FDA Continues Campaign to Upgrade Quality

These actions are part of a center-wide initiative to, in the words of spokesman Dick Thompson, focus on the safe use of the devices in practice and ways in which the manufacturers can improve their designs and quality systems to improve the safety of these devices. He told me he thinks “there are staff in all offices that regularly participate in activities to improve device safety in areas where we see room for improvement.”

In the latest expansion of this activity, CDRH told enteral feeding tube manufacturers to implement design changes to prevent misconnections that could occur from their use of standard luer lock connectors. The connectors are found on a variety of tubing sets, solution bags, and other medical products, and have been linked to misconnections involving unrelated medical delivery systems due to their ease of connection.

Misconnection examples cited by CDRH include IV infusions that are connected to epidural lines and epidural solutions (intended for epidural administration) connected to peripheral or central IV catheters.

In its letters to the manufacturers, the center recommended design changes such as color coding and labeling on tubes to flag which tubes must be connected with one another. Also, it suggested using proprietary connections so that incompatible devices could not be connected.

“FDA believes manufacturers should provide the necessary safeguards to ensure safe use of these devices and products,” the letter said. “We encourage all manufacturers to assess the risks of misconnections for these devices, carefully consider both temporary and long-term options to mitigate the risk and validate the solution(s) they deem most appropriate. FDA will assess the validation of the proposed solution during the course of the premarket review, as appropriate.”

The letters also advised industry that “a new broad-ranging standard is currently under development: ISO/IEC/FDIS 80369-1, Small-Bore Connectors for Liquids and Gases in Healthcare Applications. This  new standard, and the series of standards that will accompany it, are intended to address connector cross-compatibility issues between products used for a variety of medical applications (e.g., enteral, parenteral, IV, epidural, etc.), and will likely identify specific designs for each application to eliminate the possibility of misconnections.” FDA is an active participant in the development of the standard and believes it “will help prevent device misconnections through, for example, the use of force function design and usability testing.”

In the earlier case of FDA letters to the infusion pump sector, the agency demonstrated that it is prepared to come down hard on companies that don’t adequately heed the advice they are given. The source of persistent safety problems, infusion pumps had generated more than 56,000 reports of adverse events in the past five years, including more than 500 deaths.

In response, FDA ordered Baxter Healthcare to recall and destroy an estimated 200,000 Colleague infusion pumps currently used in the United States. An agency news release said the order was “based on a long-standing failure to correct many serious problems with the pumps.”

The other April action involving a similar CDRH letter to all registered makers of linear accelerators, radiation therapy treatment planning systems, and ancillary devices advised them on the importance of investigating the cause of nonconforming product and analyzing factors in addition to user error as part of corrective and preventive actions (CAPA). The action followed reports that hundreds of patients in several facilities in California and Alabama received excess radiation that led to skin reddening and hair loss.

AdvaMed: U.S. Innovation in Danger of Falling Behind

AdvaMed told Congress in June that the United States is in danger of falling behind in the world race to develop and market medical technology. The trade group is calling for 510(k) and premarket approval programs that support industry efforts as well as transparency provisions that don’t hinder innovation. The association’s comments came in testimony before the Senate Commerce Subcommittee on Competitiveness, Innovation, and Export Promotion.

AdvaMed president Stephen Ubl said that the United States needs a “proactive program to assure that [it] retains its commanding lead in medical technology and all the life sciences. We need a program that will allow America to take full advantage of the enormous growth opportunities for medical technology in the 21st century. We need a program that will maximize the industry’s contribution to the president’s goal of doubling exports within five years.” Such a comprehensive approach, Ubl said, will include regulatory policy, reimbursement policy, trade policy, tax policy, and policies to support research and development.

Addressing regulatory policy, he said it is very important to the future of the industry and to continued medical progress that the 510(k) approval process not be changed radically in a way “that would unnecessarily increase the time and cost of developing new products.” Ubl said the industry supports FDA’s current review of the 510(k) process with the help of the Institute of Medicine. However, he also stressed that the existing process has an excellent record of protecting the public against unsafe or ineffective products while providing a relatively speedy path to development and approval of innovative products.

FDA’s required time for PMA product approvals is troubling, Ubl said, because data show that the agency is not meeting its own review goals established as part of the user fee agreement. “We are pleased that FDA leadership has made correcting this problem a priority and hope that the newest data will show an improvement,” he said.

