FDA yesterday sent a warning letter to J&J’s DePuy Orthopaedics business relating to devices and components the company supplies as “custom” items under an exemption the company claims dates back to 1976. DePuy has subsequently issued a statement (covered on MassDevice) to the effect that it is to stop selling all of its custom fitted implants. MassDevice, in dialogue with DePuy has established that the cessation applies to all custom devices and components and not just the fourteen listed in the warning letter. Furthermore the hold is expected to be permanent.
The FDA letter can be found here. In it the agency claims that during inspections which took place between May and July of 2011 certain identified components were considered to have been “adulterated” because they are not approved for sale under Pre Market Approval (PMA) or Investigational Device Exemption (IDE) basis. FDA’s letter states that “some of the PFC Sigma Knee System components, Agility Total Ankle Prosthesis talar components and “Augments,” Global Advantage Shoulder System components, TriFlange Acetabular Cups, Femoral heads, and hip arthroplasty system adapters are adulterated, because your firm does not have approved applications for premarket approval (PMA), or approved applications for investigational device exemptions (IDE)”. In other words, you’ve modified approved products and thereby rendered them unapproved.
Company claims these were custom devices
The company response, by way of explanation as to why apparently “non-approved” devices were in existence lies in its statement that “Custom medical devices, which are provided at a physician’s request to meet a specific patient need, have been an allowed exemption to FDA premarket review under the Food, Drug, and Cosmetic Act since 1976”.
FDA helpfully defines custom devices
FDA’s retort is that a custom device should be exactly that, and goes on to list five defining criteria, such as the fact that a custom device should necessarily deviate from a device that is already available or an applicable regulatory standard. Furthermore it should not be readily available in finished form (ie it should be made on a custom basis, implying one-off) and is not generally available to other clinicians.
FDA suggests devices in question don’t meet the criteria of custom device
One of the firm’s procedures apparently describes the process by which it accepts requests from surgeons for products to match an individual patient’s anatomy (thereby rendering it a custom device). According to FDA the procedure contains a form, which appears to be completed by the Product Engineering staff (so not a clinician).
The inspection also claims that DePuy is utilizing existing lines of products that have FDA clearance or approval to manufacture these devices, so again is acting outwith its definition of custom.
DePuy’s procedures were also found to indicate that numbers of identical devices could be manufactured and “still be considered a “custom device” by your firm”.
Finally, in addition, the procedure “does not ensure that the devices at issue are not generally available in finished form or to other physicians, as is required to meet the custom device definition”.
DePuy, sensing defeat, withdraws
“While DePuy believes it had complied with FDA requirements, the company has made the decision at this time not to provide custom devices,” the company statement said.
So what’s occurred here?
Well we really don’t know do we? It seems very unlikely that FDA was unaware of this practice for the many years it’s been taking place. Everyone knows DePuy, in common with other manufacturers, makes custom implants. So what seems likely is that the agency has simply toughened its stance, whether in response to the high profile nature of medical regulations following not least the well publicised metal-on-metal hip problems. It looks tough on DePuy though, because they’ve presumably been doing exactly the same thing and been audited on it for years. The knock-on effect of ASR, which again hurt DePuy more than the other metal-on-metal hip suppliers, seems to be compounded at every turn.
What might of course now happen is that surgeons who preferred the “custom” nature of implants for the added value it delivered to their clientele, will kick up something of a fuss on the basis that their patients are being denied the optimum implant. It seems unlikely that DePuy will now resubmit all their “custom” options for mainstream approval, but that’s probably what FDA will demand of them. Of course if they’re truly custom items, even if custom means short run rather than multiple item, this is perhaps unlikely to be a commercially viable option.
Source: FDA, MassDevice, medlatest staff