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A Matter of Conscience: A Call to Action for SystemImprovements Involving Epidural and Spinal Catheters David J. Birnbach, MD, MPH,* and Charles A. Vincent, PhD† “To err is human, to repent divine, to persist devilish.” Anaesthesia.4 In addition to the essential practice stan-dards, the safe anesthesia section in the World Health Organization Guidelines for Safe Surgery 2008 also in- cludes presentations on the importance of the safe admin- nesthesiologists are continually engaged in self- assessment, and our specialty has been defined by Surprisingly, these documents contain no mention of the its commitment to minimizing errors and ensuring potential catastrophic complications resulting from acci- the safety of all patients.1 Anesthesiologists were pioneers dentally injecting IV medications into the intrathecal or in safety and continue to be seen as leaders in improving epidural space, or of injecting epidural medication into the quality of care and outcomes.2 This is well illustrated by the IV. Although the incidence of these complications is rela- Anesthesia Patient Safety Foundation, which has led efforts tively rare, millions of epidurals are placed each year and in anesthesia-related safety.a Notwithstanding this history, the risk to patients (as evidenced by continuing case 2 related areas of potentially dangerous practice continue reports, legal cases, and articles in the lay press) continues.
despite numerous previous warnings. What are these dan- Recently, the popular press has once again reported the gers? The first is the accidental administration of IV drugs heart-wrenching case of a laboring woman who became into epidural or intrathecal space. The second is the even paralyzed after the accidental injection of a nonanesthetic more dangerous administration of epidural drugs into the solution (the powerful antiseptic chlorhexidine) into her circulation via the IV catheter. With this editorial, we epidural space.c In previous reports, the offending agents challenge the anesthesiology community, along with the were an antibiotic,5 neuromuscular blocker,6 antihyperten- relevant industry and regulatory agencies, to take urgent sive or vasopressor agents,7 anesthesia induction agents,8 action and eliminate an unnecessary and preventable risk The National Reporting Learning Service in the United Kingdom continues to receive regular reports of wrongroute errors in anesthesia involving cross-connectivity be- A CRITICAL OVERSIGHTSafety in anesthesia is now embraced internationally. In the tween neuraxial catheters and Luer devices.10,11 In re- early 1990s, following major safety initiatives in the United sponse to these reports, the UK National Patient Safety States, European safety efforts were also launched. The Agency (NPSA) issued a Patient Safety Alert and recom- International Taskforce on Anaesthesia Safety set a goal to mended that starting April 1, 2011, all intrathecal bolus augment, enhance, and support published standards,3 and doses should be administered, and all lumbar puncture in 2007 the Safe Anaesthesia Working Group was convened samples obtained, using only syringes, needles, and other to review the International Standards for a Safe Practice of devices with connectors that do not connect with IVequipment.d However this deadline has passed, the goal has not been met in either the United States or the United Kingdom, and the risk thus continues. Ignoring this risk is irresponsible, and from a patient safety perspective, aseismic oversight.
From the *Department of Anesthesiology, University of Miami Miller Schoolof Medicine, Miami, Florida; †Imperial Centre for Patient Safety and Service Quality, Imperial College, London, United Kingdom.
Other accidental or incorrect-route drug administrations Accepted for publication November 7, 2011.
have been eliminated over the past decades by developing This article received no financial support.
intelligent solutions, for instance, pin key-index systems to Conflict of Interest: See Disclosures at end of the article.
prevent administration of the wrong volatile agent, and Reprints will not be available from the authors.
other methods to prevent the proverbial round peg from Address correspondence to David J. Birnbach, MD, MPH, Department ofAnesthesiology, University of Miami Miller School of Medicine, JacksonMemorial Hospital, Room C-301, 1611 N.W. 12th Ave., Miami, FL 33136.
Address e-mail to
Copyright 2012 International Anesthesia Research Society being placed within the square hole. Although these rem- We need to work together to develop one uniform, nonin- edies also have been proposed for use with epidurals and spinals, they have not been developed or evaluated. Al- No fix will be perfect, as there will always be some though solutions being considered are as yet imperfect, the degree of inconvenience if the gauge of the epidural or larger problem is that there has not been the necessary spinal catheter connector does not match a standard sy- consensus, pressure, and motivation in the United States or ringe. Assessing whether the ultimate solution involves changing the size of the epidural connector or switching While the United States has been somewhat silent on from a female to a male end is not the major barrier. What the subject of incorrect-route drug administration, the is essential at this point is that all concerned parties must United Kingdom has taken notice, although progress has meet, that a consensus regarding the most effective solution been glacially slow. The elimination of this source of be developed, and that all epidural and spinal kits use this harm was 1 of 4 specific targets for harm reduction in the new safer alternative to epidural catheter design. Further, UK Chief Medical Officer’s report, “An Organisation standardization of equipment, not only in one city or one with a Memory,” published in 2000.e In 2004, the NPSA country but across the entire globe is necessary to improve recommended that non-Luer compliant connectors be patient safety. Despite the fact that globalization is clearly used for all neuraxial procedures, and that new designs evidenced throughout our daily lives, there appears to be be tested before introduction into practice.12 In 2006, 3 little interaction between various countries when it comes connector prototypes were described, but only 1 of them to fixing this problem. Preliminary efforts are underway in has successfully completed laboratory, simulation, and several countries involving numerous, mutually exclusive clinical assessment stages.13 In 2009, the UK Parliamen- tary Health Select Committee expressed frustration with Will development and implementation of a new non- the delayed introduction of a non-Luer spinal needle. In Luer epidural catheter increase costs? Of course, but in the response, the NPSA convened an External Reference words of John F. Kennedy, “there are risks and costs to a Group on Safer Neuraxial Devices to oversee the intro- program of action, but they are far less than the long-range duction of non-Luer connectors. A number of manufac- risks and costs of comfortable inaction.” Uncomfortable as turers have now developed devices, which, although it may be, the time has come for action.
