ANESTHESIA PATIENT SAFETY FOUNDATION
NEWSLETTER

Volume 2, No. 4, pp 29-40
December, 1987
Table of Contents

Safety Highlighted At ASA in Atlanta
Safety Tapes Free; Viewing Tied to New Insurance Discount
Better Labels Will Cut Drug Errors
APSF Awards 3 Grants for Safety Research
Current Questions in Patient Safety
Refined Safety Equipment Exhibited at ASA
Technical Topics
Letters to the Editor: Comments on the 'Bad News' on Monitoring
Letters to the Editor: Service/Maintenance Impacts Safety
N.J. Works for State Equipment Standards
ASPAN Produces Educational Video Tapes
APSF President Cited by FDA for Safety Work
Notes




Safety Highlighted At ASA in Atlanta

by Bradly J. Narr, M.D. and James H. Philip, M.D.

The October American Society of Anesthesiologists annual meeting in Atlanta included several scientific and poster sessions on patient safety and epidemiology. A brief summary of selected papers concerning patient safety is given here. More details are available in the abstracts, published as a supplement to Anesthesiology.

Dr. I.B. Cooper from Massachusetts General Hospital presented data on the effect of two interventions, pulse oximetry and intensive feedback of information from self-reporting, on the rate of operating room and recovery room anesthesia related problems. No reduction in recovery room impact events was associated with feedback of complications information. However, pulse oximetry did appear to lower the rate of unanticipated effects that were possibly anesthesia-related. The design of the study precluded the author's speculation on specific reasons for the results.

Dr. D.M. Gaba from Stanford presented his model for using structured mishap analysis as a way to greater patient safety. A detailed summary of this work appeared in the September APSF Newsletter (2:24-25). A. DeAnda, working with Dr. Gaba, also presented a system for anesthesia simulation in an operating room. It uses actual operating room monitors and equipment to realistically simulate clinical situations faced by anesthesiologists. The system is employed to investigate problem solving by anesthetists during simulated anesthesia administration.

Information from the ASA Committee on Professional Liability on closed insurance claims dealing with respiratory mishaps was presented by Dr. R.A. Caplan from the University of Washington School. Although the results were preliminary, the data presented suggested that respiratory-related mishaps are a major source of risk and financial loss in anesthesiology. Close analysis of the cases indicated that capnography and pulse oximetry might have prevented the majority of respiratory related complications. Dr. Caplan reiterated that the findings must be interpreted cautiously, and continued investigation is underway.

Dr. R. Hines from Yale presented a prospective analysis of 3,244 consecutive admissions to postanesthesia recover (PAR) room. A significant finding was the high incidence of PAR complications in patients who developed intraoperative hypertension. The study verifies the necessity for vigilant monitoring of recently anesthetized patients into the PAR period.

Dr. K. Hogan of the University of Wisconsin presented convincing evidence that inhalations in diabetics are significantly more difficult than in matched controls and suggested that this may be a manifestation of "Stiff joint Syndrome", comprising insulin-dependent diabetes, short stature, limited joint mobility, and rapidly progressive microvascular disease.

Dr. E.A. Ernst of the of the University of Alabama

showed that there was no significant difference in safety between open circuit and dosed circuit anesthesia when administered by an anesthesiologist skilled in both techniques.

Mr. L. Perlstein and Dr. P.G. Barash of Yale showed that patients' perception of anesthetic care can be assessed by postcard inquiry.

Dr. H. de Sousa of the University of Pittsburgh presented data and analysis attempting to show that peritoneal insulating gas is not absorbed to a hazardous degree during laparoscopy.

Dr. R.L. Bernstein of the Orthopedic Institute of New York demonstrated that perdonation of two units of autologous blood prior to major orthopedic surgery significantly reduces the patient's chance of receiving homologous transfusion.

Dr. R.R. Papenburg from Montreal General Hospital presented data and analysis which demonstrated that warmed crystalloid is not effective in warming already-cold patients.

Dr. A.C. Pinchak from Case Western Reserve attempted to demonstrate that 27 gauge needles are satisfactory for drawing blood for potassium measurement. Their experiments utilized dogs, however, which have equal intra and extracellular potassium levels and, thus, hemolysis would have no effect on measured serum potassium in that species.

Dr. A. Buschman from Brigham and Women's

Hospital and Harvard, reported that the prevalence of hypoxemia among inpatients recovering from anesthesia in the recovery room is 14% and that hypoxemia exists even in patients without predisposing conditions or procedures.

Dr. I.P. Koch from the University of Toronto

presented data suggesting that ASA physical status classification is adequate to predict mortality in blunt trauma victims. They admitted, however, that to show this relationship, healthy patients who appeared badly injured were all classified as 4E or 5E.

Overall, the well-attended presentations reflected

a growing interest in a wide spectrum of safety related topics.

Dr. Narr, Mayo Clinic, and Dr. Philip, Brigham and Women's, Boston, were moderators of the sessions on safety at the ASA meeting.

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Safety Tapes Free; Viewing Tied to New Insurance Discount

by Ellison C. Pierce, M.D.

At least one insurance company on the west coast, NORCAL, provided a 5% discount in the liability premiums to anesthesiologists who review the ASA Patient Safety Video Tapes annually. Hospital Quality Assurance Programs assist in the undertaking by vouching for the study requirements.

Under the distribution program announced several months ago, the first three video tapes in the series have had distribution completed by Burroughs-Wellcome to all interested U.S. Hospitals of I 00-bed size or larger who have surgical suites. Over 2700 hospitals requested tapes through this program.

To have received the tapes, it was necessary to have returned a request card forwarded to the Chief of Anesthesiology at each Hospital by Burroughs-Wellcome. If Anesthesia Departments that did not return cards would like another one, they may get it by contacting their Burroughs-Wellcome representative.

