The International Medical Device Regulators Form has proposed a new system for reporting adverse events related to medical devices that will provide consistency for and reduce the burden on manufacturers.
The new system will include four lists of terms and numerical codes, only one of which (Annex A) has been released. Annex A contains 366 terms and codes for describing malfunctions and other problems with medical devices that have occurred in pre-or post-market contexts such as clinical studies and evaluations.
Annexes B, C, and D will be released shortly and will contain terms and codes for cause investigations, patient problems, and device components respectively.
Although parts of it could use more development, the document is “a solid start to achieving a common vision for adverse event definitions, designations and coding,” said Jack Garvey, principal and CEO of Compliance Architects.
He said adverse event reporting provides “the core, raw data for a company’s internal product-risk signal-detection capability,” allows regulators to aggregate and review trends and relationships between adverse events, and helps them analyze the role of those events in healthcare delivery.
“This data and the resultant reporting are essential for early identification of risky or dangerous products, and in helping these products to get corrected in the field, or removed from the market,” he said.
Garvey noted that quality data are crucial for performing good causal analyses and reaching accurate conclusions.
“By proposing core elements of a uniform, global framework with defined terminology — including improved definitions — along with more precise coding for analysis, both companies and regulators may eventually have larger, higher-quality data sets, permitting increased signal detection capability, giving regulators much earlier insight into product problems,” he said.
Nancy A. Pressly, acting deputy director in the Office of Communication and Education at the FDA’s Center for Devices and Radiological Health, said the Adverse Event Terminology Working Group will review public comments and incorporate any necessary changes.
The public comment period for all four annexes closes Dec. 2, 2016. It is expected that the final versions will be submitted to the IMDRF management committee in February 2017.