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Robyn Ringer

Surgical Principles

February 18, 2009

Alissa Blackledge

The use of steam for sterilization is fairly widespread; however, steam is seldom used as a
sterilization method by the medical device industry. Most disposable plastic devices are
terminally sterilized by ethylene oxide (EtO) or radiation. These processes provide low
temperatures that most plastics can tolerate. Steam, however, is the most commonly used
sterilization method in many healthcare facilities.
Despite its use of high temperatures, steam is a simple and inexpensive sterilization method with
many benefits. It yields little waste (entropy is its only by-product). It is also efficacious in terms
of its ability to kill microbial organisms.
With the growing complexity of medical device and drug combinations, it is essential to consider
steam. These combination devices, such as drugs in syringes, drugs on catheters, and drug-
eluting stents, often require steam sterilization because EtO cannot sterilize liquids and
irradiation breaks down many drug compounds.
Risks and Challenges
Steam sterilization has long been used in hospitals as well as in the pharmaceutical, aseptic
processing, and food industries. In many ways, it has been a victim of its own successes. For
example, steam is most often characterized by its overkill. It uses extremely high temperatures to
inactivate highly resistant nonpathogenic thermophile spores and, more recently, extremely
resistant prions, that other sterilization methods cannot destroy. Its simplicity and low capital
cost make it an inexpensive, attractive, and viable sterilization method. Typical steam
sterilization equipment costs less than one-third as much as an EtO chamber system and
controller. It costs less than one-fourth as much as gamma or E-beam equipment and facilities.
Sterilization exposure times can range from as short as 3 minutes at 134°C to as long as 3 hours
at 101°–111°C, depending upon the bioburden (see Table I). Hospitals use steam at 134°C for 3
minutes for flash sterilization in emergency situations and 121°C for 15 minutes on a routine
basis.

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