Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: @JjrkCh
Showing posts with label device registry. Show all posts
Showing posts with label device registry. Show all posts

Tuesday, June 14, 2016

Zimmer Persona Knee Revision Surgery Prompts Recall



Zimmer Persona Knee: They Don’t Make ’em Like They Used To

June 13, 2016, 08:00:00AM. By Gordon Gibb  FiDA highlight

Warsaw, IN
It’s a common refrain in the modern age: things are not as they were. People don’t respect each other, or each other’s property like they used to. The politeness of old has vanished. “They don’t make ’em like they used to.” And for the most part, things aren’t built to last. One must forgive such a lament coming from the plaintiff behind a Zimmer Persona lawsuit alleging a failed Zimmer Persona Trabecular Metal Tibial plate.

Pundits find it remarkable that while the life expectancy of Americans continues to rise - thanks in part to ongoing advancements in modern medicine, disease prevention and more active lifestyles - the quality of the “parts” employed to make us whole again continues to decline, or so it appears.

A fast-track approval process employed by the US Food and Drug Administration (FDA) to bring new products to market more quickly without the traditional, years-long clinical trial process isn’t helping.

There is little doubt that for the majority of Americans, prosthetic knee devices work well and are on track to achieve the assumed service life expectancy of 15 years or more. However, when patients begin having problems with their medical devices - again, in the minority - even an apparent small number can have sufficient statistical impact to warrant a product recall.

That’s what happened last year with the Zimmer Persona Trabecular Metal Tibial plate. The latter is a plate that sits atop the tibia and serves as the surface area for the prosthetic knee device. According to various attorneys engaged in Zimmer lawsuits, a growing minority of patients reported loosening of the plates. This, in part, appears to be exacerbated by a lack of bone growth into the tibial plate, which would serve to anchor the plate. For a statistically large number of patients, this bone growth was either insufficient or not happening at all, leading to Zimmer Persona Knee pain and failure of the artificial knee.

Just referencing the failure of a medical device, implanted into a human body and failing soon after implantation, is serious enough without consideration of where a patient might be, or the activity involved at the point at which an artificial knee fails: driving a car; crossing a busy intersection; skiing; even walking across the kitchen with a steaming hot cup of tea from which a patient could suffer scalds or serious burns were a Zimmer knee to suddenly fail.

Thus, the Zimmer Persona Recall of 2015 when the Zimmer Persona Trabecular Metal Tibial plate was voluntarily recalled by the manufacturer - a recall endorsed by the FDA. Many patients experiencing Zimmer Persona Knee pain from a failed Zimmer Persona Trabecular Metal Tibial plate and requiring revision surgery to replace the failed component(s) are filing a Zimmer Persona Metal Plate lawsuit to seek compensation for pain, suffering and even loss of income. Revision procedures are often more complex than the initial procedure, with higher rates of complication. Having to go through a second surgery so soon after the first, followed by additional rounds of physiotherapy and rehabilitation, can eat into an individual’s income and livelihood given the additional time away from work.

The Zimmer Persona Trabecular Metal Tibial plate, it should be noted, was brought to market through an FDA 510(k) Clearance, the regulator’s fast-track program that allows design updates or new devices substantially similar to those already on the market and performing well to be brought to market without having to go through a clinical trial.

Clinical trials are long-term tests on volunteer patients, conducted to establish the safety and efficacy of a medical device before it is released to market and made available to the general population. If there are problems that surface in clinical trials, the device can be revised prior to a full market release.

Zimmer Biomet (Zimmer) is not the only manufacturer recalling medical devices. Other blue-chip medical devices firms are becoming saddled with recalls. Similarly, the FDA 510(k) Clearance is available to most large device manufacturers.


Speaking of Zimmer, US Official News (4/14/16) reports another Zimmer Persona Recall, but this one has to do with packaging. According to the FDA, the recall involved the Persona Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthroplasty (REF # 42-5114-008-18).

The recall stemmed from a complaint that there were two sets of information on the box containing the product: One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-005-14/ Lot: 62646580.

The products at issue were distributed to various states in the United States as well as globally (but not Canada).


