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 have had several early-stage device company clients who are interested to get to "First In Man" (FIM) clinical use without breaking the bank. My job is to save the client enough money so they can pay my fee and have money left over for other things (like a great Christmas Party). If device sterilization is a requirement, you do not need to perform a comprehensive (full) sterilization validation study before FIM. You can ensure adequate sterility assurance on a "batch release" basis, and save the time (and money) needed to perform a full validation. For ethylene oxide (EO) sterilization of devices with a "nonpyrogenic" label claim, the following sequence of tests and batch releases can be performed to achieve full validation status per ISO 11135-1. 0. Presterilization Bioburden Enumeration and Extraction Efficiency

Damn standards! It is hard enough to keep up with the latest revisions, but even if you achieve that, who has time to actually read them to see what the changes are? Is it necessary to get all of the "different" versions of what appears to be the same standard? ISO vs. EN ISO (harmonised or not) vs. BS EN ISO vs. ANSI/AAMI/ISO .... YUCK!  Here is what I do. 1. Purchase ANSI/AAMI/ISO standard from AAMI. Why purchase from AAMI? Because they are the most economical source I have found for many medical device ISO/IEC standards if you purchase their AAMI Standards on CD Complete Collection . 2. Look at "Glossary of equivalent standards" in the ANSI/AAMI standard to see if the ANSI/AAMI version you have is "Identical" to the corresponding ISO/IEC standard. Most often, it is identical. Do not buy the pure ISO/IEC version if the ANSI/AAMI version is identical - you would be wasting your money. 3. To prove equivalence between the "normativ

Sam Lazzara Resume LinkedIn Profile   Documents Services Schedule Call   +1 510 397 9739 sam@lazzara.net Much can be learned by reading medical device labeling and promotional materials - particularly Instructions For Use (IFUs) and other safety-related information.  The IFUs of your competitors or quasi-competitors are excellent tools to facilitate product development and risk management. However, when it comes to finding labeling content on the internet, beggars cannot be choosers. Here is what this beggar has found so far: Abbott Vascular IFUs Boston Scientific Products Keep clicking and you should find "Prescriptive Information" and sometimes "Directions For Use". You can even sign up for email updates when the "DFU" is revised.  Product Safety Information How helpful! Cook Medical CR Bard No IFUs - just general product information.   ev3/Covidien Product Catalogs ev3/Covidien "Neuro" Products (

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 gram-negative bacteria release endot

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, and shall

Sam Lazzara Resume LinkedIn Profile   Documents Services Schedule Call   +1 510 397 9739 sam@lazzara.net Does your organization's Quality Policy inspire you, or tire you? First, let's review US FDA and ISO 13485 requirements and ISO 14969 guidance. After that, I am sharing my current "state of the art" model for a Quality Policy and corresponding Quality Objectives. Quality Policy Definitions ISO 9000:2005 - Overall intentions and direction of an organization related to quality as formally expressed by top management. US FDA 21 CFR 820 - Quality policy means the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility. US FDA 21 CFR 820.20 Management responsibility (a) Quality policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality p

Sam Lazzara Resume LinkedIn Profile   Documents Services Schedule Call   +1 510 397 9739 sam@lazzara.net This link shows quality system registrars who are recognized by Health Canada:  Health Canada Happy Registrar List The fact that these bodies have gone to the trouble and expense of seeking Canada recognition is indicative of their commitment to medical device quality system registration. If you ever want to market devices in Canada you will need to be using one of those registrars. Canada will only accept quality system certificates that have been issued by special third party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars.  There are 74 Notified Bodies for the Europe Medical Device Directive (MDD) and 19 Notified Bodies for the Active Implantable Medical Device Directive (AIMDD).  - 14 of the "MDD 74" are on the Canada list - 8 of the "AIMDD 19" are on the Canada list