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P. Reynolds, ‘‘Empty-Bottle Handling Is No Picnic,’’ Packag. World 42, 46 (Jan. 1995). MEDICAL DEVICE PACKAGING LAURA BIX JAVIER DE LA FUENTE School of Packaging, Michigan State University, East Lansing, Michigan INTRODUCTION Medical devices achieve their therapeutic ends via physi- cal means, as opposed to metabolic, immunological, or pharmacological processes. The Global Harmonization Task Force (GHTF) has proposed the following harmo- nized definition of a medical device: Any instrument, apparatus, implement, machine, ap- pliance, implant in vitro reagent or calibrator, software, material, or other similar or related article: a. Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of: . Diagnosis, prevention, monitoring, treatment, or alleviation of disease. . Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury. . Investigation, replacement, modification, or sup- port of the anatomy or of a physiological process. . Supporting or sustaining life. . Control of contraception. . Disinfection of medical devices. . Providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body, and b. Which does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its intended function by such means (1). By definition, devices are involved in many different aspects of healthcare. As such, devices, their manufac- turing processes, and the packaging that contains and protects them are extremely disparate. Complicated capital equipment, such as MRI tunnels and X-ray ma- chines, are medical devices, but so are simple, commodity- like items such as tongue depressors and syringes. Some are meant for mass markets, others are niche items. Some are packaged individually; others are packaged in boxes of 100 s or 1000 s. Some are reprocessed, others are disposable, and some are used for a lifetime. Risks associated with device misuse and failures are equally varied, ranging from inconvenience to patient death (2). It is estimated that the medical device and equipment market will be worth $246 billion by 2011, with a 4.6% annual growth until that time (3). This is largely driven by aging populations who frequently engage in active life- styles, a growing middle class in emerging markets, and the spread of ‘‘Western diets’’ (4). A hallmark of the device industry is innovation, which results in short life cycles for many products. ‘‘Medical devices undergo constant development based on feedback from medical practitioners and advances in other sciences relevant to medical device technology’’ (5). ‘‘With this constant innovation, the medical device industry spends heavily on research and development’’ (2); a large portion of revenues go to R&D streams. CLASSIFICATION OF MEDICAL DEVICES The great variation present in the medical device industry means that devices can be classified in a number of ways. Devices can be categorized by: . The risk associated with improper use or a failure (generally high, moderate, and low). MEDICAL DEVICE PACKAGING 713