Pitfalls and traps in medical device & biotech documentation
Connie Hoy, VP of RA-QA at Cutera, discussed essentials of document writing to avoid the pitfalls and traps, 483s, consent decrees, lawsuits, and litigation, at http://www.bio2devicegroup.org event. With clear and precise examples, the presentation highlighted some of the common mistakes that are made in generating documentation that can lead to non-conformities during inspections and costly payments during litigation.
Any kind of vague and ambiguous language should be avoided in the documents. The traps described below, may seem easy to avoid but in reality, it is easy to fall into those traps.
1) Writing in a passive voice: This is a trap where the subject of the sentence denotes the recipient of the action, rather than the performer. For instance, “injury occurred to patient” instead of “the patient was injured”. Writing in a passive voice will make it more challenging to get past the FDA and it should be avoided in complaints, non conforming investigation, CAPA etc.
2) Not presenting the facts: Documents should contain facts. What would constitute facts? A fact is what can be checked and verified by the observer. For instance, “the drug was used in animal study comprising of 8 dogs and no side effects were observed”, as opposed to “the drug is safe” or “cause of the problem is due to user error”. A substantiated statement, consisting of a fact, provides justification for the reader to believe that what is written is, in fact true.
3) Incomplete or ambiguous documentation: Documents should not be incomplete, unfinished, imperfect, or left uncertain.
4) Too much information: Documents should be concise, complete, self-contained, an auditable. Too much information lends itself to the possibility of vagueness and ambiguity. If needed, additional information (e.g. back and forth email exchange) should be included in the addendum. Concise documentation should be appropriately filed so it is easy to retrieve, when needed. During an audit, how quickly documents are retrieved can often give an indication of their brevity and completeness.
5) Email sandwich: Avoid email sandwich where a document is followed by emails and that is followed by a document. When necessary, the emails should be referred to in the document and filed separately in the appendix.
6) Not distinguishing between correctness and corrective action: A correction is an action to eliminate a detected non conformity and may include, rework, upgrade, recall etc. A corrective action is an action to eliminate the cause of a detected non-conformity, and may involve design change to prevent recurrence of the issue. And a preventive action is an action to eliminate the cause of the potential non-conformity or other undesirable situation and it may include for instance, a design change to prevent occurrence of the issue.
The interactive presentation included many with real life examples and brainstorming with the group. In conclusion, Hoy shared real-life example where in 2010, Cutera had earned several adverse reports that were MDRs on its Titan Handpiece. She discussed the steps that were taken and included opening a CAPA, doing an investigation using returned handpieces and new handpieces, determining that the root cause was parts failure due to material used in the part, taking corrective action of redesigning the part, performing a health hazard evaluation that determined that the company needed to conduct a recall, recalling 100% of the handpieces and replacing defective parts i.e. doing correction, updating risk management file, and finally taking preventive action with new material to be used in all new designs.
The presentation was followed by Q&A. Connie Hoy can be reached at email@example.com .