Highlights and Implications of the Medtec Conference in Stuttgart
Barbara Kanegsberg and Ed Kanegsberg, May 2005
WE PARTICIPATED in the Medtec conference and trade show in Stuttgart in February,
2005 during which we presented a workshop on cleaning and contamination
control issues with biomedical devices. This event provided fascinating
perspectives regarding trends in industrial processes related to biomedical
devices (specifically in standardization efforts), the merging of device
and drug, areas of commercial emphasis, and the acute concern of workshop
attendees with cleaning and contamination control.
Standardizing the Standards
Those of us involved in manufacturing in the United States are acutely
aware of the problems posed by conflicting environmental regulatory requirements.
The medical device community is understandably concerned with regulatory
and manufacturing standards and requirements. Given the plethora of standards
in the United States, Europe, and Japan, harmonization has become a recurrent
theme. One long-term effort involves devising numbered, standardized description
of devices. The FDA is actively involved in these efforts.
Drug or Device
Participants in the conference and the trade show observed the trend
toward merging implantable devices with drug delivery systems. Because
regulatory
agencies, notably the FDA, manage pharmaceuticals and devices differently,
determining whether a product is to be classified as an implantable
device or a drug delivery system has become an important issue. Tutorials
were,
in part, concerned with elucidating how a producer of a new product
should treat their product—device or delivery system. One would also expect
that the melding of drug and device will also tend to exacerbate contamination
issues. In addition, it would seem that such hybrid devices inherently
impel well-defined surface attributes.
Commercial Emphasis
The medical device community is indeed global, so it was perhaps not
surprising to see vendors from the United States. The exhibition
did have its own
distinctive flavor (beyond the European chocolates), with an emphasis
on miniature components,
automation, and advanced technology. Reportedly in response to the
decline in production of Swiss watches, several suppliers displayed
automation
equipment specifically designed for the assembly of miniature devices
in clean environments.
In addition, we observed at least a few companies that were offering
nanotech-based technology as part of the product, specifically for
specialized coatings.
Surprisingly, given the emphasis on precision and advanced technology,
very few products were offered for cleaning and surface quality.
Productive Worrying
In contrast to the exhibition, participants in our workshop on cleaning
and surface quality were acutely aware of cleaning and contamination
control issues, beyond sterilization requirements. The initial
questions related
to what cleanliness standards they might have to meet, how clean
is clean enough, how do we avoid corrosion. There was interest
in a standard
for
overall
residual contamination [1].
In addition, there were questions regarding the nuances of behavior of various cleaning agents. There was also great interest in details of vapor degreasing for cleaning and reflux condensing for extraction of contaminants. One important issue, relating to both cleanliness and to product design, related to products with on-going use in a hospital environment, specifically to minimizing the impact of those products as sources of contamination.
Most encouraging, workshop participants worried about the details
of contamination. They asked the right questions and debated
the issues.
What are the specific
contaminants of concern? How might these contaminants impact
product performance? How will a process change, a solvent or cleaning
agent
change, impact product-performance,
in both the long and short-term? How can a present process
be benchmarked for comparison with a proposed solvent change? We
debated the pros
and cons of absolute contamination levels versus the more realistic
goal of
cleanliness
relative to a device with proven performance.
One attendee raised the issue of the consequences of solvent substitution on outgassing. It is important to demonstrate that smaller amounts of solvent are adsorbed in plastics and composites. How does one know that the new solvent will not have undesirable consequences, even if the new solvent is adsorbed at a lower level? Outgassing is an important issue, and will be the subject of our next column.
Reference:
1 Kanegsberg and Kanegsberg, A2C2, July 2004 (update, ASTM
F04.15.17 committee)
Barbara Kanegsberg and Ed Kanegsberg
are independent consultants in critical cleaning, precision cleaning, surface
preparation, and contamination control. They are the editors of “Handbook
for Critical Cleaning,” CRC Press. Contact them at BFK Solutions
LLC., 310-459-3614; info@bfksolutions.com; www.bfksolutions.com.
