Sam Lazzara's Medical Device Quality Central Blog

Sam Lazzara Resume LinkedIn Profile   Documents Services Schedule Call   +1 510 397 9739 sam@lazzara.net "I am not a microbiologist but I play one on TV!" Pyrogens are substances that cause fever in humans. Pyrogenicity is the ability of a chemical agent or other substance to produce a febrile response. Pyrogenic  responses may be material-mediated, endotoxin-mediated, or mediated by other substances, such as  components of gram-positive bacteria and fungi. Material-mediated pyrogenicity This type of pyrogenicity originates from non-endotoxin substances.  The LAL test is not suitable for determining the pyrogenicity of these  substances.  For detection of material-mediated pyrogenicity, the rabbit pyrogen test  is generally recommended even though endotoxin could cause a pyrogenic response in the rabbits. Endotoxin-mediated pyrogenicity While sterilization kills bacteria, the dead cell walls (which in some gr...

Sam Lazzara Resume LinkedIn Profile   Documents Services Schedule Call   +1 510 397 9739 sam@lazzara.net Did you ever notice that in most judicial systems, the Judge is independent from the Plaintiff and Defendant? And in most sporting events there are (presumably) impartial judges and referees? It is generally accepted that personnel who are independent of an activity are more objective (impartial) than persons who are directly responsible for the success of the work. This belief has influenced medical device regulation and standards significantly, and the trend continues. Here are some examples of requirements for independence. RESPONSIBILITY ISO 13485:2003 clause 5.5.1 --> Top management shall ensure that r esponsibilities and authorities are defined, documented and communicated within the organization. Top management shall establish the interrelation of all personnel who manage, perform and verify work affecting quality, ...