The Zimmer Persona Recall was voluntary, issued by the manufacturer.
https://www.lawyersandsettlements.com/articles/zimmer-persona/zimmer-persona-lawsuit-recall-10-21533.html?opt=b&utm_expid=3607522-13.DLfjpNTnSeOVrAk1Ud2uNA.1&utm_referrer=https%3A%2F%2Fwww.facebook.com%2F

Tuesday, May 19, 2015

Patient Outcome Registries: Proprietary and Inaccessible to Oversight

Who Keeps Track If Your Surgery Goes Well Or Fails?

MAY 03, 2015 5:20 AM ET




In order to improve the quality of health care and reduce its costs, researchers need to know what works and what doesn't. One powerful way to do that is through a system of "registries," in which doctors and hospitals compile and share their results. But even in this era of big data, remarkably few medical registries exist.
Dr. Martin Makary is a surgeon at the Johns Hopkins School of Medicine. He and his colleagues published a study online this week in the Journal for Health Care Quality about the major shortcomings in the way patients are tracked after treatment.
I had a chance to speak with Makary about his interesting findings. The following is an excerpt of our conversation, edited for brevity and clarity:


Makary: For 99 percent of people in America, when they go in to have surgery, the outcome [of that operation] is not measured. Nobody's keeping track. So I'm amazed at how one-fifth of the economy, [the share accounted for by the healthcare system], functions with so little measure of its performance.
Harris: What inspired you to do this study?
Makary: I do an operation known as pancreas islet transplantation, and we send our outcomes to a national registry. I tried to get the data from that registry to better understand the disease and the outcomes from different centers, and I found out I couldn't get access to the data. I found it ironic that the data warehouse is funded by the taxpayers, and yet I can't even get access as a participating center. So it really got me curious about how many other diseases are being tracked in a national registry that is taxpayer-funded and that is also not transparent and available to the public.
Harris: What's the point of collecting the data if it's not made available to researchers who want to examine it?

Makary: The truth is, it's held in proprietary housing, and sharing it is not as easy as it sounds in principle. Instead [people who are trying to evaluate the medical system] focus too much on a few things that are very easy to measure, like patient satisfaction. Patient satisfaction may not even correlate with the appropriateness or the quality of the operation. I know people who have had unnecessary operations but are totally satisfied with them!
Harris: Turning to your paper now, what was your biggest surprise?
Makary: The biggest surprise was that [among the 153 registries we identified] there is tremendous variation among the different medical specialties. And the other big surprise was that only 18 percent had any form of auditing to verify their data. Now, on Wall Street we would never accept an 18 percent auditing rate when companies report their earnings. As a matter of fact, if a company misreports their earnings, the CEO goes to jail.
Instead of focusing on outcomes, we have a huge upfront effort to approve a new device or a new medication. We put them through the ringer. And once they're released, nobody's tracking anything. You have no idea how people are doing with a new medication or a new knee joint. New surgery is untracked for the most part.
Harris: There are financial incentives for companies not to know those answers. Hospitals, device makers, drug makers — if they're selling something already, the only news can be bad news, right?
Makary: Absolutely. Life is good right now if you get FDA approval. And hospitals don't want to spend the $60,000 to $80,000 a year to participate in a registry.
Harris: Hospitals could worry about losing patients. If you're looking at who's in the top 10 percent of all hospitals in terms of treatment outcomes, that's only 10 percent of the hospitals. And the other 90 percent might say this doesn't serve their interest in attracting patients.
Makary: You're exactly right. Hospitals are not malicious, but there's no incentive for them, from a business standpoint, to chase down their outcomes and measure their performance for internal quality improvement.

Harris: Can you give me an example of an instance where data gathered in a manner like this changed the way care was provided?
Makary: The best registry in America, in my opinion, is the cystic fibrosis registry. It has been around for 20 years. I believe that because of the cystic fibrosis registry we've been able to prolong the survival of kids with cystic fibrosis by almost two decades.
Also, Dr. Douglas Rex at Indiana University, who was frustrated at the problem that doctors were doing colonoscopies too quickly and inappropriately, decided to secretly record the videos of a whole bunch of doctors doing the procedure. He then told his colleagues, "I'm going to be watching your videos." Instantly, the quality scores improved by 40 percent.
If we're going to get serious about reining in healthcare inflation, we have to get serious about measuring our performance in health care. Everybody agrees about that. The actual work of measuring patient outcomes is what's missing.



http://www.npr.org/sections/health-shots/2015/05/01/403611589/who-keeps-track-if-your-surgery-goes-well-or-fails

Thursday, January 23, 2014

Health Activists Push Medical Device Accountability

Has Your Hip Been Recalled?


