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LSP Oxygen Regulator Recall
The National Institute for
Occupational Safety and Health (NIOSH) has determined that
aluminum body regulators used in high-pressure oxygen
systems are at risk for fires and explosions. The NIOSH
report recommends immediately replacing all aluminum
regulators used in high-pressure oxygen systems with brass
regulators. Flash fires can result from friction and heat
generated by particle impact during the release of
high-pressure oxygen flowing through the aluminum regulator.
The fires can start in aluminum oxygen regulators at
pressures as low as 25 pounds per square inch (psi), while
brass regulators will not ignite at pressures below 10,000
psi.
At the IAFF’s request, NIOSH initiated
an investigation in July 1998 to review the oxygen regulator
fire that resulted in severe burns to a member of IAFF Local
3333 Broward County, FL. The NIOSH investigation also
included technical experts from the FDA, the National
Aeronautic and Space Administration (NASA), as well as
additional outside experts. There have also been oxygen
regulator fires in numerous IAFF locals: Austin, TX Local
975; Houston, TX Local 341; Greeley, CO IAFF Local 888.;
Springfield, OR IAFF Local 1395; Gurnee, IL IAFF Local 3598;
and most recently in Oak Creek, WI Local 1848; and Truckee
Meadows, NV Local 2487. The FDA is aware of at least 16
explosions in the past five years. Every aluminum regulator
used on high-pressure oxygen cylinders has the potential to
ignite a flash fire.
Prompting the Investigation
In 1996, IAFF Local 341
informed the IAFF of an oxygen regulator that flashed in
Houston, Texas. The IAFF assisted the local and the fire
department in reporting this incident to the Food and Drug
Administration, which has jurisdiction over this product as
a medical device. Soon after, the IAFF was informed of a
similar incident in Greeley, Colo. The IAFF met with the
IAFF local affiliate to determine if this was an isolated
incident or a problem inherent with a specific
manufacturer’s resuscitator.
Soon after the IAFF heard of a similar
incident in Austin, Texas, the IAFF again contacted the FDA
and requested an investigation. Again, the IAFF was told
that an investigation had to be initiated by the device’s
owner. The IAFF asked if similar incidents had occurred, and
was informed that they do not provide this information. In
April 1997, the IAFF requested copies of all reports,
MedWatch complaints, FDA directives, inspections, and any
other information related to Life Safety Products' (LSP) or
any other manufacturer's oxygen regulators utilized on
emergency resuscitation oxygen tanks from January 1, 1995.
This request was made through the Freedom of Information
Act.
The IAFF finally received the
information from FDA, but all the information was on
microfiche--the only way they claimed they could provide
this information. The IAFF had to have all the film then
printed. A review of the information revealed that most, if
not all of the 1,000s of pages failed to any useful
information. The information was essentially page after page
of computer printout of complaints about resuscitators. The
files did not contain investigative reports or recall
notices. The printouts also involved all oxygen resuscitator
companies, not just LSP.
In May 1997, Allied Healthcare
Products issued a "recall" of oxygen regulator model
L270-020 and L270-050. The "recall" was really a notice to
retrofit existing aluminum regulators with a sintered brass
mesh screen to filter out contaminants.
Getting the Word Out
Upon learning of Broward
County, Fla., fire, the IAFF published a notice of the
manufacturer’s "recall" in the IAFF Leader, which is
sent to all IAFF local affiliate presidents. Additionally,
the recall notice and the FDA investigation form were placed
on the IAFF web site. Likewise, an article on the issue was
in the International Firefighter, which is
distributed to all IAFF members. In fact, the LSP "recall"
was not a product recall, but an alert for users to keep
oxygen cylinders and regulators clean and an offer for a
replacement inlet filter to improve the resistance of the
regulator to contamination. Neither Allied Healthcare
Products or the FDA directed the products to be removed from
service nor were any regulators "recalled."