The second three tapes in the series will be distributed in midwinter and the third triad in late winter. The last tapes in production now, Patient Safety in the PACU and Patient Safety in neuromuscular blockade, will be delivered in the spring.

Dr. Pierce is President, APSF

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Better Labels Will Cut Drug Errors

by Leslie Rendell-Baker, M.D.

"Mother dies when given two ampoules of Adrenalin in mistake for Pitocin."

This 1984 report of an anesthesia fatality highlighted the problem of poor legibility of many labels (Fig. 1). Not only is the lettering small but it is printed on clear glass. Thus, legibility depends upon having good lighting and a contrasting background.

The solution to this legibility problem is contained in ASTM Standard D4267 which had been published in 1983. This requires that the drug's name and dosage be legible at arm's length in the dimmest lighting permitted in hospital corridors (20 ft. candles). As the new D4267 standard labels have been adopted (Fig. 2) them has been a marked improvement in legibility.

Anesthesiologists Boardman Wang and Herman Turndorf of New York University in the 1970's had publicized that up 12% of doses of drugs administered in hospitals could be in error. After failing to get action from the FDA, PMA, AMA, or ASA, in 1981 a group consisting of anesthesiologists, nurses, pharmacists, manufacturers, and FDA label experts formed Subcommittee DIO.34 of the American Society of Testing and Materials (whose subcommittee DIO.32 had previously produced the child resistant medication closure). The objective was to eliminate as many hazards as possible by enhancing the legibility of the labels and coordinating the use of colors.

Figure 1 The poorly legible Adrenalin and Pitocin labels (left), contrasted (right)'With the bold print on an opaque background required by ASTM Standard D42671983.

Figure 2 The new D4267 standard labels for emetine and ephedrine are clearly legible in contrast to the old labels.

Figure 3 Samples of the standard user-applied syringe labels. When seen in color, the yellow thiopental label is clearly different from the fluorescent red of the muscle relaxants. Succinylcholine is printed with a distinctive black surround to separate it from the other relaxants. The antagonists have stripes of the same color as their agonists red for neostigmine, blue for naloxone and violet for nitroglycerine

"Patient paralyzed by succinylcholline given by anesthesiologist before induction of anesthesia in mistake for Sublimaze."

In the absence of an understanding for the coherent use of colors and generic drug names, the syringe labels used in this hospital for these two drugs were of similar color and the printed names had similar outlines. The anesthesiologist concerned has since become a strong supporter of the proposed standard's use of different bold colors to separate the various drug groups from each other (Fig. 3). In this system, labels for thiopental and other induction agents are yellow, muscle relaxants are fluorescent red (succinylcholine is distinguished by a distinctive black surround), fentanyl and other narcotics are light blue, tranquilizers are orange, vasopressors are violet, local anesthetics are gray, atropine and other anticholingeric agents are green, and all other drugs are printed in black on a white background.

Prefilled syringe chaos

Another problem is that emergency drug-filled syringes, intended for use under difficult conditions when the prompt injection of the correct drug may save a life, all look alike and their labels are poorly legible. The proposed standard labels using bold print 5 to 7 mm high on an opaque background permit the drug's name and dosage to be read at 5 feet, even through the plastic barrel of the syringe (Fig4)

"Nurse flushes Heplock with potassium chloride in mistake for sodium chloride kills patient."

Manufacturers have enthusiastically adopted colored snap-off caps for their vials as an aid in identifying the various drugs they supply. However, the manufacturers' color codes differ. So the system only works if a hospital buys all its preparations from a single manufacturer. Any change of supplier may end in tragedy as in this case where the new potassium chloride vials had the same colored cap and a similar label to the former supplier's sodium chloride vials.

The solution proposed by the subcommittee is for drugs that must be diluted for safe use to be fitted with a distinctive black metal closure with a black or natural plastic cap, both to be inscribed "Dilute Before Use" or similar instructions. Even in a drug tray as disorganized as that shown in Fig. 5, these vials would readily be identifiable. Ampoules containing drugs to be diluted before use would be distinguished by a broad black band above the neck of the ampoule

By taking multiple bites out of this problem, it is hoped to reduce the chance a user will make a mistake. However, there still remains the manufacturers' tendency to adopt labels designed to identify clearly all their own products rather than using different designs for each group of products. This makes the user's task unnecessarily difficult and stressful. Just as it would be unreasonable to have all road signs octagonal in shape with red backgrounds expecting the user to pick out the STOP sign from a mishmash of other logos so the manufacturer should follow the safety engineer's lead and differentiate between groups of products. This would help the fatigued user at the end of 24 hour emergency call to use outline shape, color and bold text at least to differentiate safely between Adrenaline and Pitocin.

Leslie Rendell-Baker, M.D. is Professor of Anesthesiology, Lcma Linda (CA) University and a long time activist for safer anesthesia apparatus

Figure 4 -'Me poor legibility of the existing pre-filled syringe labels is in stark contrast to the proposed standard labels that can even be read through the plastic syringe barrel at 5 feet.

Figure 5 The drugs which must be diluted for safe use with their black snap-off caps and closures can readily be distinguished even in this mixed-up tray.
 

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APSF Awards 3 Grants for Safety Research

by Arthur S. Keats, M.D.

The Anesthesia Patient Safety Foundation announced at its annual meeting in October the awards of its Research Grants Program, now in its second year. The purpose of the program is to support clinical research directed toward enhancing patient safety during and after anesthesia. Twenty applications were received and the three applications ranked highest by the Committee on Scientific Evaluation were funded. The grantees are:

I . Howard A. Schwid, M.D. University of

Washington School of Medicine The Anesthesia Simulator-Recorder: A Device to Quantify Anesthesiologists' Response to Critical Incidents. $35,000.

