Integration of patient safety technologies into sclerotherapy for varicose veins

Vascular and Endovascular Surgery

Volumn 42, Issue 5, 2008, Pages 446-455

  Sibbitt, Randy R ^a   Palmer, Dennis J ^a   Sibbitt Jr , Wilmer L ^b  

^a St Peter's Hospital Helena   (United States)

^b UNIVERSITY OF NEW MEXICO SCHOOL OF MEDICINE   (United States)

Author keywords

Foam; Injection; Phlebology; Safety; Sclerosing; Sclerotherapy; Syringe; Varicose vein; Varicosity

Indexed keywords

ARTICLE; BIOMEDICAL TECHNOLOGY ASSESSMENT; EQUIPMENT; HUMAN; NEEDLESTICK INJURY; OUTPATIENT CARE; PATIENT SAFETY; PRACTICE GUIDELINE; RISK ASSESSMENT; SCLEROTHERAPY; VARICOSIS;

ACCIDENTS, OCCUPATIONAL; AMBULATORY CARE; CHRONIC DISEASE; EQUIPMENT DESIGN; FEASIBILITY STUDIES; HUMANS; IATROGENIC DISEASE; NEEDLESTICK INJURIES; PAIN; SAFETY MANAGEMENT; SCLEROTHERAPY; SYRINGES; TREATMENT OUTCOME; VARICOSE VEINS;

EID: 54049116276     PISSN: 15385744     EISSN: None     Source Type: Journal    
DOI: 10.1177/1538574408318479     Document Type: Article

References (106)

