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American Association of Nurse Anesthetists Office of Federal Government Affairs

25 Massachusetts Ave., NW, Suite 550, Washington DC 20001 / (P) 202-484-8400 / (F) 202-484-8408 / www.aana.com

May 15, 2009

Mr. Neel Patel

Biomedical Engineer, Anesthesiology and Respiratory Devices Branch

Executive Secretary, Anesthesiology and Respiratory Therapy Devices Panel

Food and Drug Administration

9200 Corporate Blvd. VIA EMAIL

Rockville, MD 20850 neel.patel@fda.hhs.gov

ATTN: Docket No. FDA-2009-N-0664

Dear Mr. Patel –

On behalf of the 40,000 members of the American Association of Nurse Anesthetists

(AANA), I am pleased to present testimony before the Anesthesiology and Respiratory

Therapy Devices Panel of the Medical Devices Advisory Committee of the Food and

Drug Administration (FDA), for its hearing Thu., May 28, 2009, regarding the

SEDASYS™ Computer Assisted Personalized Sedation System (74 FR 19230,

4/28/2009).

The AANA is the professional association representing over 90 percent of the Certified

Registered Nurse Anesthetists (CRNAs) and student nurse anesthetists in the United

States. CRNAs are prepared to the master’s or doctoral level, and must be certified by

the autonomous National Board for Certification and Recertification of Nurse

Anesthetists in order to practice, and must be recertified every two years. As advanced

practice nurses, CRNAs administer about 30 million anesthetics given to patients each

year in the United States. Our services include administering the anesthetic, monitoring

and interpreting the patient’s vital signs, and managing the patient throughout the

surgery, as well as managing acute and chronic pain. CRNAs work in every setting in

which anesthesia is delivered, including hospital surgical suites and obstetrical delivery

rooms, ambulatory surgical centers (ASCs), pain management units, and the offices of

dentists, podiatrists, and general and specialty surgeons.

AANA Letter to FDA

May 15, 2009

Page 2 of 15

Our primary professional objective is anesthesia patient safety. In the absence of

substantial professional literature available to discuss the SEDASYS™ device, our

testimony speaks to the conditions under which the device may be used, if the agency

chooses to approve it. We will ask why and how the agency anticipates approving a

device that allows non-anesthesia professionals (individuals other than CRNAs or

physician anesthesiologists) to administer propofol (Diprivan) in direct conflict with the

FDA-approved labeling for this potentially dangerous drug. Further, we will raise our

concern with determining how non-anesthesia professionals using the device will be

trained and certified to rescue patients in the event of a cardiorespiratory emergency.

I. Why the SEDASYS™ Device Should Only Be Used by Anesthesia Professionals

We understand that the SEDASYS™ device is intended to enable non-anesthesia

professionals to administer propofol. Little has been published publicly about the

SEDASYS™ device.* That which has been published suggests its usage only in highly

controlled and standardized environments appropriate for a device awaiting pre-market

approval by the agency. As we have described above, propofol is administered in a wide

spectrum of offices, facilities and settings in which rescue situations can arise.

* The sole reference to SEDASYS™ we have found in the peer-reviewed literature is Pambianco D,

Whitten J, et al. An assessment of computer-assisted personalized sedation: a sedation delivery system to

administer propofol for gastrointestinal endoscopy. Gastrointestinal Endoscopy 68:3, 542-47, 2008.

Pambianco et al evaluated 24 cases in which the device was used. Ethicon Endo-Surgery has issued

statements and presentations citing studies of the device unpublished in the literature. These include

McKenna M. CAPS Technology, Computer Assisted Personalized Sedation. Presentation before the

Florida State Nursing Board Sedation Review Committee, for Ethicon Endo-Surgery, Inc. June 19, 2007.

A similar presentation was made before the Medical State Licensing Board of Indiana, for Ethicon Endo-

Surgery, Inc. February 28, 2008. Finally, see News release. Pivotal study shows physician/nurse teams

using SEDASYS™ system reduced risk of over sedation with propofol. Ethicon Endo-Surgery,

http://www.jnj.com/connect/news/all/20080520_000000, May 19, 2008. The referenced “pivotal” study

comparing propofol sedation using SEDASYS™ against “the current standard of care for sedation

(midazolam plus fentanyl or meperidine)” is not available in the literature so far as we are aware. The

news release states the study is part of the SEDASYS™ pre-market approval application to FDA.