2. Eugene K. Betts, M.D. The Children's Hospital of Philadelphia Evaluation of the Incidence of Oxygen Desaturation, Laryngospasm and Bronchospasm in Children with Upper Respiratory Tract Infections Undergoing Anesthesia. s I 9,000.

3 . Deborah S. Kitz, Ph.D. Hospitals of the University of Pennsylvania The Incidence and Magnitude of Intraoperative Physiologic Changes: A Foundation for Developing Artificial Intelligence Tools. $33,480.

Dr. Schwid has developed an anesthesia simulation system based on a graphic computer work station. He plans to modify this system by programming a variety of critical incidents into the simulator. The critical incidents simulator will then be evaluated as a training device, as a device for studying responses to critical incidents and possibly as a test of some performance characteristics of individual anesthesiologists. A scoring system for performance in this format will also be developed.

Dr. Betts will test the hypothesis that there is no significant increase in the incidence of perioperative oxygen desaturation, laryngospasm or bronchospasm in healthy children who have an upper respiratory infection at the time of their general anesthesia for day surgery operations compared to a group without infection. The study promises a definitive basis for either postponing operation in the interest of safety or going ahead in the interest of cost containment.

In Dr. Kitz's institution, many outpatients undergo operations with local anesthesia without attendance by an anesthesiologist but with an automatic physiologic data gathering system. Dr. Kitz plans to collect in a systematic fashion the hemodynamic and oxygen saturation data of these patients and to correlate them with other patient characteristics in order to identify groups of patients and operations at greater risk. The study promises to identify the risks of local anesthesia and sedation.

The Anesthesia Patient Safety Foundation awards grants annually for research in patient safety. Awards are based on competing applications. An announcement of 1988 application details and deadline appears in this issue.

Dr. Keats is Chief, Division of Cardiovascular Anesthesia, Texas Heart Institute and Chairman, APSF Committee on Scientific Evaluation.
 
 

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Current Questions in Patient Safety

Question: How should we monitor a child having general anesthesia for a MRI scan?

Answer: In monitoring patients during the performance of Magnetic Resonant Imaging (MRI, Nuclear Magnetic Resonance, NMR), the anesthetist must be aware of two physical forces that affect the performance of anesthesia equipment. One is constant, the other is not; both, however, require the anesthesiologist to adjust his expectations in the clinical situation.

The first is a constant, strong magnetic field from the large-magnet instruments. It is most powerful at the center of the machine and fade-s as the distance from the electromagnet increases. This prevents the use of ferromagnetic materials such as iron, cobalt, nickel and some forms of stainless steel. The other is radio frequency (RF signals) of 5-8 min duration directed towards the patient which produce a strong background noise in the monitoring equipment.

It is an irony that with this sophisticated, advanced technological procedure, simple devices are more suitable than complicated electronic equipment. Through trial and error, we have found that simple instruments made of nonferromagnetic material (Mapleson T-piece, precordial stethoscope, blood pressure dial), when used with common sense, will provide the basic clinical information before and during the anesthetic in this out-of-the-ordinary environment.

Anesthesiologist: As in any clinical procedure, the most important monitor is the anesthesiologist himself. One of the advantages of MRI is that magnetic fields cause no injury to living organisms. The anesthesiologist can therefore remain near the patient's side without any fear that harm will come to him/her. However, individuals having pacemakers or ferromagnetic vascular clips should avoid these strong magnetic fields.

Anesthetic machine: There is a strong pull by the magnet on the typical anesthetic machine (especially on the gas cylinders) because of the presence of a large amount of ferromagnetic material. Some countermeasures may be employed to circumvent this problem. First, the machine should be outfitted with aluminum tanks. By experience, we have discovered that the magnetic pull does not affect the functioning of the anesthetic machine or the oxygen monitor if the machine is kept in the comer of the room. To this end we modified a simple Mapleson D-system by interposing a very long inspiratory limb (6 meters) to administer the necessary anesthetic gases and the supplementary oxygen. The expiratory valve is made of aluminum with a scavenging port.

Precordial -Stethoscope: A brass precordial stethoscope (available commercially) with plastic tubing may safely he used. Though the sounds of radio frequency partially interfere with the quality of the heart sounds, a discerning ear can reliably distinguish one from the other.

Blood Pressure: Oscillatory blood pressures can be easily obtained by adding long wide bore tubing to the cuff, and using brass or plastic adapters for the junctions. As long as the dial is kept away from the magnet no interference is detected. Electrocardiogram: Our unit is provided with a wireless electrocardiogram that provides adequate display in the absence of an RF signal. The RF signal does produce a background noise, but the QRS interval can be detected with some concentration.

C02 analyzer. C02 monitors that use a suctionin8 mechanism to sample gases need only minor modification. The motor should be switched to high power and a longer tubing introduced. In the sedated patient breathing spontaneously, the end of the tubing can be taped near the nostril. The endotracheal tube adapters are usually made of aluminum and present no problem.

Pulse oximeter: the pulse oximeter can be used during the initial stages of adjustment and then when the scout images are taken. During the actual scanning when the RF signal is on (5-8 min periods) the signal from the pulse oximeter will interfere with imaging. It must therefore be turned off during these times. During the critical periods of adjusting and positioning, the pulse oximeter is always on.

Temperature: Any of the commercially available liquid crystal thermometers can be used to read the skin temperature

Practical implications: Initially, we had difficulty in determining whether a material was ferromagnetic or not. A simple test was to hold the piece of equipment tightly in the hand and move it slowly near the magnet; if a pull was felt, we did not use that particular instrument. It was interesting to notice that similar looking equipment had different magnetic pulls. We also found that it was much easier and more comforting to anesthetize or sedate the patient at a distance from the magnet; at this critical time, one should not have to worry about every piece of equipment. Then, once the patient had been "stabilized" and the monitors checked, he can be moved near and into the magnetic field. As an extra safety measure, all loose equipment is taped to the frame that the patient is lying on.

