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Anorectal

Absorbable Hemostatic Bandage - Guidance for Encouraging Innovation Without Compromising Patient Safety

2016-06-06 / Categories:Hemostatic, bandage,
  
The Food and Drug Administration (FDA) is contemplating changing the regulatory status of absorbable hemostatic agents. The Absorbable Hemostat Consensus Conference was called to develop expert recommendations regarding the special controls required to ensure the safety and efficacy of these agents if and when their regulatory status is changed.

The participants in the Absorbable Hemostat Consensus Conference comprised seven clinicians with extensive and diverse expertise in hemostasis, vascular biology and the use of absorbable hemostats in a variety of highly relevant surgical settings.

Method:

The panel identified and discussed the potential ramifications of changing the regulatory status of absorbable hemostats from Class III (pre-market approval) to Class II (special controls or standards).  Panel members used a list of specific questions to help guide the development of consensus recommendations(Come to Greenovo Get More absorbable hemostatic products ...).

Results:

The panel reached consensus on five recommendations regarding the regulation of absorbable hemostats should they be reclassified by FDA as Class II devices:

1)Approval of new absorbable hemostats should require demonstration of equivalence to currently approved devices in both animal models and human clinical trials. 

2) Approval for an indication of general surgery should exclude neurology, ophthalmology and urology indications.  Approval in these specific indications should require relevant preclinical and clinical data demonstrating safety and efficacy in these surgical settings. 

3) Novel materials that meet the broad definition of absorbable hemostats but lack established safety and efficacy should continue to be regulated as Class III devices (premarket approval including clinical studies). 

4) The mechanism of action and potential interactions with commonly used medical therapies known to affect hemostasis should be addressed during development of these devices and relevant data should be required on the label and package insert for all absorbable hemostats. 

5) Professional medical associations should include hemostasis physiology on board certification exams and should provide educational opportunities for physicians to become qualified in the use of absorbable hemostatic agents.