Hospital or healthcare-associated infections (HAIs) are acquired by patients after they are admitted to a hospital or other health care facility. According to the World Health Organization, 7% of hospitalized patients in developed countries and 10% of hospitalized patients in developing countries will acquire at least one HAI. Patients in intensive care units have dramatically higher rates of HAIs. In the United States, 1 in 25 patients develops this type of infection, resulting in 90,000 deaths per year.

Improperly sanitized medical and surgical instruments¹ can transmit infections to vulnerable patients. In 2009, the U.S. Department of Veterans Affairs reported that between 2002 and 2009 nearly 11,000 patients were exposed to HIV, hepatitis B and hepatitis C due to improperly sterilized endoscopes. After a hepatitis C outbreak in a Las Vegas surgery center sickened several people in 2008, the Centers for Medicare and Medicaid Services inspected 1,500 surgery centers and cited 28% of them for deficiencies in equipment cleaning and sterilization. In 2018, outbreaks of infections due to improperly sterilized medical instruments occurred in California, Colorado, Michigan, and New Jersey among others.

At one time, most medical instruments were made of steel or glass. Sterilization was simple. As medical instruments become more specialized, complex and smaller due to the popularity of minimally-invasive surgeries, sterilization procedures have become more complex.

Sterilization, whether by heat, chemicals, irradiation, high pressure or filtration “kills, deactivates, or eliminates all forms of life and other biological agents which are present.”² In order to ensure proper sterilization of medical instruments, the U.S. Centers for Disease Control and Prevention (CDC) recommends monitoring the sterilization process using mechanical, chemical, and biological indicators. Mechanical monitoring involves checking gauges and displays on the sterilization equipment itself to ensure that the temperature, pressure, and exposure time have reached the recommended levels. These readings can be observed while the sterilization process is happening so any anomalies or malfunctions can be caught early in the process. Chemical indicators such as tapes, strips, tabs, or special package markings contain chemicals that change color when exposed to high temperatures or other sterilizing conditions. Packages with chemical indicators allow medical personnel to distinguish between processed and unprocessed instruments, virtually eliminating the possibility of using instruments that have not undergone a sterilization process. The CDC recommends using mechanical and chemical monitoring each time instruments are sterilized. Biological monitoring involves vials, strips, or tape containing highly resistant microorganisms, strains of bacterial spores. The sterilization process is monitored by how well it kills these organisms.

This week’s market size shows the amount spent on biological and chemical sterilization indicators worldwide for 2017 and projected for 2025. Demand is expected to increase due to a growing geriatric population with chronic health conditions. Increasingly stringent regulations regarding the sterility of healthcare products in order to prevent HAIs is also expected to fuel demand for these products. Biological indicators claimed the largest market share in 2017. Leading companies that manufacture sterilization indicators include Getings AB, Cantel Medical Corp., 3M Co., Cardinal Health Inc., Matachana Group, Mesa Laboratories, and Anderson Products Inc.

¹ From here onward “medical instruments” also includes surgical instruments.
² Source: “Sterilization (Microbiology),” Wikipedia, April 3, 2019 available online here

Geographic reference: World
Year: 2017 and 2025
Market size: $548 million and $1.24 billion, respectively
Sources: “Sterility Indicators Market Size, Share & Trends Analysis Report by Type (Chemical, Biological), by Technique (Heat, Low Temperature, Filtration, Radiation, Liquid), by End User, and Segment Forecasts, 2018 – 2025,” Grand View Research Report Summary, November 2018 available online here; “Global Sterility Indicators Market Size, Share & Trends 2014-2018 & 2025 by Type (Chemical, Biological), & Technique (Heat, Low Temperature, Filtration, Radiation, Liquid) – ResearchAndMarkets.com,” Yahoo! Finance, April 25, 2019 available online here; “Health Care-Associated Infections Fact Sheet,” World Health Organization available online here; Joe Eaton, “Filthy Surgical Instruments: The Hidden Threat in America’s Operating Rooms,” The Center for Public Integrity, February 22, 2012, updated May 19, 2014 available online here; “Sterilization (Microbiology),” Wikipedia, April 3, 2019 available online here; “Biological & Chemical Indicators,” STERIS Life Sciences available online here; “Sterilization: Monitoring,” Centers for Disease Control and Prevention, March 22, 2018 available online here; Chris H. Miller, “Sterilization: Instrumental in Patient Safety,” Sterilizers.com available online here; Karen Bouffard, “Dirty Instruments Cause Second DMC Hospital to Fail Federal Inspection,” The Detroit News, November 28, 2018 available online here; Alyssa Rege, “State Declares ‘Immediate Jeopardy’ at UC San Diego Hospital Over Dirty Surgical Instruments,” Becker’s Clinical Leadership & Infection Control, June 8, 2018 available online here; Alyssa Rege, “Bone, Blood, Bugs Found on Instruments at Denver Hospital After Surgical Breach, Report Says,” Becker’s Clinical Leadership & Infection Control, June 14, 2018 available online here; Julia Jones, “3,000 People May Have Been Exposed to Bloodborne Infections at NJ Surgery Facility,” CNN, December 26, 2018 available online here.
Image source: rawpixel, “steel-black-and-white-bw-care-3309870,” Pixabay, April 11, 2018 available online here.