The Women's Health Activist
January/February 2014
By Kate Ryan
When cars, baby cribs, or even microwaves are recalled because there’s a safety problem or the product doesn’t work, you can check the unique serial number on your car, crib, or microwave to immediately discover if the one you own has been recalled, or if there’s no need for you to worry. Having systems that facilitate the quick and accurate identification of unsafe and ineffective devices is just common sense — so most people would be surprised to learn that, until six months ago, the system for tracking problems with medical devices was so ineffective that many people never even found out about recalls of defective products — which has the potential to put their health at risk.1
If, like me, you watch cop shows such as CSI or Bones, you probably think that implanted medical devices can be traced back to the medical record of the person whose body they’re implanted in. Shows like that have plenty of episodes where the murder victim is speedily and accurately identified because she has a hip replacement or pacemaker that can be tracked by its unique identification number. Unfortunately, until now that’s been fiction! In reality, the lack of a basic, commonsense system that allows someone to find out if she has a recalled device has left U.S. women and health care providers struggling to get their questions about specific products answered -- even basic information like whether the product a woman is using has been recalled.
That’s the scary news. The good news is that health advocates have finally persuaded Congress and the Food and Drug Administration (FDA) to establish a unique device identification (UDI) system and the National Women’s Health Network (NWHN) is working with the FDA to develop that system.
This is an important advance for women. The NWHN has advocated for a medical device UDI system for many, many years. This system is key to the FDA’s ability to protect millions of people from the harm caused by flawed and dangerous products.
The new protections will begin this summer, starting with the highest-risk devices like certain pacemakers, heart valves and joint replacements. Over the next seven years, the FDA will roll out requirements for medical device manufacturers to include a unique number and bar-code on the label of certain medical devices so patients, consumers, health care providers, and hospitals can track and identify these devices.2 The new UDI system will provide women who use medical devices with better information and prevent the unnecessary harm that results when recalled devices remain inside the body. The system also has the potential to improve how device problems are reported to the government, so the FDA can more quickly identify dangerous devices and remove them from the market — which will help all of us.
How much do you know about your device?
Currently, women do not have enough information about the specific devices they use or have had implanted to be able to tell if they’re affected by a specific device recall. Many patients leave surgery without knowing what company made their new hip, let alone what brand of hip they have — and it can be very difficult to track down those details later. The general information you get from scary lawsuit ads that warn of safety problems with surgical mesh or from news reports about a recall of hip implants do not provide enough detailed information about the recall, or the specific hip or mesh, for anyone to be able to tell if the product they have is affected.
You could try going to the FDA’s website to get more information about the recall, but you will only find the brand name and description of the device being recalled….which still won’t tell you if you have the specific recalled hip. The most likely place to find the relevant information is from the health care provider who either provided or implanted your device. The best-case scenario is that your provider documented which manufacturer and what specific brand or model of device you received. Unfortunately, labels for implanted devices are usually on the packaging, which is often thrown away during surgery, and the information doesn’t always make it into a patient’s medical records. Even if your provider did keep good records, it can be next to impossible to find that information if your provider has retired, moved, or gotten rid of her old patient files. The lack of a system has — until now — created enormous barriers to patient’s access to vital information.
Women are safer with more information
