New medical devices may introduce new risk exposures: Lloyd’s report

The trend in outsourcing the manufacturing of non-invasive medical devices could introduce new risk exposures, a Lloyd’s report warns.
The long-tail risk exposures for invasive medical devices could also increase due to expanding knowledge of technologies that were implemented years ago, it continues.
North American or European-based manufacturers of medical devices need to ensure that parts that are subcontracted overseas comply with all the necessary regulations, says the report, Medical devices: insuring innovation.
“Recall rates for these devices could increase if the manufacturing takes place outside countries with high compliance standards,” Stuart Sutherland, UK casualty manager for XL Insurance, told Lloyd’s.
It cites a decision in the United States, where insulin syringes, on sale at Wal-Mart, were recalled after a labelling mistake was discovered. “This could have led to patients receiving more than double the intended dose,” the report says.
Longer-term issues tend to surround the use of new technology, particularly for invasive devices, James McHugh, regional casualty manager at Catlin in London, told Lloyd’s.
“Use of exotic metals and new variations of silicone that weren’t used previously — that’s the kind of exposure that can develop its potential over several years.”
Lloyd’s cites coronary artery stents as an example of when new technology leads to new risks.
Stents, used to treat coronary disease and combined with anti-clogging agents, ensure that blood clots don’t form in the artery where the device is located.
But, patients are now developing long-term thrombosis several months after the stents have been implanted.
There are many unknowns connected with invasive devices, and medical device underwriters expect to see longer-tail risks in this area, the report continues.
“In such a specialist field, underwriters need to have a good grasp on the science and technology in order to make the right assessments,” the report says.