Regulators with the US Food and Drug Administration (FDA) regularly deal with matters of public health. From monitoring disease outbreaks to assessing products for safety and conducting postmarketing vigilance, the agency is often positioned at the bleeding edge of technology, risk and safety.
But far from limiting itself to only the threats that currently exist, it has in the past decade begun to increasingly look to threats that don't exist and how it might position its resources to address them proactively. Among the most potent of those threats: the effects of an explosion caused by a radiological or nuclear device, which FDA outlined in a 4 September proposal for a meeting with regulatory officials.
Among FDA's chief concerns are that healthcare providers, and in particular hospitals, would be unable to deal with an unprecedented influx of patients suffering from burns caused by such an event. The US currently has a burn unit capacity of around 1,850 beds, of which roughly half are occupied at any one time.
A large-scale radiological or nuclear attack could quickly overwhelm that capacity, requiring what FDA called the, "Ready availability of large quantities of medical countermeasures for resuscitation, wound management, pain relief and nutritional and airway/breathing support in the initial post-injury period."
Reports Raise Troubling Questions
But two reports published, respectively, by the New York Times and the Center for Public Integrity over the last six months bring up another troubling concern: The risk of such an attack may well be heightened by lax controls over radiological material used to make so-called dirty-bombs, and much of the material is used in medical devices regulated by FDA.
The problems, explain the reports, come from how the radioactive materials, most commonly used in imaging devices, are stored within the facilities they are used in. Investigators with the Government Accountability Office (GAO) found that many facilities used unqualified staff to look after the material.
The trend has investigators worried, explained The Times. "The materials in question cannot be used to make a nuclear bomb, but if incorporated into a device with conventional explosives they would make a 'dirty bomb' that could contaminate significant areas of a city with measurable amounts of radiation, some of it worrisome."
GAO's report, released in September 2012, highlights an awkward overlap between several regulatory agencies. For instance, while FDA regulates the medical devices that contain the material, the Centers for Medicaid and Medicare Services (CMS) oversees the hospitals, while the Nuclear Regulatory Commission (NRC) regulates the radiological material used in and left over from the devices.
GAO was particularly harsh toward NRC regulators, whom it said had failed to establish clear and concise regulations to secure radiological material, such as the use of sealed rooms, cameras and alarms. "Rather, the requirements provide a general framework for what constitutes adequate security practices, which is implemented in various ways at different hospitals."
Huge Lapses in Oversight
The extent of lax practices at some hospital settings is jarring. In one instance, a wheeled pallet of Cesium-137, a radioactive isotope formed by nuclear fission, was stored unsecured and close to the hospital's loading dock. In another instance, the security code to a locked room containing Cesium-137 was clearly printed on the door frame next to the security panel.
Though security upgrades for most facilities are in progress, the upgrades are not expected to be completed until 2025, and are voluntary.
Dirty bombs were not the only concern highlighted by experts, reports The Center for Public Integrity.
"While acknowledging that all nuclear materials should be secured, some experts worry the focus on dirty bombs obscures the danger presented by the use of highly-enriched uranium in medical devices," it wrote. "Rather than a small improvised explosive, highly-enriched uranium (HEU) could be used to make a bomb on the scale of those used in Hiroshima and Nagasaki."
"A nuclear weapon from stolen HEU could kill tens of thousands of people," explained Alan Kupperman, head of the Nuclear Proliferation Prevention project at the University of Texas, to CPI. Dirty bombs, he explained, were a mere distraction compared to the material's full potential.
Options for FDA?
It is unclear what, if any, role regulators with FDA could play in securing such material. Though the agency has some precedent for controlling drug products in postmarketing settings using Risk Evaluation and Mitigation Strategies (REMS), established under the FDA Amendment Act of 2007, it does not have the same authority to issue REMS for medical devices, though it could seek such authority from legislators.
Another tactic, should it choose to become involved, could emulate methods used to control pseudoephedrine, a nasal decongestant commonly used in the illegal manufacture of methamphetamine. Despite the drug's over-the-counter (OTC) status, the prospect of regulators taking away pseudoephedrine's OTC status has led many manufacturers to support control programs and databases to track the drug, as well as other measures to limit its sale short of requiring a prescription.
In the absence of legislation, a similar model could come to be used by FDA to require medical device manufacturers to sell their products only to facilities with adequate controls in place, or potentially provide for the secure removal of nuclear materials in cooperation with the NRC, to stave off regulatory reassessments of broader safety issues.
Until then, legislators seem poised to continue to investigate the issue, and have already introduced legislation to better control the nuclear materials.