welcome, potentially introduce new risks from a multi-plicity of non-Luer connectors. Furthermore, it seems that the design of a useful non-Luer connector is not as Name: David J. Birnbach, MD, MPH.
Contribution: This author co-wrote and approved the final
simple as many, including ourselves, might think. The small-scale evaluation of 2 of these systems has yielded Conflicts of Interest: Dr. Birnbach is the Chair of the Food and
some important lessons. In initial evaluation, both non- Drug Administration Anesthesiology and Respiratory Therapy Luer systems scored significantly lower than standard Devices Panel and the opinions expressed are those of the authors equipment for overall performance of spinal and epidu- and do not necessarily represent the views of, and should not be ral procedures, although the performance of non-Luer attributed to, the Food and Drug Administration.
systems was mostly rated as “adequate or better.”13 Name: Charles A. Vincent, PHD.
More critically, both non-Luer connectors could cross- Contribution: This author co-wrote and approved the final
connect with 1 or more other Luer connectors, but this design shortcoming has purportedly since been elimi- Conflicts of Interest: Dr. Vincent has no conflicts of interest to
nated following feedback to the manufacturers.
The authors of the evaluation commented wryly that, This manuscript was handled by: Steven L. Shafer, MD.
“introducing equipment that is fully compliant with theNational Patient Safety Agency alert poses a significant challenge to manufacturers and clinicians.” The authors 1. Berkowitz RL. Of parachutes and patient care: a call to action.
Am J Obstetrics and Gynecology 2011;205:7–9 concluded that before introducing any non-Luer device 2. Merry AF, Cooper JB, Soyannwo O, Wilson IH, Eichhorn JH.
into widespread use, independent, formal evaluation An iterative process of global quality improvement: the Inter- should be performed.13 That, unfortunately, has not yet national Standards for a Safe Practice of Anesthesia. Can J 3. International Taskforce on Anaesthesia Safety. International standards for the safe practice of anesthesia. Eur J Anaesthesiol1993;10:12–5 4. Merry AF, Cooper JB, Soyannwo O, Wilson IH, Eichhorn JH.
Why do these catastrophic errors continue to occur? Hu- International standards for a safe practice of anesthesia. Can J mans are fallible, particularly when distracted or under 5. McHaourab A, Ruiz F. Inadvertent caudal epidural injection of stress. No matter how conscientious the clinician, errors will always occur.14 The more difficult question—what are 6. Sanchez-Bailen MJ, Roca P, Beniloch R. Accidental administra- we waiting for before we remedy this risk—is much harder tion of atracurium through an epidural catheter. Rev Esp to answer. It is irresponsible for the anesthesiology com- 7. Kasaba T, Uehara K, Katsuki H, Ono Y, Takasaki M. Analysis munity to wait for industry to come up with the remedy.
of inadvertent epidural injection of drugs. Masui 2000;49:1391– 4 8. Huang SY, Wang CC, Chang WK, Chan KH, Chu CC. Intra- venous propofol precipitates the hypotension induced by inadvertent epidural thiopental injection. Acta Anaesthesiol 12. National Patient Safety Agency. Patient Safety Alerts NPSA/2009/PSA004A and NPSA/2011/PSA001. London: Na- 9. Mohseni K, Jafari A, Nobahar MR, Arami A. Polymyoclonus seizure resulting from accidental injection of tranexamic acid 13. Cook TM, Payne S, Skryabina E, Hurford D, Clow E, Georgiou in spinal anesthesia. Anesth Analg 2009;108:1984 – 6 A. A simulation-based evaluation of two proposed alternatives 10. National Patient Safety Agency patient Safety Alert. Safer to Luer devices for use in neuraxial anaesthesia. Anaesthesia Spinal, Epidural and Regional Anaesthesia Devices—Part A.
London: National Patient Safety Agency, 2009 14. Leape LL. Who’s to blame? The Joint Commission Journal on 11. Cassidy CJ, Smith A, Arnot-Smith J. Critical incident reports Quality and Patient Safety 2010;36:150 –1 concerning anaesthetic equipment: analysis of the UK National 15. Lanigan CJ. Safer epidural and spinal connectors, Anaesthesia Reporting and Learning System (NRLS) data from 2006 –2008.
Anaesthesia 2011;66:879 – 88


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