ok...first...already got into this w/ jackson...
forget china...YES...if you are outsourcing to there...cover your ass...AND...you HAVE to B FDA...approved...all that...
now...as lab owners...he was giving me a rash if :censored:...w/o actually...POINTING my lab name out...but...my "hobby shop" as he called it....was...NOT in COMPLIANCE...w/ FDA..BS...
actually..i had been doing everything ...well...almost everything...i was doing it...but it ALL wasn't being documented....
in short...i called the board...there IS CRAP we HAVE to be accountable for....WHEN that magic date is...??not sure...but here is what "jackson" says...AND...NADL...says it IS CORRECT...now, the part about a CDT onboard...EVERY lab..that is only a few states...NOT a nationwide thing...never heard it was part of the deal...
THIS...is what WE..as LAB OWNERS...are "supposed" to be doing...
COMPLIANCE
1) Carefully scrutinize the companies we choose to do business with, only selecting vendors with a proven track record of producing quality products, providing excellent training and standing behind those products. If it's a new company, or a little company, you are taking chances. There is one company who I have spoken about here who is private labeling ziconia. When I had problems with a product I bought from them, they went into radio silence and quit returning calls or e-mails. Would you stake your reputation and bank account on this kind of company? Do they have FDA registration for the application they are advertising, and do you have all the FDA mandated packaging and markings?
2) Review your products annually. What is an accepetable remake percentage? How is this product performing in-house and introarally? What is in the scientific (CRA) literature about it? Are the reports from the field favorable? Are you finding that certain types of cases are working better or worse than others? Does your experience contradict the manufacturers indicated uses? Should you keep doing this product?
3) Update your standard operation procedures and manufacturing protocol. Are you following the manufacturers most up-to-date instructions for use? Has anything been changed or updated since you were trained on the product, have they changed any perameters, formulas or materials? Have they added or changed any indications, contraindications? If you were trained by a contracted technician, did he teach you any shortcuts or tricks that disagree with the instructions for use? Did you get any certificates or licensing documentation? Is it properly filed and can it be renewed annually? Even if it's voluntary, do it. You need it if you start having failures.
Be sure every technician who touches a product is trained and documented to do that work, and keep track of everyone who touched a case. Never try out a new technician on a real case, and do not play with new techniques or materials on live cases.
4) Are you calibrated? We all saw the failures reported when zirconia frames were not being fired at the right temperatures and rate of climb. Those were just very minor differences, and they still looked perfect even though they were flawed. How will your products be affected if your equipment is not performing properly, and temperatures are too high or too low, or timing and cycle sequencing are off? If these products fail because of your machinery, whose fault is it? Yours or theirs?
5) Control Inventory. Have a strict process for who has access to materials that might be mishandled, contaminated or expired. Do not mix and match old materials and if new materials are released, resist your hoarding instincts and dispose of them. Have a process for checking that the materials you receive are what you ordered, and that you have a system in place to identify materials in the event of a recall. Only use qualified vendors and do not substitue any restorative constituents. Die stone yes. Opaque, NO.
6) Failures and corrective action The FDA has guidelines of what kind of products need to be reported in the event of a failure, and I have posted that material here before. Regardless of if you need to report failures, you still need to track them. The same thing with complaints or other problems. You also need a process for evaluating and taking corrective action. If you still have failures or if you suspect a product is faulty, you can still report this to the FDA. Maybe you are not alone, and lots of these things are going bad.
again...NOT my words...have to give credit to JACKSON for making this simple to read...
BUT THIS IS WHAT WE ARE REQUIRED TO DO...!!!!
hope this helps...
