By: Judy Tingley, MPH, RN, member of the ACC’s Clinical Quality Committee.

The Centers for Medicare and Medicaid Services (CMS) readmission payment penalties went into effect on Oct. 1.  Mandated by the Patient Protection and Affordable Care Act, this quality improvement initiative imposes financial penalties on more than 2,200 hospitals with Medicare readmission rates above the national averages.  The unintended consequence of these penalties is yet to be determined.

This new crackdown will have the greatest impact on the “safety net” hospitals that treat our poorest patients.  Current studies demonstrate that much of the variance in readmissions is due to factors beyond the hospital's control.  Many of these community hospitals have limited resources, antiquated medical records systems, serve late presenting and/or underinsured clients, and are at greatest risk for financially failing.  This reality reaffirms that quality metrics identification and measuring outcomes has never been more important.  As we move toward data driven reimbursement models, it is critical that the implementation of “patient centric quality metrics” does not get lost in the quagmire of financial and regulatory demands.  Quality needs to remain the focus of “quality metrics.” 

Of late, safety measure techniques used by the airline industry have been meaningfully translated to health care delivery systems.  Pre-operative checklists (modeled after pre-flight checklists) have significantly improved patient safety.  Just as regular and consistent communication between the crew and air traffic control helps thwart potential problems and keep the skies friendly, so should regulators, payers, hospitals, patients and practitioners communicate to keep patient safety at the forefront.  If not, we should brace for the impact of the unintended consequences of making worse a system that is very much in need of patient centric reform.  

Our population is changing and if you’ve seen one patient, you’ve seen one patient.  There will never be a one-size-fits-all model to eliminate readmission.  Therefore, the impact of demographic characteristics, co-morbidities, socioeconomic parameters, post-discharge environmental factors and regional health care delivery disparities all must be considered in strategically planning meaningful cost efficient care.  As our patient population ages the economic impact of this reality is yet to be seen:

• Half of older women 75+ live alone
• Persons reaching age 65 have an average life expectancy of 18.1 additional years
• The 85+ population is projected to increase to 9.6 million in 2030
  

Improved efficiency and reduction in avoidable readmissions is imperative.  Methods to better identify patients at risk for readmission, reduction of hospital complications, improvement in transitional care and overall communication between providers and patients are important ways of improving quality care.

There remains much work to be done in order to transform today’s health care into the efficient quality centric delivery system needed for the future.  The ACC has taken the lead in providing tools to help practitioners review and provide a transition of care plan.  Specifically, Hospital to Home (H2H) is a national quality improvement initiative developed to help hospitals reduce all-cause readmissions among patients with heart failure or acute myocardial infarction.  As health care providers, we must continue striving toward a coordinated multi-disciplinary strategy to effectively address improving quality of care in a fiscally responsible way.  If we fail, brace for impact!

This post is authored by James Tcheng, MD, FACC, co-chair of the ACC’s Informatics Committee

As we kick off the 7th Annual National Health IT Week, I’m reminded of just how far discussions around health IT have evolved in a relatively short time. Only a few years ago, the conversation was focused on how to choose an electronic health record (EHR) system. Today, we have moved beyond basic implementation to discussing how best to leverage systems to provide meaningful and timely clinical decision support, improve patient communications, reduce errors, and improve delivery of high quality care.

A recent ACC survey of cardiovascular practices found that 74 percent of practices are using, or are in the process of implementing, an EHR system. In addition, most practices are either already participating or plan to participate in the federal EHR Incentive Program. This is great news on a number of fronts. Not only does more structured and interoperable data enable increase quantitative decision making and improve clinical decision support, the availability of data will ultimately enable a learning health care environment that continuously returns information useful to improving health care delivery, quality, and outcomes. (Important note: Oct. 3 is the last day for eligible professionals to begin their 90-day reporting period for the 2012 EHR Incentive Program. To get the maximum incentive payment, Medicare eligible professionals must begin participation by 2012).

That’s not to say we don’t still have challenges. In fact, one of the biggest challenges is how to best optimize the potential of health IT now that so many providers are on board.  Health technology solutions are inherently complex, requiring substantial resources to maintain and optimize. But there are severe constraints on available resources, and funding is not distributed equally. Changes in the IT portfolios will need to occur without compromising care during transition periods.  Also given the fast-moving nature of health IT, maintaining the security and privacy of information is a challenge. (This will definitely need to be a focus as we move forward with exciting opportunities around mobile technologies).