Anesthetic Technique: Any anesthetic technique can be used during MM. In our practice, we found IM methohexital (30 mg/kg) to he satisfactory in children without any major neurological abnormalities. In children on anticonvulsant medications, IM methohexital (8-10 mg/W will provide a more predictable result. In patients with airway or major neurological problems, or in cases of failure with methohexital, general endotracheal anesthesia can be administered. Since such patients require only a light level of anesthesia, most can be discharged for home on the day of their procedure

Answer by N. Goudsouzian, M.D., Director, Pediatric Anesthesia, Mass. General Hospital, Boston.

Addendum:

The MRI scanner has presented us with unique challenges in patient monitoring. The most obvious difficulty is in closely observing the patient, because of his location in the long tunnel of the scanner that is not always well lit. The distance also makes it difficult to hear breath and heart sound through the necessarily long tubing of the precordial stethoscope. Auscultation is further complicated by the loud noise coming from the scanner.

Our use of electronic monitoring is also severely compromised, because the electromagnetic radiation emanation from the scanner tends to jam the monitoring equipment and the monitors tend to emit signals that interfere with the proper functioning of the scanner. Any electric monitoring cables that travel to the patient from the monitors act as antennae carrying stray signals to the scanner and thereby markedly reducing the quality of the image.

Use of television cameras will probably become commonplace in the scanner rooms. Because magnetic fields distort electron beams, traditional television cameras with vacuum tube image detection are not satisfactory. Solid state cameras will be useful because there is no electron beam that is deviated by the magnetic field. In addition, they can operate in low levels of light. By placing the camera in the right location, it could be possible to obtain a clear view of the patient's face with the aid of a zoom lens. The television monitor has to relocated at a significant distance from the scanner. The future availability of large flat solid-state color monitors will make it possible to place the monitor in most convenient locations.

High quality heart and lung sounds can be obtained with electronic assistance. The precordial stethoscope can be connected to a length of wide bore tubing and the other end connected to a condenser microphone. The scanner may, however, make so much noise it would be difficult to hear the heart and lung sounds. The machine noise can easily be reduced by using two concentric layers of tubing and by electronically filtering out high frequency sounds. The patient sounds are then monitored over a speaker or can be transmitted to the anesthesiologist over an infra-red light beam.

Pulse oximetry also tends to interfere with the performance of the MRI scanner and is affected by the scanner. Our attempts to correct this by use of a fiber-optic pulse oximeter have been unsuccessful in that the fiber-optic cable acts as an antenna carrying stray signals in both directions. We hope that by shielding the cable of the oximeter, the monitor will be able to perform without distorting the image of the MRI scanner.

Addendum by Francis X. Vacanti, M.D., Mass. General Hospital, Boston

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Refined Safety Equipment Exhibited at ASA

By John H Eichhorn, M.D.

Products and equipment exhibited at the ASA annual meeting in October, 1987, in Atlanta continued to stress patient monitoring and the positive implications for anesthesia patient safety of earlier warning of untoward development during an anesthetic.

New developments in the major technologies of oximetry, capnography, and gas analysis centered more on refinements than new concepts. New brands, combinations of monitors, and also improved software, displays, and operating features were widespread. [for a more detailed discussion of these and others types of equipment, see Witcher CE, Safety technology shown at ASA. APSF Newsletter, 1986 (Dec.); 1:24.1

Pulse oximeters were offered for the first time by many manufacturers. An informal count showed at least 25 different brands represented in the very large exhibit hall. Several manufacturers have bundled together with capnographs and/or gas analyzers. Some of the instruments give a percent N20 by subtraction of the 02 and C02 from 100, but others will contain actual multigas analyzers, usually based on infrared absorption.

Among pulse oximeters, a wide spectrum of features are available. Small portable battery powered relatively simple models were shown while some of the larger models sported various alarms, displayed messages, and trending capabilities. Printers are available. While some models have automatic gain control to process the signal obtained from the sensor for maximum sensitivity, others do not and use the variation in the signal as an indicator of the adequacy of peripheral blood flow.

One new development was the introduction of a reflectance pulse oximeter. As opposed to a traditional transmittance model, which shines light through tissue, the reflectance oximeter bounces light off any flat area of skin that is well perfused (no underlying bone). This is claimed to allow sensing of sites less prone to confounding variables such as peripheral vasoconstriction.

Capnographs continue to be the mainstay of ventilatory monitoring. Again, packaging permutations abound but the underlying technology is familiar. Improved sampling via nasal prong-like devices is being claimed as an advance for monitoring patients who are not intubated. Some capno8raphs also can measure FiO2 by taking a quick reading during the inspiratory phase. Also, one model combines a capnograph with an airway pressure monitor so that there are two waveforms, ETC02 and pressure, simultaneously on a VDT screen.

Gas analysis with stand-alone mass spectrometers, infrared, or Raman analysis continue to be refined with regard to features, controls, and alarms although not all the displayed models are ready for customer purchase..

Radiostethoscopes to allow amplified heart and breath sounds at various distances from the patient continue to be available. A new entry in this area is a stethoscopic monitor based on infrared (IR) transmission (similar to a TV remote control). A stethoscope on the patient connects to a control box that sends omnidirectional IR signals to a receiver worn on the shirt of the anesthetist. This connects to a conventional ear piece. The IR signal is not subject to static interference from electrocautery as radio signals may be. This particular stethoscope can be adjusted to emphasize either heart or breath sounds. Further, there is a synthetic voice prompt that can give spoken messages in the ear piece regarding a change in temperature detected by the probe on the esophageal stethoscope. Voice prompts can also be triggered by activation of alarms on a pulse oximeter or noninvasive blood pressure cuff interfaced with the stethoscope control box. Reaction to this technology will be of interest as computer-generated voice prompts associated with monitor alarms are controversial.

