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.

Today, Baxter focuses on safety across the product life cycle, from product development and enhancements, to post-market research and via pharmacovigilance and post-market surveillance. The company also collaborates with hospitals to assess their processes to address patient safety, and partners with customers and third-parties 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:

• Supporting Reduction of Pathogens
• Focusing on Decreasing Medication Errors
• Addressing Parenteral Nutrition Safety
• Complying with Government Regulations
• Addressing Product Safety Issues

Supporting Reduction of Pathogens

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 contacting outside air, helping to minimize contamination.

Despite evidence that use of closed systems can reduce pathogens, many hospitals, particularly in developing countries, continue to use open systems. The compatibility of the Baxter IV System with both infusion pump therapy and gravity applications can help nurses maintain a closed IV system that meets safety standards for IV replacement¹. Baxter’s IV Standard Set Closed System can reduce the number of set-ups and teardowns which can decrease the risk of touch contamination².

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, to convert to closed systems throughout the country. In Colombia, where the government now recommends closed systems, approximately 75% of hospitals have converted. In 2010, Baxter worked with four Ministry of Health-affiliated hospitals in Mexico to implement closed systems.

In 2008, Baxter launched the V-LINK with VitalShield protective coating device, the first needle-less IV connector with an antimicrobial coating. In vitro testing has shown that the device killed at least 99.99% of six common pathogens known to cause catheter-related bloodstream infections, including MRSA. The reduction in colonization or microbial growth on the device has not been shown to correlate with a reduction in infections. The antimicrobial agent is not intended to be used as a treatment for existing infections. VitalShield protective coating is contraindicated in patients with hypersensitivity to silver or silver components.

Focusing on Decreasing Medication Errors

The Institute of Medicine in the United States estimates that medication errors injure 1.5 million people each year, and that 7,000 die annually as a result.³ Other research shows even more severe mortality statistics in other countries.

Baxter helps address potential 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 doses under sterile conditions and deliver them to the hospital ready for administration. In August 2011, for example, Baxter partnered with Cho Ray Hospital in Ho Chi Minh City, Vietnam, to establish a center for compounding IV therapy, the first of such a facility to be located in a Vietnam hospital. The new Vietnam IV Admixture (VIVA) Center is dedicated to compounding IV chemotherapy for about 80 patients a day.

Baxter also continues to improve product packaging and labeling to help 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.

In April 2012 Baxter completed its purchase of SIGMA International General Medical Apparatus, LLC (SIGMA). SIGMA develops and manufactures smart infusion pump technology including the Spectrum large volume pump (LVP), which provides advanced safety and clinician-friendly features. The Spectrum smart infusion system 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 of the pre-determined dosing limits, the pump will alert the clinician before the infusion begins. In conjunction with the SIGMA transaction, Baxter acquired SIGMA’s product development pipeline, which includes a platform of multiple infusion technologies with advanced safety feature capabilities. Within the pipeline is a syringe infusion pump that has been submitted to the U.S. Food and Drug Administration (FDA) for review and clearance. The 510(k) is pending and the pump is currently for available for sale in the U.S. Syringe pumps are small infusion pumps used to deliver more precise amounts of IV medications and fluids to patients.

Baxter's Medical Products business also helps hospitals through its Connections Portfolio, which focuses on three key principles - simplification, streamlining and standardization. These programs, administered by Baxter clinical experts, are based on objective observational, interviewing, and data collection methodology that identify opportunities for improvement in practice and product utilization. In addition, the clinical offerings help to increase staff productivity and patient safety and includes specific recommendations and action plans to improve alignment with nationally recognized regulations, standards and guidelines. In 2011, Baxter launched the Tubing Misconnections Self-Assessment for Healthcare Facilities, designed to help institutions identify products and practices that pose a risk of inadvertent tubing misconnections. The objectives are to:

• Identify and prioritize devices and practices vulnerable to tubing misconnections,
• Establish processes and device selection protocols to safeguard against misconnections.

Addressing Parenteral Nutrition Safety

Parenteral nutrition (PN), commonly referred to as IV nutrition, is one way that people receive nutrition when they cannot eat. Instead, nutrition is supplied through an IV tube inserted directly into the veins. The amount, type, and method of nutrition are tailored to each patient to meet their nutritional needs. Preparing and delivering this type of nutrition involves complex sterile preparations which must be performed in a carefully controlled environment with quality control measures in place from prescription to formulation and delivery. When these quality control measures are not in place, product sterility, stability and compatibility can be impacted, potentially putting patients at risk.

