Devine Guidance
Complaint Files – Stop the Complaining

Dr. Christopher Joseph Devine, President, Devine Guidance International

Sometimes it seems like the telephone just will not stop ringing. If you work for a medical device manufacturer and are tasked with managing customer complaints, you just might want to scream. However, if the product complaints are beginning to pile up, take notice, for your customers are trying to tell you something. If you fail to address customer complaints or concerns, eventually the phone will stop ringing. Why? Well if you have to ask why, then all hope is lost. However, the doctor is obliged to provide an answer to the age-old question why. The phone will stop ringing, because your competition will be taking care of your customers. However, your organization will probably not be off the proverbial hook. FDA may show up for a cup of coffee and an unannounced inspection in an attempt to understand what in the heck is going on with your medical device manufacturing establishment. In fact, it is the doctor’s personal observation that when a device establishment is racking up large numbers of complaints, the numbers of MDRs are increasing accordingly; and that is what attracts the agency’s attention. So stop complaining and enjoy this week’s guidance; and remember, Dr. D’s guidance is never marked by “tergiversation” (look-it-up).
 
Subpart M—Records
Sec. 820.198 Complaint files
(a) Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Such procedures shall ensure that:
  1. All complaints are processed in a uniform and timely manner;
  2. Oral complaints are documented upon receipt; and
  3. Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 of this chapter, Medical Device Reporting.
(b) Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate.
 
(c) Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary.
 
(d) Any complaint that represents an event which must be reported to FDA under part 803 of this chapter shall be promptly reviewed, evaluated, and investigated by a designated individual(s) and shall be maintained in a separate portion of the complaint files or otherwise clearly identified. In addition to the information required by 820.198(e), records of investigation under this paragraph shall include a determination of:
  1. Whether the device failed to meet specifications;
  2. Whether the device was being used for treatment or diagnosis; and
  3. The relationship, if any, of the device to the reported incident or adverse event.
(e) When an investigation is made under this section, a record of the investigation shall be maintained by the formally designated unit identified in paragraph (a) of this section. The record of investigation shall include:
  1. The name of the device;
  2. The date the complaint was received;
  3. Any device identification(s) and control number(s) used;
  4. The name, address, and phone number of the complainant;
  5. The nature and details of the complaint;
  6. The dates and results of the investigation;
  7. Any corrective action taken; and
  8. Any reply to the complainant.
(f) When the manufacturer’s formally designated complaint unit is located at a site separate from the manufacturing establishment, the investigated complaint(s) and the record(s) of investigation shall be reasonably accessible to the manufacturing establishment.
 
(g) If a manufacturer’s formally designated complaint unit is located outside of the United States, records required by this section shall be reasonably accessible in the United States at either:
  1. A location in the United States where the manufacturer’s records are regularly kept; or
  2. The location of the initial distributor.
Complaints
The doctor is going to begin by stating; “You need to script a procedure that addresses§820.198;” however, do not stop there. The complaint procedure also needs to link to Medical Device Reports (MDR) and the need to file MDRs within five or 30-days. In fact, the complaint management procedure should have a direct link to whatever document your organization employs for 21 CFR, Part 803, Medical Device Reporting. If your establishment is selling product into the European Union (EU), then a link to the requirements delineated within MEDDEV 2.12-1, Revision 7, Guidelines on a Medical Devices Vigilance System, is also warranted.

If you choose to do so, you can make one cohesive complaint management SOP that covers all bases. However, as your organization progresses into multiple markets, the requirements will start to multiply, as well. The doctor is not going to waste the time of the readers by reviewing all of the tiny nuances needing to be addressed in a SOP. You can purchase Devine Guidance for Complying with the FDA’s QSR from Amazon.com. However, Dr. D is going to address the salient requirements that a complaint management procedure needs to encompass.

Essential elements of a complaint management SOP
So what are the essential elements of complaint management? Once the SOP has been scripted, it starts with training. Obviously, the in-house folks tasked with managing complaints need to be trained. However, do not forget about the front-line employees, the sales force.

Regardless of how benign a customer complaint might appear to be, it needs to be reported. For example, if a physician puts an itsy-bitsy-teeny-weeny hole in a surgical glove because of a sharp edge on a catheter handle, that is a complaint. Is it going to be an MDR, probably not? If a device fails to work out of the box it is going to be a complaint. Is it going to be an MDR, probably not? If a member of your sales team is reading a medical journal and stumbles upon an article that “disparages” (look-it-up) on of your organization’s medical devices, that my friends is a reportable complaint. Is it going to be an MDR? It depends and Dr. D is not talking about adult diapers. The need to report will be premised on the outcome of the investigation. 

 That being said, essential elements of a complaint management SOP are:
  • Collecting basic complaint information (read §820.198 for specifics);
  • Recovering the device that the complaint is premised on;
  • Decontaminating the device, if it has been used;
  • Performing a thorough root cause investigation;
  • Employing a decision tree to determine if the complaint is reportable as and MDR in the United States (reference Part 803); a vigilance report in the EU (reference MEDDEV 2.12-1); or reportable elsewhere;
  • If deemed necessary and appropriate, opening a Corrective Action in the CAPA System to address and correct the complaint;
  • Making sure all complaints are reviewed and approved by a person with a clinical/medical background (note: should be a physician, nurse practitioner, or registered nurse); and
  • Sending a follow-up letter to the complainant, if one is requested (a well-worded professional response always a nice gesture). 
Takeaways
For this week’s guidance, the doctor will leave the readers with five takeaways.
One – if you receive a complaint, consider it valuable feedback from your customer. They are reaching out to your organization.
Two – always perform an in-depth failure investigation.
Three – not all complaints are required to be reported as MDRs; however, you better make sure that the complaints that rate as MDRs are reported.
Four – ensure an individual with a clinical/medical background reviews and approves all complaints.
Five – if your organization fails to correct the issues associated with a complaint, trust the doctor when I say; “Your competition will gladly help your customers move their business!”
In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success. 

References: 

  1. Code of Federal Regulation. (2013, April). Title 21 Part 803: Medical device reporting. Washington, D.C.: U. S. Government Printing Office.
  2. Code of Federal Regulation. (2013, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
  3. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
  4. MEDDEV 2.12-1, Revision 7. (2012, March). Guidelines on a medical device vigilance system. Retrieved September 26, 2013, from http://www.obelis.net/docs/Guidelines_MEDDEV_212-1_rev7_march_2012.pdf
 
 

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