Improve the safety of medical devices
An overview of Consumers Union’s Safe Patient Project Initiative
Medical devices, like eyeglasses and contact lenses, are a part of our everyday lives and are a growing part of the health care we receive. Complex devices like artificial hip joints, surgical mesh, and cardiovascular stents, are permanently implanted and can be essential for sustaining life. These high-risk devices can cause serious harm if they break, leak, stop functioning or disintegrate. Even low-risk devices, like contact lens solution and alcohol swabs have recently caused patients harm that could have been prevented. Unlike prescription drugs, most devices do not require proof that they have been tested on humans and found to be safe and effective prior to being cleared by the Food and Drug Administration (FDA) for distribution or sale. And the system for monitoring and tracking what happens with devices once they are on the market is weak and does not adequately protect people using them.
Consumers Union’s Safe Patient Project, is working to make medical devices safer and more effective. In 2012, Congress must reauthorize the Medical Device User Fee Act (MDUFA) for the next five years. User fees were established to help to fund the FDA’s review of new medical devices and should provide the resources needed for improved oversight of these devices. The reauthorization legislation should improve the current pathways followed to bring devices onto the market and improve the system of monitoring devices after being implanted in patients or sold to consumers. The fees paid by medical device makers are currently quite modest, with most companies paying less that $5000 to obtain approval for devices that may make them millions to billions of dollars. In 2012, the fees should be increased to reflect the level of work required by FDA to review and ensure the long-term safety of complex devices.
Improve how devices are approved
The medical device industry has been heavily lobbying Congress, claiming that onerous regulation by FDA stifles innovation and threatens American jobs. With an aging population using more of these products each year, innovation is important, but it should not trump safety. The device industry is far less regulated than the drug industry. For example, even the standards that require clinical trials for the fuller pre-market approval (PMA) of devices are weaker than those used for drug approval. Drugs must show substantial evidence of safety and effectiveness where devices must merely show “reasonable assurance” of safety and efficacy.
However, less than 1 percent of devices even go through the more rigorous PMA process. More than 90 percent of all medical devices are now cleared through an alternative fast track process created 35 years ago that allows devices to be put on the market after merely showing that the new device is similar to an existing one (called a “predicate”). No clinical trials or findings of safety and effectiveness are required. This “510(k)” process, named after a section of the Food, Drug, and Cosmetic Act, was originally intended for low and moderate risk devices but is frequently used to approve devices that most consumers would consider high risk. Although the technology and complexity of these devices has escalated significantly, the quick and easy process is still being used to move forward most devices intended for permanent implantation, such as artificial hip and knee joints, as well as some life sustaining devices such as automated external defibrillators. Of additional concern, current law restricts the scientific evidence the FDA can request from the device maker (to determine whether a new device is substantially equivalent to an existing one) to that which is the “least burdensome” on the manufacturer rather than what is optimally needed for a thorough assessment. This restriction also applies to the PMA review process.
Recent high-profile device failures such as those occurring with all metal hip implants and surgical mesh that were approved through the 510(k) process illustrate that lax approval standards are sending faulty high risk devices to the market, where they cause considerable preventable harm to patients and significant cost to the health care system.
Recommendations to improve the processes for device approval:
- Require all permanently implantable devices and all life-sustaining devices to go through the Pre-Market Approval (PMA) process, requiring more stringent review, including safety and effectiveness testing, rather than the expedited 510(k) process.
- Exclude pre-1976 devices from serving as predicates, so devices being submitted for approval have to show substantial equivalence to a more current device.
- Once a device is found to be unsafe (either recalled or when FDA issues a warning), that device should no longer be allowed to be used as a predicate for device makers in the 510(k) clearance process. Devices cleared based on a recalled predicate should be reviewed for similar problems.
- Eliminate the “least burdensome” requirement when the FDA asks for additional information in its review of medical devices.
- Raise the standard for PMA approval of devices from “reasonable assurance” of safety to “substantial evidence” of safety to bring it in line with the standard for drugs.
- Give the FDA adequate resources for thorough review of the increasing number and complexity of device applications.
Improve how devices are tracked after approval
When an implanted device is recalled or removed from the market, patients cannot simply stop using them. Removal of the device requires surgery, sometimes multiple surgeries, and it may take months or years to repair the damage done by the device. Some patients are permanently disabled or die due to complications from a device.
Even if the premarket approval processes are improved in 2012, closely monitoring what happens when devices such as hip joints, pacemakers, stents, breast implants and insulin pumps enter the market becomes crucial to providing information about their safety and effectiveness.
When an implantable device is recalled because it does harm or fails to work in patients, additional surgery is required to remove, repair or replace it. When implanted devices break, leak, cease to function or disintegrate, they can cause permanent disability and death.
Adequate tracking of what happens to patients using medical devices, requires a good system of collecting information about adverse reactions to the device from health care providers and patients; a system of unique identifying numbers to track which patients have which devices; a proactive broad-based review of medical records to identify unsuspected adverse reactions; routine post market studies by device manufacturers; and a functioning recall system that gets problem devices off the market as soon as possible.
In 2007, the FDA was authorized to do active surveillance of clinical experience with devices through the Sentinel Initiative, which is not yet functional, but is developing ways to use existing health data from large entities like the VA and private insurers to analyze problems occurring with medical devices. This initiative needs to be on a fast track. Additionally, the existing system for manufacturers, consumers and health care providers to report problems with devices (and drugs) is functioning poorly, even as the number of reports has steadily risen over the years. For example, the reporting forms are complicated and confusing, manufacturers’ reports often lack critical information about problems in a timely manner, and the FDA is not promptly evaluating the reports. The GAO reported that the FDA needs more resources to improve post market surveillance activities and the IOM found that “the inadequacy of the current postmarketing surveillance system and the resulting lack of data make it impossible to confidently draw broad conclusions about the safety and effectiveness of products that are on the market.”
Recommendations to improve post-market monitoring of devices:
- Require a national system for tracking devices so that patients and doctors can be contacted when problems with a particular device are identified. Currently, there is no universal way to find out which devices were implanted into which patients.
- Establish registries so patients can be notified directly if there is a problem or recall with a device rather than only communicating with manufacturers and doctors. A recent study published in Health Affairs estimated that if the United States had in place a registry for hip-replacement surgery, it could avoid about $2 billion in total costs for these surgeries in 2015.*
- Enable the FDA to use its recall authority more effectively and provide the agency with authority to require device makers to do long term post market studies, regardless of which process is used in the pre-market phase.
- Give the FDA adequate resources to fully implement existing patient protection programs for monitoring and reporting adverse events such as MedWatch, MAUDE and the Sentinel initiative. Used effectively, these programs can help the FDA identify early and ongoing problems with medical devices that are causing harm to patients.
*An earlier version of this document improperly attributed the source of this estimate to the Institute of Medicine.