1. Kobayashi S., Crooks S., Eckmann DM Dose- and time-dependent liquid sclerosant effects on endothelial cell death. Dermatol Surg. 2006 ; 32: 1444-1452.
2. Munavalli GS, Weiss RA Advances in techniques for endovenous ablation of truncal veins. Skin Ther Lett. 2006 ; 11: 4-7.
3. Whiddon LL The treatment of venous ulcers of the lower extremities. Proc Bayl Univ Med Cent. 2007 ; 20: 363-366.
4. Bergan J., Cheng V. Foam sclerotherapy for the treatment of varicose veins. Vascular. 2007 ; 15: 269-272.
5. Dietzek CL Sclerotherapy: introduction to solutions and techniques. Perspect Vasc Surg Endovasc Ther. 2007 ; 19: 317-324.
6. Zimmet SE Sclerotherapy treatment of telangiectasias and varicose veins. Tech Vasc Interv Radiol. 2003 ; 6: 116-120.
7. Hirsch SA, Dillavou E. Options in the management of varicose veins. J Cardiovasc Surg (Torino). 2008 ; 49: 19-26.
8. Hamel-Desnos C., Ouvry P., Benigni JP, et al. Comparison of 1% and 3% polidocanol foam in ultrasound guided sclerotherapy of the great saphenous vein: a randomised, double-blind trial with 2 year-follow-up. "The 3/1 Study". Eur J Vasc Endovasc Surg. 2007 ; 34: 723-729.
9. Puggioni A., Kalra M., Gloviczki P. Superficial vein surgery and SEPS for chronic venous insufficiency. Semin Vasc Surg. 2005 ; 18: 41-48.
10. Meissner MH, Gloviczki P., Bergan J., et al. Primary chronic venous disorders. J Vasc Surg. 2007 ; 46 (suppl S). 54S - 67S.
11. Meissner MH, Eklof B., Smith PC, et al. Secondary chronic venous disorders. J Vasc Surg. 2007 ; 46 (suppl S). 68S - 83S.
12. Rabe E., Otto J., Schliephake D., Pannier F. Efficacy and safety of great saphenous vein sclerotherapy using standardised polidocanol foam (ESAF): a randomised controlled multicentre clinical trial. Eur J Vasc Endovasc Surg. 2008 ; 35: 238-245.
13. Gibson KD, Ferris BL, Pepper D. Foam sclerotherapy for the treatment of superficial venous insufficiency. Surg Clin North Am. 2007 ; 87: 1285-1295.
14. Coleridge Smith P. Saphenous ablation: sclerosant or sclerofoam? Semin Vasc Surg. 2005 ; 18: 19-24.
15. Frullini A., Cavezzi A. Sclerosing foam in the treatment of varicose veins and telangiectases: history and analysis of safety and complications. Dermatol Surg. 2002 ; 28: 11-15.
16. Tessari L., Cavezzi A., Frullini A. Preliminary experience with a new sclerosing foam in the treatment of varicose veins. Dermatol Surg. 2001 ; 27: 58-60.
17. Bowes LE, Goldman MP Sclerotherapy of reticular and telangiectatic veins of the face, hands, and chest. Dermatol Surg. 2002 ; 28: 46-51.
18. Weiss RA, Weiss MA Ambulatory phlebectomy compared to sclerotherapy for varicose and telangiectatic veins: indications and complications. Adv Dermatol. 1996 ; 11: 3-16.
19. de Roos KP, Nieman FH, Neumann HA Ambulatory phlebectomy versus compression sclerotherapy: results of a randomized controlled trial. Dermatol Surg. 2003 ; 29: 221-226.
20. Ramelet AA Phlebectomy. Technique, indications and complications. Int Angiol. 2002 ; 21 (2 suppl 1). 46-51.
21. Garde C. Ambulatory phlebectomy. Dermatol Surg. 1995 ; 21: 628-630.
22. Puggioni A., Kalra M., Gloviczki P. Superficial vein surgery and SEPS for chronic venous insufficiency. Semin Vasc Surg. 2005 ; 18: 41-48.
23. Vedantham S., Rundback JH, Khilnani NM, et al. Development of a research agenda for endovenous treatment of lower-extremity venous reflux: proceedings from a multidisciplinary consensus panel. J Vasc Interv Radiol. 2005 ; 16: 1575-1579.
24. O'Hare JL, Earnshaw JJ The use of foam sclerotherapy for varicose veins: a survey of the members of the Vascular Society of Great Britain and Ireland. Eur J Vasc Endovasc Surg. 2007 ; 34: 232-235.
25. Natali J., Benhamou AC Iatrogenic vascular injuries. A review of 125 cases (excluding angiographic injuries). J Cardiovasc Surg (Torino). 1979 ; 20: 169-176.
26. Rudström H., Björck M., Bergqvist D. Iatrogenic vascular injuries in varicose vein surgery: a systematic review. World J Surg. 2007 ; 31: 228-233.
27. Benhamou AC, Natali J. Complications of sclerosing and surgical treatment of leg varices. Apropos of 90 cases. Phlebologie. 1981 ; 34: 41-51.
28. Härtel S. Complications and side effects of sclerotherapy. Z Arztl Fortbild (Jena). 1984 ; 78: 331-332.
