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Wagner Victoria E. - Antimicrobial Coatings and Modifications on Medical Devices

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Antimicrobial Coatings and Modifications on Medical Devices
Author:
Wagner Victoria E / Zhang Zheng
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Springer International Publishing
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2017
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Cham
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Springer International Publishing AG 2017

Zheng Zhang and Victoria E. Wagner (eds.) Antimicrobial Coatings and Modifications on Medical Devices 10.1007/978-3-319-57494-3_1

1. Antimicrobial Modifications on Critical Care Implants

Zheng Zhang 1 , Victoria E. Wagner 1 and John C. Victor 1

(1)

Global Advanced Engineering, Teleflex Inc., Cambridge, MA 02139, USA

Zheng Zhang

Email:

Keywords

Healthcare acquired infections Medical devices Biofilm Antimicrobial Coatings

1.1 Introduction

Medical devices are defined by the FDA as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes [].

While most medical devices function as designed, there can be serious and often severe complications associated with their use. These include wear, thrombosis, and occlusion that can impair the device performance and impact the health and mortality of the patient. Healthcare acquired infections (HAIs) are a leading cause of mortality and morbidity globally. In 2007, HAIs were the fourth leading cause of death in the United States , with an estimated 1 in 25 patients in the United States per year alone suffering from HAIs [].

1.1.1 Bacterial Colonization and Biofilm Formation on Medical Implants

Biofilms are communities of microorganisms encased in extracellular polymeric substances (EPS) attached to a surface. Biofilm development is ubiquitous and the pathway is fairly well understood and described in discrete stages [ describes these phenomena in more detail.

Indwelling devices are especially prone to biofilm formation. Surfaces on indwelling devices usually are quickly coated with host proteins and glycoproteins, such as fibronectin, fibrinogen, vitronectin, albumin, and immunoglobulin [].

Microbes living in biofilms are more recalcitrant to antibiotic and antiseptic treatment versus free-floating planktonic cells []. This is theorized to be due to a number of factors, including shift in metabolism, exchange and upregulation of genes that encode proteins involved in antimicrobial resistance such as efflux pumps or enzymes like beta-lactamases, and the protective encasement of EPS that forms a physical barrier to exogenous antimicrobials. Therefore, most strategies to prevent biofilms usually seek to inhibit the initial adhesion events when microbes tend to still be susceptible to antimicrobial treatment.

1.1.2 Device-Associated Infections, Clinical Importance, and Regulatory Issue

In the early 1980s, clinical evidence implicated microbial biofilms as causative agents in device infections . Microscopic imaging demonstrated that microbial biofilms were found on medical devices, such as pacemaker leads and prosthetic joints, recovered from infected patients [].

Typically, the medical device serves as a nidus for the formation of microbial biofilms which are correlated with a majority of device infections []. Many of these approaches are described in more detail throughout this book and not discussed here. Despite best efforts, clinical treatment to resolve biofilms usually involves replacement of the device.

New therapies (as well as the limited usefulness of current ones) to address biofilm-centered device infection have been hampered in development from the reliance of test results on free-floating, planktonic-grown cells. This includes measures such as minimum inhibitory concentration (MIC) , which describes the effects of antimicrobials on planktonic cells. The understanding that most microbes adopt a biofilm lifestyle in nature has resulted in a paradigm shift in both industry and government regulatory agencies. These include the development of more relevant in vitro and in vivo test methodology that utilizes biofilm-grown cells to characterize new treatments as well as an entire new language of treatment efficacy and standards. Chapter outlines several of the more recent advances in guidance from federal agencies which govern device approval and the implications for the medical device industry.

1.2 Device-Associated Infections and Complications in ICUs

HAIs currently are the most common complications affecting hospitalized patients [ lists the three device-associated infections, devices, main etiologic agents, and other device-relevant complications.

Table 1.1

Typical device-associated infections , related devices, etiologic agents, and other device-relevant complications that related to infections

Device-associated infections	Related devices	Main etiologic agents	Other device-relevant complications
Catheter-related bloodstream infection (CRBSI)	Central venous catheters (CVCs) such as peripherally inserted central catheters (PICCs) and jugular axillo-subclavian central catheters (JACCs) hemodialysis catheters, etc.	S. epidermidis , S. aureus , Candida albicans , P. aeruginosa , K. pneumoniae , and E. faecalis	Catheter-related thrombosis (CRT), catheter occlusion
Ventilator-associated pneumonia (VAP)	Endotracheal tubes (ETTs), tracheostomy tubes (TTs)	P. aeruginosa , S. aureus , Enterobacteriaceae, Haemophilus spp., Streptococcus spp., Acinetobacter spp., S. pneumoniae , Neisseria spp., Stenotrophomonas maltophilia , coagulase-negative staphylococci	Device occlusion
Catheter-associated urinary tract infections (CAUTIs)	Urinary catheters such as Foley catheters and intermittent catheters ureteral stents	S. epidermidis , E. faecalis , E. coli , P. mirabilis , P. aeruginosa , K. pneumoniae , and other Gram-negative organisms	Encrustation, catheter blockage

1.2.1 Catheter-Related Bloodstream Infection (CRBSI)

CRBSI is defined as the presence of bacteremia originating from an intravenous catheter []. Contamination from other infection sites of infusate can be the intraluminal source but less commonly.

The most common organisms causing CRBSIs are staphylococci (both coagulase-negative staphylococci and S. aureus ), enterococci, aerobic Gram-negative bacilli, and yeast. Certain pathogens are found to be associated with specific host, treatment, catheter site, and catheter characteristics. S. aureus infections are a significant cause of morbidity and mortality in patients using hemodialysis catheters []. Catheter materials can be especially vulnerable to certain microbial colonization. For example, C. albicans occurs more readily on silicone elastomer catheter surfaces than polyurethane catheters.

1.2.1.1 Catheter-Related Thrombus (CRT)

Thrombosis and infection complications are common and associated with substantial morbidity and cost. In a study of cancer patients with CVCs, about 41% required device removal before the end of treatment owing to such complication infection, thrombosis, blockage, and leakage [].

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