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We all know that documents are important because they prove to everyone, including FDA, what is going on with your design and manufacturing processes. But a lot of device companies tend to forget that they are also important because they can show whether a firm placed revenue goals ahead of patient-safety ones.

March 5, 2008

1 Min Read
Risk Avoidance Writing: A Necessary Tool for Device Personnel

And that can not only get a firm in trouble with FDA, but also expose it to product-liability lawsuits.With that in mind, Nancy Singer, president of Compliance-Alliance Inc. and a member of MD&DI's Editorial Advisory Board, has recently been offering a course on risk avoidance writing. The premise is that writing your documents properly -- and yes, that includes emails -- can help you avoid unnecessary consequences. A memo that seems insignificant can hold just as much weight in court or during an FDA inspection as a whole series of process validation documents. "Documents are like diamonds," Singer said. "They are very precious, and they last forever."Proper writing is one key to showing outsiders that you are doing the right thing. For example, certain "dangerous words" must be avoided. In memos, it is best to just state facts and not editorialize negatively; this can be seized upon by an FDA inspector, a plaintiff lawyer, or a jury. Words to be avoided include "illegal," "attack," "excuse," "shortcut," "wrongful," "catastrophic," and "misleading." There are ways to convey concern without using words that imply that someone at the firm has done something malicious or indicate that the firm has placed profits ahead of patients. Equally bad are words that obfuscate instead of clarify; those may make it seem like a firm has something to hide.Singer has given this presentation for several companies and at a few events, and will be giving it again in a preconference workshop at the Medical Device Regulatory, Reimbursement, and Compliance Congress at Harvard University on March 26.

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