29. Hohlbaum GG Iatrogenic damage in sclerotherapy of varicose veins. Z Lymphol. 1990 ; 14: 32-35.
30. Rudström H., Bergqvist D., Ogren M., Björck M. Iatrogenic vascular injuries in Sweden. A nationwide study 1987-2005. Eur J Vasc Endovasc Surg. 2008 ; 35: 131-138.
31. Goldman MP, Sadick NS, Weiss RA Cutaneous necrosis, telangiectatic matting, and hyperpigmentation following sclerotherapy. Etiology, prevention, and treatment. Dermatol Surg. 1995 ; 21: 19-29.
32. McMaster P., Everett WG Fatal pulmonary embolism following compression sclerotherapy for varicose veins. Postgrad Med J. 1973 ; 49: 517-518.
33. Yamaki T., Nozaki M., Sasaki K. Acute massive pulmonary embolism following high ligation combined with compression sclerotherapy for varicose veins report of a case. Dermatol Surg. 1999 ; 25: 321-325.
34. Chan HT, Low J., Wilson L., Harris OC, Cheng AC, Athan E. Case cluster of necrotizing fasciitis and cellulitis associated with vein sclerotherapy. Emerg Infect Dis. 2008 ; 14: 180-181.
35. Stücker M., Reich S., Hermes N., Altmeyer P. Safety and efficiency of perilesional sclerotherapy in leg ulcer patients with postthrombotic syndrome and/or oral anticoagulation with phenprocoumon. J Dtsch Dermatol Ges. 2006 ; 4: 734-738.
36. Goldstein M. Complications of sclerotherapy. Phlebologie. 1979 ; 32: 221-228.
37. Nitecki SS, Bass A. Inadvertent arterial injury secondary to treatment of venous insufficiency. Vascular. 2007 ; 15: 49-52.
38. Munavalli GS, Weiss RA Complications of sclerotherapy. Semin Cutan Med Surg. 2007 ; 26: 22-28.
39. Künzlberger B., Pieck C., Altmeyer P., Stücker M. Migraine ophthalmique with reversible scotomas after sclerotherapy with liquid 1% polidocanol. Dermatol Surg. 2006 ; 32: 1410-1413.
40. Geukens J., Rabe E., Bieber T. Embolia cutis medicamentosa of the foot after sclerotherapy. Eur J Dermatol. 1999 ; 9: 132-133.
41. Bergan JJ, Weiss RA, Goldman MP Extensive tissue necrosis following high-concentration sclerotherapy for varicose veins. Dermatol Surg. 2000 ; 26: 535-541.
42. Oesch A., Stirnemann P., Mahler F. Acute ischemic syndrome of the foot following sclerotherapy of varicose veins. Schweiz Med Wochenschr. 1984 ; 114: 1155-1158.
43. Saliou C., Duteille F., Soyer J., Sraieb T., Turc I., Laurian C. Iatrogenic intra-arterial injection during sclerotherapy of the external saphenous vein. J Chir (Paris). 1997 ; 134: 65-68.
44. Kas A., Begue M., Nifle C., Gil R., Neau JP Cerebellar infarction after sclerotherapy for leg varicosities [in French]. Presse Med. 2000 ; 29: 1935.
45. Forlee MV, Grouden M., Moore DJ, Shanik G. Stroke after varicose vein foam injection sclerotherapy. J Vasc Surg. 2006 ; 43: 162-164.
46. Guex JJ, Allaert FA, Gillet JL, Chleir F. Immediate and midterm complications of sclerotherapy: report of a prospective multicenter registry of 12,173 sclerotherapy sessions. Dermatol Surg. 2005 ; 31: 123-128.
47. Kiehlmann I., Lechner W. Complications in the treatment of leg ulcers. Curr Probl Dermatol. 1999 ; 27: 170-173.
48. Magee RH A complication of sclerotherapy. Med J Aust. 1999 ; 171: 166.
49. Sladen JG Compression sclerotherapy: preparation, technique, complications, and results. Am J Surg. 1983 ; 146: 228-232.
50. Marrocco-Trischitta MM, Guerrini P., Abeni D., Stillo F. Reversible cardiac arrest after polidocanol sclerotherapy of peripheral venous malformation. Dermatol Surg. 2002 ; 28: 153-155.
51. Brzoza Z., Kasperska-Zajac A., Rogala E., Rogala B. Anaphylactoid reaction after the use of sodium tetradecyl sulfate: a case report. Angiology. 2007 ; 58: 644-646.
52. Stricker BH, van Oijen JA, Kroon C., Ovink AH Anaphylaxis following use of polidocanol. Ned Tijdschr Geneeskd. 1990 ; 134: 240-242.
53. Dill-Müller D. Medical emergencies following dermatological injections and infusions. Hautarzt. 2006 ; 57: 195-201.
54. Bihari I. Injection sclerotherapy for varicosities of the lower limb: 25 years of experience with 115000 injections. Orv Hetil. 2007 ; 148: 51-58.
55. Cho YP, Kim E., Choi SJ, et al. Compartment syndrome after compression sclerotherapy. Ann Vasc Surg. 2005 ; 19: 428-430.