AANA Letter to FDA

May 15, 2009

Page 3 of 15

We note that the FDA-approved labeling of the drug which SEDASYS™ is intended to

administer, propofol, directs that under all circumstances it must be administered by

persons with expertise in general anesthesia. Since we assume a device administering

propofol would require the intervention of a healthcare professional to set-up and

program the device before its use on a patient, the healthcare professional performing

those tasks should be subject to the same warnings and requirements that FDA has

established for propofol for unassisted injection. As such, should the panel recommend

the agency approve the SEDASYS device, the panel should restrict this device to use

only by anesthesia professionals, who are expert in general anesthesia and in patient

rescue.

II. Properties of Propofol, as Described by FDA, Require that Persons

Administering It be Expert in General Anesthesia; Any Device Administering

Propofol Should be Subject to the Same Constraints in the Interest of Patient Safety

and so as Not to Weaken the Existing Warnings for Propofol Administration

The current FDA-approved, bolded warning on propofol (FDA-Approved Label for

DIPRIVAN® (propofol) Injectable Emulsion (Rev 08/05), available at

http://www1.astrazeneca-us.com/pi/diprivan.pdf) states:

For general anesthesia or monitored anesthesia care (MAC)

sedation, DIPRIVAN® Injectable Emulsion should be administered

only by persons trained in the administration of general anesthesia

and not involved in the conduct of the surgical/diagnostic

procedure. Patients should be continuously monitored, and facilities

for maintenance of a patent airway, artificial ventilation, and oxygen

AANA Letter to FDA

May 15, 2009

Page 4 of 15

enrichment and circulatory resuscitation must be immediately

available….

In the elderly, debilitated or ASA III/IV patients, rapid (single or repeated)

bolus administration should not be used during general anesthesia or MAC

sedation in order to minimize undesirable cardiorespiratory depression

including hypotension, apnea, airway obstruction, and/or oxygen

desaturation.

Several attributes of propofol justify this warning. Many of these attributes are published

on the FDA Draft Final Printed Labeling for generic propofol (FDA, Application

#075392, Gensia Sicor Pharmaceuticals, Approval Date 9/19/2000). Others relate to the

literature, education and professional experience of CRNAs and anesthesiologists.

Propofol is preferred for anesthesia care for many procedures, including certain

gastrointestinal diagnostic procedures, because of the comparatively rapid dissipation of

its sedative effects. Patients wake up from propofol quickly, compared with other drugs

used for sedation. However, unlike many other pharmaceuticals used for sedation or

induction, there is no agent that reverses the effects of propofol. Beyond a certain dose,

propofol stops a patient’s breathing, with each patient responding somewhat differently to

a given dosing pattern. If breathing is halted, the patient transitions from sedation into a

general anesthetic state. The healthcare provider must ventilate the patient, and

understand and manage the physiological changes that can occur during a general

anesthetic state. Under many gastrointestinal procedures for which sedation is used, the

patient lies prone. If an airway emergency occurs, the patient must be placed in the

supine position to immediately secure an adequate airway.

The issue, therefore, is not whether a healthcare provider may adequately administer

propofol with the assistance of a device such as the SEDASYS™. The question is

whether a healthcare provider, untrained in general anesthesia, can adequately address the

AANA Letter to FDA

May 15, 2009

Page 5 of 15

known complications of propofol administration to ensure patient safety were such a

device to administer a dose of propofol leading to these complications, by human error in

programming or otherwise.

Such experiential factors are buttressed by the FDA’s own labeling, worth excerpting at

some length here (FDA, Application #075392), and by the literature:

“Addition of a potent opioid (e.g. fentanyl) when used as a premedicant

further decreases cardiac output and respiratory drive.

“During maintenance, propofol causes a decrease in ventilation usually

associated with an increase in carbon dioxide tension which may be

marked depending upon the rate of administration and other concurrent

medications (e.g. opioids, sedatives, etc.).