Once the new UDI system is fully implemented, women will be able to ask for their device’s specific UDI number when they get the device. That way, a woman will have all of the information she needs when she hears about an FDA device recall, and that may minimize both unnecessary worry and unnecessary harm. If her device hasn’t been recalled, she can stop worrying about the potential harm immediately – no need to make an unnecessary trip to her provider because she kept a record of what device she has and hopefully so has her provider. If her device has been recalled, she can promptly schedule an appointment with her health care provider and talk about whether she needs to stop using the device — or, if it's an implanted device, if she should get it removed and replaced.
The new UDI system will also improve the device recall system and decrease the amount of harm caused by slow or incomplete device recalls. With UDIs, it will be easier for hospitals and providers to stay current on the latest safety information and list of recalled devices. They will have the information that will allow them to check medical records for affected UDI numbers so they can contact patients directly with the recalled device, rather than waiting for patients to learn about the recall and seek information themselves.
Making it easier to for hospitals to identify and track recalled devices will also prevent unsafe devices from being given to patients in the first place. Without UDIs, recalled devices are, unfortunately, likely to remain in use, and a patient could have surgery and receive a device that has already been identified as flawed and potentially dangerous. While we’d all like to believe this is extremely rare, right now there’s no way to know how often it occurs. Of the approximately 700 medical device recalls that happen each year, about half of the faulty devices (53 percent) stay on the market, because manufacturers currently have no way to track their devices electronically. The UDI system will allow hospitals and providers to scan the bar-codes of all the medical devices in their supplies and assess the safety of the devices they intend to use. When a hospital or other health care provider is notified of a recall, the new UDI system will allow them to quickly find and remove any recalled devices from their storerooms.
Tracking devices will improve public health
The UDI system will have broader benefits for everyone, including people who do not have a medical device. That’s because it will also increase the accuracy of the information about all of the devices on the market.
Currently, when someone experiences a problem with a medical device, she or he can report it to the FDA, which maintains lists of what are called “adverse events.” But, these reports often lack detail, and may only state that a patient had a problem related to surgical mesh, or a hip, in general. While reports from health care providers sometimes include more information about the problematic brand or manufacturer, it still isn’t usually enough information to help the FDA estimate the extent of the problem. Is there just one faulty device out there? Do the adverse event reports indicate there’s a problem with one batch of a device stemming from a manufacturing problem? Or, do the reports signal that there is a larger issue with the design for a particular device model?
Under the new system, patients and providers will be able to include a UDI number in their adverse event reports, and the FDA will gain access to better information to help answer those questions and more quickly flag bigger problems.
Making the UDI system work for you!
Once the UDI system is fully in place, when you hear about a device recall, you’ll be able to find out whether the recall affects your specific device by checking the UDI number on the label against the FDA recall alerts and safety notifications. To do this, you’ll need to keep the label of any device you purchase or are given at a health care facility (like an insulin pump) and/or have surgically implanted (like an artificial hip). If you have a medical device implanted through surgery, make sure that the UDI number is included in your medical record and ask for a copy of the number to keep on hand. That way you can check the FDA’s safety notifications and recall alerts to see if your UDI number is on the recall list.
At the NWHN, we will continue to watchdog the roll-out of the UDI system to ensure that it meets women’s needs. We will advocate for the FDA to raise awareness about the new UDI system and to clearly communicate to patients and other consumers any recalled UDI numbers. We will also continue to push for more devices to be directly marked with the UDI number so people won’t need the label to keep track of their UDI number.
We want to ensure that you have the information you need as quickly and easily as possible. Knowing your UDI number will empower you to take action to protect your health when you hear about a possible safety problem or recall.
Kate Ryan is the NWHN Senior Program Coordinator
Additional resources
                NWHN’s article about device regulations: http://nwhn.org/blog/medical-mishaps-what-you-need-know
                NWHN’s article about Metal-on-Metal (MoM) hip replacement devices: (http://nwhn.org/newsletter/node/1369).

