APIC Book Review

INTERNAL BLEEDING: The Truth Behind America’s Terrifying
Epidemic of Medical Mistakes
Robert M. Wachter, MD, Kaveh G. Shojania, MD
Rugged Land, LLC; New York City, New York; February 2004

Internal Bleeding is the authors’ call to action for creating a culture of safety within the healthcare environment. Wachter and Shojania take the IOM report one step further while they attempt to explain to the public why so many lives are lost each year in our flawed healthcare system. The book’s 22 chapters are divided into four main parts that describe the healthcare system, its errors, the consequences of those errors, and some potential cures. The subject matter is presented quite dramatically. The entire first chapter is devoted to the story of two women, Joan Morris and Jane Morrison, who were "mixed up" by a series of medical errors made at a large academic medical center. No less than 17 errors were identified in the cases on retrospective review.

Each chapter begins with a thought-provoking quote relevant to medicine, safety, or systems in general. A special photo section features photos of some of the catalysts of the patient safety movement, as well as one radiograph of a sponge left in a pelvic cavity. Several useful appendices are included, such as "Dangerous abbreviations used in prescribing," as well as "Questions you may want to ask your hospital, medical group, or doctor."

Any clinician who has been in healthcare for more than a couple of years can find at least one scenario with which to identify in this book. There are many examples of chilling stories of serious and sometimes deadly mistakes made in healthcare. Clinicians may find this book useful in providing examples of patient safety issues to address in their own Patient Safety Committees. Patients will find a guide to steps they can take to ensure a safer stay in the hospital. Together, we find hope for a safer tomorrow in healthcare.

Reviewed by Kim Strelczyk, RN, MSN, CCRN, CIC
Manager Infection Control, Methodist Dallas Medical Center
Dallas, Texas

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Choosing Effective Topical Antiseptics

From efficacy to convenience, allergies to skin irritation, choosing the right antiseptic agent for a facility can be a daunting task. Can a healthcare worker be sure that the antiseptic meets the appropriate efficacy and safety requirements? Are these antiseptics meeting the needs of the facility from a time, compliance and ease of use perspective? How does one choose the best antiseptic?

In 2002, the Center for Disease Control and Prevention (CDC) estimated that nearly two million patients in the United States are affected by a healthcare-acquired infection and about 90,000 of these patients die as a result*. These numbers are staggering. As part of an overall infection prevention program, the right topical antiseptic choice is a key step in the prevention of healthcare-acquired infections. This is why it is important for healthcare workers to understand the different types of topical antiseptic agents available in the market today and the key characteristics affecting the efficacy and safety of each product.

What are the regulatory guidelines for topical antiseptics?
In the realm of topical antiseptics (also known as topical antimicrobials), there are two pathways of development: a new drug application or the Federal Drug Administration’s Tentative Final Monograph (FDA’s TFM) (TFM - 21 CFR Parts 333 & 369 Tentative Final Monograph for Healthcare Antiseptic Drug Products; Proposed Rule, June 17, 1994).

New Drug Applications
Drug submissions are termed New Drug Applications (NDA) or Abbreviated Drug Applications (ANDA). If the proposed product has ingredients or concentrations that are not recognized as safe and effective in this FDA’s TFM list, it must go through a drug application process. One of the most common active ingredients that requires this process is Chlorhexidine Gluconate (CHG). The drug application process demands that the product in question be subjected to rigorous testing to prove safety and efficacy.

FDA’s TFM
The TFM outlines certain ingredients and concentrations that have been proven to be safe and effective for use in topical antiseptic product development. A few examples of ingredients on this list are povidone-iodine (PVP-I) and alcohol.

The FDA's TFM is the established regulatory requirement that has been set forth to govern topical antiseptic product development. It addresses three categories: See Table #1.

Every proposed product that is generally recognized as safe and effective in the TFM ingredient listing must meet the standards as detailed in the TFM requirements. These criteria were developed to ensure that all over-the-counter (OTC) drugs put forth in the marketplace would be safe and efficacious for the end user. See table #2 for summaries of the TFM requirements for testing.

Click here to download supporting graphs (Microsoft PowerPoint).

What do these tests mean?

• In-Vivo Glove Juice Test - Determines efficacy of the product. The product is applied to hands, gloves are donned, sampling solution is injected into the glove and bacterial levels are tested at fixed time intervals (the higher the log reduction the more effective the test product is).
• In-Vivo Abdomen/Groin Test - Determines efficacy of the product. Bacterial counts are quantified pre-prep and post-prep on human abdomen (dry) & groin (wet) sites and log reductions are calculated (the higher the log reduction the more effective the test product is).
• Antimicrobial Spectrum - Determines how rapidly the product kills a broad variety of microorganisms. This study evaluates the test product against 25 ATCC (American Type Culture Collection) organisms and Clinical isolates at a 99% concentration over multiple exposure times.
• Time-Kill - Determines how rapidly a 10% dilution of the product kills a broad variety of microorganisms. This study evaluates the product against 25 ATCC organisms and Clinical isolates at a 10% concentration over multiple exposure times.
• Minimum Inhibitory Concentration (MIC)- Tests the ability of the product to be diluted and still retain its ability to stop the growth of microorganisms.
• Point Mutation Assay - Determines the possible development of microbial resistance to the product.

