Among the data gathered in the Post-marketing Surveillance system there will be some reports which are considered to be “complaints”. These are defined as :
“Any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, safety or performance of a medical device that has been placed on the market”. (ISO 13485)
Under the quality system requirements:
“The supplier shall establish and maintain a documented feedback system to provide early warning of quality problems and for input into the corrective action system..... The supplier shall maintain records of all customer complaint investigations.... If any customer complaint is not followed by corrective and/or preventive action, the reason shall be recorded. …” (ISO 13485)
Thus, within his quality system, the manufacturer has to establish documented criteria for determining which events/incidents and reports are considered to be “complaints” (other than, for example, requests for routine refurbishment, return of obsolete (dated) stock, or other matters). These and similar decisions should be taken by appropriately qualified and properly trained personnel according to the company’s authorised documented procedures, appropriate records of all such decisions must be retained. The manufacturer must also have procedures and personnel for the analysis of data and condition details of returned devices and complaints.
As part of the requirement for Post-medical Surveillance systems, the Medical Device Directives quality system and verification annexes require that the manufacturer report certain adverse events or incidents associated with the use or function of devices to Competent Authorities:
“This undertaking must include an obligation for the manufacturer to notify the Competent Authorities of the following incidents immediately on learning of them ;
- any malfunction and deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
- any technical or medical reason connected with the characteristics or performance of a device leading for the reasons (above) to systematic recall of devices of the same type by the manufacturer.”
This requirement is known as “Medical Device Vigilance” and is further described in a Commission guidance document (Final draft guidelines on Medical Devices Vigilance system, 1993, still under revision). Information on events reported to one Competent Authority may be circulated to Competent Authorities in other Member States and to the European Commission itself.
As an additional item within the data and details collected through the Post-medical Surveillance system is relevant information on events which, by definition, must be reported as vigilance reports. The manufacturer must have the necessary documented procedures and appropriately trained and experienced staff for the evaluation and reporting of such events :
“If the European Standard is used for compliance with regulatory requirements, the supplier shall establish, document and maintain procedures to notify the regulatory authority of those incidents which meet the reporting criteria”. (EN 46001, clause 4.14)
Not all reports are confirmed on further investigation or require corrective action. For multinational manufacturers operating in the United States, it should be noted that the requiring criteria under European medical device vigilance and United States Food and Administration medical device reporting differ. The manufacturer should carefully review the respective reporting criteria with regard to its products and develop decision making algorithms accordingly.
Adverse event reporting requirements are also elements of current or proposed medical device regulatory schemes in other countries, e.g Australia, Canada, and Japan. Those requirements must also be considered when establishing complaints handling and event reporting functions of the quality system. At the international level, there is activity intended to harmonise reporting requirements and procedures.