Defining Quality: The FDA’s Position on Good Manufacturing Practices

Where does the U.S. Food and Drug Administration (FDA) stand on good manufacturing practices (GMP), the set of regulations that govern manufacture and testing of medical devices and other medical products like pharmaceuticals, diagnostics, and food? And what of the universal device identification?

FDA regulations

Good manufacturing practices are, in general, a quality system that follows certain basic principles. These principles govern the manufacturing process, including the control and evaluation of process changes; the drafting of documentation, including instructions and procedures; the training of operators; the records of manufacture and distribution; and the handling of recall and complaint.

According to information from the FDA, “The current good manufacturing practices requirements set forth in the quality system (QS) regulation… require that domestic or foreign manufacturers have a quality system for the design and production of medical devices intended for commercial distribution in the United States.”

However, the FDA information goes on to say that QS regulations are an “umbrella” covering any number of devices “from simple surgical hand tools to very complex computerized axial tomography scanners.” The FDA acknowledges that it’s not practical for regulations to specify details, but only to require “general objectives such as the use of trained employees, design reviews, design validation, calibrated equipment, process controls, etc.” For these regulations, “remanufacturers are considered manufacturers” and are responsible for “drafting of master records, rebuilding per the master records, inspection and testing, calibration of measurement equipment, control of components, updating of labeling, processing of complaints, and any other GMP requirement applicable to the activity being performed.”

Still, the FDA has been “slow moving” on GMP, says Dr. Alan Lambert, chair of Butzel Long’s New York health care practice. He explains that treating remanufacturers similarly to original equipment manufacturers makes sense. “If a safety standard applies to the original manufacturer, how can you have less for a remanufacturer or hospital?” 

Lambert explains that GMP requirements can be a good way to control health care costs and examine device efficacy, but part of this control requires the use of device identification mechanisms.

Device identification

According to Lambert, the FDA began requiring identification codes for pharmaceuticals and biologicals in 2004; however, they’re reluctant to expand to devices because of the lack of a database. But the FDA has had the authority to track [devices] from manufacture through the end of the life cycle for some time.

However, the device market has embraced identification codes because of market demand. “A high percentage of hospitals have demanded some sort of identification,” says Lambert. “A lot of identification has been driven by the market, not by the FDA.”

There are some practical patient-care and economic reasons for wanting identification. “Hospitals want to identify in case of adverse events,” says Lambert. “Lot identification will allow much more narrow recalls.” If an adverse event occurs, being able to identify the particular lot impacted will mean that a much smaller pool of devices or products will be subject to recall, allowing patient care to continue with unaffected lots of product while problematic units leave the market.

This doesn’t mean, however, that providing device identification mechanisms is always an inexpensive proposition. It can be a significant cost of business for smaller organizations with lower profit levels, says Lambert. However, he points out that there are cost efficiencies in being able to limit and respond to recalls, avoid lawsuits for product liability, and control and improve patient care. It’s all about balancing short-term versus long-term costs.

Tracking devices has not yet been a major focus of the FDA, and it’s easy to see why. “The FDA is finding that this is so much more complicated than they thought. There is conflicting and confusing information; establishing a uniform identification [system] isn’t easy,” Lambert says.

This isn’t to say that the FDA hasn’t taken a look at the issue. According to Lambert, the agency has tried to receive feedback on how the database should be established and what types of equipment should be considered low-risk. After all, some equipment has such a low rate of problems that it’s not worth tracking because the probability of identifying a problem that affects an entire lot or series is very low; most likely, any problems will be “one off” occurrences.

However, Lambert says that the FDA has been looking at an issue. The most recent consideration was part of a hearing held at the end of February. And it’s clear that the FDA has the authority to require identification of medical devices. They’re proceeding carefully, however, as the costs could run into billions of dollars.

Benefits of regulation

Requiring identification and tracking of medical devices, along with regulating GMPs, could have benefits as well as great cost requirements. Lambert explains that these regulations could yield long-term data on problems and results with a variety of devices, assisting with choosing what sort of devices are efficacious and should be paid for by the government or private payers.

Identification could also lead to better consumer information. “We’re going to see data put out to patients or hospitals,” says Lambert. It may be necessary for device manufacturers to drill down to the case [level] and make a business case that their product is the best choice for certain kinds of patients or types of cases, Lambert adds.

Manufacturers—including remanufacturers—may find themselves assessing and analyzing data, such as outcomes and adverse events affecting different patient populations with which their devices are used. This will allow feedback to flow to regulating agencies like the FDA, as well as providing data on which to base changes in process and procedure. Speaking directly to remanufacturers, Lambert recommends to “make sure you can get data back, analyze it, and communicate [results].”

If the FDA does choose to get more involved in device identification and tracking, the regulating body will join other groups with regulations governing health care providers. For example, the National Fire Protection Association already has codes on the books impacting hospitals.

Overall, the degree to which the FDA will get more involved in regulations affecting device manufacturers remains to be seen.

For remanufacturers, however, now is a good time to consider policy and procedure and ensure that devices can be identified, tracked, and examined in a way that is cost effective and improves patient care.

This article first appeared in the Medical Dealer.

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