“During monitored anesthesia care (MAC) sedation, attention must be

given to the cardiorespiratory effects of propofol. Hypotension,

oxyhemoglobin desaturation, apnea, airway obstruction, and/or oxygen

desaturation can occur, especially following a rapid bolus of propofol.

During initiation of MAC sedation, slow infusion or slow injection

techniques are preferable over rapid bolus administration; and during

maintenance of MAC sedation, a variable rate infusion is preferable over

intermittent bolus administration in order to minimize undesirable

cardiorespiratory effects….

“With increasing patient age, the dose of propofol needed to achieve a

defined anesthetic end point (dose-requirement) decreases….”

The anesthesia literature since the FDA’s 2000 approval of generic propofol further

describes propofol’s properties. Though propofol has well understood sedative properties,

AANA Letter to FDA

May 15, 2009

Page 6 of 15

Drs. Frolich, Price, Robinson et al more recently found that “subjects rated both pain

intensity and unpleasantness higher when sedated with propofol…. This effect was

unexpected and may be explained by a difference of subjective pain experience by a patient

and the perceived level of analgesia by a healthcare provider in sedated patients. This

finding calls further attention to the need for adequate analgesia in patients sedated with

propofol.” (Frolich M, Price D, et al. The effect of propofol on thermal pain perception.

Anesth Analg 2005;100:481-6). Propofol does not possess analgesic properties.

Therefore, anesthesia professionals understand the patient’s need for medication that will

control pain during procedures. The addition of opiate medications provides analgesia and

when used concomitantly with propofol has the potential to cause apnea. Anesthesia

professionals recognize this possible outcome and are fully prepared to manage apnea,

should it occur.

In reviewing literature associated with emergency medicine, Drs. Wilbur and Zed

buttressed findings of the FDA approved labeling of propofol in stating that while

propofol provided “markedly shorter induction and recovery times than

midazolam…(a)pneic episodes (>30 seconds) occurred in 23% of propofol recipients,

28% of thiopental recipients, and 7% of etomidate and midazolam recipients…. Propofol

is a cardiovascular depressant that causes dose-related blood pressure reductions…. In

the 6 DCC (direct current cardioversion, parenthetical added) studies reviewed, 21

(23.3%) of 90 patients who received propofol experienced apnea episodes longer than 30

seconds.” (Wilbur K, Zed P. Is propofol an optional agent for procedural sedation and

rapid sequence intubation in the emergency department. Can J Emerg Med 2001;3:1

which references Can J Anaesth 1988;35:479-83, Anaesthesia 1990;45:872-5, J

Cardiothor Vasc Anesth 1991;5:566-8, Acta Anaesthesiol Scan 1991;35:609-15, Anesth

Analg 1993;77:690-4; Crit Care Med 1993;23:1509-13).

AANA Letter to FDA

May 15, 2009

Page 7 of 15

The anesthesia literature underscores age and body mass index as factors in appropriate

propofol dosage. (Niiyama Y, Omote K, et al. Effects of gender, age and body mass

index on sedation level during infusion of propofol by target-controlled infusion. J

Anesth 2002;96:A63)

Given the propofol-related literature, it is clear that training in the administration of

general anesthesia and in managing propofol’s known properties (e.g., physiological

responses and the possible complications that can occur from administration) are required

to assure patient safety. The professionals who have such training are CRNAs and

anesthesiologists. Any device designed to control the administration of propofol to a

patient will require operation by a healthcare professional. Those healthcare

professionals should be limited to those with training in general anesthesia and patient

rescue.

III. Prior to Consideration of SEDASYS™ for Approval, Professional

Organizations Have Widely Recommended That FDA Maintain Current Warnings

on Propofol Constraining Its Use to Anesthesia Professionals Only

Recognizing the powerful attributes of propofol, several professional organizations have

issued policy statements speaking directly to the safety concerns associated with the drug

which the SEDASYS™ device is intended to administer. These organizations include

societies of healthcare professionals, and nongovernmental standardsetting bodies

authorized to accredit or certify various types of healthcare facilities where procedures

requiring sedation are provided.

