Biomedical Engineering Reference
In-Depth Information
the product will normally deal with a significant level of regulatory oversight
and issues of air, water, and hazardous solid waste pollutions. For example,
Teflon
®
, a common biocompatible fluoropolymer used in various device
coating applications, requires perfluorooctanoic (PFOA) as a raw material in
its production. This is a controversial acid which may cause cancer and
teratogenesis in those exposed.
EH&S
AND
D
RILLING
,
G
RINDING
,
C
UTTING
,
AND
O
THER
M
ACHINING
P
ROCESSES
Fine and coarse particles are many times produced in significant
concentrations while processes such as drilling, grinding, cutting, and other
light machining is required on the medical device during manufacturing. In
addition, since some level of cutting oils are normally used during these
operations, the generation of significant levels of oil- and water-based aerosols
can also be troublesome to the exposed employee. As with the previous
processes and resultant stressors, most nations deal with this issue by
establishing short-term and long-term occupational exposure limits as a means
to limit employee exposures. These are established either generically or
specifically, based upon the toxicity, size, and morphological properties of the
generated particles or aerosols. They are also normally determined on a time-
weighted average (TWA) basis.
Air pollution concerns for most of these operations are localized. In effect,
they are normally dealt with as fugitive emissions. Since most medical device
manufacturers produce relatively small products, the quantities of most of the
lubricants used in either grinding, drilling, or cutting operations is somewhat
small; thus, the use of stacks to emit the pollutants into the environmental is
minimal. However, the production of the raw materials by suppliers within the
country or internationally will produce, in many cases, significant levels of air
pollutants contributing to ambient air issues and such global detriments as
global warming and acid rain.
Since machining operations utilizing petroleum-based cutting oils can
produce significant quantities of sludge and/or liquid wastes, nations typically
apply regulations to this waste stream both on-site and in transport. In
addition, many manufacturers are required by regulations to monitor the storm
water and various outfalls on location to make sure that significant
concentrations of ecological damaging chemicals do not get into the
