Hospital groups complain about the delay in rule-setting, the long implementation timetable for the unique device identifier rule, and a new database.
Manufacturers of the most potentially dangerous medical devices, such as pacemakers, external defibrillators, and certain implants, now have a timetable of Sept. 24, 2014 to label them for easier recall. The U.S. Food and Drug Administration's long-awaited final rule will allow adverse events to be more quickly investigated.
The label, called a unique device identifier or UDI, must be a unique number that includes the product's lot or batch number, expiration date, and manufacturing date, the rule says.
The one-year deadline is for Class III devices, generally defined as those that support or sustain human life or are essential for human health or prevent injury.
For Class II devices, such as infusion pumps, some non-invasive surgical materials, and electric wheelchairs, manufacturers have three years. The UDI deadline for Class I devices, considered the least likely to have quality issues or cause harm, such as bandages, is 2020.
The FDA also is launching the Global Unique Device Identification Database (GUDID), which the agency will administer. The database won't include specific patient identifying information, but in the rule the FDA said that it "plans to make most of the data reported under this rule available to the public."
The 160-page rule was ordered by Congress in 2007, and hospital officials have complained about the length of time the FDA took to issue the proposed rule, which didn't come out until last November. And some don't understand why full implementation will take another six years.
"What's good news is that it's out," says Amanda Forster, vice president of public relations for Premier healthcare alliance, a group purchasing and quality improvement organization representing 2,900 hospitals. "What's bad, though, is that it's an excessively long timetable. The real risk here is for patient safety."
"I'm scratching my head, trying to understand why the timetable for implementation in the rule is as long as it is. Frankly, it's shameful."
Forster explains that "whenever there's tainted food in the grocery store— peanut butter or broccoli—the FDA can issue a notice and say these food products are tainted, and within hours grocery stores comb through shelves and pull everything off to keep it out of circulation.
"We can't do that with medical devices."
But she notes that the process by which hospitals and doctors indicate which products were used with which patients is complicated.
"People call things by different names," she says. Some may say Medtronic pacemaker or some may say Medtronic PM…and lots of hospitals in the absence of a UDI system come up with their own numbering system."
Because labels are not automated, staff must spend hours combing patient medical records, sometimes going back years, to find patients who may be walking with implanted devices.
The manual process will inevitably introduce errors, she says. "Because it's not automated, things get missed. Or someone can write down a 7 instead of a 1."
Lack of a UDI system today can be expensive and labor-intensive.
According to last October's McKinsey & Company report, "the typical recall of a medical device can take up to about 2 man-days of effort in the hospital (involving various departments: procurement, logistics, medical physics), and in some cases more time, especially for implanted devices, where substantial effort is required to contact affected patients."
The FDA indicated it received nearly 300 comments to last year's proposed rule, most of them favoring most parts of the rule. However, the Medical Device Manufacturer's Association requested numerous changes, such as two-year delays for any implementation and restrictions on the FDA launching any investigations based solely on UDI information.
"MDMA believes FDA has underestimated the costs of the healthcare system from implementing UDI," the organization said in its comment letter last Nov. 7.
"This transition will require the medical technology industry to spend significant resources to comply. With smaller companies facing a looming medical device tax, increased user fees, and a reduction in venture capital investment, allowing as much flexibility and time to comply is critical."
One significant change between the proposed rule and the final rule is that the proposed rule did not require GUDID to receive information about whether a device is incompatible with a magnetic resonance imaging machine, which has resulted in adverse events and patient harm. The final rule requires GUDID to receive information about "whether a patient may be safely exposed to MRI or similar technologies while using the device or while the device is implanted in the patient."
The patient advocacy group Public Citizen also applauded the rule but lamented its delay and implementation timetable.
"More prompt action by the FDA likely would have prevented numerous deaths and injuries related to unsafe medical devices," says director Michael Carome.
The timetable for UDI implementation:
- Sept. 24, 2014 — Labels and packages of Class III medical devices and devices licensed under the Public Health Service Act must bear a UDI. Dates on labels must be formatted and data submitted to GUDID.
- Sept. 24, 2015 — Labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI. And these devices must bear UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.
- Sept. 24, 2016 — Class III devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.
- Sept. 24, 2018 — Class II devices that are required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. The labels and packages of Class I medical devices and devices that have not been classified into Class I, II, or III must bear a UDI. And data for Class I devices and devices not classified that are required to be labeled with a UDI must be submitted to the GUDID database.