The AANA and the American Society of Anesthesiologists (ASA) published a Joint

Statement regarding propofol administration April 14, 2004

AANA Letter to FDA

May 15, 2009

Page 8 of 15

(http://www.aana.com/news/2004/news050504 joint.asp, and

http://www.asahq.org/news/propofolstatement.htm ):

“Because sedation is a continuum, it is not always possible to predict how

an individual patient will respond. Due to the potential for rapid, profound

changes in sedative/anesthetic depth and the lack of antagonistic

medications, agents such as propofol require special attention.

“Whenever propofol is used for sedation/anesthesia, it should be

administered only by persons trained in the administration of general

anesthesia, who are not simultaneously involved in these surgical or

diagnostic procedures. This restriction is concordant with specific

language in the propofol package insert, and failure to follow these

recommendations could put patients at increased risk of significant injury

or death.

“Similar concerns apply when other intravenous induction agents are

used for sedation, such as thiopental, methohexital or etomidate.

“*This statement is not intended to apply when propofol is given to

intubated, ventilated patients in a critical care setting.”

Subsequently, the Accreditation Association for Ambulatory Health Care (AAAHC)

endorsed the above statement “regarding the safe use of propofol and other intravenous

drugs that do not have antagonist medications.” (AAAHC statement, 5/24/2005,

http://www.aaahc.org/eweb/docs/prs_rel_propofol.pdf ) The AAAHC accredits over

4,000 ASCs and other healthcare facilities in the United States.

The American Association for the Accreditation of Ambulatory Surgical Facilities

(AAAASF) has further stipulated restrictions on the administration of propofol in its

AANA Letter to FDA

May 15, 2009

Page 9 of 15

accredited facilities. The AAAASF’s standards for ambulatory surgical facilities

(December 2007) provide as follows:

1000 ANESTHESIA (RG 1000.1) (STD 820-850)

1000 Delivery of Anesthesia

1000-15 All anesthetics other than topical or local anesthetic

agents are delivered by either an anesthesiologist, or by a CRNA (under

physician supervision if required by state or federal law or by a policy adopted by

the facility), or by an anesthesiology assistant as certified by the National

Commission for the Certification of Anesthesiologist Assistants under the direct

supervision of an anesthesiologist. Parenteral sedation, other than propofol, may

be administered by a registered nurse under the supervision of a qualified

physician.

The AAAASF’s accreditation program classifies facilities based on the type of anesthesia

used in a facility for procedures. Class C facility is defined as the following:

Class C:

In a class C facility all surgical, endoscopic, and/or pain management procedures

may be performed under the following anesthesia:

1. topical anesthesia

2. local anesthesia

3. parenteral sedation

4. regional anesthesia

5. dissociative drugs, including propofol

6. epidural anesthesia

7. spinal anesthesia

8. general anesthesia with or without endotracheal intubation or

laryngeal mask airway anesthesia

AANA Letter to FDA

May 15, 2009

Page 10 of 15

With respect to the administration of anesthesia in these facilities, AAAASF provides as

follows:

Propofol and agents 6 through 8 may be administered only by an

anesthesiologist, a Certified Registered Nurse Anesthetist (CRNA) under

physician supervision if required by state or federal law or by policy adopted by

the facility; or an anesthesia assistant (as certified by the National Commission

for the Certification of Anesthesiologist Assistants under direct supervision of an

anesthesiologist).

AAAASF’s standards for surgical procedures performed in physician offices (February

2008) also provide as follows:

900 ANESTHESIA (RG 1000.1)

10 Delivery of Anesthesia

910-010 All anesthetics other than topical or local anesthetic

agents are delivered by either an anesthesiologist, or by a CRNA (under

physician supervision if required by state or federal law or by a policy adopted by

the facility), or by an anesthesiology assistant as certified by the National

Commission for the Certification of Anesthesiologist Assistants under the direct

supervision of an anesthesiologist. Parenteral sedation, other than propofol, may

be administered by a registered nurse under the supervision of a qualified

physician."