Stand-alone ventilator pressure monitors with high and low pressure alarms and an alarm for PEEP level were shown.

Specific patient ventilation monitors for use with patients receiving intraspinal narcotics are claimed to allow earlier return to regular patient rooms.

A new noninvasive blood pressure monitor gives a continuous waveform display (with trending) by use of oscillotonometry of the arm. It maintains a low pressure (e-g., 20 mm HS) and senses changes in arterial wall elasticity.

Continuous real-time blood gas monitoring is offered, either as an adjunct to extra-corporeal cardiopulmonary by-pass or via intra-arterial technology. These devices are still being evaluated for potential utility as both safety and physiologic monitors.

Finally, several disposable components intended to protect immunocomprornised patients from potential exposures and to help contain secretions from infected patients were shown. One was a completely disposable single-use C02 absorber canister.

In all, the marked emphasis on patient safety through advances in technology continues. Further refinements as well as new concepts are expected in the coming year.

Dr. Eichhorn, Harvard Medical School and Beth Israel Hospital, Boston, is Editor of the APSF Newsletter.
 
 

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Technical Topics

Advantages, Dangers of Completely Disposable Breathing Systems

The ever expanding AIDS epidemic has heightened the awareness of anesthesia personnel to the risk of contagious hazards in the workplace. When five years ago, it would have been rare to see a practitioner routinely using gloves when placing an intravenous or intraarterial line, it is now commonplace, not only in major urban hospitals, but also in suburban settings.

With this concern for contamination and infection in the operating room, hospitals are turning more and more to disposable equipment, such as breathing circuits, masks, laryngoscopes and airways. There has also been increased interest in completely disposable anesthesia circuits including the Y piece, breathing tubes, APL valve, unidirectional valves and carbon dioxide absorber. These units connect directly to the common gas outlet of the traditional anesthesia machine. While there is the obvious advantage of offering a totally disposable circuit with the familiar semiclosed circle architecture, there are also drawbacks.

In the late 1970's, manufacturers' representatives, anesthesia care providers and regulatory officials produced the first of several voluntary consensus standards affecting anesthesia equipment. The best known is probably the American National Standards Institute (ANSI) Z79 dealing with anesthesia gas machines. These standards and the anticipated 1988 F29.01.01 anesthesia machine standard from the American Society for Testing and Materials (ASTM), however, do not address the issue of anesthesia breathing systems distal to the common gas outlet.

As a result, and until such a standard is issued (work is presently underway on one ASTM draft F29.01.02), there are as many variations in the low pressure systems as there are manufacturers and assemblers of the components. When replacing the traditional portion of your low pressure system down stream from the common gas outlet with a totally disposable circle system, performance of the whole system may be radically altered.

Potential limitations with disposable circle systems may include incompetency of the one way or flutter valves or, conversely, the valves may present increased resistance during assisted or spontaneous ventilation. In addition, the APL valves may be coarse in their adjustability, making it difficult to avoid overinflation or a deflated reservoir bag. Absorber volume may be reduced which limits the efficiency of carbon dioxide removal and channelling of unprocessed gas through the absorbent is possible.

Another way, however, to provide a totally disposable anesthesia circuit for adults and children that does not require an absorber or the decontamination of nondisposable metal components at the end of a case is through the use of the Bain coaxial modification of the Mapleson D circuit. While the Bain is available with a machined metal head that provides a fixed position for the reservoir bag and an access port for a ventilator, it can be used by connecting the reservoir bag directly to the end of the Bain coaxial tube, obviating the need for the machined metal head. One additional step is required, however; the tail on the reservoir bag must be cut open and connected to the scavenger system. A simple C clamp may be applied to the tail to adjust airway pressure and prevent the bag from deflating, but at the same time allowing excess gas to escape. It is also possible to connect the Bain circuit to a ventilator without using the machined metal head.

Most anesthesia departments have familiarity with the Bain circuit. By modifying the Bain system as described, a totally disposable breathing system is produced that can save time and money by reducing both decontamination efforts in anesthetizing locations and the inventory of disposable supplies that must be kept on hand.

Topic prepared by David E. Lees, M.D. Professor and Chairman of Anesthesia, New York Medical College, member of the APSF Newsletter Editorial Board.

Commentary:

Dr. Lees addresses an important practical problem how to deal with the increasing pressures to decontaminate anesthesia apparatus. Disposables are a convenient and possibly cost-effective alternative His suggested modification to the Bain breathing system perhaps should be called a Bain modification to the Jackson-Rees system, since that is the configuration that arises. Certainly, this is not a fundamental change in design, but it still creates new ways for errors and failures for the unwary. Practical, effective safe waste-gas scavenging for such systems is not readily available Furthermore, the Bain system, as any breathing system, has its own unique and peculiar failure modes and presents numerous opportunities for misuse, especially by a new user. Suggestion: Don't modify equipment or use it for a new application without giving careful thought and doing some in-vitro testing in search of its clinical effectiveness, characteristics, and hazards. There are just too many anecdotes about anesthetists who have gotten into trouble by improvising or using homemade modifications of equipment.

Jeffery B. Cooper, Ph. D. Massachusetts General Hospital

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Letters to the Editor: Comments on the 'Bad News' on Monitoring

Editor's note: After the September editorial that included reference to anesthetists being out of the room or not monitoring, the following piece from the March, 1957 ASA Newsletter was recalled and is reprinted hem with permission of the author.

Popping Off! (To Air Is Human)

"In recent months I've been exposed to a rather tremendous dose of what might be called 'casual anesthesia.' You know the kind, I'm sure. Its theme song is titled 'Once in a While' (once in a while squeeze the bag, once in a while take a pulse, once in a while stay near the head, etc.), and subtitled 'But Not Too Often!' At the risk of rendering myself vulnerable to a fulminating case of 'Foot-in-Mouth' disease, I'd like to cite an Aesop's Fable. .

