Patient Safety and Production Pressure: Industry’s Perspective

Lori Cross

"It is better to be prepared for an opportunity and not have one than to have an opportunity and not be prepared."

Leaders of major medical corporations face unprecedented demands for product safety, efficiency, and value, and must be prepared to predict which challenges will lead to the most significant new business opportunities – the corporate version of production pressure. Today, more than ever, significant and growing "production pressures" crisscross the medical supply and pharmaceutical industries. For instance, some health insurers and HMOs now encourage patients to split higher-dose tablets of their medication in order to reduce prescription drug costs. Industry leaders must understand and respond to these pressures. These forces may represent business opportunities (to increase convenience of dosing sizes and sales to the consumer), or hidden dangers (many pills are not scored or intended to be split, which leads to marked fluctuations in patient drug doses and then levels). Industry must be a watchdog for financial or medical ideas which compromise product integrity and patient safety.

Technology is often viewed as the solution to demands for improved efficiency. We expect technology to facilitate accomplishing more, in less time, with fewer errors, and with less effort and consumption of (human and material) resources. The attributes of winning innovations are not automatic, though, and require arrival during a time of a strong need, provision of a clear and visionary solution, and implementation smoothly and quickly. The first success factor, a strong need for change, is exemplified by the redesign of safety features for anesthesia equipment during the 1980s. The strong need was perceived by all practitioners in the form of the malpractice insurance crisis at that time, especially for anesthesiologists. New safety features and equipment redesign were therefore eagerly endorsed and utilized by the anesthesia community who were in danger of losing malpractice insurance at any price. The second success factor, a clear vision of the future, is also central to the proliferation of important change. In the example, the publication, and endorsement of the 1986 Harvard Standards for Intraoperative Monitoring arrived and reinforced both the need, and the vision, for advances in patient safety and intraoperative monitoring. Manufacturers and practitioners in such organizations as the newly founded Anesthesia Patient Safety Foundation (APSF) worked together to provide a clear, consistent vision. Thus, the universal adoption of pulse oximetry filled the vision of improved anesthesia provider vigilance (compared to the recognition of cyanosis) for oxygenation problems. Currently, a number of hospitals and anesthesia departments are promoting a vision of information management systems, refining systems which will archive vast amounts of medical information. The final factor for success, the ability to make the change, is evident in advances like continuous capnography and pulse oximetry, which required low-cost microchip technology and other miniaturized electronics for widespread acceptance and application.

On the industrial side, production pressures are currently evident as medical practitioners and hospital purchasers demand increasingly valuable products and support services at lower and lower costs. This forces companies to identify the key elements of customer value to provide clear guidance to future solutions. For instance, a company must decide whether to spend its resources on educational programs for practitioners, or try to make its products easier to use? Should industry improve the accuracy and quality of devices or find ways to provide longer product life at lower costs? The answers to these questions will reward companies which strive to improve manufacturing techniques, enhance product delivery and service, and optimize product usability.

Manufacturers know that the corporate "winner’s circle" will be made up of organizations that can manage both sides of the patient safety equation—lower costs and improved product design and quality. This powerful combination provides safer anesthesia equipment to more anesthesia providers around the world. A recent sign of the globalization of safer anesthesia, the ISO/IEC Joint Working Group on Anesthetic Workstations has submitted a harmonized document for balloting within ISO, IEC, and CEN. This is the first document submitted for simultaneous balloting to all three organizations. This is an example of safety standards applied to anesthesia equipment achieving global harmonization. Such harmonization allows industry to provide the highest-quality products to medical practitioners in an international market, maximizing both the value and safety of anesthesia equipment and pharmaceuticals.

Ms. Cross is a member of the APSF Executive Committee and Vice President and General Manager, Anesthesia Delivery and Ventilation Business Area, Datex-Ohmeda, Madison, WI.