56. Zipper SG Peroneal nerve damage after varicose vein sclerotherapy with ethoxysclerol. Single case description with malpractice relevant questions. Versicherungsmedizin. 2000 ; 52: 185-187.
57. Scurr JH, Shields DA, Shami SK, Coleridge Smith PD Medico-legal aspects of venous surgery. Phlebologie. 1993 ; 46: 609-612.
58. Natali J., Farman T. Forensic medical implications in the course of sclerotherapy of varicose veins. J Mal Vasc. 1996 ; 21: 227-232.
59. The Joint Commission. National Patient Safety Goals. Web site http://www.jointcommission.org/PatientSafety.
60. Needlestick Safety and Prevention Act. US Congress, 2000. Library of Congress Web site http://thomas.loc.gov.
61. Cuny EJ, Fredeking R., Budenz AW Safety needles. New requirements of the Occupational Safety and Health Administration bloodborne pathogens rule. J Calif Dent Assoc. 1999 ; 27: 525-530.
62. Adams D., Elliott TS Impact of safety needle devices on occupationally acquired needlestick injuries: a four-year prospective study. J Hosp Infect. 2006 ; 64: 50-55.
63. Kotsiopoulos O., Delaney B. Confidential reporting of patient safety events in primary care: results from a multilevel classification of cognitive and system factors. Qual Saf Health Care. 2007 ; 16: 95-100.
64. Fisman DN, Harris AD, Rubin M., Sorock GS, Mittleman MA Fatigue increases the risk of injury from sharp devices in medical trainees: results from a case-crossover study. Infect Control Hosp Epidemiol. 2007 ; 28: 10-17.
65. Vincent C., Davy C., Esmail A., et al. Learning from litigation. The role of claims analysis in patient safety. J Eval Clin Pract. 2006 ; 12: 665-674.
66. Woods DM, Thomas EJ, Holl JL, Weiss KB, Brennan TA Ambulatory care adverse events and preventable adverse events leading to a hospital admission. Qual Saf Health Care. 2007 ; 16: 127-131.
67. Apold J., Daniels T., Sonneborn M. Interdepartmental collaboration and transparency in patient safety. Jt Comm J Qual Patient Saf. 2006 ; 32: 672-675.
68. Waring J., McDonald R., Harrison S. Safety and complexity: inter-departmental relationships as a threat to patient safety in the operating department. J Health Organ Manag. 2006 ; 20: 227-242.
69. Dunn D. Surgical site verification: A through Z. J Perianesth Nurs. 2006 ; 21: 317-328.
70. Seiden SC, Barach P. Wrong-side/wrong-site, wrong-procedure, and wrong-patient adverse events: are they preventable? Arch Surg. 2006 ; 141: 931-939.
71. Healey AN, Sevdalis N., Vincent CA Measuring intraoperative interference from distraction and interruption observed in the operating theatre. Ergonomics. 2006 ; 49: 589-604.
72. Berguer R., Forkey DL, Smith WD Ergonomic problems associated with laparoscopic surgery. Surg Endosc. 1999 ; 13: 466-468.
73. Berguer R. Surgical technology and the ergonomics of laparoscopic instruments. Surg Endosc. 1998 ; 12: 458-462.
74. Lai F. Human factors engineering for designing the next in medicine. Stud Health Technol Inform. 2007 ; 125: 262-264.
75. Kimberlin C. Device manufacturers: a partner in quality assurance. Biomed Instrum Technol. 2006 ; 40: 435-436.
76. Williams DM Engineering improvements in endovascular devices: design and validation. Ann N Y Acad Sci. 2006 ; 1085: 213-223.
77. Khuri SF, Henderson WG, Daley J., et al, and Principal Site Investigators of the Patient Safety in Surgery Study. The patient safety in surgery study: background, study design, and patient populations. J Am Coll Surg. 2007 ; 204: 1089-1102.
78. Schutz AL, Counte MA, Meurer S. Assessment of patient safety research from an organizational ergonomics and structural perspective. Ergonomics. 2007 ; 50: 1451-1484.
79. Hanke CW Patient safety in dermatology. Dermatol Surg. 2004 ; 30: 1451-1453.
80. Heget JR, Bagian JP, Lee CZ, Gosbee JW John M. Eisenberg Patient Safety Awards. System innovation: Veterans Health Administration National Center for Patient Safety. Jt Comm J Qual Improv. 2002 ; 28: 660-665.
81. Bagian JP, Gosbee J., Lee CZ, Williams L., McKnight SD, Mannos DM The Veterans Affairs root cause analysis system in action. Jt Comm J Qual Improv. 2002 ; 28: 531-545.
82. Stalhandske E., Bagian JP, Gosbee J. Department of Veterans Affairs patient safety program. Am J Infect Control. 2002 ; 30: 296-302.