Similar to AAAASF’s standards for ambulatory surgical facilities, AAAASF’s

procedural standards also classify facilities based on anesthesia used for procedures and

limit administration of propofol to anesthesia professionals, as follows:

Class C:

AANA Letter to FDA

May 15, 2009

Page 11 of 15

In a class C facility all endoscopic, and/or pain management procedures may be

performed under the following anesthesia:

1. topical anesthesia

2. local anesthesia

3. parenteral sedation

4. regional anesthesia

5. dissociative drugs, including propofol

6. epidural anesthesia

7. spinal anesthesia

8. general anesthesia with or without endotracheal intubation or

laryngeal mask airway anesthesia

Propofol and agents 6 through 8 may be administered only by an

anesthesiologist, a Certified Registered Nurse Anesthetist (CRNA) under

physician supervision if required by state or federal law or by policy adopted by

the facility; or an anesthesia assistant (as certified by the National Commission

for the Certification of Anesthesiologist Assistants under direct supervision of an

anesthesiologist).

Registered nurses may administer agents 3 and 5 (except for propofol) under the

supervision of a qualified physician. Propofol anesthesia may be administered

only by a CRNA or an anesthesiologist.

Lastly, all of the relevant facility accreditation manuals issued by The Joint Commission

(2009) for hospitals, critical access hospitals, ambulatory care, and office-based surgical

practices, require that “individuals administering moderate or deep sedation and

anesthesia are qualified and have credentials to manage and rescue patients at whatever

level of sedation or anesthesia is achieved, either intentionally or unintentionally.”

IV. Should FDA Approve the SEDASYS™ Device, How Will the Agency Assure

Clinicians Operating the Device Can Rescue Patients?

AANA Letter to FDA

May 15, 2009

Page 12 of 15

We have presumed that the SEDASYS™ device has been tested in highly controlled

environments, where procedures associated with the device’s use and the characteristics

of patients treated with the aid of such a device were subject to strict oversight and

documented procedures. Should the device be approved by FDA, it will enter the broader

market of healthcare delivery where procedures and oversight may not be nearly so strict

or controlled. Further, approval cannot be based solely on the instances in which the

device and the human systems supporting it have worked well. Rather, approval also

needs to examine and scrutinize device performance and patient safety during those times

when either the device or the procedural team surrounding the patient does not properly

perform.

One method of ensuring a margin of safety with a device that administers propofol is to

require, as does the approved propofol label, that it be operated only by a person expert in

general anesthesia, such as a CRNA or anesthesiologist, as we have recommended.

Alternatively, if the FDA authorizes pre-market approval of SEDASYS™ as the

manufacturer has requested so that it may be operated by clinicians who are not

anesthesia professionals, the agency and the manufacturer bear an exceedingly heavy

responsibility to ensure that persons operating this device possess the requisite skills and

training necessary to rescue patients in all possible scenarios (e.g. failure of the device,

error in programming the device, other health complication with the patient). It is

erroneous and dangerous to assume that using SEDASYS™ somehow renders nonanesthesia

providers qualified to administer a potentially dangerous anesthetic drug such

as propofol and ensure patient safety in the process.

Unfortunately, representatives of the developer of the device have advised health

professional governing bodies in at least one state that requiring persons operating the

device to undertake even one competency-based evaluation presented an “unnecessary

AANA Letter to FDA

May 15, 2009

Page 13 of 15

burden” on nurses and facilities. (McKenna M. Letter to Ms. Vicky Stone-Gale, Florida

Sedation Advisory Committee of the Florida Board of Nursing, on behalf of Ethicon

Endo-Surgery. Jan. 18, 2008) In its letter, the manufacturer recommended the state

adopt language that “nurses can administer anesthetic agents with a drug delivery device

approved by the U.S. Food and Drug Administration, with FDA-approved labeling that

allows such administration for moderate (conscious) sedation by nurses who are not

anesthesia providers, when used under the supervision of a physician.” Ethicon Endo-

Surgery specifically objected to language requiring that “a registered nurse must

successfully complete a criteria-based competency evaluation, which reflects the extent

of the privileges requested,” adding further that “(t)he administration of sedation by a

nurse is still given under the direction or supervision of a physician because the physician

must order the drug, the dosing, the frequency and the route of administration.” Such

statements appear to be based on two faulty presumptions: that propofol is like any other

drug (which, as we have established, it is not), and that the SEDASYS™ device

developed to administer propofol is a simple mechanism (which it is not).

