Issue 21, July
Joint Commission accredited organizations and interested health care
professionals, Sentinel Event Alert identifies the most frequently
occurring sentinel events, describes their common underlying causes, and
suggests steps to prevent occurrences in the future.
During the on-site
survey of accredited organizations, JCAHO surveyors assess the
organization's familiarity with and use of Sentinel Event Alert
information. Organizations are expected to (1) review each Sentinel
Event Alert, (2) consider the suggestions, as appropriate to the
organization's services, and (3) implement the suggestions, or reasonable
alternatives, or provide a reasonable explanation for not implementing
Please route this issue to
appropriate staff within your organization. Sentinel Event Alert may
only be reproduced in its entirety and credited to the Joint Commission on
Accreditation of Healthcare Organizations.
"Ideally, a practitioner licensed by
state law, such as a pharmacist assistant, a pharmacist technician, or a
trained designee, should check the gas before use to ensure that the patient
is receiving the correct medical grade gas."
--Duane Sylvia, consumer safety officer, FDA Office of Compliance,
Center for Drug Evaluation and Research
JCAHO Sentinel Alert
The Joint Commission
received two reports of medical gas mix-ups in 2000 that resulted in the
death of four patients and injury to five patients. In the past four years,
the Food and Drug Administration (FDA) has received four reports that
resulted in seven deaths and 15 injuries. In early April 2001, the FDA
issued a Guidance for Hospitals, Nursing Homes, and other Health Care
Facilities--Public Health Alert1 that focuses on its reports
of medical gas mix-ups, their common causes and the FDA's recommendations
for preventing occurrences. This alert is being distributed to help spread
the word to health care organizations about steps that can be taken to
prevent deaths and injuries from compressed gases, which include industrial
and medical grade gases. Medical grade gases are considered prescription
drugs and include oxygen, compressed air, carbon dioxide, helium, nitrogen
and nitrous oxide. These medical gases are either used in medical treatment
and procedures, or to power medical equipment. Industrial grade gases should
never be used medically. Medical gases come in many different types
of vessels, but three of the FDA's four cases involved cryogenic vessels and
their connectors, so this alert will focus on the problems associated with
The FDA's public health alert highlights several common causes in its cases
of medical gas mix-ups that are related to 1) lack of proper training of
personnel responsible for the delivery, connection or identification of
medical grade gas vessels, 2) removal of gas-specific connectors, and/or 3)
improper labeling (in one case) or storage of medical gas vessels. Three of
the FDA's four cases involved maintenance or delivery personnel who were not
trained to recognize built-in safeguards--specifically connection
incompatibility. Connectors for cryogenic oxygen vessels are specially
fitted so that they are compatible only with oxygen delivery systems. In
most cases, the health care organization's personnel responsible for medical
gases were not trained to recognize the labeling used to identify the grade
or type of gas in vessels. In some cases, medical grade and industrial grade
product vessels were stored together, and the wrong grade gas was selected
or delivered accidentally.
The FDA, the Compressed Gas Association (CGA) and medical gas manufacturers
are exploring new safeguards, including silver brazed connections on
cryogenic vessels that are impossible to remove. The CGA is a safety and
standards organization for medical and industrial gases; its membership
includes manufacturers of medical and industrial gases and equipment, as
well as distributors. In December 2000, the CGA issued SB-262,
a safety bulletin that recommends the use of silver brazed connections on
cryogenic liquid cylinders in medical gas service. Other safeguards being
considered are standardized color-coding and better labeling of cryogenic
vessels. While a health care organization has no control over labeling used
by its medical gas supplier or the training of its medical gas delivery
personnel, there are measures that an organization can take to help prevent
deaths or injuries from medical gas mix-ups.
The FDA recommends the following procedures be taken to prevent medical gas
mix-ups at health care organizations.
With respect to personnel training, all employees who handle medical
Should be alerted to
and reminded of the possible hazards associated with using medical gas.
Should be trained to
recognize and carefully examine medical gas labels.
Should be trained to
make sure each vessel they connect to the oxygen system bears the proper
label--if your supplier uses 360-degree, wrap-around labels to designate
Should be trained to
connect medical gas vessels properly if they are responsible for changing
or installing cryogenic vessels. These personnel should understand how
vessels are connected to the oxygen supply systems and be alerted to the
serious consequences of changing connections. Adapters must never
be used to make a connection.
With respect to
equipment and gas storage:
If your facility
receives medical gas deliveries, store medical grade products separately
from industrial grade products. The storage area for medical grade
products should be well defined with one area for receiving full cryogenic
vessels and another area for storing empty vessels.
The fittings on
cryogenic vessels should not be changed under any circumstances. If a
cryogenic vessel fitting does not seem to connect to the oxygen supply
system fitting, the supplier should be contacted immediately. The vessel
should be returned to the supplier to determine the fitting or connection
Once a cryogenic
vessel is connected to the oxygen supply system, but prior to introducing
the product into the system, a knowledgeable person should ensure that the
correct vessel has been connected properly.
practitioner licensed by state law, such as a pharmacist assistant, a
pharmacist technician, or a trained designee, should check the gas before
use to ensure that the patient is receiving the correct medical grade gas,"
says Duane Sylvia, consumer safety officer with the FDA's Office of
Compliance at its Center for Drug Evaluation and Research.
JCAHO recommends that organizations address the recommendations with respect
to personnel training, equipment and gas storage as listed above.
1Guidance for Hospitals, Nursing Homes, and other Health Care
Facilities-Public Health Alert, April 2001; U.S. Department of Health
and Human Services, Food and Drug Administration, Center for Drug Evaluation
and Research; available at
2SB-26; December 8, 2000; Compressed Gas Association; available
for purchase by non-members for $6 at the CGA Web site,
www.cganet.com, or by