1. The Food and Drug Administration’s definition of a “medical device” is available here: http://www.fda.gov/aboutfda/transparency/basics/ucm211822.htm

2. Read more about the new rules on the FDA’s website: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDevi...

Friday, April 12, 2013

Proprietary Silo for Medical Devices: PCORI Irrelevant?


Where Is the Patient Stakeholder?  FiDA highlight.

By Jaimy Lee  Modern Healthcare
Posted: April 9, 2013 - 8:00 am ET


Health insurer UnitedHealthcare and about 50 hospitals say they will conduct research comparing some of the costliest medical devices on the market and then use that data to inform their purchasing decisions as part of a joint venture.

UnitedHealthcare and Dignity Health, a 37-hospital system based in San Francisco, formed  SharedClarity last year.

Since then, the Phoenix-based venture has added Baylor Health Care System, which operates 11 hospitals in Texas, and Advocate Healthcare, a 10-hosptial system based in Oak Brook, Ill., as its newest members. There are plans to include up to seven other health systems over the next few months.

“Our members have a tremendous thirst for getting independent information about how medical devices perform,” said Mark West, SharedClarity's president and a former vice president of supply chain management for UnitedHealthcare.

Implantable medical devices are among a hospital's most expensive supply costs. The prices of these devices are also rising, making them a concern for hospitals and insurers seeking to better manage the costs of pricey procedures such as hip and knee implants. 

Many hospitals have implemented cost-cutting strategies for devices and other physician-preference items, and some have formed new ventures that aim to address the costs of these products. Earlier this year, the Cleveland Clinic and VHA announced a joint venture that aims to target the costs of physician preference items.

However, SharedClarity is unique in that the venture was formed between an insurer and a health system. SharedClarity said it will identify the best-performing devices in 30 categories by using clinical data gathered from member hospitals and claims information from UnitedHealthcare, West said. The device categories range from stents and defibrillators to pacemakers and knee and hip implants. 

The hospital systems then plan to pool their purchasing volume to negotiate better prices on what they find to be the best-performing devices. In addition, hospitals that are part of UnitedHealthcare's provider networks will have access to those devices at prices negotiated by SharedClarity, although the prices will be less favorable than what the member hospitals receive.

The studies are expected to begin this spring. Richard Roth, Dignity's vice president of strategic innovation, said he expects the first purchasing decisions to be made next fall.

“As Dignity is entering in accountable care organizations and we're doing bundled payments and we're continually demonstrating the tenets of reform, this is going to be a valuable intelligence tool as we're caring for patients,” Roth said.

Both providers and insurers have lamented a lack of independent data about how implants perform, as well as lack of transparency about how they are priced. As more hospitals and insurers are taking on risk-based reimbursement strategies, they say there is a need for better data.

The higher failure rates of metal-on-metal hip implants, which led to revision surgeries and thousands of lawsuits against Johnson & Johnson, would have been caught sooner if data about the performance of those devices had been captured, according to West. 


SharedClarity will not only compare types of device and how they perform, it will also research how some devices fare when compared to different types of treatments or therapies.

“Our goal is to shed a light on this and create transparency,” Roth said.

Monday, February 18, 2013

Patient/public access to implant data still missing!


Physicians face limited choice in medical device selection as hospitals push to slash supply-chain costs

 Modern Healthcare
By Jaimy Lee   FiDA highlight  
Posted: February 15, 2013 - 12:01 am ET

 Gagged by their supply contracts, some hospitals have devised a simple way to educate physicians about the cost of pricey implants: using color-coded stickers to indicate the level of a device's price.

Many of these hospitals are barred by confidentiality clauses with device manufacturers that limit, in some instances, whether hospitals in the same health system can share pricing data about the devices they purchase. Instead, they mark the devices with colored tags specifying high-, medium- or low-cost options.

The widespread use of confidentiality clauses—which limit price transparency and hospitals' ability to shop for devices based on price—and longstanding relationships between physicians and device companies are the two major factors driving costs higher on implantable devices such as artificial knees and hips or cardiovascular stents, which are among the most expensive items hospitals buy.

 They are frequently called physician preference items because orthopedic and cardiovascular surgeons traditionally make the final decisions as to which devices a hospital will use. Only over the past five years or so have some hospital administrators started to implement strategies to reduce the costs of these items.

However, mounting pressure on hospital margins, the increasing number of physicians employed by hospitals and the shift to new payment models that align the financial priorities of hospitals, physicians and a patient's cost of care indicate that the concept of a physician's preference may soon be a thing of the past.

“This will be an area where there is a lot of opportunity for cost containment because it's an area that has really run rampant in the past and has not been well controlled by many hospitals,” says Dr. Kevin Bozic, vice chairman of orthopedic surgery at the University of California at San Francisco. “There's not as much flexibility and fat in the system. They're going to have to be much more efficient and function with the same discipline as other businesses.”