We also need to move beyond the current emphasis on financial levers to push Meaningful Use compliance.  The real drivers ultimately will be increases in usability, efficiency, and productivity.  Until a true return on investment can be achieved, health IT will remain on the wrong side of the ledger, and thus will be subject to compromise.  A plan for long term assistance with the costs of Health IT should be considered.

When it comes to health IT, my best advice is to never be afraid to tear down what was previously built. Technology evolves rapidly and what was once a good plan/design/technology may not be optimal in the future. We need to be flexible and forward thinking – as do governments, consumers and health care systems. To borrow the National Health IT Week theme, we need to come together with “one voice, one vision [to] transform health and care.”

Be a part of Health IT Week:

• Take part in the “Health IT is…” Twitter Chat on Friday, Sept. 14. at noon ET moderated by @HIMSS and @HealthStandards. Use the hashtag #HITsm and follow ACC's @Cardiology account.
• Visit the ACC’s Health IT Resource Center for information on e-prescribing, the EHR Incentive Program, and choosing and using an EHR.
• Share your thoughts on Health IT on this blog, or on the ACC’s Facebook page.
• For additional information about National Health IT Week, visit healthitweek.org
  

This post was authored by John Rumsfeld, MD, FACC, chief science officer and chair of the NCDR.

The ACC in Touch Blog has spent the last two months exploring Appropriate Use Criteria (AUC), including what the criteria are; how to implement AUC in practice; and what AUC might look like in the future. This week’s post is focused on the National Cardiovascular Data Registry (NCDR®) and its ties to AUC. What might those ties be, you ask?

Well, the NCDR began in 1997 as a quality improvement initiative of the ACC to help hospitals and clinicians measure and benchmark the quality of their care. Today, the NCDR has six national hospital-based programs and one ambulatory care program (PINNACLE).  While much of the data collected in NCDR maps to the ACC/AHA clinical practice guideline recommendations, NCDR is committed to capturing data for quality metrics from the suite of ACC science documents, including performance measures and AUC.

The NCDR is involved with AUC in several ways. The CathPCI Registry already has data mapped to the coronary revascularization AUC.  Hospital participants receive quarterly CathPCI Registry outcomes reports that now include AUC for coronary revascularization metrics. The new ‘point of care’ CathPCI tool supports assessment of individual cases with regard to AUC category. The CathPCI AUC metrics are intended to support local quality improvement efforts for use by hospitals to compare themselves to a national rate, evaluate individual cases with regard to appropriateness, and determine if a quality improvement process is needed. Importantly, by ‘operationalizing’ the collection of data to measure AUC through NCDR, important feedback has been provided by hospitals and ACC members toward improvement of the AUC. The NCDR data elements will be updated with each version of the AUC that is released.

Currently, AUC on implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) are under development. Once finalized, AUC metrics will be created for the ICD Registry reports as well.

As additional AUC are created by ACC and partnering organizations, the NCDR will strive to capture relevant data – in the inpatient and ambulatory care settings – to support measurement and benchmarking for hospitals and practices. Moreover, the NCDR programs are evolving to integration with clinical workflow. As point of care tools become available to support clinical decisions, including appropriateness, NCDR will incorporate them into its programs. NCDR is committed to measuring and improving quality of care and patient outcomes, and as AUC are part of the Science and Quality documents of the ACC and its partnering organizations, NCDR is committed to the valid measurement and feedback of AUC.

For more information about NCDR, visit www.ncdr.com. For more information about AUC, visit www.CardioSource.org/AppropriateUse.

Today the first Appropriate Use Criteria (AUC) for peripheral vascular ultrasound and physiological testing was released. Developed by the ACCF in collaboration with 10 other professional societies, the criteria help clinicians maximize the appropriate use of certain noninvasive vascular tests when caring for patients with suspected or known non-coronary arterial disorders.

It is estimated that more than 20 million adults in the U.S. have some form of vascular disease. Since ultrasound and other noninvasive laboratory tests can be essential tools to help clinicians evaluate vascular blockages and disease, the AUC were created in order to ensure the effective use of these diagnostic imaging tools.

The new criteria focus on indications where ultrasound and physiological testing is frequently considered. Of the 159 indications rated, 117 were rated as appropriate, 84 were rated as uncertain, and 54 were rated as inappropriate.

