CASE STUDY-3

Presented by:
Maria Memon -19BME22
Laiba khan – 19BME20
Kaswa Memon – 19BME19
Barkha Kumari – 19BME09
Highlights an instance where a sterilizer and
sterilization technology was sold to hospitals
without regulatory approval.
April 13, 1998, the FDA issued a safety alert regarding the use of the AbTox
Plazlyte™ sterilization system. The Plazlyte™ sterilizers utilized a proprietary, low
temperature gas plasma, along with vaporized peracetic acid. Although the system
provided sufficient lethality, the FDA had not cleared the safety, performance or
instructions for use of this sterilizer. The sterilizers were sold directly to hospitals
seeking alternatives for ethylene oxide sterilizers. The warning was initiated due to
serious eye injuries to corneal endothelial cells which resulted in corneal
transplantation in some patients. The problem occurred when surgical instruments
were sterilized, and copper and zinc salts formed on the surfaces of the sterile
instruments. The copper compound residues were toxic to corneal endothelia and
resulted in blindness (FDA, 1998). During the time period of January 8–14, 1998,
six of eight patients undergoing intraocular surgery incurred corneal edema and
opacification of the cornea (CDC, 1998)
AbTox Plazlyte™ sterilization system

 AbTox is the Gas plasma sterilization that are energized gases.

Various particles (ions, radicals, electrons) and/or radiation (UV light)
generated on plasma formation can have potent microbicide effects.
Plasma are generated by applying energy to a gas or gases, such as
oxygen, argon and nitrogen. Plasma have been investigated for a
variety of decontamination applications including cleaning,
disinfection and sterilization. They are used directly for their
antimicrobial properties but also indirectly as part of
disinfection/sterilization processes. The choice of gas/gases is
important for optimization, not only for efficacy against
microorganisms but also for surface compatibility
 United states of America , AbTox. The food and drug administration has warned
hospitals and physicians against the use of the AbTox Plazlyte Sterilization Sytem,
because the agency is aware of at least 10 injuries associated with ophthalmic
surgical instruments which had been sterilized with this system. These reports
involved serious injuries to the cornea with damage to vision.
 The product’s manufacturer, Abtox, Inc., of Mundelein, Ill. has initiated a
worldwide recall for this model of device. This device has never been cleared by
FDA.
 The problem appears to be formation of toxic salt from the chemical sterilants
when the device is used on surgical tools made of copper, brass or zinc.
 The firm has notified each of the 155 institutions, numerous foreign accounts and
individuals who received these unapproved sterilization systems about the recall.
Users of these systems should be aware of the following:
 Do not use the AbTox Plazlyte Sterilization system to sterilize ophthalmic
instruments;
 Verify that ophthalmic devices in inventory were not previously sterilized with
this system;
 Do not sterilize any equipment and/or devices which may have been soldered or
may contain brass, copper or zinc components; and
 Do not process any equipment and/or devices in containers which may have been
soldered or contain brass, copper or zinc components
 Corneal Decompensation After Intraocular Ophthalmic
Surgery—Missouri, 1998
 During JANUARY 8-14,1998, six of eight patients undergoing elective intraocular
surgery at a Veterans Affairs medical center (VAMC) in St. Louis, Missouri, developed
corneal endothelial decompensation (corneal edema and opacification) #24 hours after
surgery. All had been operated on with instruments sterilized by the Abtox Plazlyte
system (Abtox, Inc., Chicago, Illinois).
 In November 1997,thehospital discontinued using ethylene oxide to sterilize
instruments used in ophthalmic surgery and began using the Abtox Plazlyte
sterilization method.1,2 From November 5, 1997, through January 14, 1998, a total of
49 patients had ophthalmic surgery that involved instruments sterilized in the Abtox
Plazlyte machine. This method uses a vaporized mixture of peracetic acid, acetic acid,
and hydrogen peroxide in combination with low temperature.The vapor is removed
with argon, oxygen, and hydrogen gas. The Abtox Plazlyte system has not been cleared
by the Food and Drug Administration (FDA) for either safety or performance.
 Instruments routinely used in ophthalmic surgery often have small hinges and
small lumens.
 Preliminary results using inductively coupled plasma atomic emission
spectrometer analyses performed at CDC revealed copper and zinc in water rinsed
through cannulas sterilized in the Abtox Plazlyte system.When this rinsate was
infused into human and rabbit corneas, corneal decompensation occurred.
 On January 14, 1998, the use of the Abtox system was discontinued at the St.
Louis VAMC, and ophthalmic instruments were sterilized by steam autoclave.
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