The Lion, the Mouse and the Fox

A Eon, fatigued by the heat of a summer's day, fell fast asleep in his den. A Mouse ran over his mane and ears, and woke him from his slumbers. He rose up and shook himself in great wrath, and searched every comer of his den to find the Mouse. A Fox, seeing him, said "A fine Lion you are, to he frightened of a Mouse:' "'Tis not the Mouse I fear," said the Lion; "I resent his familiarity and ill-breeding."

Little liberates are great offenses. Samuel I. Joseph, M.D. Baltimore, MD

To the Editor: Concerning the APSF Newsletter September, 1987 in the Editorial asking for suggestions, I state:

If no monitoring equipment is available, do not provide any kind of anesthesia unfit this is bought.

If there is monitoring equipment, but it's not used by the anesthesiologist

(a) Deny membership in the ASA for such a person;

(b) Contact him/her directly in an educational effort; and

(c) Notify the hospital administrator and the insurance companies for the hospital and for the anesthesiologist.

For the anesthesiologist who leaves the O.R. while a patient is under anesthesia, leaving no anesthesia person, I suggest:

(a) Contact that person to stress a need to prevent that situation. If no remedy:

(b) As in (a) and (c) above

Criminals should not be allowed to work as

anesthesiologists. I was petrified by your statements! Hit hard please. Thank You.

Leonardo M. Allende, M.D. Miami, FL

Editor's note: Dr. Allende may be proposing hardhitting actions because he comes from an area that is among the most expensive for malpractice insurance. One million dollars coverage costs nearly $ 1 00,000 per year.

To the Editor:

I read with interest the editorial in the September APSF Newsletter by Dr. Pierce regarding the good and bad news about liability rates and standards of practice. I am President-elect of the New Hampshire Medical Society and sit in on the meeting of our own JUA here in New Hampshire I have become convinced that anesthesia can be made a safer experience for our patients and liability rates should reflect this.

Unfortunately, those of us who still take administering anesthesia so casually that they do not employ even the most basic monitors such as an EKG machine will forever drag us down unless we penalize them so severely that they no longer can afford to practice this way.

As sad as it makes me to realize it, there are those among us that seem to understand only finances and if that is the case, we must demonstrate to them that state-wide organizations such as JUA:s can and will enforce a higher standard of care than these practitioners apparently are willing to currently provide

I presume that this would take the form of surcharges and deductibles on liability insurance. While these are being tried in some areas, perhaps our own national and state organizations should Set on the bandwagon and push the individual states to do this. If individual practitioners understand that if they do not employ reasonable amounts of monitoring, then not only can they be held liable for negligence in the event of an untoward outcome, but the first five or ten thousand dollars of any award would come directly out of their pocket.

Similarly, if they have a pattern of such behavior that results in patient injury and awards, then they will be charged a higher liability premium than those of us who employ appropriate monitors. Obviously, settlements and awards for situations that are not the direct result of misuse or nonuse of monitoring devices would be excluded.

Working with legislators and listening to the reports at our JUA meetings makes me realize how very tired I am of taking the rap for those among us who don't seem to care enough about what they are doing. I am also convinced that if we do not continue to clean up our act while we still have a chance, the state and federal governments will force it upon us. When they do that, no one would be so foolish as to believe that they will do it better than we could do it ourselves. The central question, of course, is, will we?

James D. Butterick, M.D. Manchester, NH

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Letters to the Editor: Service/Maintenance Impacts Safety

To the Editor:

Dr. Meyers (APSF Newsletter, December, 1986) and Dr. Frazier (APSF Newsletter, June, 1987) express concerns regarding training and standards for in-house technician maintenance of anesthesia machines as well as the qualifications of "third party" service representatives.

In our hospital with six operating rooms, the BMETs (biomedical engineering technicians) have attended "factory" authorized training programs and service all of the electronic monitoring equipment on a regular basis.

We feel that the hazard to the patient of a faulty anesthesia delivery system is so great and the medico-legal implications so significant that we negotiate a preventive maintenance and service contract with the manufacturer for the anesthesia "gas" machines. We feel that a manufacturer's service representative who services six to ten machines per day has a much greater likelihood of knowing what the inherent problem in a particular machine might be and how to solve it. In addition, the factory representative is trained in servicing new equipment before it comes to market and can be a valuable source of information when decisions to buy new equipment are made.

Incidentally, it is comforting that the manufacturer shares the liability, should there be a problem related to service.

Ralph Braunscweig, M.D.

Chief, Anesthesiology Service Truman Veterans Hospital Columbia, MO

Further Concerns:

Service Personnel Training Critical to Safe Equipment

To the Editor:

The article written by Wesley I Frazier, M.1)., in the June Newsletter is timely. AN available service options in all areas of technology used in hospitals (not just anesthesiolo8y) are being scrutinized for efficacy and cost effectiveness.

Point 3 in the support service program should be the main area of development for these reasons: 1) even though items such as pulse oximeters, capnometers, mass spectrometers, etc. are now widely used in the OR, the testing equipment required to maintain and calibrate these and other devices used by anesthesia personnel are too difficult to operate and the results too technical for most lay persons to utilize and interpret, 2) the testing equipment required, if maintained in a separate "anesthesia repair shop" would create a costly duplication of service and equipment, 3) biomedical technicians and engineers are more qualified to deal with factory service representatives and to determine their technical abilities, and 4) the necessary equipment failure profile/history data generated by both in-house and outside (third party or factory) service can be better handled and analyzed by technical people trained to deal with these data.