In particular, arterial vascular testing was found to be “appropriate” in about half of the clinical situations evaluated.  For example, there was “significant consensus regarding the appropriateness of cerebrovascular duplex ultrasound for evaluation of the patient with signs or clinical symptoms of cerebrovascular disease with 7 of 8 clinical indications rated as appropriate and 1 clinical indication rated as uncertain.”

Overall, vascular studies were deemed appropriate when clinical signs and symptoms were the main reason for testing. For example, it is reasonable to order a lower extremity vascular study for a patient who reports calf pain upon walking that resolves with rest. Tests that were conducted in patients with existing atherosclerotic disease or to establish a “baseline” after a revascularization procedure were also considered appropriate based on ratings.

Of the indications rated as “uncertain,” the panel noted variations in practice and important gaps in the evidence that made it difficult to determine appropriateness.  For example, there was uncertainty regarding the use of cerebrovascular duplex for assessment of the asymptomatic patient with risk factors or comorbidities associated with carotid artery stenosis, with 6 of 7 indications receiving an uncertain score. According to the writing panel, clinical and cost-effectiveness studies on non-invasive vascular testing are needed in order to gain more clarity.

Notably, one in five uses of vascular testing were determined to be “inappropriate” meaning that, although doing the test does not cause harm, the information gleaned would not further inform clinical judgment.

This new document joins the growing list of clinical guidelines that currently includes AUC for echocardiography, cardiac computed tomography, cardiac magnetic resonance imaging, cardiac radionuclide imaging, coronary revascularization and diagnostic catheterization. The intent of AUC is to “avoid over- or underutilization, thereby promoting optimal healthcare delivery along with justifying healthcare expenditures and promoting the best outcomes for patients with minimal risk.”

Over the past month here on the ACC in Touch blog, we’ve featured a special series – “Back to the Basics” of AUC – to discuss what the AUC are, how to use them now, how the AUC can/will be used in the future, as well as the various ACC resources and tools available. Click here to read more.

Read more about the new AUC document on CardioSource here. Also be sure to check out my interview with CardioSource Video News on the new AUC document below. I invite you to leave any comments or thoughts below.

This post was authored by James Fasules, MD, FACC, Senior Vice President of Advocacy.

E-prescribing has been shown to improve safety and convenience for patients and clinicians, while also saving clinicians and pharmacists time and money. In an effort to encourage e-prescribing use, the Centers for Medicare and Medicaid Services in 2009 launched the E-Prescribing Incentive Program. As part of the program, providers that met the program criteria are able to earn an incentive payment on top of their Medicare Part B earnings.

Three years later, the program is still moving forward. Providers who e-prescribe 25 times between Jan. 1 and Dec. 31, 2012 will receive a one percent bonus – a definite incentive in this time of declining reimbursement. (Other restrictions apply and can be found here.) The newest addition, however, is that all eligible providers not participating in the program are subject to gradually increasing penalties. While it’s too late to avoid the 2012 penalty, there is still time to avoid the 1.5 percent penalty for 2013 … although the June 30 deadline is fast approaching.

According to CMS, individual eligible professionals and group practices can avoid the penalty by meeting the following six-month reporting requirements between now and the end of June:

• Individual eligible professionals: 10 e-prescribing events via claims
• Small e-prescribing group using the group practice reporting option (GPRO): 625 e-prescribing events via claims
• Large e-prescribing group using the GPRO: 2,500 e-prescribing events via claims

More information is also available here.

In addition, individual eligible professionals and group practices can also avoid the penalty by filing for a significant hardship exemption. Hardships exemptions are available to providers who are unable to electronically prescribe due to local, state, or federal law or regulation; have or will prescribe fewer than 100 prescriptions during a six-month reporting period (Jan. 1 – June 30); practice in a rural area without sufficient high-speed Internet access; or practice in an area without sufficient available pharmacies for e-prescribing. Hardship exemptions must be submitted through the Quality Reporting Communication Support Page no later than June 30. These requests are granted on a case-by-case basis and all decisions are final. Given the issues experienced last year by providers trying to request exemptions via the website, CMS has developed two documents outlining how to navigate the support page (Quality Reporting Communication Support Page User Guide and Tips for Using the Quality Reporting Communication Support Page). The College urges members not to wait until the deadline to file for an exemption!

For more information on health IT visit CardioSource.org/HealthIT.

This post was authored by Michael Wolk, MD, MACC, past president of the ACC.

