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Medical Device Complaint Handling Practices

A Compliance-Alliance survey 


Nancy Singer



In 2005, FDA cited medical device firms for deficiencies in their complaint handling procedures more frequently than in any other area.

Many firms could improve their systems by comparing them with others. To help firms do this, Nancy Singer , Compliance-Alliance teamed up with Richard DeRisio of KCI. The survey asked about key elements in complaint handling procedures.

The survey had 30 questions , asking individuals to fill it out anonymously.

Below is a preliminary analysis of the results covering :


Demographic Information

Number of FTEs Processing Complaints

Interesting Insights

Commercial Software Applications

Motivating Customers and In-House Personnel to Report Complaints

Getting the Device Back From the Customer

Not Investigating Complaints

Goal for Closing Complaints

Demographic Information

* 232 industry representatives completed the survey
*   37 firms manufacture Class I devices
* 145 firms manufacture Class II devices
*   50 firms manufacture Class III devices 

Number of FTEs Processing Complaints

On average, the number of FTEs processing complaints was related to the number of employees in the firm.

*    0 - 100 employees            : 1 FTE processes complaints
* 101 - 10,000 employees       : 2 - 5 FTEs process complaints
* 10,001 - 50,000 employees   :  6 - 10 FTEs process complaints




Nancy Singer founded Compliance-Alliance LLC to specialize in professional development for those employed in the drug and medical device industries. Previously she was the founder and the Executive Director of the Medical Technology Learning Institute, an educational entity within AdvaMed that provides training on FDA/CMS regulatory requirements. She also served as AdvaMed's Special Counsel for FDA compliance and enforcement matters. In her role as Special Counsel, Nancy was a member of the FDA/industry working group that evaluated and suggested reforms to the FDA inspectional process.


She then represented the industry on the working group that conceived and validated the procedures for the Quality System Inspection Technique (QSIT). She served as the industry spokesperson on the educational programs that taught QSIT to representatives of FDA and the medical device industry. For her efforts, she received Vice President Gore's Reinventing Government Hammer Award and the FDA Commissioner's Special Citation Award.
Nancy's email address is

Interesting Insights

  • Only 85% of firms are screening service calls to see if they meet the definition of a complaint.

  • Only 62% routinely send an acknowledgement to the complainant.

  • Only 34% always send a letter to the complainant following closure of complaints.

Commercial Software Applications

23% reported using a commercial software application to process complaints.

Firms generally like the following features in their applications:

  • Easy to use

  • Effective in capturing consumer and product information, automatic response generation, tracking, and reporting

  • Global system: all of the divisions can use the same system

  • Powerful search capabilities; easy to sort types of complaints

  • MDR and Vigilance Reporting forms are built into the database

Firms generally dislike the following features in their software applications (i.e., questions that firms should ask when evaluating a web-based system):

  • Long configuration time
  • Training employees is a challenge
  • Difficulty in generating reports
  • Annual cost of updates and maintenance
  • Difficult to modify the program to meet firm's needs

Motivating Customers and In-House Personnel to Report Complaints

Survey respondents use the following tactics to motivate customers to report complaints:

  • Provide easy access for communication (toll free #, web site, receptive sales reps.)
  • Build a relationship by letting customers know you are trying to solve the problem
  • Provide technical assistance to facilitate proper device use
  • Go beyond the reported complaint to ensure total customer satisfaction
  • Make it easy for the customer to obtain a free replacement for a defective device

Survey respondents use the following tactics to motivate in-house personnel to report complaints:

  • Have top management reinforce the value to the business of effective complaint handling
  • Design a simple reporting form and provide training on its use
  • Publicize actions taken in response to issues raised by complaints.
  • Provide positive reinforcement for reporting, analyzing and acting upon complaints

Getting the Device Back From the Customer

65% report difficulty in this area.

Survey respondents used the following tactics to motivate people to return the device:

  • Be responsive: Have a courier or salesperson personally pick up the product
  • Provide free shipping and product replacement or credit
  • Continue to follow up with the customer until the firm gets the product back
  • Tell customers about the importance of their feedback in improving product quality
  • Provide information on corrective and preventive actions

Not Investigating Complaints

The most popular reasons cited for not investigating complaints include:

  • Complaint is for a product not manufactured by the firm (55%)

  • An adequate investigation of the alleged compliant failure mode has already been preformed (55%)

  • Corrective action is already open for the same failure mode (52%)

  • A failure investigation is already open for the same complaint (39%)

  • Complaint does not involve a possible failure of the device, labeling, or packaging to meet specifications (35%)

  • Firm is unable to obtain the device for analysis (21%)
    (The preamble to the QS Regulation contains information regarding making a "good faith" effort to recover devices. An investigation can include, for example, testing similar devices (e.g., same lot), reviewing DHRs and complaint historical data.)

Closing Complaints

Firms use the following criteria in determining when a complaint is considered closed:

  • A corrective action has been initiated or it has been determined that no action is required (42%)
  • A corrective action is reported (23%)
  • A failure investigation has been completed (20%)
  • A corrective action has been completed (1%)
  • Other (14%)

Goal for Closing Complaints

Firms reported the following time frames as a goal for closing complaints:

*     Less than 30 calendar days (37%)

  • 31 - 45 calendar days (18%)

  • 40 - 60 calendar days (23%)

  • More than 60 calendar days (1%) (These are probably the   firms who close complaints after the corrective action is implemented and closed.)

  • 16% Other

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