FDA Says Medtronic Needs Followup Inspections to Confirm Corrections
The FDA hit two Medtronic device facilities with warning letters last week, citing faulty device history records and CAPA procedures.
In one warning letter following up on an April-May inspection of a Medtronic facility in Juncos, Puerto Rico, the agency noted the company failed to validate production processes for its Blackwell implantable cardiac defibrillators, leading to a recall. Medtronic promised to update its process validation and its change control process.
The inspection also found a failure to document certain activities in the device history records for the cardiac defibrillators. In response, the company committed to updating product identification and traceability procedures, as well as its training of new hired and manufacturing personnel. Medtronic further promised to implement tighter procedure controls for the defibrillators and assess manufacturing areas to identity similar problems elsewhere.
In the second warning letter to Medtronic concerning its cardiac rhythm and heart failure (CHRF) facility in Mounds View, Minnesota, the agency noted that an April/May inspection of the facility found design transfer was approved for the defibrillators prior to qualification of certain processes and the processes were implemented at the Juncos manufacturing facility even though a classification was never conducted.
In response to the findings, Medtronic committed to reviewing all manufacturing processes, and assessing any of the processes at issue for current implantable therapy and diagnostic devices to evaluate the validation status of all processes that were not fully verified.
The inspection also found the Juncos facility made a change to a manufacturing process without the approval of Medtronic CHRF as required by company procedures. In response, the facility promised to review CAPAs for the past year relating to CHRD products in the field and determine whether they were appropriately escalated to CRHF for review.
The FDA wrote in both warning letters that Medtronic’s responses to the issues appeared to be adequate, but that follow-up inspections will be necessary to confirm compliance.
Read the two letters here: www.fdanews.com/09-13-18-MedtronicWL.pdf. — Zack Budryk
Overused and Typically Inappropriate Corrective Actions An auditor or inspector can quickly get a sense of the quality of an investigation by looking at the number of events where “training” was the corrective action. Training is often the default solution because “human error” was the designated root cause. Training, as important as it is in developing knowledge and skills, should be the last option considered in your corrective actions. Why? It is the most unreliable and often most expensive solution because in and of itself, training rarely solves the underlying problem, meaning there will most likely be a recurrence. One other over-used corrective action is “changing the procedure,” which usually involves adding something to the SOP. Rarely does the investigation team simplify the procedure or redesign the task. James Reason, a noted professor of psychology who has studied human error, says that since the most common failure when using a procedure is to skip a step, it doesn’t make much sense to add something to a procedure — making it longer — and giving the user more things that can be potentially skipped. Einstein said that anyone can make something complicated; it takes a real genius to make it simple. Preventing recurrence of deviations requires that we do our creative best when coming up with a solution. There can be some confusion about the terms correction, corrective action and preventive action. According to definitions in ISO 9000-2005, a correction is the action used to eliminate a detected nonconformity while a corrective action is an action to eliminate the cause of a detected nonconformity. For example, if a labeling machine is putting crooked labels on bottles, the immediate action would be stopping the labeler; the correction would be removing the misplaced labels (if possible or scrapping the bottles altogether) and re-labeling them — you are fixing the thing that was affected. The corrective action would be fixing the labeler so it doesn’t put crooked labels on the bottles. A true preventive action might be looking at other labeling equipment at other sites (where the problem has not yet been seen) to identify if that same fix is appropriate. Preventive actions are those taken to eliminate the cause of a potential nonconformity. Excerpted from the FDAnews management report: Quality Management Essentials – Expert Advice on Building a Compliant System. |