We’ve come a long way over the past eight years with the development of Appropriate Use Criteria (AUC). To understand why these criteria are important to our daily practice, we must remember why the concept was first developed. More than a decade ago, usage statistics for diagnostic imaging was shown to have the fastest growth among all medical services covered by Medicare. At the same time, health plans in California were starting to review and question PCI and CABG cases based on RAND appropriateness criteria developed during the 1990s. The ACC’s Medical Directors' Institute, as well as leaders from our Board of Governors, saw this as both a challenge and an opportunity to look at both over- and under- use of procedures.

Upon approval by the Board of Trustees, we accepted the challenge of providing guidance regarding appropriate use of cardiovascular procedures, and ran with it. We created an Appropriateness Criteria Working Group involving several ACC leaders and published the document, ACCF Proposed Method for Evaluating the Appropriateness of Cardiovascular Imaging. Soon after, in October 2005, the first AUC document was published for SPECT MPI, ACCF/ASNC Appropriateness Criteria for Single-Photon Emission Computed Tomography Myocardial Perfusion Imaging (SPECT MPI). Upon completion, we held a summit to receive feedback on the process and how it might be improved. This information was used to refine the process including introducing early review of proposed clinical scenarios, larger expert panels, more comprehensive lists of clinical scenarios and ongoing coordination with clinical guidelines and other ACC policy documents. To date, the ACC has developed AUC for echocardiography, cardiac computed tomography, cardiac magnetic resonance imaging, cardiac radionuclide imaging, coronary revascularization and diagnostic catheterization. Currently under development are documents on implantable defibrillators and cardiac resynchronization, peripheral arterial and venous ultrasound, ultrasound use in pediatric patients, and multi-modality imaging use in heart failure, chest pain, and stable ischemic heart disease.

AUC define “when to do” and “how often to do” a given procedure in the context of scientific evidence, the health care environment, the patient’s profile and a physician’s judgment. The criteria can help inform individual patient care decisions but are best used to evaluate patterns of care by physicians over time.  All of the criteria are developed by panels of clinical experts from the ACC Foundation and its partner organizations based on evidence and when necessary expert opinion. The panels assess the benefits and risks of a procedure for different indications or patient scenarios and then determine whether the indication is appropriate, uncertain, or inappropriate. It is important to note that AUC ratings often contain more detailed scenarios than the recommendations covered in practice guidelines and thus subtle differences are possible. The criteria are also based on current understandings of technical capabilities and potential patient benefits of the procedures examined, and future evidence development will require these ratings to be updated on a regular basis.  In general, the documents have been updated every one to two years with all except the CMR AUC having been revised at least once since their original ratings.

I wrote in a 2004 President’s Page that "some may not see the importance of the College's efforts to address appropriateness. Some might argue that explicit guideline performance indicators can be divisive and prefer we not enter this arena. However, if we do not lead in this effort, others may set criteria that may not be wise either for us as physicians or for our patients.”

Eight years later, I believe the same scenario rings true. (Although looking at today’s use of radiology benefit management companies, I would change the last part of the sentence to “others WILL set criteria …”) It is our duty as a profession to work together with policymakers, payers and other medical societies to ensure patients are receiving the most appropriate care, while also reducing unnecessary health care costs and limiting wide variations in care delivery. This is about “doing the right thing” and is best done by our own standards based on the latest science.

For more information about AUC visit CardioSource.org/AppropriateUse.

This post is from a special AUC series on the blog focusing on the “basics” of what the AUC are, how to use them now, how the AUC can/will be used in the future, as well as the various ACC resources and tools available. Click here to read more.

This post was authored by William J Oetgen, MD, MBA, FACC, ACC's senior vice president of Science and Quality.

The Hospital to Home (H2H) initiative was launched in 2009 as a joint effort of the ACC and the Institute for Healthcare Improvement. Three years later, the goal of H2H continues to be a 20 percent reduction of hospital readmissions within 30 days for patients admitted with either acute myocardial infarction or heart failure. Three important activities that address core concepts have been identified as targets for improvement:

1. Medication Management Post-Discharge: Is the patient familiar and competent with his or her medications and is there access to them?
2. Early Follow-Up: Does the patient have a follow up visit scheduled within a week of discharge and is she or he able to get there?
3. Symptom Management: Does the patient fully comprehend the signs and symptoms that require medical attention and whom to contact if they occur?

In addition, H2H strives to create a learning community that shares expertise, experience and tools – and works together to improve the transition from hospital to home. The H2H community was developed to address these “challenges.” And, in a remarkable example of collegiality and cooperation, H2H members are collaborating and sharing information to help each other.