V. The FDA Itself Has Indicated the Issues Surrounding Propofol Administration

are Complex, Raising Reasonable Concerns About a Device that Would Administer

Propofol Without an Anesthesia Professional Present

The agency has invested considerable time examining the merits of a 2005 citizen

petition recommending that FDA amend the “Warning” labeling of propofol, so that the

labeling would permit persons other than those expert in general anesthesia to administer

the drug. Following months of expert comments, including comments from AANA, the

agency stated to the petitioner, the American College of Gastroenterology (Axelrad, J.

Letter from FDA to Cooper and Stern of Williams & Connolly re: Docket No. 2005P-

0267/CP1, Dec. 21, 2005):

AANA Letter to FDA

May 15, 2009

Page 14 of 15

Your petition requests that the Agency remove from the labeling of propofol

(Diprivan) the warning that the drug product should be administered only by

persons trained in the administration of general anesthesia and not involved in

the surgical/diagnostic procedure.

FDA has been unable to reach a decision on your petition because it raises

complex issues requiring extensive review and analysis by Agency officials.

In closing, we ask the FDA to take seriously our patient safety concerns as the agency

evaluates pre-market approval of the SEDASYS™ device. This device is intended to

administer a drug, propofol, which is different from other drugs, in that there is

absolutely no agent available to reverse its effects. Failure of the device, or of the

personnel using the device, leaves the patient in need of immediate cardiopulmonary

rescue by a professional knowledgeable about anesthesia, and trained, credentialed and

immediately available to provide this care.

Thank you for the opportunity to submit written testimony to the Anesthesiology and

Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee of the

Food and Drug Administration regarding the SEDASYS™ device. We stand ready to

answer any further questions you may have. Please direct any questions or comments

about this testimony to our AANA Washington, DC office by contacting Frank Purcell,

Senior Director Federal Government Affairs, 202-741-9080, fpurcell@aanadc.com.

Sincerely,

Jackie S. Rowles, CRNA, MBA, MA, FAAPM

President

 

______________________________________________________________

 

New Jersy CRNAs Must Apply for APN Status

 

From: Jana Conover
Subject: New NJ APN requirement
To:
Date: Friday, July 25, 2008, 10:19 AM

This is an e-mail to state nurse anesthetist association presidents and government relations committee chairs, with a copy to the AANA's Board of Directors, State Government Affairs (SGA) Division, staff directors, various other AANA staff, and the AANA's Government Relations Committee (GRC).

 

The New Jersey Board of Nursing (BON) has adopted amendments to its rules, effective June 16, 2008, that add CRNAs as a type of advanced practice nurse (APN) in New Jersey .  The adopted rules require that both (1) CRNAs currently practicing in New Jersey , and (2) CRNAs without master’s degrees who may wish to practice in New Jersey now or in the future, must apply for and obtain APN status by June 16, 2009.  Additional information concerning these rules, including application requirements and information, is posted on the member side of the AANA website at http://www.aana.com/MemberHome.aspx under Government Affairs > State Issues > News.  The information currently posted on the AANA website will also appear in the September 2008 AANA NewsBulletin

 

Because these rules require both (1) CRNAs currently licensed in New Jersey, including those who may live in other states, and (2) CRNAs who do not have master’s degrees who may wish to practice in New Jersey in the future, to apply for APN status by June 16, 2009, we wanted to notify all 50 state nurse anesthetist association presidents and government relations committee chairs concerning this application deadline.

 

To inform as many CRNAs as possible about this change, we request that you consider publicizing this information by referring your state association members to the AANA website posting and the September issue of the AANA NewsBulletin.  This could be accomplished by publishing information in your state association newsletter, posting information on your state association website, e-mailing information to your state association membership, or by announcing the change at state meetings.  We greatly appreciate any assistance you are able to provide in publicizing this information.

 

If you have any questions, please do not hesitate to contact me.

Jana Conover, BA
Assistant Director of State Government Affairs
American Association of Nurse Anesthetists
222 S. Prospect Ave., Park Ridge, IL 60068-4001
Phone: 847-655-1132
Fax: 847-655-8830
Email:
jconover@aana.com
http://www.aana.com

 

Supporting Our Members—Protecting Our Patients

 

 

______________________________________________________________________________________

 

NEVADA ENDOSCOPY SCANDAL

 

The following is a response from the AANA regarding Anesthesiologists denegrating CRNAs in the wake of the Nevada endoscopy scandal.  Please use the information to address concerns that may come from patients, surgeons or the public.

