Gastroenterology Urology Devices Reclassification of Implanted Blood Access Devices

Document ID: FDA-2012-N-0303-0002
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: No Topics associated with this document
Federal Register Number: 2012-15024
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Document Subtype:	Notice of Proposed Rulemaking (NPRM)
Received Date:	June 20 2012, at 12:00 AM Eastern Daylight Time
Start-End Page:	36951-36955
Page Count:	5
Comment Start Date:	June 20 2012, at 12:00 AM Eastern Standard Time
Comment Due Date:	September 18 2012, at 11:59 PM Eastern Standard Time

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Blood Access Index

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Reference 1 Draft guidance entitled Class II Special Controls Guidance Document Implanted Blood Access Devices for Hemodialysis available at

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Reference 10 Trerotola SO Johnson MS Harris VJ Shah H Ambrosius WT McKusky MA Kraus MA Outcome of tunneled hemodialysis catheters placed via the right internal jugular vein by interventional radiologists

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Reference 11 Prabhu PN Kerns SR Sabatelli FW Hawkins IF Ross EA Long-term performance and complications of the Tesio twin catheter system for hemodialysis access

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Reference 12 Schnabel KJ Simons ME Zevallos GF Pron GE Fenton SS Sniderman KW Vanderburgh LC: Image-guided insertion of the Uldall tunneled hemodialysis catheter technical success and clinical followup

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Reference 13 Nassar GM Ayus JC Infectious complications of the hemodialysis access

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Reference 14 Power A Singh SK Ashby D Cairns T Taube D Duncan N Long term Tesio catheter access for hemodialysis can deliver high dialysis adequacy with low complication rates

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Reference 15 Duncan ND Singh S Cairns TD Clark M El Tayar A Griffith M Hakim N Hamady M McLean AG Papalois V Palmer A Taube D Tesio Caths provide effective and safe long term vascular access

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Reference 16 Eisenstein I Tarabeih M Mage D Pollack S Kassis I Ofer A Engel A Zelikovic I Low infection rates and prolonged survival times of hemodialysis catheters in infants and children

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Reference 2 Eisenhauer ED Derveloy RJ Hastings PR Prospective evaluation of central venous pressure CVP catheters in a large citycounty hospital Ann Surg

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Reference 3 Vanholder V Hoenich N Ringoir S Morbidity and mortality of central venous catheter hemodialysis: a review of 10 years experience Nephron 47 274 279 1987

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Reference 4 Almirall J Gonzalez J Rello J Campistol JM Montoliu J Puig de la Bellacasa J Revert L Gatell JM Infection of hemodialysis catheters incidence and mechanisms

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Reference 5 Boyle MJ Gawley WF Hickey DP Drumm J Murphy DM Hanson JS Glacken P Experience using the Quinton Permcath for haemodialysis in the Irish Republic Nephrol Dial Transplant

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Reference 6 Randolph AG, Cook DJ, Gonzales CA, Pribble CG: Ultrasound guidance for placement of central venous catheters: a meta-analysis of the literature. Crit Care

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Reference 8 Wivell W Bettmann MA Baxter B Langdon DR Remilliard B Chobanian M Outcomes and performance of the Tesio twin catheter system placed for hemodialysis access

View Attachment:

Reference 9 Lund GB Trerotola SO Scheel PF Jr Savader SJ Mitchell SE Venbrux AC Osterman FA Jr Outcome of tunneled hemodialysis catheters placed by radiologists

View Attachment:

Reference7 Arnold WP Improvement in hemodialysis vascular access outcomes in a dedicated access center

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Gastroenterology Urology Devices Reclassification of Implanted Blood Access Devices

Details Information

Attachments:

Blood Access Index

Reference 1 Draft guidance entitled Class II Special Controls Guidance Document Implanted Blood Access Devices for Hemodialysis available at

Reference 10 Trerotola SO Johnson MS Harris VJ Shah H Ambrosius WT McKusky MA Kraus MA Outcome of tunneled hemodialysis catheters placed via the right internal jugular vein by interventional radiologists

Reference 11 Prabhu PN Kerns SR Sabatelli FW Hawkins IF Ross EA Long-term performance and complications of the Tesio twin catheter system for hemodialysis access

Reference 12 Schnabel KJ Simons ME Zevallos GF Pron GE Fenton SS Sniderman KW Vanderburgh LC: Image-guided insertion of the Uldall tunneled hemodialysis catheter technical success and clinical followup

Reference 13 Nassar GM Ayus JC Infectious complications of the hemodialysis access

Reference 14 Power A Singh SK Ashby D Cairns T Taube D Duncan N Long term Tesio catheter access for hemodialysis can deliver high dialysis adequacy with low complication rates

Reference 15 Duncan ND Singh S Cairns TD Clark M El Tayar A Griffith M Hakim N Hamady M McLean AG Papalois V Palmer A Taube D Tesio Caths provide effective and safe long term vascular access

Reference 16 Eisenstein I Tarabeih M Mage D Pollack S Kassis I Ofer A Engel A Zelikovic I Low infection rates and prolonged survival times of hemodialysis catheters in infants and children

Reference 2 Eisenhauer ED Derveloy RJ Hastings PR Prospective evaluation of central venous pressure CVP catheters in a large citycounty hospital Ann Surg

Reference 3 Vanholder V Hoenich N Ringoir S Morbidity and mortality of central venous catheter hemodialysis: a review of 10 years experience Nephron 47 274 279 1987

Reference 4 Almirall J Gonzalez J Rello J Campistol JM Montoliu J Puig de la Bellacasa J Revert L Gatell JM Infection of hemodialysis catheters incidence and mechanisms

Reference 5 Boyle MJ Gawley WF Hickey DP Drumm J Murphy DM Hanson JS Glacken P Experience using the Quinton Permcath for haemodialysis in the Irish Republic Nephrol Dial Transplant

Reference 6 Randolph AG, Cook DJ, Gonzales CA, Pribble CG: Ultrasound guidance for placement of central venous catheters: a meta-analysis of the literature. Crit Care

Reference 8 Wivell W Bettmann MA Baxter B Langdon DR Remilliard B Chobanian M Outcomes and performance of the Tesio twin catheter system placed for hemodialysis access

Reference 9 Lund GB Trerotola SO Scheel PF Jr Savader SJ Mitchell SE Venbrux AC Osterman FA Jr Outcome of tunneled hemodialysis catheters placed by radiologists

Reference7 Arnold WP Improvement in hemodialysis vascular access outcomes in a dedicated access center

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