Medical Device FAQ
What additional insured status do medical device GPO and hospital contracts require?
Hospital purchase agreements and GPO contracts almost always require the manufacturer to name the hospital, health system, or GPO as an additional insured for products and completed operations, frequently on a primary and non-contributory basis. For a device maker, products and completed operations is the operation, so this is the load-bearing requirement.
The gap that catches manufacturers is that most commercial general liability policies provide blanket additional-insured for ongoing operations but exclude products and completed operations from that blanket. A device company that assumes its blanket AI endorsement satisfies a hospital contract can discover at contract review that the products/completed-ops piece is missing.
The fix is an endorsement that extends additional-insured status to products and completed operations - the ISO CG 20 37 or a manuscripted blanket equivalent - added before the contract effective date, along with primary and non-contributory wording where required. Confirming the endorsement schedule against each hospital or GPO contract is a standard part of onboarding a new purchase agreement.
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