Greetings to all my colleagues once again.
I have a few ‘Metrological Retreats’ every year, where I find myself with more old friends than I can count. I can also say that I never leave without a sizeable amount of new knowledge to take away, and if you haven’t had a chance to attend an NCSLI or MSC Conference, I can’t stress enough what you’re missing.
I can remember the days when I once attended these conferences as nothing more than a guest, but those days were fairly short lived, and over the years I’ve contributed an increasing amount of my time volunteering, teaching and presenting. This has provided insights into what it takes to make these venues a success, as well as making countless friendships, too.
This conference being no exception to the rule, I felt it would be nice to write a quick report from my perspective.
I was happy to again present my ongoing tutorial, ‘Healthcare Metrology Program Documentation Best Practices’ which has been quite successful and well-attended, as well as presenting two papers this year, which kept me quite busy as usual. One of the sessions in which I presented was developed by Walter Nowocin of MedTronic, Inc., who was awarded Best Session for his work preparing it. Walter chairs the NCSLI Healthcare Metrology Committee, which is a very dear resource to so many of us in our industry, so I was happy to see this award go to ‘one of our own’.
In total there were three sessions that had dedicated Healthcare Metrology content, which is an encouraging development for the healthcare industry; we are building momentum not only in conference participation, but also in attendance. The Healthcare Metrology Committee meetings were the most heavily attended that I can recall since I’ve attended the MSC, which further confirms my observations. Much of the meeting agenda was centered on the upcoming rewrite of NCSLI RP-6 – Calibration Quality Systems for the Healthcare Industries.
Jun Bautista of Genzyme presented ‘Impact of Proposed Changes to USP 41 & USP 1251 on Healthcare Industry’. This was a particularly unique perspective and forecast as Jun, an active member of the Healthcare Metrology Committee, participated on the rewrite of both of these USP documents. Ian Ciesniewski of Mettler Toledo followed up additional details on these National Formulary chapters and technical notes.
Roberto Benitez presented ‘Healthcare Metrology vs. Industrial Metrology’, which was an interesting case study on this field in Mexico. Jay Bucher of Bucherview Metrology presented ‘Slaying Your Dragons – Educating The ISO and FDA Auditor/Inspector about Calibration, Traceablity and Uncertainty’, which dealt with the ever present reality and strategies of regulatory audits. Walter Nowocin presented ‘What We Can Learn from Calibration Related FDA Warning Letters’, an overview of the most recent FDA Warning letters and Form 483s.