Connection Without Infection

Marshall Kerr of PFM Medical, Inc. examines the growing concern of hospital-acquired infections.

“PFM Medical utilizes science and research to develop innovative and effective solutions”
-Marshall Kerr

Vascular catheter infections are one of the most serious healthcare-associated infections worldwide. Despite historic efforts to prevent and treat these infections, the incidence, morbidity and mortality, and associated costs continues to rise to a level of intolerance by consumers, government agencies and payers. The current demand for improvement is compelling and the healthcare system is eager to acquire new and smart technologies to eliminate this risk.

Catheter-related bloodstream infection begins with colonization of either the extraluminal and/or the intraluminal surface of the catheter. Prevention strategies for the reduction of extraluminal colonization center around skin antisepsis. Disinfection of access sites including needle-less connectors, injection ports, and the internal surface of catheter hubs and stopcocks is a critical strategy for prevention of intraluminal colonization.

The Joint Commission’s 2009 National Patient Safety Goals (www.jointcommission.org/patientsafety/nationalpatientsafetygoals) require the use of injection site and hub disinfection protocols before accessing vascular catheters but do not designate a methodology for the procedure, such as antimicrobial agent, agent concentration and time or method of application.

The 2008 SHEA / IDSA Catheter-Related Bloodstream Infection prevention strategies (Marschall J, et. al., ICHE. 2008; 29, supp.1:S22) also include disinfection of injection sites, needleless connectors and catheter hubs. The recommendation designates use of an alcoholic chlorhexidine (CHG) preparation or 70 percent IPA as the agents of choice, but again lacks methodology.

Currently the 70 percent isopropyl alcohol (IPA) prep pad is mostly used for connector and injection site disinfection, but with highly variable results. The prep pad device, designed for skin antisepsis, is a questionable method for access site disinfection because of the variety of connector configurations, lack of established methodology for application, inconsistent application technique among clinicians, touch contamination with use, application time required and notably the inability to clean internal hub surfaces of catheters or stopcocks.

Colonization of the internal surface of the hub of the catheter and stopcocks is a major risk factor for bloodstream infection in both short term and long-term venous and arterial catheters. While this is recognized, procedures for disinfection of catheter hubs and stopcocks have not been established, as there is no technology available to safely or effectively accomplish disinfection of the internal surfaces of these devices.

PFM Medical has met the challenge with a device specifically designed to address these issues. The Site-Scrub is constructed of a housing containing multi-sectioned polypropylene foam brushes. The foam is saturated with a 5 percent chlorhexidine and 70 percent isopropyl alcohol solution that, along with the mechanical scrubbing, minimizes the agent contact and procedural time to 10 seconds.

The Site-Scrub is positioned onto the needleless connector, injection port or female luer hub and rotated for eight complete turns (as observed by visualization of an indicator bar on the external housing) over 10 seconds. When the Site-Scrub is used on catheter hubs or any female luers, the unique design of the multi-sectioned foam configuration allows the foam sections to be positioned within the lumen and to scrub the lumenal surface of the hub. It is this unmatched feature that sets the Site-Scrub apart from all other disinfection devices and meets all the requirements and recommendations for access site and hub disinfection with one device.

Site-Scrub is representative of PFM Medical’s focus on safety and device disinfection as well as the company’s overall approach to bringing products to market. With the ability to first identify and understand problems that exist in the healthcare system, PFM Medical then utilizes science and research to develop innovative and effective solutions. PFM Medical, Inc. was established in 2000 and is a subsidiary of the German company pfm Produkte für die Medizin AG, which was founded in 1971 and has been one of the leading German marketing and sales specialists for medical technology products.

The PFM Medical family has offices and manufacturing facilities worldwide that are certified to ISO 13485 standards. PFM Medical, Inc. is based out of Southern California and serves as headquarters for North and South American marketing, manufacturing, and distribution activities. Through ongoing emphasis and efforts in R&D, PFM Medical is committed to developing and manufacturing new and exciting products and unique solutions that will positively impact the healthcare market.

Marshall Kerr is President and CEO of PFM Medical, Inc. His career in the healthcare industry spans over 30 years with a broad range of experience from sales, distribution, and R&D, to consulting for several small to large medical manufacturers. Kerr provides direction and leadership in designing, developing and marketing products in device disinfection, vascular access, surgical and interventional cardiology.