The Next Era in GI Surgery BioDynamixTM Anastomosis The Colon Ring FORMS AND PROTOCOLS Clinical Training Team
DATA COLLECTION It is important for us to gather and document information apropos to the Preop and Intraop Data Forms. In order to document communication of appropriate instructions and information concerning use of the ColonRingtm (Preop Form) and to demonstrate results in sufficient patients (Intraop Form), completion of these forms is our only way to obtain meaningful data. Most of our reps have expressed regret at not having enough controlled clinical data, but gathering accurate commercial data should go a long way to demonstrate meaningful results that can be shared with our surgeons. Also, since virtually all of the early users among our surgeons will acknowledge the importance of obtaining that kind of data, they will most likely be willing to assist us in providing that information. I would suggest the following routine:
PREOP DATA FORM During one of your initial visits with a surgeon interested and willing to use the ColonRingtm, discuss the items listed on the Preop Form with the surgeon and complete the form electronically as soon as possible after the visit. Once completed, the form should be emailed to Joanna McNamara and Wendell Eicher so the data can be filed. This Preop data is important for: Identifying appropriate contact information for the surgeon. Verifying what has been discussed with the surgeon as well as when. Allowing clinical coverage personnel to have access to contact information and usage preferences when you are not present.
PREOP DATA FORM ......ClinicalSurgical CasesCAR 27 DataBaseIndividual Case DataFormsField_Data_Preop.doc
INTRAOP DATA FORM When you are present for a case, gather the appropriate data requested on the Intraop Data Form during the case, asking clarification from the surgeon as necessary, and complete the form electronically as soon as possible after the visit. Once completed, the form should be emailed to Joanna McNamara and Wendell Eicher so the data can be filed. This Intraop data is important for: Identifying appropriate contact information for the surgeon for subsequent follow-up as necessary. Documenting essential information from the case which may help in: Allowing better analysis of overall outcome data. Allowing better understanding of any subsequent adverse event.
INTRAOP DATA FORM ......ClinicalSurgical CasesCAR 27 DataBaseIndividual Case DataFormsField_Data_Intraop.doc
Phase III Evaluation Form This form will be used to evaluate personnel during their Phase III training. Any fully certified NiTi employee will be expected to complete this form (in Excel format it may be completed electronically) and email it back to me for recording it on file. ....CertificationsCertification ProcessPhase III EvaluationsBLANK PHASE III EVAL FORM.xls
NiTi Surgical Field Training May 11th, 2011 Customer Complaints John McInroy May 2011
What is a Complaint? Definition of a Complaint from QA-13-02 Any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, efficacy or performance of a device after it is released for distribution. Why do the FDA and other organizations take complaints so seriously? 9
What is NOT a Complaint? Deficiencies that, unequivocally, are not caused by NiTi Surgical Solutions Ltd. Products, Commercial Dispute, Deficiencies that are reported during R&D validation stage (i.e., before their formal release for marketing), Inquiries for information. 10
FDA Complaint Non-Conformances The number one reason for writing a non-conformance was because complaint handling procedures were inadequate. All complaints are processed in a uniform and timely manner; Oral complaints are documented upon receipt; and Complaints are evaluated to determine whether the complaint represents an event that must be reported to the FDA. 11
FDA Observations (cited in warning letters) “...You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties....” 12
Complaint Process Flow Complaint Receipt Complaint Ack. letter NiTi US Function NiTi Israel Functions Reporting 5 day or 30 day? Corrective / Preventive Action? Investigation No No Yes Yes Report MDR Close Complaint Initiate CAPA Trending 13
US Field Complaint Responsibilities Complete Customer Complaint form No. 1 (F-13-02-1) First 2 pages are a must for all complaints ! Only when it is a clinical issue complaint, complete App. A (3 pages) of the form Forward information to appropriate CS personnel Report ASAP – time is critical (MDR reporting) 14
Specific Issues Requiring Attention Complete every field or use N/A Lack of date consistency (DD/MMM/YY) Omission of contact information Only use CURRENT revision of form Double check that what was filled-in is appropriate for the form fields 15
Specific Issues Requiring Attention (cont) Keep email referencing a single device/event if possible Do not change the forms, as they are written Corrections, if hand written should be made with one line through, initial and date (all docs) F-13-02-1 Rev 06 Customer Complaint Form No.1 16
ADVERSE EVENT REPORT ......ClinicalSurgical CasesCustomer Complaint FormsF-13-02-1 Rev 06 Customer Complaint Form No. 1 For Users.doc
Doing it “right the first time” can save time and money
Being “out of compliance” can have harsh consequences
Process starts with US Sales, continues to Israel CS/QA/RA and mostly ends up at FDA.