Posted 21 May 2013
By Alexander Gaffney, RF News Editor
Earlier this year, the US Food and Drug Administration (FDA) said it wanted industry's input regarding how it could establish standardized-and mandatory-labeling for medical devices, postulating that it could stand to benefit from the same basic requirements now enforced for pharmaceutical products. Now the device industry is responding, saying it needs flexibility and freedom from the requirements of a proposed database.
At present, there are no regulations defining a standardized approach for how content should be structured or formatted on a medical device, often referred to as structured product labeling (SPL). This is considerably different than other FDA-regulated products, such as food or pharmaceutical products, which are required to adhere to strict requirements regarding everything from the font size and required information to layout and required statements. The logic behind the push to standardize medical device labeling is the same as it is for existing labeling conventions, FDA explained.
There is a "growing need for medical device labeling to be delivered in a clear, concise and readily accessible format so that patients, caregivers and healthcare providers may access and utilize device labeling as efficiently and effectively as possible," FDA wrote in its 4 January 2013 FederalRegister posting announcing the meeting.
Patient safety may also be negatively affected by the absence of a standard, FDA explained. "There is no single available source of medical device labeling for people to view, search and download for devices that are used in clinical and non-clinical environments." Unlike pharmaceutical products, which typically have a shorter shelf life, the longevity of medical devices may mean that their instructions for use and warning labels are damaged or illegible after a few years. If these labels are unavailable, patients may be harmed in the process.
But patients could also come to harm even if the labels are present, FDA said. "FDA is concerned that the lack of standard content and format may translate into an increased risk of medical device error," it wrote. If a warning section, for example, is placed in an unusual place, a physician may inadvertently skip over it, potentially subjecting a patient to unnecessary harms.
FDA said it had already contracted with a company to develop a standardized device label format, but was still assessing the usefulness of a "quick guide"-type format for labeling that would present information in an "at-a-glance" format.
A recent FDA meeting, held 29 April 2013, was an opportunity to discuss those issues, as well as two others: the potential use of symbols in device labeling, and the launch of an online database to be used to catalog medical device labels.
In comments submitted to FDA's docket in response to that meeting, the medical device industry indicated that it is hesitant about standardizing device labeling and other related components-at least not without flexibility built into the process.
Medical device association AdvaMed, for example, says that "the development of a standardized Table of Contents (TOC) for device Instructions for Use (IFU) may be a useful tool if adequate allowances are made for the broad range of device types, users and environments." That flexibility will depend largely on the type of device, it said. For example, the TOC needed for an in vitro diagnostic device will differ significantly from an implantable active medical device or a single-use one, it noted.
FDA also needs to recognize that laboratory-use only diagnostic devices (often referred to as lab-developed tests, or LDTs) should be outside the scope of its efforts, AdvaMed said.
As to the possibility of an online repository of device labeling, AdvaMed said several challenges persist. For example, the skill needed to operate a lower-risk home use device, such as a catheter, differs tremendously from the skill needed to operate a complicated piece of equipment present in a home-use setting. "Use case scenarios range from information needed for reference to an immediate critical need," AdvaMed explained.
As some devices are restricted to use by qualified persons in certain facilities, the organization said it was worried that "the free and unfettered access to instructions for use via the Internet of restricted devices may be in conflict with the safe and effective use of the device as understood by the FDA designation of 'restricted device.'"
"A Solution in Search of a Problem"
AdvaMed also took issue with the storage of Structured Product Labeling (SPL) information in a third-party unique device identification database. That information currently resides with manufacturers, though pharmaceutical labeling does exist with FDA.
"The use of SPL for device labeling, however, remains a solution in search of a problem," it added. Calling the format "difficult to use" and requiring the reassembly of existing data to fit the format, Advamed said various industry-provided sources already filled the need of the UDI database for SPL.
In addition, AdvaMed said that the storage of device instructions by a third party-in this case, FDA-"increases the potential for users to obtain the incorrect information that they assume FDA has reviewed and approved the information for their device."
"The use of the Internet to access device information for use in emergency situations is potentially dangerous or impractical," it added. Instead, that data "should flow through manufacturer-trained Customer Service personnel" via information found on-ironically enough-the label or "e-labeling platforms."
Johnson & Johnson
Manufacturing giant Johnson & Johnson's comment reflected similar concerns, noting that it wants multiple types of formats to reflect the various different types of devices and audiences. "The standard format for physician/health care professional labeling should be different from the standard format for patient/caregiver labeling," the company said, mirroring AdvaMed's comment on that very issue.
"Consider the risk level of the device, user health literacy level and risk of user error to patient safety in the decision for required content," J&J wrote.
But the company also raised a concern that may be far more practical for most device manufacturers: Would changing the device packaging configuration require a new 510(k) submission? The company raised the prospect that new labeling, especially such as a package insert near a sterile device, might affect sterilization and shipping validation. J&J wasn't sure how regulators would treat the issue, but advised FDA to consider "alternative distribution methods" for those "additional materials," and not to require a new 510(k).
Guidance, the company added, would be helpful to determine which information, forms and submissions are necessary to support labeling standardization.
In addition, J&J raised the prospect of having the International Medical Device Regulators' Forum (IMDRF) or the International Organization for Standardization (ISO) work to prepare the proposed standard. This would serve to "ensure any new proposals do not contradict existing international standards or any working drafts of proposed standards being developed to support similar requirements," it explained.