At the same time, the costs of many implantable device procedures continue to rise. Orthopedic procedures accounted for most of the growth in Medicare implantable device procedures from 2004 to 2009, with spending on those procedures increasing 8.1% annually for five years, according to a Government Accountability Office report from January 2012.

There is little publicly available data showing the individual prices of implantable devices and whether those prices are rising. But the same report found examples of “substantial price variation,” with one hospital paying $4,500 for a specific primary total hip construct and another paying $8,000 for the same product.

“The cost of joint implant constructs used for knee and hip replacement vary widely and are major contributors to the variation in the cost of care for patients undergoing total joint replacement,” according to a separate study published last year in the Journal of Bone & Joint Surgery.

With hospital margins under pressure, many large health systems and integrated delivery networks have become increasingly aggressive about implementing cost-cutting initiatives that target medical devices. They usually focus on reducing prices and the number of manufacturers—which can lead to better volume discounts—as well as seeking better utilization practices.


Hospitals have introduced gain-sharing programs that allow physicians to share in cost savings. They're also creating device registries that track performance to help inform purchasing decisions and instituting bundled-payment models that may also reduce costs and improve quality.

However, there are no specific efforts under way to ban the use of confidentiality clauses.

Jeffrey Lerner, president and CEO of the ECRI Institute, an independent health technology assessment organization, says that increased awareness of the clauses, as well as the ongoing cost pressures and market changes, could lead to increased pricing transparency.

But there's more to reducing a health system's supply costs than just addressing price, says Brent Johnson, vice president of supply chain and imaging services and chief purchasing officer for Intermountain Healthcare, Salt Lake City. There is greater financial benefit when Intermountain better manages utilization and standardizes practices rather than solely focusing on price, he says.

“In this industry, we tend to tiptoe around physicians. That they are allowed preference is a huge conflict of interest most of the time,” Johnson says. “When the physician has a choice between keeping his loyalty and whatever benefit he gets from the vendor and keeping his salary whole, he'll abandon the preference in a minute.”

Many physicians develop preference for specific devices or manufacturers early in their careers. In a fee-for-service model, physicians have little incentive to choose less-expensive devices and more often than not their interests are closely aligned with those of the manufacturer rather than the hospital. This is changing.

“There have been more attempts to align the interests, financial or otherwise, of hospitals and physicians,” UCSF's Bozic says. “More physicians are employed by hospitals; more physicians are entering into joint ventures or co-management agreements with hospitals; and newer payment methodologies such as bundled payments are effectively putting both the hospital and the physicians at risk for the cost of care, (which) aligns their incentives around improving quality and reducing costs.”

The Affordable Care Act is at the center of many of these changes. Along with the introduction of new payment models, such as accountable care organizations and patient-centered medical homes, the inclusion of the Physician Payments Sunshine Act is expected to make the financial relationships between physicians and manufacturers more transparent.

Related content


Under the Sunshine Act, device companies are required to collect data about the payments, gifts and other “transfers of value” they give to physicians. That data will be posted online beginning in September 2014, which might give hospitals and physicians an incentive to reduce the appearance or prevalence of certain relationships.

“That level of disclosure may be operating to weaken the bond between the implanting surgeon and the company,” ECRI's Lerner says.

In fact, physicians are increasingly getting involved with supply chain-led initiatives to reduce costs. Dr. Richard Parker, chairman of orthopedic surgery at the Cleveland Clinic, has been working closely with the 11-hospital system's supply-chain staff since 2008. Parker, a sports medicine surgeon, was named chair of orthopedic surgery in 2009. “When I moved into that leadership role, I became much more acutely aware of costs,” he says.

With the move toward what Parker calls “value-based medicine,” physicians are becoming more engaged in supply decisions, especially in the cases where a change in device can affect patient care or when the price of a device makes up a large percentage of certain DRGs. He says there is little pushback from other physicians who may question some standardization efforts.

“We attract individuals who, quite frankly, value the brand of the organization more than their individual brand,” Parker says. “They realize that in order for this to continue we have to get our arms around these things.”

At Intermountain, the doctors who are members of physician preference committees for orthopedics, cardiovascular, neurology, trauma and surgical services items are “already more engaged, accepting of change and know this is where we're headed,” Johnson says.

