Safety

Patient safety is at the core of everything Baxter does. The company was founded in 1931 on its ability to produce safe intravenous (IV) solutions for hospitals at a time when most hospitals were not equipped to prepare their own IV solutions. Those that tried often produced solutions that were inconsistent in quality and caused adverse reactions in patients. Baxter solved this problem by mass-producing IV solutions in glass-vacuum containers under carefully controlled conditions and shipping them to hospitals ready for use.

Today, Baxter focuses on safety across the product life cycle, from product development and product enhancements, to pharmacovigilance and post-market research. The company also collaborates with hospitals to redesign processes to enhance patient safety, and partners with customers and third-party groups to develop patient and clinician educational materials and raise safety standards worldwide. This section includes examples of these efforts as well as other ways the company enhances patient safety worldwide.

• Reducing Bloodstream Infections
• Decreasing Medication Errors
• Improving the Safety of Hemophilia Therapy
• Enhancing the Safety of Home Dialysis
• Ensuring Product Integrity
• Complying with Government Regulations
• Addressing Product Safety Issues

Reducing Bloodstream Infections

In 1971, Baxter introduced the first flexible, plastic IV bag. As the first "closed system" IV container, the bag does not require venting during administration. This keeps the solution from coming in contact with unfiltered outside air, where contaminants could enter the solution and infect the patient.

Despite evidence that use of closed systems can reduce bloodstream infections, many hospitals in developing countries continue to use "open" systems due to a lower acquisition cost. The lower cost of these products, however, can be outweighed by the expense of complications associated with bloodstream infections.

A study published in the January 2011 edition of the Journal of Infection Control and Hospital Epidemiology concluded that switching from open to closed-system infusion containers significantly decreased central line-associated bloodstream infections (CLABSI) and all-cause mortality in intensive care patients. The analysis of four previous studies conducted in Argentina, Brazil, Italy and Mexico revealed that using closed system infusion containers reduced CLABSI by 67% and all-cause mortality by 23% when compared to open systems.¹

Baxter works with governments and healthcare providers to help conduct studies, set standards and implement conversion to closed IV systems in numerous markets to improve public health. For example, Baxter worked with the government of Brazil, which now requires all of the country's nearly 8,000 hospitals to use closed IV systems. In Colombia, where the government now recommends the use of closed systems, approximately 75 percent of hospitals have converted. In 2010, Baxter worked with four Ministry of Health-affiliated hospitals in Mexico to implement closed systems.

Patients also can acquire bloodstream infections when medication is administered through an IV catheter. Some can be deadly, including treatment-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA), which causes nearly 20,000 deaths a year in the United States alone, according to the U.S. Centers for Disease Control and Prevention (CDC). In 2008, Baxter launched the V-LINK device, the first needle-less IV connector with an antimicrobial coating. In vitro testing has shown that the device kills at least 99.99% of six common pathogens known to cause catheter-related bloodstream infections, including MRSA.

In the United Kingdom, a study at Queen Elizabeth Hospital in Birmingham – part of a broader initiative by the National Health Service to assess the effectiveness of a range of infection-control technologies – compared the V-LINK device to a non-antimicrobial device in more than 200 patients (see summary document). While no episodes of catheter-related bloodstream infection were observed in any patients during the study period, the V-LINK device had significantly less internal microbial contamination, which, the study concluded, “may lead to a reduced risk of such infection.” A similar study is being conducted at Emory University Hospitals in Atlanta, Georgia, United States.

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Decreasing Medication Errors

The Institute of Medicine in the United States estimates that medication errors injure 1.5 million individuals each year, and that 7,000 people die annually as a result.² Other research shows even greater mortality statistics in other countries.

Baxter helps decrease medication errors in several ways. The company's premixed IV drugs are ready to use so hospital pharmacists do not have to prepare these critical drugs themselves. Baxter was the first company to work with other pharmaceutical firms to premix their drugs in IV solution, and is the only manufacturer of frozen premixed drugs for compounds that are not stable at room temperature.

For IV drugs that must be administered in a very specific dose or have other special requirements, Baxter operates pharmacy compounding centers in some countries. Hospital pharmacies transmit prescriptions electronically to the Baxter compounding center, where pharmacists and technicians prepare patient-specific premixed drugs under sterile conditions and deliver them to the hospital ready for administration.

