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Comments Mostly Support FDA on Unique Device Identifier

With some notable exceptions, most public comments received by FDA on its proposal to require unique device identifiers (UDI) support both the essential thrust and the details of the proposal. Individual companies, however, sought various exceptions from it.

In its comments, the Consumer Healthcare Products Association (CHPA) said it agrees with that part of the proposal that would exempt nonprescription Class 1 from UDI labeling and data reporting requirements.

“The imposition of these requirements to Class 1 and nonprescription devices at retail would, rather than advancing FDA’s goals, add unfocused and unnecessary complexity to a market-based system where nonprescription devices include universal product codes for each stock-keeping unit,” the CHPA letter said. “Further, the law under which this requirement would be implemented envisions its application to devices that are implantable, life-saving, and life-sustaining. Neither Class 1 nor nonprescription drugs at retail would fall within that scope.”

Opposition to all exceptions was voiced in a comment by Suresh Nirody. “There should be no general categories or classifications of devices excluded by rule,” Nirody wrote. “Given the importance of the public health objectives that will be facilitated by the existence and use of UDI, the number of items or categories exempted from the UDI requirement should be minimized to the fullest extent possible.” The letter praises the UDI proposal as “an important milestone [that] is vital to the achievement of the public health objectives enumerated in the proposed rule’s executive summary.”

Merck’s Consumer Care said it supports the proposed exemption from the UDI requirement for OTC Class 1 and 2 devices and devices that pose very low risk. The company asked for confirmation that Internet purchase of Class 1 and 2 OTC devices also qualifies for an exemption. Merck said it does not support a provision that would allow voluntary labeling of a device with a UDI. The reason? It may be confusing for retailers and healthcare agencies if some manufacturers include a UDI and others do not.

In its comments, the American Hospital Association said a fully implemented UDI system will enable a medical device tracking system for hospitals to use in patient care, response to safety recalls, and supply chain management. Thus, it urged FDA to accelerate the time of the complete rollout of a UDI system from the proposed seven years after adoption of a final rule to three years. “Safety advocates and patients have waited a long time for the UDI,” the associated wrote, “and we see no compelling reason to wait an additional seven years.”

In its comments, Kaiser Permanente called on FDA to: 

  • Prioritize patient safety.
  • Adopt a single UDI standard.
  • Support cross-references in the UDI database.
  • Provide database governance, change control, and maintenance.
  • Align and coordinate UDI with HIPAA and other federal and state requirements and programs.
  • Enable comparative effectiveness research.

Medline, which says it manufactures more than 17,000 unique medical convenience kits, some of which contain more than 50 medical devices, asked FDA to proceed cautiously in seeking to apply the UDI system to such kits. “FDA should separately weigh the costs/benefits of the UDI system for medical convenience kits and should ensure that any UDI requirements that apply to kits provide real value to patients and providers without increasing the cost or complexity of this valuable service.

“In general, we believe that the proposed rule is unclear and incomplete as it relates to medical convenience kits, leaving many important issues unresolved,” Medline wrote. “We believe FDA should hold further public consultation on this topic prior to completion of the final rule. FDA should hold a public workshop and provide an additional opportunity to submit comments once a more complete version of the medical convenience kit section has been developed.”

Novo Nordisk asked FDA to except certain Class 2 single-use devices such as certain types of needles from the requirement to bear a UDI on the individual unit-of-use of the device (each needle). The company proposed that such devices bear a UDI on the next, higher level of packaging.

The Health IT Standards Committee said that the proposal will have many benefits for health and healthcare and that the proposed UDI database is particularly notable as a positive step in the right direction for healthcare and supporting processes. It said that proposed exemptions from UDI requirements for retail devices are troublesome and problematic. Many devices that are proposed to be excluded are integral to healthcare and can be paid for by Centers for Medicare and Medicaid Services programs, it added.

B. Braun commented that the assumption that all people and functions in a hospital or other clinical setting will have and use the required equipment to scan product data, real time, to prevent using outdated or recalled product before it reaches the patient will be extremely difficult and costly to implement and maintain. Systems required to manage data will be complicated and prone to errors, the company warned. And scanning disposable devices every time one is needed is unlikely and highly taxing on healthcare providers. “With limited resources, scanning of products may not be considered a necessity or provide any value to healthcare.”

The Medical Imaging and Technology Alliance said it expects “substantial increases in device manufacturer costs associated with the initial implementation of this regulation and continued compliance with its requirements.” The group said there will be increases associated with implementation costs, transactional costs, follow-up costs, and maintenance costs. It also urged FDA to work with other regulatory bodies globally to achieve a harmonized regulation.

The mHealth Regulatory Coalition said that while it recognizes the significant value that the UDI system may have for public health, FDA should consider the impact of the proposed rule on the mobile health industry. The coalition said it supports the rule’s proposed retail exception but wants clarification as it relates to mHealth technologies. It also supports the proposed exception for Class 1 devices that are exempt from good manufacturing practice requirements.

