When is a device officially a medical device? And when is a distributor officially a manufacturer? The US Food and Drug Administration's (FDA's) latest warning letter to Rhode Island-based Medsource may raise some new questions from companies that don't realize they have to abide by FDA regulations.
In the case of Medsource, FDA decided that its distribution of orthopedic surgical instrument trays means it is a device manufacturer and distributor because the products "are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body."
On its website, Medsource describes itself as only a distributor of other manufacturers' orthopedic products, sports medicine equipment and physical therapy products.
The agency's inspection of Medsource's device operations in March found that the company failed to properly control its storage areas and stock rooms to prevent "mix-ups, damage, deterioration, contamination or other adverse effects pending use or distribution."
Inspectors also found that orthopedic trays awaiting delivery to customers were stored immediately next to an area where employees inspected trays already used in surgery. Also, FDA found a container of gasoline immediately next to orthopedic trays and other instrument trays.
Medsource's failure to establish acceptance activities, even for devices being returned to its facility for further distribution, was also cited by FDA, as was its failure to establish and maintain procedures for verifying and validating corrective and preventive actions.
Other questions about the company's quality systems were raised.
The agency also told Medsource that it should be aware that one of the products it distributes -- Optecure + CCC (Allograft Demineralized Bone Matrix + CCC) -- is a medical device because when Demineralized Bone Matrix is combined with bone void filler, the ensuing product is considered a medical device, meaning "the methods used in, or the facilities or controls used for its manufacture, packing, storage, or installation should be in conformity with the Current Good Manufacturing Practice (CGMP) requirements for devices."
Medsource did not respond to a request for comment by press time. The company has until 15 October to respond to FDA.