Training becomes paramount in this situation. Anesthesiologists must take an active role in developing rapport with the biomedical departments and advocating their involvement, including factory training programs, to the hospital administrators. In addition, anesthesia groups should develop training programs and seminars to better tram biomedical personnel specifically in anesthesia practices. This could be (and should be) done in biomedical engineering schools, but could delay implementation of programs by up to four years, eliminate many already competent technicians from working on such devices, and would probably not "fly" at small institutions that cannot support "specialized" technician positions.

There can be no substitute for cooperation between the anesthesia department, biomedical engineering, and the hospital Administration when projects such as equipment support programs are considered. Pre-selection evaluations MUST include input from all areas of expertise. It is during this period that hospital based biomedical personnel can establish base line control over cost and quality of support service. A comprehensive policy is needed that satisfies the operational and safety concerns of anesthesia practitioners, the accuracy, quality of repairs, safety, calibration, and code conformance considerations of the biomedical engineering department, and the cost issues for the hospital administration.

National guidelines, if developed, must be flexible enough to allow for implementation in even the smallest hospitals and should reflect actual requirements. Certification programs should be based on both written skills and demonstrated abilities. Tests designed for academic purposes only do not ensure technical competence.

As with all hospital-based equipment, the user bears the ultimate responsibility for safe use. Anesthesiologists must learn from biomedical engineering personnel the basic principles of function and biomedical personnel must learn application from the anesthesia department.

Additionally, I disagree with the letter to the editor by Michael Shaffer, D.Sc., that most hospital based biomedical departments are limited in time and abilities to perform only the most perfunctory tests. We do not use the standards of the ICAH as our only guidelines. Perhaps Dr. Shaffer should investigate several other sources of "guidelines" such as the AAMI, ASME, etc. Meeting ICAH standards is only a small part of most biomedical engineering policy and procedures. Even if this were true, to meet the criteria of ". . . clean, calibrated, and safe operation. . " encompasses more than just perfunctory testing.

Please consider these thoughts and try to apply them in a practical manner. Thank you.

Michael E. Seaver, Manager Biomedical Engineering St. Mary Hospital Quincy, IL
 

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N.J. Works for State Equipment Standards

by Harvey Hatchfield, M.D.

Issues in patient safety must he addressed from many different aspects. Among these are the questions of physician training and qualifications, equipment quality and quantity, hospital awareness of the safety issue, appropriate staffing, quality assurance, and ongoing review of standards as well as performance.

In the state of New Jersey, this matter has been addressed by the N.J. State Society of Anesthesiologists through its Executive Committee with ultimate ratification by the membership at large

Early in the course of these efforts, attempts were made to raise the level of awareness of the state's anesthesiologists by frequent reminders of the urgency of the patient safety issue. There were many articles in the state society newsletter addressing safety, liability concerns, and the frequency of patient injury.

The N.J. State Medical Society sponsored professional liability insurance company addressed the issue of anesthetic incidents by surveying the patterns of cases reported. This led to a study of anesthetic injuries presented as a scientific exhibit at the NISSA Annual Meeting which was then modified, expanded and presented again at the ASA Annual Meeting. The insurance carrier also published a specialty-specific newsletter for all anesthesiologists addressing the most commonly reported anesthetic injuries and noting changes in patterns over the course of several years.

The NISSA also took the forefront in advising the State Board of Medical Examiners on matters of staffing of anesthesia personnel and of the sphere of activity considered appropriate for nurse anesthetists. The Society also came out with recommendations for supervision of CRNNs and ratios that were felt proper.

The question of anesthesia equipment was addressed by the society and monitoring issues were brought to the attention of the office of the State Health Commissioner. These discussions and negotiations were largely the work of Dr. Ervin Moss, who convinced the state agency responsible for inspecting hospitals of the importance of up-to-date anesthesia equipment with appropriate safety features. After many long and difficult sessions, state authorities now seem to be aware that hospital inspectors need to be trained to evaluate the level of adequacy and safety of anesthesia equipment rather than the mundane details formerly addressed. One hospital was previously cited for dust on an anesthesia machine shelf when no mention was made of safety interlocks or disconnected alarms! Fortunately, this situation seems to be changing.

State standards are also being instituted for anesthesia personnel and staffing. These include the requirement that, by 1989, department directors be board certified and that anesthesiologists supervising non-physician personnel be in a ratio of no more than 2:1 and not performing services for another patient of his/her own while supervising.

A draft of the recommendations for anesthesia equipment addresses safety features for the equipment which include the following:

1. Diameter index safety systems (DISS) are to be used on all anesthesia machines to prevent interchangeability of oxygen and other gases (especially nitrous oxide.)

2. AD hose-s and adapters are to be color coded. 3. Cylinders for emergency use are to be

attached to all anesthesia machines and are to be pin-indexed. Single washers shall be used.

4. An oxygen failure protection devise ("fail-safe" system) is to be used to announce failure and will, at lowered levels of oxygen pressure, discontinue the flow of nitrous oxide.

5. An oxygen concentration monitor will be activated within the breathing circuit displaying the inspired oxygen level.

6. A vaporizer exclusion system is to be used to assure that only one volatile anesthetic can be used at one time.

These proposed standards have been approved by the Executive Committee of the NISSA and we expect them to be approved by the State Department of Health with implementation in the near future. Such standards, it is believed, will go a long way in helping retire obsolete and unsafe anesthesia machines which represent such a hazard to patients. These hazards are well appreciated by all anesthesiologists but, in too many cases, the funds for upgrading or replacing such machines are not made available. With the application of these reasonable, minimal equipment standards, we believe we can help save lives and prevent patient injuries.

Dr. Hatchfield, formerly of the NJSSA Executive Committee, now practices in Rhineback, N.Y.

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ASPAN Produces Educational Video Tapes

The American Society of Post Anesthesia Nurses has produced a series of educational video tapes specific for the professional who provides care to the post anesthesia patient.

