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Published on Friday, 12 August 2011 19:12

HAIs - an Industry Perspective

Many surgical instrument designers, manufacturers and users have begun chanting a new mantra regarding reposable devices that is “How Clean is Clean?” What has spurred this new vision of what actually comprises a clean surgical instrument or a clean healthcare delivery tool prior to sterilization?

Based on the most recent statistical information released on hospital acquired infections (HAIs), (AHA, 2010), which are based on a data analysis from the Healthcare Cost and Utilization Project (HCUP) performed in 2007, there is obviously a problem with the ability of healthcare organizations to identify, contain or rectify HAIs (Lucado et al, 2010). The HCUP statistics indicate the following:

• Over 42,000 adult patients acquired infections during their hospital stay in 2007.
• Hospital patients with infections due to medical care had an average length of stay 19.2 days longer than patients without infections.

The associated Burden of Healthcare-Associated Infections in the United States equates to approximately:

• -1.7 million infections in hospitals per year
• -Most (1.3 million) were outside of ICUs
• -9.3 infections per 1,000 patient days
• -4.5 infections per 100 admissions
• -99,000 deaths associated with infections each year.

Based on these numbers there are significant costs that are associated with them that are not only associated with the entities where the infections occur, but also to the industry as a whole. Based on a study that included 30 hospitals ranging in size from 30 to 500 beds, “Using conservative estimates, the cost of HAI’s for the 30 study hospitals was close to $50 million USD or $1.9 million per facility. These hospitals had rates of HAI at or below nationally published rates. Based on the results of the study, the cost of the HAI’s dwarfed the amount of money that was spent on the respective infection control programs in the study hospitals by a factor of 10 x 1.”

Even with the documented numbers of exposures and costs there is more. HAI’s have additional costs and consequences that reach far beyond the mere numbers that are quoted. Loss of life, loss of confidence and the additional losses of time and money expended on law suits both prosecuting and defending the occurrences. With all of the negative effects of HAIs that have become so prominent, there must be new ways to successfully fight this unacceptable epidemic.

One of the issues that affect the mind set of healthcare personnel is the fact that in healthcare “cleanliness” or the definition of what is considered “clean” is currently defined as a process, not an objectively measured result. According to the CDC in the guidelines for disinfection and sterilization “cleaning” is defined as the removal of visible soil (e.g. organic and inorganic material) from objects and surfaces. This type of definition does not specify a level of cleanliness that must be obtained nor does it specify an acceptable reduction in bacteria levels.

In addition to the removal of bioburden from exterior surfaces, what about the interior lumen of canulated instruments employed during minimally invasive surgeries? When reusable scopes and other instruments are cleaned between uses what methodology is used to verify the cleanliness of the instrument prior to sterilization; or what qualifies the readiness of the instrument for use on another patient?

Cleanliness protocols are dictated to the user by the manufacturer of the instrument and many of those instruments have manual cleaning processes that are subject to limitations such as human error or insufficient cleaning qualifications. Some instruments are subject to manual brushing, which can be subject to limited brush reach, bristle deterioration and/or insufficient scrub time. Other instruments are subject to manual fluid streams that can yield insufficient chemical ratios or faulty manual porting.

Even some automated processes can have limitations. Ultrasonic cleaning, has limited cleaning success on shielded surfaces and devices are subject to recontamination upon removal from cleaning bath.

Each one of these cleaning techniques is dictated by the manufacturer and the buyer is then responsible for carrying out the cleaning of the instrument based on these directions. Once followed however, where is the proof, they achieved repeatable, sufficient results.

In addition to cleaning shortcomings, suction tubes and laparoscopic devices pose additional challenges for manual cleaning, which can include the design of the instrument itself. It is impossible to sterilize an instrument with remaining bioburden. If it is not removed from the surface or interior lumen of a device, it will still pose an unacceptable risk to patients.

The problem is not being solved by traditional means. This is obvious to those that are tracking the epidemiology of HAIs. The fact HAIs are not diminishing speaks volumes. A new method of collaboration needs to take place. Device manufacturers must look for partners with an expertise in cleaning. Join their respective knowledge sets and design devices that address the issues of cleanliness and infection reduction, otherwise healthcare delivery and the public at large are in for a long winter of infectious modalities.

*This article was originally published on HAIfocus.com on September 12, 2011.

References:

• -Centers for Disease Control and Prevention (2008), Guideline for Disinfection and Sterilization in Healthcare Facilities.
• -Cost of Healthcare-associated infections (HAI) and Hospital Budgets for Infection Control and Prevention (IC): Just a Drop in the Ocean? DJ Anderson1,2, KB Kirkland3, Z Kanafani1,2, JJ Engemann1,2, P Thacker1,2, KS Kaye1,2, DJ Sexton1,2. April. 2006.
• -Lucado, J. et al (2010) Adult hospital stays with infections due to medical care, 2007. HCUP Statistical Brief [Healthcare Cost and Utilization Project/Agency for Healthcare Research and Quality] #94.