Over the past few years since H2H was established, individual and hospital participation in H2H has steadily increased. Currently, 2,294 individuals and 1,326 hospitals (39 percent of all U.S. hospitals) have united around the shared goal of lowering the risk of readmission.

Members of H2H have engaged in lively discussions of challenges and success strategies on the H2H listserv and on webinars designed to share experiences and best practices. We are continuously seeking ways to encourage participation and easier ways to access the tools and resources of the community.

During an ACC.12 session in Chicago, a panel of experts convened to discuss and identify tools and ideas to reduce hospital readmissions including a neighborhood watch solution that enlists trained volunteers from nearby universities to educate patients and make follow-up phone calls. We had several great ideas presented and the discussions underscored how the best way we can find the answer is by working together.

Reducing readmission rates is not straightforward and each institution must tailor its strategy to its particular setting and resources. Research in this area is still evolving, but with available knowledge it is now possible to make progress. In order to be successful and reach our goal, we must continue to learn from what we do – and from each other.

For more information on H2H visit www.H2Hquality.org.

KevinMD had a great guest post recently by Mary Pat Whaley on the time associated with a patient visit. I think the title sums up the blog well: “Your 10-Minute Office Visit Needs 8 People and 45 Minutes of Work.”

As Whaley notes, even the shortest of office visits have a lot of work behind-the-scenes that needs to be done; seeing the patient is just a small part of the overall visit.  And, I would submit that far more than 8 people and much more than 45 minutes is required.   Health care is a regulation- and administration-heavy field, and this requires time to make sure the regulatory and administrative rules are followed. For example, HIPAA requires privacy forms to be filled out prior to the patient being seen. Verifying someone’s insurance information is time-intensive. Not to mention ensuring that we charge the patient the right co-pay based on their insurer and insurance plan. On top of that, pay-for-performance programs require time- and technology-intensive data collection during and after the visit. All of this, and more, makes up one “10-minute office visit.”

Whaley concludes: “The practice, the patients and the overseers of health care want each visit to be non-rationed, safe, high-quality, error-free, holistic, pleasant, clean, accurate, efficient and reimbursable.  It’s what we all want.  And it ain’t cheap.”

I have to agree with her. The complexity of the American health care system is incredible. And, the layers of complexity account for much of the cost. Our system has been built by accretion.  We “reform” the system by adding on layers of regulation, of bureaucracy, of administration.  As you look behind the eight people figured in this visit, the cost if not the time includes coders, compliance workers, claims specialists, re-claim specialists, computer network and now electronic health record experts,  lawyers, front office personnel, and even standard maintenance personnel for the  building.

As the regulation and administrative burdens add on, the cost of practicing gets greater and it is harder to cover these expenses with income.  Add to that more and more cuts to cardiology, and it’s no wonder that a large number of private cardiology practices are integrating with hospitals. Last year, the ACC reported the results of a survey of ACC members that found nearly 40 percent of private group practices were currently integrating with hospitals or merging with other practices. An additional 13 percent of all cardiovascular practices were considering hospital integration or a merger in the next three years to help stem the financial burden.

These are uncertain times for cardiology and for the House of Medicine in general.  To be clear, the ACC supports the triple aim of better health, better health care, and at less cost. But to get there, we will have to deal with the repercussions of massive changes, and may I say probably the accretion of more layers, to our health care system. In my opinion, “dealing” with the repercussions will not be enough – we need to shape the discussions if we want to be pleased with the health care system structure of the future.  And, maybe we can even help peal away some of the layers.

The ESC Congress for the first time is having two sessions dedicated to clinical registries in order to highlight the growing number of innovative registries, the data they collect and the conclusions that can be drawn from this data. The sessions focus on “Risk and Treatment Reality” and “Interventions and Devices” and showcase registries from France, Italy and more.

The prominent treatment of the registry data trials at ESC Congress 2011 is a testament to their growing importance. Registry research is unique because it uses real-world data. The patients included in the registry are not chosen because they have limited comorbidities or fit a certain profile, like in clinical trials, but are included simply because they are a patient at a participating hospital. What this means is that we can see what the effects of certain treatments are on patients who may never qualify for a clinical trial. The results are a better understanding of adverse outcomes and better treatment protocols. The ACC frequently requests for FDA to require new drug and device manufacturers to conduct post-market approval studies through registries to ensure that the new drug/device doesn’t have any adverse events not caught in the clinical trials.