The tapes, available for sale in VHS or Beta

format, present a thorough overview of the specialty of post anesthesia nursing. Comprehensive in their scope, they may be used for orientation, continuing education, inservice education and review for post anesthesia nursing certification.

The entire set, which is divided in four series, represents 28 separate presentations. The four series include the following:

(1) PACU Nursing-An Overview and Anesthetic Agents (including nursing process in the PACU, psychosocial-physiological implications, legal and ethical issues and anesthetic agents).

(2) PACU Respiratory Care (includes anatomy and physiology of respiratory system, airway management and pathology).

(3) PACU Assessment & Intervention (includes fluid and electrolytes, renal and urological, ABG interpretation, hematology, endocrine system and pain management).

(4) Review Of Systems (includes gastrointestinal,

ear, nose and throat, neurological and cardiovascular care).

The tapes may be purchased individually, in a series, or by the entire set (28 tapes).

For further information contact, A.S.P.A.N., P.O. Box 11083, Richmond, VA 23230, (804) 359-3557.
 

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APSF President Cited by FDA for Safety Work

by Peter B. Carstensen

Ellison C. Pierce, Jr., M.D., President of the Anesthesia Patient Safety Foundation, received a special citation for his work in anesthesia patient safety from the Food and Drug Administration (FDA) on July 10, 1987.

Dr. Pierce was presented with the Commissioner's Special Citation in recognition of the outstanding leadership he has provided over the past several years to advance anesthesia patient safety in the United States. The Agency commended Dr. Pierce for his exceptional vision and courage in assuming and fulfilling this important leadership role.

The FDA cited Dr. Pierce for his initiatives in organizing the Anesthesia Patient Safety Foundation in 1985, whose Board of Directors includes anesthesiologists and representatives from biomedical engineering, device and drug manufacturers, the FDA, hospitals, the insurance industry and nurse anesthesia. The FDA observed that in the short time since the establishment of the Safety Foundation it has become a recognized leader in patient safety through its important and comprehensive national program to improve patient safety in anesthesia.

In nominating Dr. Pierce (who is also chairman of the ASA committee on Patient Safety and Risk Management) for the award, the FDA cited him for his role in initiating production of the ASA educational video tape series, "ASA Patient Safety Program '" This educational series for anesthesia providers' covers a wide range of important anesthesia patient safety issues. The FDA, which contributed significantly to the production of the tapes, expressed confidence that they would have a continuing and significant impact on anesthesia patient safety.

Dr. Pierre's critical role in developing the "Anesthesia Pre-use Checkout Recommendation" with the FDA was also recognized. The checkout recommendation serves as a guide for users of anesthesia equipment in performing a daily check of their equipment before use on the patient. (APSF Newsletter, September, 1986).

Mr. Carstensen is Engineering Consultant, Center for Devices and Radiologic Health, U.S. Food and Drug Administration. Reprinted with permission from the ASA Newsletter.

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Notes

Equipment used in this 1894 nitrous oxide anesthetic administered by Dr. J.H. Branson at the National Homeopathic Hospital in Washington was most likely serviced (if at all) by the user, While there was no "modem" equipment or technique, at least the O.R. furniture was more stylish than today's.

Video on Safety and Costs Available Free

A new video production which addresses the issue of improving patient safety within an environment of cost containment is now available from the Anesthesia Patient Safety Foundation.

This 30-minute videotape entitled "Safety and Cost in Anesthesia," presents the scope, costs and implications of adverse outcomes, and proposes potential solutions for risk reduction through the coordinated actions of all parties involved in the quest for improved anesthesia safety.

The program is based primarily on presentations delivered at a February 1987 workshop on Anesthesia Safety and Cost Containment held in Gainesville, Florida, which was co-sponsored by the Anesthesia Patient Safety Foundation and the University of Florida College of Medicine.

Speakers and attendees represented at the workshop included anesthesiologists, hospital administrators, quality assurance managers, insurance officials, manufacturing executives, lawyers and a training director from the airline industry.

VHS-format copies of the video program are available at no charge from the Anesthesia Patient Safety Foundation. Please write to the Anesthesia Patient Safety Foundation, 51 5 Busse Highway, Park Ridge, IL 60068. The APSF acknowledges Dr. I.S. Gravenstein of the University of Florida College of Medicine for his participation in the development of this program, and Ohmeda for video Production and funding.

The Anesthesia Patient Safety Foundation Newsletter is the official publication of the nonprofit Anesthesia Patient Safety Foundation and is published quarterly in March, June, September, and December at Overland Park, Kansas. Annual membership: Individual $25.00, Corporate $500.00. This and any additional contributions to the Foundation are tax deductible. @Copyright, Anesthesia Patent Safety Foundation, 1988.

The opinions expressed in this newsletter are not necessarily those of the Anesthesia Patient Safety Foundation or its members or board of directors.

APSF Executive Committee:

Ellison C. Pierce, Jr., M.D., President; W. Dekle Rountree, Jr., Vice-President; E.S. Siker, M.D., Secretary; Burton A. Dole, Jr., Treasurer; Jeffrey B. Cooper, Ph.D.; Joachim S. Gavenstein, M.D.; James E Holzer, J.D.

Newsletter Editorial Board:

John H. Eichhorn, M.D., Stanley 1. Aukburg, M.D., Jeffrey M. Beutler, C.R.N.A., M.S., Ralph A. Epstein, M.D., David E. Lees, M.D., Bernard V. Wetchler, M.D., Mr. Mark D. Wood

Address all general, membership, and subscription correspondence to: Administrator

Anesthesia Patient Safety Foundation 515 Busse Highway

Park Ridge, IL 60068

Address Newsletter editorial comments, questions, letters, and suggestions to: John H. Eichhorn, M.D.

Editor, APSF Newsletter; Dept. Anesthesia Beth Israel Hospital, DA-717 Boston, MA 02 2 1 5