The idea of leasing MIT1000a machines to individuals MUST include sufficient support and control by MIT on the lessees. Do you realize how much potential liability each MIT1000a represents? Many of the posters on this board seem to believe that widespread use of the MIT1000a will eliminate food poisoning outbreaks. My feeling is that use of the MIT1000a will greatly reduce the incidents, but never eliminate them totally because the process is based on SAMPLING, which is NEVER a guaranteed method because there is an economic tradeoff to be found between the number of samples to be taken versus the cost of the failure to take enough samples to guarantee 100% coverage.
I spent the early part of my engineering career with a company that made safety equipment for the offshore oil drilling industry. I know firsthand what it is like to be grilled during deposition hearings by attorneys for the families of the deceased or badly injured. These guys are merciless, cast their nets far and wide, and can magnify what would seem to be the slightest lack of foresight into a willful act of failure to practice due diligence. The company I worked for made a great product, had a good maintenance program for the equipment and excellent training programs for the crews that had to use the equipment in an emergency. Where management dropped the ball was in developing a quality assurance program to verify and record that requirements were being met on every one of our installations. Thus, the company was easy prey for lawyers, and its insurance rates went up so high that they wound up being taken over by a competitor.
When SGR posted that Mr. Brennan was open to suggestions from investors, I sent him an e-mail expressing my concerns on this issue. He never replied. I know that MIT is in a tight spot financially right now, but when the CERTS gets approved and the sales orders start rolling, in I hope that Mr. Brennan will have the time and funds to devote to addressing this problem. In my subsequent career, which was mainly in aerospace, I worked for highly technical companies which were certified per ISO-9001. I understand that there are standards for medical equipment such as ISO 13485 and others. It will be absolutely necessary that MIT get certified to an applicable ISO standard and make it mandatory that its lessees be trained in and comply to that ISO standard. Otherwise they would never be able to obtain or afford the liability insurance needed. But even if MIT drops the idea or leasing, getting certified to an applicable ISO standard will be of huge benefit to the company and its shareholders.
Question for Mr. Brennan at the Jan 5 DEMO. “DO YOU PLAN TO GET M.I.T. CERTIFIED PER ISO 13485 (or other more applicable standard) AS PART OF YOUR BUSINESS PLAN?
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Just one example of how working to an ISO Standard would upgrade MIT’s current method of operating the MIT1000a.
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The MIT User Guide Log Entry sheet shown on page 15 of the User Guide calls for the following data entries:
• Incubation Temperature
• Incubation Start (time and date)
• Incubation End (time and date)
The manual gives and operating range for the MIT1000 of 49F to 95F, but the important issue is the temp. of the machine while the sample was being tested because it should be in the
same range as the required Incubation Temp. There should also be a place for recording this in the log. Furthermore, I think any lawyer worth his salt would challenge the validity of using points of time for such critical data. A continuous temp. recording chart which is kept as part of the data package for the test would hold a lot more weight in a trial.
P.S. I hope that some of you attending the DEMO are familiar with ISO and can understand what I am talking about.
AI