Of course, that’s not to say that registries aren’t without limitations. Currently, it’s challenging to connect care between the outpatient and inpatient settings because the U.S. will not implement a unique patient identifier system that could connect a patient’s progress in the hospital to the ambulatory setting and, in some cases, back to the hospital. We’ll need to find a way to work around this. With the growing emphasis on reducing readmissions, hospitals will need to have a better understanding of why and which types of patients are most frequently readmitted. Registries should be able to help fill this gap.

ACC’s registries suite, NCDR (National Cardiovascular Data Registry), has experienced a landmark year in terms of the science researchers have produced. The following studies have been some of the most interesting:

1. Non–Evidence-Based ICD Implantations in the United States (JAMA, 305;1). Researchers found that ICD implantations were not in accordance with practice guidelines in 20+% of patients, most commonly because of newly diagnosed heart failure or an MI within 40 days.
   
   
2. Patterns and Intensity of Medical Therapy in Patients Undergoing PCI (JAMA, 305;18). The authors conclude that optimal medical therapy is underutilized in patients with stable CAD.
   
   
3. Association of Door-In to Door-Out Time with Reperfusion Delays and Outcomes Among Patients for Primary PCI (JAMA, 305;24). Study showing improvement is needed in the treatment of heart attack patients who require transfer to another hospital for primary PCI).
   
   
4. Appropriateness of Percutaneous Coronary Intervention (JAMA, 306;1): This study concluded that although the majority of patients are appropriately selected for PCI procedures, there are opportunities for improvement, especially in the non-emergency setting.
   
   
5. Hospital Variability in the Rate of Finding Obstructive Coronary Artery Disease at Elective, Diagnostic Coronary Angiography (JACC, 58;8). Former ACC Prez Pam Douglas, MACC, et al., find that hospitals vary greatly when it comes to the rate at which obstructive CAD is found in patients without known heart disease undergoing elective diagnostic coronary angiography or catheterization.

These are just five of the hundreds of studies using NCDR data that have been published over the registries’ 14-year history. We may not always like what the studies find, but it’s the measurement that pushes cardiology as a profession to move forward and to find ways to more consistently implement best practices and guidelines. By measuring patient care in an appropriate and actionable way, registries bring to light the invaluable improvements being made by physicians and care teams.

I commend ESC for bringing registry data to the forefront of their meeting. I think we’ll see more and more about registry data in the future, as it addresses some of the gaps left by clinical trial data.

The prestigious Institute of Medicine (IOM) earlier this month opined concerned that most medical devices are cleared for sale without sufficient evidence that they are safe and effective -- even though we tend to delay approvals of devices far longer than the EU, Canada and most of the developed world. IOM’s assessment should give everyone pause -- particularly because they declared the current regulatory approach (related to the FDA 510K approval process) to be so messed up that we should scrap it and start over. FDA reacted immediately that they disagreed, stating they would instead work to fix the problems acknowledged in the 510K regulatory system.

The IOM committee found no major new horror stories related to existing devices on the market, but worried that FDA and the public have no good way to determine where risk may exist because there is virtually no good clinical data to rely on. Hello. The NCDR has the clinical data they seek; and if we could get the feds to offer incentives to help us diffuse the PINNACLE Registry across more outpatient practices, we could track post-approval performance and look for even low-signal adverse events incredibly effectively!

The IOM committee commented specifically on what they termed "highest-risk" CV devices, such as implantable defibrillators and replacement heart valves. They noted that clinical trials with relatively few enrolled patients are used to demonstrate safety and effectiveness of such devices, deeming that they afford only a “moderate risk,” based on having the manufacturer show that they are “substantially equivalent” to devices previously cleared. The added concern is that those devices in turn may have been cleared because they were “substantially equivalent” to earlier devices that may no longer be in use -- a ‘house of cards’ process.

IOM deserves credit for spotlighting the issues. But, not only the FDA objected to IOM’s recommendations: the device industry, already frustrated with the cumbersomeness of the 35-year old 510K process, are yet even more worried about and opposed to completely scrapping the process. They want to see it streamlined instead. What we need to do is show FDA, IOM and industry what the broad use of registries could do to carefully track ALL patients who are device recipients. That’s what needs to happen! Upcoming FDA hearings on the IOM recommendations and the future of the 510K process will give us an opportunity to promote this potential of using our registries to provide more rigorous and effective surveillance of CV devices after they are on the market.