Abstract
The trend toward an aging population in the highly developed countries of the world has the demand for innovative biomedical devices and tools at record levels. The products desired in this market are typically smaller and more portable than their predecessors, and require more sophisticated components and allied manufacturing technologies and automation techniques. In essence, similar to traditional consumer products, biomedical devices such as patient monitors, drug delivery systems, therapeutic devices, and life assisting devices have all decreased in size yet still have market expectations of enhanced performance characteristics and features. This chapter focuses on medical device manufacturing from the environmental, engineering control, and monitoring perspectives.
This is a preview of subscription content, log in via an institution.
References
American Conference of Governmental Industrial Hygienists. (2005). Threshold limit values for chemical substances and biological exposure indices. Cincinnati: ACGIH.
American Conference of Governmental Industrial Hygienists. (2001). Air sampling instruments (9th ed.). Cincinnati, OH: ACGIH.
American Conference of Governmental Industrial Hygienists. (1995). Industrial ventilation: A manual of recommended practice (22nd ed.). Cincinnati: ACGIH.
Burgess, W. A., et al. (1989). Ventilation for control of the work environment. New York: Wiley.
Burton, D. J. (2003). General methods for the control of airborne hazards. In The occupational environment: Its evaluation, control, and management (2nd ed.) (S.R. DiNardi). Fairfax, VA: AIHA.
Conviser, S. (2000). The future of ethylene oxide sterilization. Infection control today. http://infectioncontroltoday.com/articles/061feat.html. Accessed December 2015.
Environmental Science and Technology Online. (2005). It’s in the microwave popcorn, not the Teflon® pan, Science News report November 16th. Accessed December 2015.
European Agency for Safety and Health at Work. (2006). Indicative occupational exposure limit values. http://europa.eu.int/comm/employment_social/health_safety/docs/oels_en.pdf. Accessed December 2015.
European Environmental Agency. http://www.eea.eu.int. Accessed December 2015.
European Union. (1996). Council directive 96/29/EURATOM. Official Journal, L159, 0001–0114 (June 29, 1996).
European Commission Guide to Good Manufacturing Practice Revision to Annex 1. (2003). Manufacture of sterile medicinal products. http://pharmacos.eudra.org. Accessed December 2015.
Gaggeler, H. W., et al. (1989). The epiphaniometer, a new device for continuous aerosol monitoring. Journal of Aerosol Science, 20(6), 557–564.
George, D. K., et al. (2003). An introduction to the design of local exhaust ventilation systems. In The occupational environment: Its evaluation, control, and management (2nd ed.) (S.R. DiNardi). Fairfax, VA: AIHA.
Institute of Occupational Medicine for Health & Safety Executive. (2014). (Research Report 274). http://www.hse.gov.uk/research/rrpdf/rr274.pdf. Accessed December 2015.
International Commission on Non-Ionizing Radiation Protection. (2002). General approach to protection against non-ionizing radiation. Health Physics, 82(4), 540–548.
International Organization for Standardization. http://www.iso.org. Accessed December 2015.
International Organization for Standardization. (2000). Cleanrooms and associated controlled environments-part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1, ISO 14644-2:2000. Geneva: ISO.
International Organization for Standardization. (1999). Cleanrooms and associated controlled environments-part 1: Classification of air cleanliness, ISO 14644-1:1999. Geneva: ISO.
Heinsohn, R. J. (1991). Industrial ventilation: Engineering principles. New York: Wiley-Interscience.
Hitchock, A., et al. (2003). Nonionizing radiation. In S.R. DiNardi (Ed.), The occupational environment: Its evaluation, control, and management (2nd ed.). Fairfax, VA: AIHA.
Kittleson, D. B. (1998). Engines and nanoparticles: A review. Journal of Aerosol Science, 29(6), 575–578.
Maslansky, C. J., & Maslansky, S. P. (1993). Air monitoring instrumentation. New York: Van Nostrand Reinhold.
Maynard, A. D. (2004). Examining elemental surface enrichment in ultrafine aerosol particles using analytical scanning transmission electron microscopy. Aerosol Science and Technology, 38(4), 365–381.
National Institute of Safety and Hygiene at Work. http://www.mtas.eu/insht/en/principal/insht_en.htm. Accessed December 2015.
National Institute of Occupational Safety and Health. (2005). Pocket guide to chemical hazards. Washington, DC: US Dept. of Health and Human Resources.
Nickerson, R., & Sheu, M. (2000). Plasma cleaning of medical devices. Critical Cleaning in Precision Manufacturing.
Reitz, V. (2004). Sterilization for beginners. Medical Design Magazine—06/2004. http://www.medicaldesign.com/articles/ID/12003. Accessed December 2015.
Ritter, G. W. (2000). Using adhesives effectively in medical devices. Medical Device and Diagnostic Industry Magazine. http://www.devicelink.com. Accessed December 2015.
Salditt, P. (2004). Trends in medical device design and manufacturing. Journal of SMT, 17(3), 19–24.
SKC, Inc. (2004). Comprehensive catalog and sampling guide. Eighty Four, PA: SKC Inc.
Soule, R. D. (1991). Industrial hygiene engineering controls. In G. D. Clayton & F. E. (Eds.), Patty’s industrial hygiene and toxicology (4th ed.). New York: Wiley.
The InfoShop. (2003). Biomedical applications of nanoscale devices. The InfoShop report September 12th. Accessed December 2015.
US Environmental Protection Agency. http://www.epa.gov. Accessed December 2015.
US Occupational Safety and Health Administration. http://www.osha.gov. Accessed December 2015.
Virginia Commonwealth University. Dr. Daren Chen’s faculty webpage, http://mechanical-and-nuclear.egr.vcu.edu/faculty/chen/. Accessed December 2015.
Acknowledgments
The authors thank Springer and Wiley publishers for allowing the authors permission to reprint and update this chapter that was originally published in, ‘Surface Engineered Surgical Tools and Medical Devices,’ originally published by Springer in 2007 (ISBN 978-0387-27026-5). Reprinted with kind permission from Springer Science+Business Media B.V and Wiley Publishers.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Open Access This chapter is licensed under the terms of the Creative Commons Attribution-NonCommercial 2.5 International License (http://creativecommons.org/licenses/by-nc/2.5/), which permits any noncommercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license and indicate if changes were made.
The images or other third party material in this chapter are included in the chapter's Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the chapter's Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder.
Copyright information
© 2016 Springer International Publishing Switzerland
About this chapter
Cite this chapter
Handy, R., Whitt, M., Lafreniere, M., Jackson, M.J. (2016). Medical Device Manufacturing: Environment, Engineering Control and Monitoring. In: Ahmed, W., Jackson, M. (eds) Surgical Tools and Medical Devices. Springer, Cham. https://doi.org/10.1007/978-3-319-33489-9_10
Download citation
DOI: https://doi.org/10.1007/978-3-319-33489-9_10
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-33487-5
Online ISBN: 978-3-319-33489-9
eBook Packages: EngineeringEngineering (R0)