Baxter continues to improve product packaging and labeling to reduce the potential for medication errors. The company was the first to develop a readable bar code for clear, flexible IV bags, which present challenges for conventional bar-code technology. Baxter also has created distinctive labeling, particularly for medications most likely to cause serious harm if mis-administered.

To help reduce medication errors associated with the use of electronic infusion pumps, which control the delivery of IV drugs to patients, Baxter has an exclusive agreement with SIGMA International General Medical Apparatus, LLC (SIGMA), to provide the SIGMA Spectrum Infusion System (large-volume infusion pump) to customers. The SIGMA Spectrum pump features Dose Error Reduction Software with hospital-defined Drug Libraries including dosing limits and clinical advisories. When a clinician programs an infusion, the software verifies that the dose meets facility-determined parameters. If the programmed infusion is outside the pre-determined dosing limits, the pump will alert the clinician before the infusion begins.

In 2010, Baxter worked with Intermountain Healthcare – a system of 23 hospitals, 150 clinics and 900 physicians throughout Utah and southeastern Idaho in the United States – to integrate the SIGMA Spectrum pump with Intermountain's electronic medical record (EMR) system. This provides continuous wireless connectivity between the pump and Intermountain's EMR system to further enhance patient safety and increase staff efficiency. Doctors and pharmacists can send infusion orders electronically directly to the pump, where they are displayed on an LED screen during programming. Once infusion begins, the pump automatically sends infusion data to Intermountain's EMR system at regular intervals to support clinical documentation requirements. The data also can be tracked, measured and analyzed to support improvement of long-term clinical outcomes.

Baxter's Medical Products business also helps hospitals reduce medication errors through its Connections portfolio. Focusing on three key principles - simplification, streamlining and standardization - the portfolio offers programs that reduce variability of processes to create a safer environment. These programs, administered by Baxter clinical experts, identify and address gaps between current practices and the latest national standards, including The Joint Commission, the National Patient Safety Foundation and the United States Pharmacopeia.

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Improving the Safety of Hemophilia Therapy

When people with hemophilia began contracting HIV from blood products in the early 1980s, Baxter was the first to develop a heat-treatment process that killed blood-borne viruses, including HIV, which may have been present in plasma-derived factor VIII - the clotting protein missing from the blood of people with hemophilia A. Plasma-derived factor VIII was the only factor VIII therapy available at that time. Baxter continued its efforts to advance the safety of hemophilia therapy, introducing the first genetically manufactured, or recombinant, factor VIII in 1992, and the first recombinant factor VIII processed without any blood additives in 2003.

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Enhancing the Safety of Home Dialysis

In 1978, Baxter introduced continuous ambulatory peritoneal dialysis (CAPD) - a self-administered home therapy - as the first practical alternative to clinic-based hemodialysis for treating end-stage kidney disease, or irreversible kidney failure. In CAPD, patients manually infuse solution through a surgically implanted catheter into their abdominal cavity, where the solution draws waste and excess fluid across the peritoneum (or abdominal membrane) that would normally be removed by healthy kidneys.

When CAPD was introduced, peritonitis - an infection of the peritoneum - was common, due in part to patient handling of the connection site. In 1978, peritonitis rates averaged about one event for every three patient months on the therapy. Baxter began introducing a series of innovations to make solution exchanges easier and reduce handling of the connection site. One such innovation was the "twin bag" system, which combines infusion and drainage in a single closed system. By 1990, peritonitis rates in many peritoneal dialysis (PD) programs had dropped to approximately one for every 35 patient months. Today, some PD programs boast peritonitis rates as low as one for every 70 patient months.

Baxter also has advanced patient safety through automated PD systems, which perform solution exchanges overnight, while a patient sleeps. In early 2011, Baxter received clearance to market in the United States software enhancements to its HomeChoice automated PD device. This new software is intended to enhance patient safety by introducing new safeguards, such as new functionality and adjustments to default settings and allowable ranges, to help reduce the potential for improper programming parameters and patient use errors. Features include: post-therapy displays alerting patients to contact their clinicians if abnormal results are noted, new drain logic to encourage more complete PD fluid drains to reduce the residual fluid volume present in the patient's peritoneal cavity, and other software changes to help avoid complete solution fills when there may be residual fluid present in the peritoneal cavity.

