the SEDASYS™ Computer-Assisted Personalized Sedation System (CAPS)

1. the SEDASYS™ Computer-Assisted Personalized Sedation System (CAPS) Steven J. Morris MD JD FACP President, Atlanta Gastroenterology Associates, LLC Director, GI Lab, Emory University Midtown Hospital Associate Clinical Professor of Medicine Emory University School of Medicine Chairman, PreventingColorectalCancer.Org 28 May 2009

2. Our Experience with Propofol • Over 250,000 patients in the past 6 years • All cases done in conjunction with Anesthesia trained personnel • Uniformly positive experience for our patients: • Safe • Painless • Rapid Recovery • Increased Access

3. Issues with Sedasys CAPS Safety………..Propofol Safety……….Gastroenterologist Safety……….Complications

4. Propofol FDA approved product label:… propofol used for sedation or anesthesia “should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical or diagnostic procedure.” Labeling is clear and has withstood challenges to broaden the scope of administration. Recently, a water soluble pro-drug of propofol, Fospropofol, was approved by the FDA with the restriction that it be used by clinical personnel who have been trained in life support techniques and are not directly participating in the procedure. 

5. Gastroenterogists Not trained in the administration of general anesthesia. They are involved in the conduct of the surgical and diagnostic procedure.

6. Lack of Training by Gastroenterologists Cohen et al1: “…sedation-related education is underrepresented in US gastroenterology professional training. Moreover, sedation-related continuing education is not commonly available to mid-career endoscopists.” Zuccaro G2: “…proper and ongoing training of endoscopists and assistants in the management of problems such as respiratory arrest is woefully inadequate. Most gastroenterologists receive the bulk of training in sedation and analgesia just as their counterparts did 20 years ago.” 1.Cohen LB et al: AGA Institute Review of Endoscopic Sedation. Gastroenterology 2007:133:675-701 2.Zuccaro G: Sedation and Analgesia for GI Endoscopy. Gastrointestinal Endoscopy 2006; 63:95-96

7. Complications/Adverse Events Question: ..whether the use of CAPS in administering propofol prevents the progression of sedation to unintended depths i.e. deep sedation or general anesthesia.3 Conclusion: Large interpatient variability in propofol requirements ….exact mechanism is currently unknown but probably multifactorial (age, circulation times, genetic polymorphism). 3.Irvani M: On computers, nurses, and propofol: further evidence for the jury. Gastrointestinal Endoscopy 2008; 68:510-512

8. Danger !! “The bottom line is that, no matter how precise of a control is exercised over sedation depth, in a large patient series, there will be incidences in which unintended deep sedation or general anesthesia is reached. This occurs not infrequently under the supervision of an anesthesiologist, but with their advanced airway skills, the patient is ‘rescued’. If the personnel who are administering propofol do not possess the necessary airway management skills, the outcome could be catastrophic.” 3.Irvani M: On computers, nurses, and propofol: further evidence for the jury. Gastrointestinal Endoscopy 2008; 68:510-512

9. Sedasys “ This new technology represents an exciting breakthrough in the use of computers to properly administer and monitor sedation in patients undergoing a variety of procedures,” said Daniel Pambianco, M.D., Charlottesville Medical Research and lead study author. “ When used with a TRAINED ANESTHESIOLOGIST, this device may help manage the potential risks associated with sedation and ensure that each patient is cared for based on their own needs.”4 4. Medical News Today, May 22,2006

10. Sedasys Study “…included 1,000 subjects who underwent sedation for colonoscopy and EGD at eight sites and compared the SEDASYS™ System to the current standard of care for sedation (midazolam plus fentanyl or meperidine)….” THIS IS NOT THE STANDARD OF CARE ANY LONGER IN MANY MAJOR MEDICAL COMMUNTIES.

11. AGA Institute Review of Endoscopic Sedation1 “..benzodiazepines and opioid narcotics…lack the pharmacologic properties necessary to achieve optimal sedation during an endoscopic procedure..” “..opioid analgesics are associated with troublesome side effects such as respiratory depression, bradycardia, nausea and vomiting. “…long acting and their residual effects may be experienced for hours after completion of an endoscopy.”

12. Standard of Care • The evolving Standard of Care is the collaboration of Gastroenterologists and Anesthesia personnel in the Endoscopic setting. • Better outcomes5,6 • NO shortage of personnel • Sedasys needs to be studied versus that standard before any consideration of use in the endoscopic setting. 5. Koch, ME et al. Higher Rates of Colon Polyp Detection. SUNY Stony Brook, U of Penn. 6.Hoda KM et al. More Large Polyps are Seen on Screening Colonoscopy with Deep Sedation Compared with Moderate Conscious Sedation. Division of Gastroenterology, OHSU, Portland, OR.

13. Conclusion Propofol is not safe to be administered by CAPS or any other method without trained anesthesia personnel in attendance. Gastroenterologists do not possess the training necessary to administer propofol with or without the Sedasys CAPS system. Complications are inevitable and will be catastrophic and cause irreversible damage.