Biomedical devices, miniature surgical devices, medical device manufacture

Overview
Biomedical device manufacture involves precision cleaning of critical components. Given the host of competition sensitive and regulatory issues, we provide a general outline of projects.

As cleaning and contamination control consultants, BFK Solutions participates in ASTM working groups; we have conducted a number of educational programs. Barbara Kanegsberg is active in the ASTM F04.15.17 Working Group to establish residue standards for permanent metal implantable devices. In 2003, she delivered an invited presentation at the ASTM F04 sponsored Workshop Addressing Cleanliness Issues In Biomedical Devices. In 2004, Barbara Kanegsberg conducted an invited seminar for residents and faculty at the University of Southern California, Graduate School of Periodontics.

Select References, Cleaning and Contamination Control, Biomedical Devices:

“Cleaning, Contamination Control, and Surface Quality, Implications for Dental Implants and Biomedical Devices,” seminar for residents and faculty, USC Graduate School of Periodontics, Los Angeles, CA, October 7, 2004.

“Cleanliness Issues for Biomedical Devices,” chairperson and participant in full day tutorial, with D. Albert, J. Broad, M. Chawla, and E. Kanegsberg, Medical Design and Manufacturing West 2004 Conference, Anaheim, CA, January 5 – 8, 2004, second workshop with updates and modifications, at Medical Design and Manufacturing, Minneapolis, October 19, 2004.

“Cleanliness and Surface Quality in Biomedical Devices,” invited presentation at ASTM F04-sponsored Workshop Addressing Cleanliness Issues In Biomedical Devices, Kansas City, MO, May 7, 2003. (DAVID: LINK HERE, MAYBE CONVERT TO PDF)

“Cleaning Issues and Approaches,” Life Science Contamination Control Forum, Washington, D.C February 11 - 13, 2003."Cleaning for Biomedical Applications," B. Kanegsberg, presentation and proceedings, Precision Cleaning 97, Cincinnati, OH, April 15 - 17, 1997.

Miniature Surgical Devices

• critical cleaning process, many materials of construction
• evaluated alternative solvents
• streamlined, process; 18 step process reduced by over two-thirds

A small, specialty manufacturer of miniature devices for critical surgery needed to remove fluxes and oils from a complex sub-assembly comprised of a several different metals. The products are high-value; and the production operation is small, primarily bench-top assembly. The goals of the project were to replace 1,1,1-trichloroethane which was in very short supply and, if possible, to streamline the 18 step process while achieving a very reliable build.

Several different solvents were tested; many either did not remove the soil or compromised the surface treatment of the metal. With additional testing, a process was developed which provided reliable cleaning without damage to the substrate. Cleaning steps for the sub-assembly were reduced by over two-thirds.

Troubleshooting, contaminants on surgical devices
Particulate contaminants were found on newly-manufactured miniature surgical devices. The particles were adherent; but were a source of concern. After identification of the contaminant, the source of contamination was found and resolved. Recommendations were made to modify the cleaning process to minimize sources of contamination and to maximize removal of any similarly recurrent contaminant.

Troubleshooting, contaminants, diagnostic detector
Particulate contamination in a diagnostic detector resulted in explosive failure during use. While not an immediate hazard, such failure slowed testing and produced consternation among all clinicians and patients. Part of the problem was that the product had not been designed for ease of manufacture. Additional processes were developed to remove greater numbers of particles.

Workshops, Medical Device Manufacture
BFK Solutions conducts in-house workshops and brainstorming sessions for device manufacturers. As part of our consultation, we provide on-site and documentation review for new, relocated, and ongoing operations.