Regulatory Focus™ > News Articles > 2019 > 6 > IVDs Top the List of Devices Seeing Field Safety Corrective Actions, Report Shows

Regulatory NewsRegulatory News
Posted 24 June 2019 | By Ana Mulero 

IVDs Top the List of Devices Seeing Field Safety Corrective Actions, Report Shows

2915 More field safety corrective actions (FSCAs) were issued for in vitro diagnostic (IVD) devices than any other device types in the first half of 2019, according to a report published Monday by UK-based MedBoard.
The graphic below shows that IVDs FSCAs totaled 1,251 at the top, followed by cardiology and radiology. The highest number of IVDs FSCAs were reported in Switzerland, the US, Germany, Italy and the UK. Yet IVDs FSCAs were ranked the highest in the European region, the Asia-Pacific region and Brazil, while cardiology and orthopedics were higher in North America. 

MedBoard CEO and founder Ivan Perez referred to the predominance of IVDs FSCAs in all analytics and charts as “remarkable” and said, “it will be interesting to see how these figures evolve in the future, especially with the increasing development of software and IVDs.”
Another factor Perez said could influence the figures regarding IVDs FSCAs relates to the implementation of the EU in vitro diagnostic regulation (IVDR) as 80% of IVDs will require a level of notified body certification under IVDR from 26 May 2024. “It is noticeable though, that in terms of IVDs, Switzerland recorded more IVDs FSCAs than the US,” Perez told Focus.
Out of 5,557 FSCAs from the 21 markets published between 1 January through 15 June, 12 EU markets represent an aggregate total of 3,124 FSCAs. Most of the FSCAs in Europe were concentrated in Switzerland (519), followed by Germany (444), Italy (350), Spain (328) and the UK (302). The EU’s total is higher than the totals in all other regions for the same time period but there were still 1,279 FSCAs in North America, 1,000 in the Asia-Pacific region and 154 in Brazil, as the graphic below illustrates. 

The mid-year report also ranks FSCAs by manufacturers. Out of 744 manufacturers that have had FSCAs in the 21 countries this year, Philips, Abbott and Siemens have the most with between 200 and 300 FSCAs each. Zimmer Biomet, Medtronic, GE Healthcare and Maquet Cardiovascular each had between 150 and 200 FSCAs each.
MedBoard will also make public a comparison report with the previous three years in the coming weeks to provide some perspective on the data seen in the mid-year report, according to Perez.
MedBoard Report


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy
No data found