Specific to the LSP regulators and their "recall,"
the IAFF asked that NIOSH provide technical assistance to
the IAFF by investigating this incident. The IAFF does not
believe that the FDA has conducted a proper evaluation of
the failures of this device in the field in any of the
locations reported to the IAFF (Austin, Broward County,
Greeley, Houston, Oak Park, or Truckee Meadows). It is
obvious to the IAFF that FDA’s alliance is with the medical
device companies and not the user of the product. Unlike
NIOSH, the FDA relies solely on the manufacture’s
investigation and the resulting recommendations or
"recalls."
On February 4, 1999, Allied Healthcare
Products issued a new "recall" to replace its LSP aluminum
oxygen regulators with brass regulators. This is a voluntary
action by the manufacturer and not mandated by FDA.
Furthermore, the "recall" only affects LSP regulators,
approximately 60 percent of the high-pressure oxygen
regulator market. The FDA has done nothing to ensure that
the remaining manufacturer’s regulators will be recalled.
In light of the NIOSH report, the
IAFF immediately sent a letter to the Food and Drug
Administration (FDA) demanding a full recall of all aluminum
body regulators used in high-pressure oxygen cylinders.
Furthermore, the IAFF demanded that the FDA require each
manufacturer to contact each regulator owner, document the
contact, and provide the retrofit brass regulators at no
cost to the owners.
IAFF members should immediately check
the high-pressure oxygen regulators owned by their fire
department. All aluminum regulators must be replaced with
brass regulators. Until the aluminum regulators are
replaced, the NIOSH and FDA report has made interim
recommendations.
Allied Healthcare Products,
manufacturer of LSP regulators, has agreed to replace the
aluminum regulators with brass regulators. If a different
company manufactures the aluminum regulators, fire
departments should contact that company or the distributor
from whom they bought the regulator. Fire departments should
demand that the aluminum regulators be replaced with brass.
Fire Departments can contact the Allied Healthcare Products
recall coordinator at:
LSP Regulator Recall Center
Allied Healthcare Products, Inc.
1720 Sublette Blvd.
St. Louis, MO 63110
(800) 231-5273
(Monday through Friday 8 a.m.-5 p.m. CST)
(888) 216-4624 (fax)
For more information please contact
the IAFF’s Department of Occupational Health and Safety.
What You Can Do
Oxygen Regulator Storage,
Maintenance and Handling
- Prohibit smoking around oxygen.
- Store oxygen cylinders in an
upright position.
- Store oxygen in clean, dry
locations away from direct sunlight.
- Prevent post valves, regulators,
gauges, and fittings from contacting oils, greases,
organic lubricants, rubber or any other combustible
substance.
- Make sure that any cleaning,
repair or transfilling of oxygen equipment is performed
by qualified, properly trained staff.
- Do not work on oxygen equipment
with ordinary tools. Designate special tools, clean them
and store them for use with oxygen equipment only.
- Ensure that any components added
to the regulator (e.g., gauge guards) are installed so
that they do not block the regulator vent holes.
- Use plugs, caps and plastic bags
to protect "off-duty" equipment from dust and dirt.
- Minimize particulate migration
from the cylinder by installing a standoff tube
(bayonet) at the inlet of the post valve.
Oxygen Regulator Use
- Replace aluminum regulators with
oxygen regulators constructed of materials having oxygen
compatibility at least equivalent to brass.
- Make sure that staff using oxygen
equipment are adequately trained in its operation and in
oxygen safety, and have knowledge of manufacturer’s
instructions for using the equipment.
- Visually inspect the post valve
gasket and regulator inlet prior to installation. If
they are not visually clean they should not be used.
- Momentarily open and close
("crack") the post valve to blow out debris prior to
installing a regulator.
- Ensure that the regulator is set
with the flow knob in the off position before attaching
it to the cylinder.
- Position the equipment so that
valve is pointed away from the user and any other
persons.
- Open the cylinder valve slowly
and completely to minimize the heat produced and achieve
the desired flow conditions within the equipment.
- Do not look at the regulator
pressure gauge until the cylinder valve is fully opened.
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