Contains definitions of blood tests and interactions, abbreviations and a fairly long list of examples for each category of non-contact, indirect and direct contact externally communicating devices and implant devices.
A statement that in certain cases a combination of coagulation, platelet assessments, hematology and complement could substitute for thrombosis testing.
Only parts that are blood contacting (direct and indirect) should be tested.
Controls should be used and if a predicate is available should be used.
A decision tree is presented on when to conduct blood compatibility evaluations.
2 tables are listed for implant devices and direct contacting externally communicating devices by type of device and then categories to be addressed. All products must evaluate hemolysis. Mechanical hemolysis as a category has been introduced. The category of Thrombosis which previously was a stand alone category of the in vivo evaluation is now a comprehensive category of coagulation, platelet activation, complement, hematology and in vivo or ex vivo evaluation. Most implants in blood contact also have to evaluate thrombosis. Most externally communicating devices must evaluate coagulation and platelets as well.
Devices that have blood contact for less than a minute do not need to be tested. Devices that store an injectable for more than a minute should be evaluated for hemolysis even though they may not contact blood for more than a minute.
Human blood should be used where possible, unless the test method has been established using animal blood.
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A statement that in certain cases a combination of coagulation, platelet assessments, hematology and complement could substitute for thrombosis testing.
Only parts that are blood contacting (direct and indirect) should be tested.
Controls should be used and if a predicate is available should be used.
A decision tree is presented on when to conduct blood compatibility evaluations.
2 tables are listed for implant devices and direct contacting externally communicating devices by type of device and then categories to be addressed. All products must evaluate hemolysis. Mechanical hemolysis as a category has been introduced. The category of Thrombosis which previously was a stand alone category of the in vivo evaluation is now a comprehensive category of coagulation, platelet activation, complement, hematology and in vivo or ex vivo evaluation. Most implants in blood contact also have to evaluate thrombosis. Most externally communicating devices must evaluate coagulation and platelets as well.
Devices that have blood contact for less than a minute do not need to be tested. Devices that store an injectable for more than a minute should be evaluated for hemolysis even though they may not contact blood for more than a minute.
Human blood should be used where possible, unless the test method has been established using animal blood.
Continue reading below
Annex A discusses considerations for animal tests, in vitro tests and device categories of cannulae, catheters and guidewires, extracorporeal oxygenators, hemodialysis and apheresis devices and equipment, ventricular assist devices and artificial hearts, heart valve prostheses, vascular grafts, stents and vascular grafts.
Annex B discusses the recommended tests. It discusses some endpoint analysis for thrombosis. This is followed by a short statement about hemolysis and then a redirection to Annex D. A very long discussion on coagulation with a graphic of the coagulation cascade follows. Recommendations for thrombin-antithrombin and fibrin ELISA assays. Partial Thromboplastin time is suggested. Platelet activation and platelet count, complete blood count, Leukocyte activation and complement system.
Annex C is an informative discussion on the non-anticoagulated venous implant (NAVI) and the anticoagulated venous implant (AVI). The typically used scoring scheme is presented as well as the general protocol requirements along with problems encountered and implant locations.
Annex D is in regards to the hemolysis tests and the specifics such as wave length used and pass fail criteria.
Annex E discusses the complement testing
Annex F is less common tests but not a lot of discussion about them.
Finally, Annex G specifies that APTT, PT and TT, bleeding time, reticulocyte counts and complement evaluations of CH-50, C3 and C5 convertases are not recommended.
Annex B discusses the recommended tests. It discusses some endpoint analysis for thrombosis. This is followed by a short statement about hemolysis and then a redirection to Annex D. A very long discussion on coagulation with a graphic of the coagulation cascade follows. Recommendations for thrombin-antithrombin and fibrin ELISA assays. Partial Thromboplastin time is suggested. Platelet activation and platelet count, complete blood count, Leukocyte activation and complement system.
Annex C is an informative discussion on the non-anticoagulated venous implant (NAVI) and the anticoagulated venous implant (AVI). The typically used scoring scheme is presented as well as the general protocol requirements along with problems encountered and implant locations.
Annex D is in regards to the hemolysis tests and the specifics such as wave length used and pass fail criteria.
Annex E discusses the complement testing
Annex F is less common tests but not a lot of discussion about them.
Finally, Annex G specifies that APTT, PT and TT, bleeding time, reticulocyte counts and complement evaluations of CH-50, C3 and C5 convertases are not recommended.