83. Williams L. Changing systems the hands-on way. The VA National Center for Patient Safety's Museum. Md Med. 2005 ; 6: 16-18.
84. Ratzlaff JI Needle safety technology. SCI Nurs. 2002 ; 19: 17-20.
85. Cook RI Safety technology: solutions or experiments ? Nurs Econ. 2002 ; 20: 80-82.
86. Winston FK, Schwarz DF, Baker SP Biomechanical epidemiology: a new approach to injury control research. J Trauma. 1996 ; 40: 820-824.
87. Cleveland JL, Barker LK, Cuny EJ, Panlilio AL ; National Surveillance System for Health Care Workers Group. Preventing percutaneous injuries among dental health care personnel. J Am Dent Assoc. 2007 ; 138: 169-178.
88. Muntz JE, Hultburg R. Safety syringes can reduce the risk of needlestick injury in venous thromboembolism prophylaxis. J Surg Orthop Adv. 2004 ; 13: 15-19.
89. Sibbitt RR, Sibbitt WL Jr, Nunez SE, Kettwich LG, Kettwich SC, Bankhurst AD Control and performance characteristics of eight different suction biopsy devices. J Vasc Interv Radiol. 2006 ; 17: 1657-1669.
90. Nunez SE, Draeger HT, Rivero DP, Kettwich LG, Sibbitt WL Jr, Bankhurst AD Reduced pain of intraarticular hyaluronate injection with the reciprocating procedure device. J Clin Rheumatol. 2007 ; 13: 16-19.
91. Bankhurst AD, Nunez SE, Draeger HT, Kettwich SC, Kettwich LG, Sibbitt, WL Jr. A randomized controlled trial of the reciprocating procedure device for intraarticular injection of corticosteroid. J Rheum. 2007 ; 34: 187-192.
92. Sibbitt WL Jr, Sibbitt RR, Michael AA, et al. Physician control of needle and syringe during traditional aspiration-injection procedures with the new reciprocating syringe. J Rheumatol. 2006 ; 33: 771-778.
93. Draeger HT, Twining JM, Johnson CR, Kettwich SC, Kettwich LG, Bankhurst AD A randomized, controlled trial of the reciprocating syringe in arthrocentesis. Ann Rheum Dis. 2006 ; 65: 1084-1087.
94. Nunez SE, Draeger HT, Kettwich SC, Kettwich LG, Bankhurst AD, Sibbitt WL A randomized, controlled trial of the reciprocating syringe in local anesthesia. J Emerg Med. 2008. In press.
95. Moorjani GR, Michael AA, Peisjovich A., Park KS, Sibbitt WL Jr, Bankhurst AD Patient pain and tissue trauma during syringe procedures: a randomized controlled trial. J Rheum. 2008. In press.
96. Moorjani GR, Bedrick EJ, Michael AA, Peisjovich A., Sibbitt WL Jr, Bankhurst AD Integration of safety technologies into rheumatology and orthopedic practice: a randomized controlled trial. Arthritis Rheum. 2008. In press.
97. Sander O. Intra-articular corticosteroid injections with the reciprocating procedure device reduced procedural pain and duration more than the conventional syringe. Evid Based Med. 2007 ; 12: 106.
98. Sibbitt RR, Sibbitt WL Jr, Palmer DJ, Bankhurst AD Needle aspiration of peritonsillar abscess with the new safety technology the reciprocating procedure device. Otolaryngol Head Neck Surg. 2008. In press.
99. Bodian EL Sclerotherapy: a personal appraisal. J Dermatol Surg Oncol. 1989 ; 15: 156-161.
100. Hota B. Contamination, disinfection, and cross-colonization: are hospital surfaces reservoirs for nosocomial infection? Clin Infect Dis. 2004 ; 39: 1182-1189.
101. Tadiparthi S., Shokrollahi K., Juma A., Croall J. Using marker pens on patients: a potential source of cross infection with MRSA. Ann R Coll Surg Engl. 2007 ; 89: 661-664.
102. Barnett TE The not-so-hidden costs of surgical site infections. AORN J. 2007 ; 86: 249-258.
103. Heeg P., Roth K., Reichl R., Cogdill CP, Bond WW Decontaminated single-use devices: an oxymoron that may be placing patients at risk for cross-contamination. Infect Control Hosp Epidemiol. 2001 ; 22: 542-549.
104. Kölbel T., Hinchliffe RJ, Lindblad B. Catheter-directed foam sclerotherapy of axial saphenous reflux: early results. Phlebology. 2007 ; 22: 219-222.
105. Ceulen RP, Bullens-Goessens YI, Pi- Van De Venne SJ, Nelemans PJ, Veraart JC, Sommer A. Outcomes and side effects of duplex-guided sclerotherapy in the treatment of great saphenous veins with 1% versus 3% polidocanol foam: results of a randomized controlled trial with 1-year follow-up. Dermatol Surg. 2007 ; 33: 276-281.
106. Cornu-Thenard A., de Cottreau H., Weiss RA Sclerotherapy. Continuous wave Doppler-guided injections. Dermatol Surg. 1995 ; 21: 867-870.