Far from being frowned upon, complaints should serve as an opportunity for medical device manufacturers to understand the customer’s expectations better and lead to improvements in the product quality.
The FDA describes a complaint as “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution”.
FDA’s complaint handling guidelines are critical for ensuring that an organization maintains safety with regard to the medical devices they manufacture. Errors in medical devices can result in complaints, and improper handling of complaints can lead to problems for the patient, ranging from injury to fatality.
It is to prevent these problems that the FDA has issued complaint handling guidelines. FDA’s thinking is based on the reasoning that a complaint may be an indicator of serious safety, but implementing effective complaint handling guidelines can greatly mollify the gravity of the issue. It is also the first step to initiating new product development, which in turn has the potential to greatly reduce risks associated with noncompliance.
Regulations in place
Provisions relating to effective complaint handling provisions are contained in FDA 21 CFR Part 820 and GxP regulations.
Firstly, these complaint handling guidelines require medical device manufacturers to maintain complaint files. Manufacturers have to make this the first step towards establishing a sustainable complaint management system.
Secondly, Section 198 of Part 820 warrants the following:
What should records of investigation contain?
Records of investigation should contain the following:
- Identifiers related to the device and reported event
- If Medical Device Reporting is made, it should investigate the following:
- Whether there were any specifications the device failed to meet
- Whether it was for treatment or for diagnosis that the device was being used
- In what way the device was related to the reported event, if applicable