In September 2011, leaders from several major safety associations came together to organize a PN Safety Summit. Baxter, a leading maker of PN therapies, sponsored the summit, hosted by the American Society for Parenteral and Enteral Nutrition (ASPEN). At the event, experts in clinical nutrition discussed safety issues surrounding PN and developed recommendations for improvement, including increased standardization of prescription processes, order review and verification and formulation processing, as well as additional education for PN prescribers.

One of the safety issues covered was the ongoing shortage of vitamins, electrolytes and other IV nutrition ingredients that has critically impacted hospitals nationwide. A 2011 study by the American Hospital Association found that 89% of U.S. hospitals have experienced nutrition product shortages. Further, drug shortages within a six-month period led to 58% of patients requiring IV nutrition receiving a nutritional formulation that may not have addressed all of their nutritional needs and 32% experiencing an adverse outcome⁴. Organizations such as ASPEN and Baxter are working to address these shortages to ensure patients continue to receive the life-sustaining therapies they need.

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 (DEA), the Environmental Protection Agency (EPA), the Occupational Health and Safety Administration (OSHA), the Department of Agriculture (USDA), the Department of Labor, the Department of Defense (DOD), Customs and Border Protection (CBP), the Department of Commerce, the Department of 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 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 or clearance from the FDA before it can market and sell its products in the United States. Other countries have similar pre- and post-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.

Addressing Product Safety Issues

When Baxter identifies a potential 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, such as notification of revised labeling, correction of the problem at the customer location, withdrawal of the product from the market 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 FDA classified this as a Class 1 recall, the most serious type of recall, with potential for death and injury. 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 of COLLEAGUE infusion pumps were addressed by the company in 2007 and 2009. Pursuant to the consent decree, in July 2010, the FDA ordered removal of all COLLEAGUE infusion pumps in the United States by July 14, 2012. Baxter has been executing the removal these pumps, offering eligible customers a refund or an option to replace them.

In December 2010, Baxter informed the Medicines and Healthcare products Regulatory Agency (MHRA) and other EU Authorities that endotoxins had been detected in some batches of its peritoneal dialysis (PD) solutions manufactured at its Castlebar, Ireland facility. In PD patients, endotoxins can potentially cause an inflammatory reaction known as sterile peritonitis. While only a very small proportion of bags were likely to contain endotoxins, these could not be identified. In response to this finding, Baxter shut down production of the solutions at this plant to investigate the problem, and the European Medicines Agency (EMA) recommended that all potentially affected PD solutions be withdrawn as soon as replacement product became available to meet patients’ need. The company worked closely with EMA and its Committee for Medicinal Products for Human Use (CHMP) to ensure the production of endotoxin-free PD solutions. In October 2011 following its inspection of the Castlebar site, the Irish Medicine board confirmed the reinstatement of the facility’s good manufacturing practice status, authorizing it to resume the release of PD solution products.

Additional details on regulatory matters currently being addressed by the company are available under the heading "Certain Regulatory Matters" in Baxter’s most recent filing with the U.S. Securities and Exchange Commission on Form 10-Q. Details on product liability, patent, commercial and other legal matters currently being addressed by Baxter are available in the note to the company’s consolidated financial statement entitled “Legal Proceedings” in Baxter’s most recent SEC filing on Form 10-Q.

The devices referenced within are Rx only. For safe and proper use of all devices please refer to the complete Instructions for Use.

1	O’Grady NP, Alexander M, Dellinger EP, et al. Guidelines for the Prevention of Intravascular Catheter-Related Infections. Infection Control Hosp Epidemiol. 2002 Dec;23 (12):759-69.
2	Raad I, Hanna HA, Awad A, et. Al. Optimal Frequency of Changing Intravenous Administration Sets: Is it safe to prolong use beyond 72 hours? Infection Control Hosp Epidemiol. 2001 Mar;22 (3):136-39.
3	"Preventing Medication Errors," Institute of Medicine, July 2006.
4	ISMP Medication Safety Alert. April 7, 2011 Vol. 16, Issue 7.