Ubl also said that while transparency is a laudable objective, and some of FDA’s recommendations are well-intentioned and even meritorious, the group is concerned that “some of the recommendations dealing with release of information on products that are in the review process and cannot be legally marketed will undermine intellectual property and discourage investment in breakthrough products while providing no significant public health benefits. We hope that the final recommendations will address these concerns.”

Reforms Touted at Device Innovation Workshop

Medical devices should be assigned “presumptive” coding and payment coverage by CMS at the time such devices are approved by FDA, according to Jack Lasersohn. The former National Venture Capital Association Medical Industry Group chairman made the remarks during a June FDA-sponsored public workshop on device innovation.

Diabetes Research Institute medical director David Klonoff suggested that FDA should encourage development of standards for medical devices to ensure their interoperability with similar products.

And head of the radiology department at the Rochester, MN–based Mayo Clinic Richard Ehman said he believes FDA should take a more discriminating or “nuanced” view of researchers’ perceived conflicts of interest in medical devices undergoing clinical development, depending on the extent of their monetary or other stake in regulatory approval.

These are only a few of many suggestions aired at the Gaithersburg, MD, workshop conducted by the Council on Medical Device Innovation. It was intended to identify unmet public health needs; to consider ways to eliminate barriers to innovation; and to facilitate medical device development, including the role that federal agencies can play in achieving this end.

The interagency council, established by CDRH, includes representatives from FDA, CMS, CDC, the National Institutes of Health, the U.S. Department of Veteran Affairs, the Agency for Healthcare Research and Quality, Defense Advanced Research Projects Agency, and the Department of Defense. Council members were exposed to more than a dozen stakeholder presentations, with a wide variety of suggestions for promoting innovation, many of which would involve changes or modification to the CDRH approval process.

Center for Medical Technology Policy consumer and patient alliance coordinator Justine Seidenfeld said that any effort to identify public health needs related to medical devices should include input from patients and consumers as well as insurers or third-party payers. She said that establishment of R&D priorities will necessarily involve criteria setting and “horizon scanning” by physicians and other technical experts, but that priorities must also reflect “the values of the American public.”

The development of new medical devices in the United States is almost totally dependent on venture capital funding—and this source is rapidly drying up in favor of more promising investments, Lasersohn said. He explained that “uncertainties” in the regulatory approval process, and particularly the length of time to gain approvals, now constitute serious and, indeed, crippling barriers to innovation. He accused FDA of being “overly risk-averse,” and suggested that the process for approving truly novel medical devices is “broken.”

Lasersohn said that FDA staffers are “not comfortable” approving novel devices and, for this reason, have often asked for impractical “super-superiority” studies (i.e., trials involving 2,000–10,000 patients). As a remedy for this situation, Lasersohn suggested developing a separate regulatory track for novel products, including early participation by senior FDA officials in consideration of novel applications, the use of outside expert reviewers where there is a lack of in-house FDA expertise, and appointment of a “medical innovation czar” to serve as a CDRH ombudsman to monitor and assist in the progress of novel product applications through the regulatory process.

Lasersohn further noted that coverage decisions by CMS can “make or break” a novel product just entering the market, and he suggested that CMS should be involved with FDA in approving clinical trial designs for novel products. He also said CMS should become more transparent concerning how coverage decisions are made.

Intel Corp. Digital Health Group quality assurance and regulatory affairs director Bonnie Norman addressed meeting attendees via telephone. She stressed the economic and other advantages of making more extensive use of home-based telehealth technologies. But she indicated that a significant barrier to their more widespread use lies in reluctance by healthcare providers to recommend or adopt these technologies. To help overcome this barrier, she suggested federal sponsorship of focus groups and workshops to promote telehealth technologies—what she called new models of care—and acceptance of large peer-reviewed studies in support of expanded product claims (such as reductions in hospital readmissions).

Norman urged FDA, AHRQ, and other agencies to share any information or data with CMS that substantiate favorable health outcomes related to remote patient monitoring devices. Finally, she suggested that CMS reimburse patients for installation of broadband as part of a home-based healthcare system, noting that while seniors constitute a population that could most often benefit from telehealth technologies, they are also least likely to have access to broadband connections in their homes.