Five key characteristics to consider when selecting a good topical antiseptic
A topical antiseptic is an agent that has the power to kill bacteria on the skin. Although the ability to dramatically reduce the number of infection-causing microorganisms is functionally the most important characteristic of an effective antiseptic, there are other attributes that are significant to a good product. For example, the safety of a product and its ability to maintain low irritation levels also play a key role. Healthy, intact skin is a natural barrier of defense against infection. Therefore, manufacturers are striving to create products that maintain a good balance between efficacy and safety in order to maintain healthy skin. The following are five characteristics of a good topical antiseptic.

• Fast action - the ability of a product to act quickly and be effective with the first application.
• Persistence - the ability of a product to exhibit a prolonged or extended activity, which prevents or inhibits the growth of organisms that remain on the skin after application. It also refers to the ability to prevent the reestablishment of bacteria that are contracted in the environment.
• Breadth of spectrum - the ability of a topical antiseptic agent to demonstrate good activity against a wide range of microorganisms.
• Efficacy - the ability of a product to decrease microorganism counts. Efficacy is typically expressed in terms of log reductions.
• Safety - Topical antiseptics are tested for their inherent safety attributes per regulations established in ISO (International Organization for Standardization) 10993. These regulations ensure the product is nonirritating and nontoxic.

What are the differences between the various antiseptic agents' active ingredients?
There are so many topical antiseptics agents from which to choose.
Table #3 details the comparison of several topical antiseptics with regards to the five key characteristics.

Knowing all this, how do you choose?
The balancing act can be challenging when choosing the best antiseptic agent for your facility. It is essential to factor in compliance with the requirements established by the FDA, the needs of the hospital (cost, ease of use, etc?) and, most importantly, the requirements of the end user.

Does the product meet the FDA's requirements?
If the product is recognized as safe and effective under the FDA's TFM, ask the manufacturer to provide data proving that the product in question meets that criteria - both in vivo and in vitro testing. These data should be readily available. If the product does not fall in the TFM ingredient listing, ask the manufacturer for documentation of the FDA drug application approval. This is the first step to understanding if the product is even in compliance with the regulatory requirements.

What are the key needs for your hospital?
Once you have established that the product is in compliance, assess the most important needs of your hospital-convenience, time, ease of use, safety, efficacy, cost, etc? Based on these requirements, choose a topical antiseptic agent that is most appropriate for your needs. This will help increase compliance to the guidelines as well as compliance in product usage.

What are the requirements of the end user?
Knowing the requirements of the end user is imperative to selecting the right antiseptic for your facility.

• Do you have an iodine sensitive patient or healthcare worker?
  Consider CHG as a good alternative to PVP-I
• Will the prep be on mucous membranes?
  Be sure to check the manufacturer's warnings regarding use of the product on mucous membranes.
• Do you have a healthcare worker with dry skin?
  Products that support hand health and wellness should be considered.
• Are there time constraints?
  You may want to choose products that save time while still achieving high efficacy (one-step patient preoperative skin preparation, for example)

Products intended for use as topical antiseptics must meet rigorous performance criteria guided by FDA documents in order to be considered effective in reducing healthcare-acquired infections. By factoring in compliance to the requirements, the needs of the hospital and the requirements of the end user, healthcare workers can help avoid the occurrence of infections and increase compliance. As part of an overall infection prevention program, the right topical antiseptic agent choice is a key step in prevention of healthcare-acquired infections.

*CDC Releases New Hand Hygiene Guidelines. CDC Media Relations, 2002, October 25. Retrieved October 6, 2004, from http://www.cdc.gov/handhygiene/pressrelease.htm.

Cardinal Health Series Authors:

Evelina Baranov (evelina.baranov@cardinal.com) is a scientist for Cardinal Health Infection Prevention Surgical Business.  Her responsibilities include research and development for patient preoperative skin preparations, surgical scrubs, healthcare personnel handwashes and hair removal systems.  She has a bachelors of arts in Biology from Lake Forest College.

Eric Ellingson, MChE, MBA (eric.ellingson@cardinal.com) is the Director of Research and Development for the Infection Prevention Surgical Business at Cardinal Health.   His responsibilities include managing the research and development for patient preoperative skin preparations, surgical scrubs, healthcare personnel handwashes, hair removal systems, suction/irrigation systems, wound drains and suction canisters.

Elizabeth George Hutson (liz.hutson@cardinal.com) is the Product Manager for Cardinal Health’s Infection Prevention Prep products. Her responsibilities include management of the preoperative skin preparation line of products, education and services.   She has a bachelors of science in Chemical Engineering from the University of Illinois- Champaign.

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