The Most Frequent Medical Adverse Event

HAIs are the most frequently occurring medical adverse event worldwide, with a prevalence of around 7-10%.^{2, 3}

HAIs are a serious patient safety issue and burden to society.^4,5 Facilities and practitioners may also suffer financial as well as reputational damage as a result of HAIs associated with their facility.

HAIs Add Considerable Cost to Delivering Healthcare

HAIs are a significant cost to the Canadian healthcare system.⁵ Researchers have estimated 8000-12000 deaths per year are linked to HAIs, making them the fourth leading cause of death for Canadians behind cancer, heart disease and stroke.^4,5

HAIs are Preventable

A systematic review and meta-analysis found 35-55% of HAIs are preventable with existing multifaceted infection prevention and control interventions, regardless of a country’s income level.⁶

The Role of Medical Devices in HAIs

Sterilization and disinfection of medical devices play an important role in the prevention of HAIs. Multiple studies document failures in medical device reprocessing, some of which have led to outbreaks and patient exposure.^7-9

In 2014 the Government of Saskatchewan's Infection Prevention and Control Program released an alert on the improper reprocessing of transvaginal ultrasound probes. The alert included a call to action for healthcare facilities to ensure all necessary reprocessing steps for reusable medical devices were being followed to meet Accreditation Canada and the Canadian Standards Association (CSA) standards for reprocessing.¹⁰

The U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) released a Health Alert in 2015 urging healthcare facilities including hospitals, ambulatory surgical centers, clinics, and doctors’ offices, review all reusable medical device reprocessing practices.¹¹

In 2017, The Joint Commission in the USA released a Quick Safety Alert that reported 74% of all immediate threat to life declarations (ITLs) were from improper sterilization or high-level disinfection (HLD) of reusable medical devices.¹¹ Noncompliance with TJC infection control standards had increased in hospitals, critical access hospitals, ambulatory and office-based surgery facilities.¹²

Population Level Study: Infection Risk after Ultrasound

In the first of its kind, a study commissioned by UK National Health Authorities (Scotland) revealed an "unacceptable risk" of patient infection following ultrasound. The study revealed an increased infection risk in the 30 days following endocavitary ultrasound. Commissioned by a national health authority, the study revealed an increased infection risk in the 30 days following endocavitary ultrasound.¹³

90.5% of facilities were not performing HLD of these probes at the time of the study.

Public Health Risk Reality

Of the 982,911 patients followed, 330,500 were gynecological patients. 60,698 of these patients had undergone transvaginal ultrasound.

The national health authority now recommends HLD for endocavitary ultrasound probes.