In contrast to generally favorable comments by individual companies, the Advanced Medical Technology Association (AdvaMed) recommended changes it said would make the system more practical and useful. While it expressed support for FDA’s main goal in the proposal, AdvaMed said implementation of a UDI system “is a costly proposition, one that should be carefully considered such that it is implemented correctly the first time, and that its ongoing use is practical, economical, and of value to patients, healthcare providers, industry, and the FDA.”

Among significant changes to the proposed rule suggested by AdvaMed were:

  • Manufacturers of Class 3 devices should be given two years after the final UDI rule is issued to comply with the rule’s labeling requirements, instead of one year. 
  • FDA should develop a specific list of devices exempt from UDI direct marking requirements, such as absorbable sutures or stents, because such devices can’t be directly marked.
  • FDA should clarify that devices manufactured before the final UDI rule’s effective date but held in inventory are not subject to the rule.

 “AdvaMed has long supported establishment of a UDI system,” association president Stephen Ubl said, “and believes that if appropriately implemented, such a system holds the promise of more accurate and consistent post-market surveillance.” He offers the following caveates: “[...] it is important to understand that any benefit from a UDI system depends on device users consistently and effectively utilizing the system for tracking recalls, adverse event reporting, and within electronic health records. FDA’s proposed rule is a good first step and we are committed to working with FDA and other stakeholders to develop an effective UDI system that takes into account the diversity of medical devices and provides information useful to understanding their post-market performance.” 

Digital Health Startup Focuses on Diabetes Prevention

Digital Health Startup Focuses on Diabetes Prevention

By 2050, an estimated 48 million people in the U.S. will be diagnosed with type-2 diabetes, according to the CDC. The disease is already an epidemic, affecting more than 25.8 million in the United States. UnitedHealth Group has predicted that, unless the growth rate slows, more than half of the U.S. population will either have prediabetes or diabetes by 2020.

The idea behind the Omada Health program was conceived in IDEO's Medical Products division in Palo Alto, CA.  

The program draws inspiration from from the Diabetes Prevention Program as well as the Quantified Self movement.

The employees of the Omada Health stand outside of the company's office in San Francisco. 

On the bright side for those who are prediabetic, type-2 diabetes has been shown to be preventable or its onset delayed. Consider the NIH-sponsored multicenter study known as the Diabetes Prevention Program (DPP) that demonstrated that a comprehensive behavioral weight-loss program was more effective in treating prediabetes than drug therapy

Inspired by the DPP, a digital-health startup known as Omada Health has unveiled its first product offering—an online diabetes prevention platform for the general public. Known as Prevent, the interactive program offers users personalized coaching and enables them to communicate with other participants. It also offers users digital tracking tools—a wireless scale and pedometer, to help them set goals and stay on track with them.

In a recent 230-person study organized by the startup, participants lost an average of 13.7 pounds (or 6.4% of their bodyweight) after 16 weeks. In the DPP, a similar percentage of weight loss in conjunction with other lifestyle changes proved effective in preventing or delaying the onset of type-2 diabetes. “It’s not like you have to skinny down to your beach body from when you were 23. You just need to make some basic changes and lose about 7% or so of your body weight and work to keep that off and you'll have a good shot at not going on to get type-2,” says Sean Duffy, who cofounded the company with Adrian James.

The idea of the program was hatched at IDEO's Medical Products division in Palo Alto in 2011, where the Duffy and James were employed. Dennis Boyle, a co-founder of IDEO, had set aside a budget to explore business and product opportunities in the chronic disease prevention space. Omada Health grew out of that exploration. 

Inspired by the Diabetes Prevention Program, the two founders ultimately decided to build an online platform based on the DPP designed to help the millions of people with prediabetes. They then decided to found a company around their idea and were accepted into Rock Health’s first class of startups. In late 2011, they had raised more than $800,000 in seed funding.

As diabetes is notoriously expensive to treat, which heightens the needs for systems that can save money. “If you can help somebody with prediabetes not go on to get type-2 diabetes at about the same rate as the original DPP, it actually saves the health system money. If you look at therapeutics and medical interventions, it is really only something like 10% fall in that category,” he adds. “It is very tough to convincingly show ROI in areas of prevention but, because diabetes costs are so high, helping people with prediabetes makes sense.”

The startup has a bit of a mix in terms of its initial customer base. “On the B2B side, our customers are primarily going to be providers who carry risk and self-insured employers who are already paying for diabetes prevention,” he says. “Obviously, on the direct to consumer side, you can self pay. Our dream would be for this to really be covered by people who wouldn’t be able to cover it on their own. We think there is a possibility of that happening,” he says, pointing to a Senate bill introduced by Al Franken that would have Medicare reimburse for lifestyle programs based on the DPP. “If we run a peer reviewed trial that shows that our results are equivalent or better than the DPP, we feel like we have a shot at that.” 

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz 

Senate Probe Questions Medtronic Payments to MDs

A 16-month investigation by Senate Finance Committee chairman Max Baucus (D-MT) and senior member Chuck Grassley (R-IA) found “questionable ties between Medtronic and the physician consultants tasked with testing and reviewing Medtronic products.”

The senators say that Medtronic employees never disclosed that they were collaborating with physician authors to edit, and even write, segments of published studies on the company’s InFuse bone growth product.