 

 

AANA added new reply to NV issue


Reality Check: The Truth Behind the Distortions
*AANA NewsBulletin,* April 2008

People in Glass Houses Shouldn't Throw Stones

Since Alice Magaw first provided anesthesia care for the surgical patients
of Dr. Charles Mayo, nurse anesthetists have enjoyed an outstanding
relationship with and built a sterling reputation among physicians with whom
they work. Unfortunately, over the years some anesthesiologists and other
physicians, and the organizations that represent them, have distorted facts
in order to discredit CRNAs and even to create fear in the general public
about anesthesia care provided by CRNAs. The AANA has never hesitated to
rebut these attacks, using the truth as its primary weapon of defense.

*The purpose of the "Reality Check" column is to present misinformation
about CRNAs that has appeared in a public forum, to state the facts, and to
empower CRNAs to address these issues with their patients, healthcare
colleagues, and employers and payers, should the need arise.*

*AANA members may use this column as necessary: Post to state association
websites, reprint in state association newsletters, use as background or
support materials for a meeting, etc. *

*If you have questions, comments, or suggestions for future columns, please
contact Christopher Bettin, AANA Senior Director of Communications, at* *
cbettin@aana.com* <../mail?view=cm&tf=0&ui=1&to=cbettin@aana.com>*.*
*
*

*Distortion*
When it comes to infection control, all healthcare professionals work in
glass houses. Any CRNA, anesthesiologist, or other healthcare professional
who does not strictly adhere to accepted standards and guidelines for safe,
aseptic injection practices puts their patients at terrible risk.

Recently, at the Endoscopy Center of Southern Nevada run by Dr. Dipak Desai,
an outbreak of hepatitis C was attributed to the reuse of syringes which
contaminated single-use vials of medication that was then given to multiple
patients (Nevada State Health Division investigation report). Five nurse
anesthetists were implicated and turned over their nursing licenses pending
further investigation.

Almost immediately stones began to fly, thrown by members of the medical
community.

The American Society of Anesthesiologists (ASA) posted on its website (*
www.asahq.org* <http://www.asahq.org/>) a press release titled, "ASA
Encourages Patients to Ask for An Anesthesiologist," which goes out of its
way to tell the public that anesthesiologists were not involved in the
hepatitis C outbreak at the Endoscopy Center. In the release, ASA President
Jeffrey Apfelbaum, MD, says, "Before undergoing any procedure involving
sedation or general anesthesia, patients need to be aware of what type of
anesthesia they will be receiving and most important—who will administer
their anesthesia."

In an article in the *Las Vegas Sun* (March 9), Dr. Christopher Millson, a
Las Vegas-based anesthesiologist, was reported to have said that "an
independent anesthesiologist would have gone 'toe to toe' with Desai and
prohibited the dangerous injection practices."

And in an interview with Nevada columnist Jon Ralston, Dr. Ed Kingsley,
president of the Nevada State Medical Association, said, "I think there is
more likelihood that if this had been an MD anesthesiologist, that would not
have taken place." (*Las Vegas Sun*, March 10)

*Selective Memories
*In the wake of the stone throwers' comments, a new idiom was easily spun
off of the old: "People in glass houses who decide to throw stones should
not have selective memories."

In formulating their opinions for public consumption, the stone throwers
either didn't consider or disregarded the following:

- "In 1995, Rosenberg et al. surveyed 2,530 anesthesiologists, a
10-percent random sample of ASA members, to assess whether anesthesiologists
are adhering to infection control guidelines, including protecting their
patients from exposure to infectious diseases. Alarmingly, 39 percent of
anesthesiologists reported reusing syringes from one patient to another." (
*ASA Newsletter*, December 2002)
- In 2002, at the AANA's request, Cooper Research, Inc., of
Cincinnati, Ohio, conducted a telephone survey of anesthesiologists, other
physicians, CRNAs, other nurses, and oral surgeons to determine provider
attitudes and practices concerning reuse. Three percent of the
anesthesiologists who responded indicated they reuse needles and/or syringes
on multiple patients; the other provider types reported reuse at 1 percent
or less for each group.
- In October 2007, Dr. Kamal Tiwari, an anesthesiologist, was accused
of reusing syringes on an unspecified number of patients at a surgery center
in Bloomington, Ind. At least two tested positive for hepatitis C.
- In November 2007, reports surfaced out of Long Island, N.Y., that
anesthesiologist Harvey Finkelstein, MD, was under investigation by the New
York State Department of Health for allegedly reusing syringes to draw up
medicine from multi-dose vials and exposing thousands of patients to
blood-borne pathogen infection.