Joseph Smith, chief medical officer for West Wireless Health Institute, a nonprofit foundation based in La Jolla, CA, reinforced earlier comments by Norman relating to economic advantages of telemedicine. “The cost of healthcare is an unmet need,” he said at the workshop.

He noted that complications from chronic disease account for approximately 75% of healthcare expenditures, and that home-based technologies can provide continuous monitoring and care for chronically ill patients, instead of the “episodic” model of care associated with visits to hospitals and physicians’ offices. However, he cited reimbursement uncertainties and legal concerns as barriers to greater use of these technologies.

The concluding session was open for short (two-minute) presentations by individuals wishing to offer pertinent comments related to device innovation issues. Among these, there were calls for better metrics to evaluate pediatric devices and more clarity about regulatory requirements for all products, as well as timely notification to sponsors and would-be sponsors when regulatory requirements are changed.

One commenter suggested that FDA consider using third-party certifications for some products in lieu of the current regulatory process (as, for example, Underwriters Laboratories certifies the safety performance of electrical and electronic products).

An advocate for patients with genetic disorders noted that there is need for greater attention to ensuring long life and durability of implant devices because complications most often arise when the implants must be replaced. In a related comment, it was suggested that consideration be given to establishing a “victims compensation fund” for individuals who suffer adverse events related to implants or other novel devices. Such a fund, it was pointed out, would likely serve to “encourage innovation by avoiding a need for litigation.”

Public Citizen Cites Eight Weaknesses in Device Reviews

Changes in legislative, regulatory, and FDA discretionary approaches to medical device review and approval are needed, according to a study by staff at Public Citizen published online in the July issue of PLoS Medicine. The authors identified eight “addressable weaknesses at the FDA level and above that impede the agency’s ability to review devices for efficacy” and cite a recent example of problems in each of the eight areas.

They noted that although the eight weaknesses are considered separately, they often interact with each other. And they identified three overarching issues that provide a context in which the three weaknesses take place.

First, they said, amendments from 1997 direct FDA to consider the least burdensome means of showing device effectiveness, giving industry recourse to challenge many requests it regards as onerous. Second, user fees paid by industry for device review bind FDA to specific review time goals. Such fees “shift the agency from being merely a regulator to being financially dependent upon the very industry it is charged with regulating,” Public Citizen said.
Third, FDA appears to have permitted scientific approaches that fall short of rigorous.

“Addressing the eight issues will require, in our opinion, remedial actions in three dimensions: legislative, regulatory, and agency practice, and certain problems will be susceptible to more than one approach,” the article said.

A chart in the study identified the eight issues as:
 

The article included a “competing interest” disclosure for former Public Citizen executive Peter Lurie, who joined FDA in December 2009 as senior advisor in the Office of the Commissioner. It noted that the manuscript was submitted before he began employment at FDA and that the opinions expressed are his personal views and not the official position of FDA or the U.S. government.

CDRH spokesman Dick Thompson commented that the agency “will take the recommendations and thoughts included in this document under consideration as we continue to address many of the issues raised.” He said the center is reviewing its 510(k) clearance program to improve decision making and better support FDA’s public health mission.

FDA Faulted for Delaying Unique Device Identifier Rule

The Advancing Patient Safety Coalition (APSC), which includes the American Hospital Association, American Nurses Association, Premier, and VHA, says it is taking FDA “an unreasonable amount of time to publish a proposed rule” calling for a unique device identification (UDI) system. The FDA Amendments Act of 2007 included language requiring FDA to promulgate regulations establishing a national UDI system for medical ­devices.

In a statement, APSC says that by developing such a system, hospitals could improve efficiency and patient safety by easily identifying and contacting all affected patients about important device issues. “A UDI system also can benefit FDA by allowing the agency to improve processes for monitoring and rapidly identifying device malfunctions,” the coalition says.

The group also argues that a UDI system has the potential to advance patient safety by helping the healthcare industry
 

The group says that unlike drugs, medical devices can’t be identified in a systematic and consistent manner. The result is an ad hoc approach resulting in increased clinical risks to patients, it says. The clinical risks include implanting a defective, counterfeit, or recalled product; inability to track the recipient of a faulty product if it is recalled; and inability to appropriately track adverse events.