Barbara Kanegsberg
As we indicated in the previous issue of Clean Source, manufacturers
of implantable medical devices, manufacturers of other medical
and clinical related products, and pharmaceutical companies
are increasingly
aware of the importance of cleanliness as well as the interplay
of cleaning and sterilization issues.
It is critical for health care professionals including doctors,
dentists, nurses, and clinical chemists to understand not only
sterilization
issues but also to be aware of cleaning, contamination control, and
surface quality. Health care professionals can provide valuable feedback
to manufacturers of implantable devices and surgical devices, perhaps
preventing problems before they arise. Certain instruments require
cleaning and surface protection as well as sterilization; and as
instruments and peripheral product become smaller and more complex,
understanding
and optimizing methods for cleaning and (for want of a more elegant
term) maintenance is crucial.
Health care professionals are increasingly aware of and concerned
with non-living contamination control issues. One important outcome
of this
awareness is to stop problems before they escalate. Cleanliness and
contamination control begin well before the cleanroom; and once a
contaminant is introduced, it is often intractable; additional cleaning
steps may
be required. Contamination can result in unacceptable performance
or at worst in catastrophic product failure. Even with ambitious
process
monitoring programs, unanticipated contamination can occur. Engineers
and operators at all stages of fabrication from the machine shop
to the job shop to the cleanroom have a role in spotting potential
process
problems.
For critical products, the end-user (in this case the health care
professional also has an important monitoring role. Open, collaborative
communication
between health care professionals and manufacturers inevitably leads
to improvement of both the design and surface quality of devices
and instruments. Given anticipated innovation and miniaturization,
this
collaboration must be enhanced during development of new devices.
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