Although these nationally publicized incidents involving anesthesiologists
occurred less than six months prior to the Nevada incident involving CRNAs,
the ASA release, Dr. Millson, and Dr. Kingsley called into question the
safety of CRNAs and assured the public about anesthesiologist safety, as
though nothing had previously happened.

*The Perils of Stone Throwing
*Almost as soon as Dr. Kingsley's words had left his mouth, the glass house
of the stone throwers took a direct hit and shattered into a million pieces.

On March 11, in an article titled "Another violation, many clinics:
Anesthesiologist admits risky practice," the *Las Vegas Sun* reported that
Dr. Scott Young, an anesthesiologist working at a gastrointestinal clinic in
Las Vegas, had been observed by health inspectors reusing syringes and
potentially contaminated vials of medication on multiple patients.
According to the Statement of Deficiencies and Plan of Correction sent by
the State of Nevada Health Division to the clinic's administrator (*
http://health.nv.gov/docs/gdcslsod.pdf*<http://health.nv.gov/docs/gdcslsod.pdf>),
"The anesthesiologist was asked what the process was when he went from a
used Propofol vial to a new patient. The anesthesiologist stated that he
would change the needle and reuse the same syringe."

In the same March 11 *Las Vegas Sun* article, Dr. Millson offered a
half-hearted defense of Dr. Young's actions: "…while Young was not following
the recommended practices, his case appears much different from what
occurred at the Endoscopy Center of Southern Nevada, because Young was
injecting into a 'high-port' IV line, relatively far from the patient's
vein, minimizing the risk of blood backflow. In comparison, the Endoscopy
Center patients' injections were occurring in IV ports at the arm, he said.
Also, Millson said, while it's not recommended to reuse Propofol, the
likelihood of its hosting infection is extremely slim if the vial is
consumed swiftly."

Brian Labus, senior epidemiologist for the Southern Nevada Health District,
responded to Dr. Millson's remarks in the article by pointing out that the
risk to patients would have been about the same at both clinics. "They're
single use items, plain and simple," Labus told the newspaper.

To leave no doubt in the minds of CRNAs or any other provider reading this
column: injecting with a used syringe or from a contaminated medication vial
into a high port on an IV line is not safe practice. Blood backflow is blood
backflow, so don't consider doing it. Further, if the "likelihood" of
something is "extremely slim"—such as swiftly consumed Propofol hosting
infection—then it is still greater than zero and far too big a risk to take
with your patients.

*The Public Trust
*Although it is disappointing that members of the medical community put the
AANA in a position of having to play the "who did what when" game, the AANA
remains focused on correcting this deadly infection control problem for the
sake of all patients. Any time a nurse anesthetist, anesthesiologist, or
other healthcare professional reuses a syringe or needle, or improperly uses
medication vials, patients are put at risk. The *AANA Infection Control
Guide*<http://www.aana.com/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=732>
clearly
states: "*Properly dispose of all needles and syringes after use. Do not
reuse needles and syringes. Once used, all needles and syringes are
contaminated. They are single use items*." Guidelines published by the
American Society of Anesthesiologists (ASA) are just as clear.

It is incumbent upon all anesthesia professionals to do their utmost to
follow safe injection and infection control practices. If the goal of
anesthesiologists and CRNAs truly is to ensure the safety and well-being of
our patients, then the anesthesiologists would do well to leave the stones
on the ground and join us in focusing on the task at hand. The public is
best served by a focus on the "what" of infection control (the healthcare
practices that will improve care) rather than "who" provides the healthcare
(the type of professional delivering the care).