who have more health issues that make them prone to getting
an HAI. Patients have comorbidities such as diabetes and high blood pres-
sure, or are on immunosuppressants which also increase the risk of infection.
In addition to these patient-related factors there are resource factors
that can increase the potential for a patient to get an HAI. Poor infrastruc-
ture including poor environmental hygiene and waste disposal can increase
the occurrence of HAIs. Inadequate staffing will result in the tendency of
health-care workers to skip steps and to work faster than is safe. Infection
control procedures require a meticulous attention to details. Skipping steps
or performing those steps too quickly can result in problems. For example,
medical device manufacturers provide step-by-step instructions for cleaning
reusable devices. It is well known that many times these instructions are not
followed exactly. On September 11 2015, the US FDA and CDC issued a
joint CDC Health Advisory to alert all US hospitals that there was an im-
mediate need for HCFs to review procedures for cleaning, disinfecting, and
sterilizing reusable medical devices. In this alert, it was stated that “recent
infection control lapses due to noncompliance with recommended repro-
cessing procedures highlight a critical gap in patient safety” [3]. Staff at some
HCFs have been poorly trained in basic infection control practices and do
not have adequate knowledge of how to do their jobs. This is particularly
true in ancillary support service departments such as environmental services
and sterile processing. In addition to inadequate training, many facilities
lack standard procedures. Procedures need to be standardized to ensure a
consistent quality service. It is not possible to evaluate the quality of the
department’s services when different employees are providing the same ser-
vice or product in different ways. In September 2016, a forum on Medical
Technology and HAIs was held. This meeting was a collaboration of AAMI,
AHA, CDC, FDA/CDRH, and the Joint Commission. The purpose of