“The studies as published may have inaccurately represented InFuse’s risks and may have placed added weight on side effects of alternative treatments,” the senators write. They say the company also maintained significant, previously-undisclosed financial ties with physicians who write studies about InFuse, making $210 million in payments to doctors over 15 years.

“Medtronic’s actions violate the trust patients have in their medical care,” Baucus said. “Medical journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients are at serious risk when companies distort the facts the way Medtronic has.”

Major investigation findings include:

  1. Medtronic’s undisclosed involvement in drafting, editing, and shaping the content of medical journal articles written by its physician consultants who received significant amounts of money through royalties and consulting fees from the company.
  2. An e-mail exchange showing that a company employee recommended against publishing a complete list of adverse events or side effects possibly associated with InFuse, this list was omitted from the journal article.
  3. Medtronic officials inserted language into studies that promoted InFuse as a better technique than an alternative by emphasizing the pain associated with the alternative.
  4. Documents indicating that Medtronic prepared one purportedly “independent” expert’s remarks to an FDA advisory panel meeting before InFuse was approved, and subsequently hired the expert.

A company statement says the firm cooperated with the inquiry and disagrees with some of its findings, especially with any suggestion that it improperly influenced or wrote any of the peer-reviewed published manuscripts discussed in the report, or that Medtronic intended to under-report adverse events.

“In fact,” the statement says, “Medtronic reported to FDA the potential adverse events addressed in the staff report, and these risks were reflected in the product’s FDA-approved label. In addition, the staff report’s characterization of payments received by physicians is also misleading and unfair. The vast majority of such payments were royalty payments made to compensate physicians for their intellectual property rights and contributions, not consulting payments.” Medtronic says it agrees with many of the report’s recommendations to ensure increased transparency for industry interactions with doctors.

FDA Whistleblowers Lose Document ‘Discovery’

The court’s opinion says that the whistleblowers had provided a sufficient factual basis of government misconduct and that the court should review the documents in question to determine whether withholding was appropriate.

The ruling says the court determined that the documents in question “do not reflect the sort of government impropriety necessary to defeat the legal privileges invoked” by the department and thus were properly withheld or redacted under an FOIA exemption relating to evidence of government misconduct. The judge said the documents in question “involve the typical deliberations that the court would expect of government actors and do not evince the sort of corrupt decision-making process that would support an exception” to the exemption.

RSNA 2012 Overview: Solving the Scatter and Problems with Patient Data

Andrew Dallas is president and CTO of Full Spectrum Software

The meeting had particular emphasis on breast cancer detection utilizing new technologies intended to help reduce the incidence of false positive and false negative diagnoses. Challenges regarding the difficulty in imaging and thus in early diagnosis in women with dense breast tissue are being addressed.  For software engineers and companies developing diagnostic instruments, it is important to understand what tools are available to help accelerate the adoption of these new technologies.

Supporting better detection, a continuing trend is improvement of the quality of imaging software. Improvements comes from several areas  - new software algorithms for the removal of noise that is a product of scatter,  improvement of software tools available to practitioners in the form of fusion of imaging modalities and the integration of sonographic data as a new modality applied to breast cancer detection. While the value of sonography in breast cancer detection is making its way through research and into the main stream, it seems inevitable that it, along with other innovative imaging technologies will soon be included in the quiver of tools available to our healthcare providers. It is important, therefore to consider adoption of tools and toolkits as not only a cost effective means of commercializing software products but also as potential hedges against compatibility challenges. While commercial solutions exist, leveraging the enormous body of work available in VTK, ITK, IGSTK and others warrant consideration. If your team has chosen not to use these tools in the past, it is time to give them a good, hard look to consider how they have evolved in recent years.

Another movement that seems to be gaining momentum is networking of patient data. With the mandate from the Affordable Healthcare Act regarding electronic health records (EHR), there is pressure on the industry to standardize. Many of us lucky enough to have networked healthcare providers have experienced the benefit of EHR already. While the project was launched in 2009, RSNA’s pilot program, RSNA Image Share is now in clinical use. Patients are now able to access and share their data among several institutions. RSNA Image Share was implemented using defined standards and reportedly provides capabilities that satisfy patient confidentiality and security needs. The published standards and existing body of work are likely to encourage wider adoption and hopefully facilitate greater compatibility between vendors. Perhaps this is a major step forward after Google’s retirement of Google Health as there are reportedly two dozen facilities that are expected to join the program in the next year. Those of us who have built interfaces to Microsoft HealthVault and Google Health should take notice. Cloud computing solutions and sharing repositories are rapidly evolving and an ecosystem should precipitate from open standards. 

It was a pleasure attending RSNA this year. As much as it is an opportunity for me to meet with clients and make new connections, it is as much an opportunity to witness the growth of our industry in one behemoth of a convention. For software teams that don’t have the opportunity to directly observe the newest products and trends, I hope this article will encourage you to take a virtual tour of the RSNA exhibiters and the RSNA organization itself.

 —Andrew Dallas

MD+DI Salary Survey 2012: Data Tables

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