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Ensuring Product Integrity

Counterfeit and/or altered medical products pose growing risks to patient safety worldwide. Baxter launched a product integrity initiative in 2007 to safeguard the company’s products from these threats.

While maintaining product integrity is complex and multifaceted, it encompasses three key aspects: product authentication features, track and trace features, and tamper evident features.

In a pilot of Baxter's product integrity initiative, the company implemented product authentication and security features on select Baxter products. Today, 12 products contain layers of product integrity features such as watermarks and other security features on their primary packaging. The company continues to implement such features across its product lines, and works with industry experts to adopt the latest technology in all aspects of product integrity.

Baxter’s Corporate Product Integrity Reporting Policy requires that all product complaints, adverse events, counterfeiting, tampering, diversion and product theft be reported, and that those events be investigated by the company’s Product Surveillance, Pharmacovigilance and/or Brand Integrity functions.

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Complying with Government Regulations

Baxter's operations and products are subject to extensive regulation by numerous governmental agencies worldwide. In the United States, the federal agencies that regulate the company's facilities, operations, employees, products (their manufacture, sale, import and export) and services include: the Food and Drug Administration (FDA), the Drug Enforcement Agency, the Environmental Protection Agency, the Occupational Health and Safety Administration, Customs and Border Protection, and the departments of Agriculture, Labor, Defense, Commerce, Treasury and others. Because Baxter supplies products and services to healthcare providers that are reimbursed by federally funded programs such as Medicare, the company's activities are also subject to regulation by the Center for Medicare/Medicaid Services and enforcement by the Department of Health and Human Services. State agencies also regulate the facilities, operations, employees, products and services of the company within their respective states.

Outside the United States, Baxter products and operations are subject to extensive regulation by governmental agencies, including the European Medicines Agency in the European Union. International governmental agencies also regulate public health, product registration, manufacturing, environmental conditions, labor, imports, exports and other aspects of the company's global operations.

The U.S. FDA, as well as other governmental agencies worldwide, administers requirements covering the testing, safety, effectiveness, manufacturing, labeling, promotion and advertising, distribution and post-market surveillance of Baxter's products. The company must obtain approval, clearance or licensure from the FDA before it can market and sell most of its products in the United States. Other countries have similar pre-market registration requirements. Even after the company obtains regulatory approval to market a product, the product and the company's manufacturing processes are subject to continued review by regulatory authorities.

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Addressing Product Safety Issues

When Baxter identifies a quality or safety issue with one of its products or determines that products manufactured or marketed by the company do not meet company specifications, published standards or regulatory requirements, it investigates and takes appropriate corrective action. This may include withdrawal of the product from the market, correction of the problem at the customer location, providing notice to the customer of revised labeling and/or other actions.

For example, Baxter's COLLEAGUE Volumetric Infusion Pump is an electronic device that controls the flow of IV drugs to patients. In 2005, Baxter notified customers of several issues that had the potential to disrupt the delivery of therapy and placed a hold on shipments of new pumps until these problems could be corrected. The U.S. FDA classified this as a Class 1 recall. In June 2006, Baxter announced a consent decree with the FDA under which the company pursued remediation of the pumps.

Additional Class 1 recalls related to remediation and repair and maintenance activities were addressed by the company in 2007 and 2009. Pursuant to the consent decree, in July 2010, the U.S. FDA issued a final order regarding the recall of the company’s COLLEAGUE infusion pumps currently in use in the United States. Baxter is executing the recall over the two years following the final order by offering its customers an option to replace their COLLEAGUE pumps.

For more information on regulatory matters currently being addressed by the company, refer to the discussion in the section entitled "Certain Regulatory Matters" in Item 7 of Baxter’s annual report on Form 10-K.

1	"Impact of Switching from an Open to a Closed Infusion System on Rates of Central-Line Associated Bloodstream Infection: A Meta-Analysis of Time-Sequence Cohort Studies in 4 Countries," Infection Control and Hospital Epidemiology, January 2011, Vol. 32, No. 1.
2	"Preventing Medication Errors," Institute of Medicine, July 2006.