The first time the supply-chain team tackled the costs of orthopedic devices was in 2007, when the 21-hospital system was spending about $32 million annually on that device category alone.

That same year, Johnson received approval from the system's administrators to share up to 30% of documented first-year savings on the costs of orthopedic devices with the system's orthopedic surgeons. By supporting Intermountain's strategy to implement standard pricing policies—physician support pressured suppliers to comply—the physicians could use the savings to purchase other equipment, supplies or training.

The approach worked, and Intermountain now re-evaluates the cost of physician preference device categories every two years. The average savings for every category assessment is about 20% each time, Johnson says.

However, he views many of the pending payment reforms as the potential forces in driving the concept of “preference” out of the industry. If a physician has to take a 20% deduction on the cost of a procedure or agree to use a limited number of suppliers, the physician will be more likely to support standardization, Johnson says.

“Healthcare reform isn't just about cost. We've got to manage utilization,” he says. “We need physicians and surgeons to not just be loyal to one supplier, we need them on board to help us manage utilization and standardization and value beyond just price.”

So while market and regulatory change may be coming, it may not be occurring as quickly as some hospitals would like. Physician preference items are usually among a hospital's most expensive supply costs. With few organizations willing to make further cuts to labor costs—an organization's highest expense—they are instead focusing on reducing their second-largest expense—supplies—with physician preference items being a key target.

“Nonlabor (cost) is now getting a lot of attention because we squeezed everything we can out of the labor side,” says Ed Hardin, vice president of supply chain management for Christus Health in Texas. “We can't afford to make those kinds of cuts, so we've got to get more efficient and more effective about how we run our supply chain.”

Physician preference items account for about 57% of total supply costs for Christus Health, Hardin says, a percentage that has increased 10% since 2008. “It's rising as a percentage of total supply expense, whereas commodity spend has gone down,” he says.

As the cost of physician preference items continues to make up a larger percentage of total supply costs, some hospital systems have looked outside of their networks in an effort to better address the costs of these devices.

Cleveland Clinic and Dignity Health, both large health systems, have formed separate joint ventures that specifically aim to address the costs of physician preference items.

San Francisco-based Dignity Health developed a for-profit company called SharedClarity with UnitedHealthcare and up to 10 additional and unnamed health systems.

“These organizations are combining data to help inform healthcare organizations about the best-performing medical devices through comparative effectiveness studies,” according to SharedClarity's website. “For the first time, these exclusive studies will enable doctors and administrators to make informed decisions based on clinical proof rather than manufacturer influence.”

When the Cleveland Clinic announced its joint venture with VHA this month, it stressed that it will focus on how it can reduce the costs of physician preference items for its hospitals. However, there are also plans to bring in VHA members, Cleveland Clinic affiliates and other organizations.

The Greater New York Hospital Association recently received approval from the U.S. Justice Department to establish a voluntary gain-sharing program for its member hospitals. UCSF's Bozic says the university is looking into the possibility of developing a similar program.

ECRI's Lerner says more hospital systems will form partnerships or other ventures to help them rein in the costs of these devices. “Change brings a lot of experimentation,” he says. “We have to see how it actually plays out.”

One of the largest concerns for executives who manage supply-chain purchasing at hospitals is how to obtain and use clinical data that allow them to choose between competing devices. The goal: improving patient outcomes and avoiding repeat operations known as revisions. As payers turn toward bundled payments, avoiding revisions can also lower costs. Kaiser Permanente and the Cleveland Clinic have each maintained system device registries that can better track how a device performs after implantation.

Government registries in Australia and the United Kingdom were the first to discover that metal-on-metal hip implants were failing at a faster rate than other hip devices. More than 93,000 metal-on-metal hip implants sold by Johnson & Johnson's DePuy Orthopaedics unit were later recalled, which led not only to revisions but also to thousands of lawsuits.

In addition, the number of recalls in recent years may have caused a splinter in the relationships between physicians and manufacturers.

“There have been disappointments for physicians,” Lerner says. “We've had high-profile recalls. You have this gigantic problem with metal-on-metal implants, which makes a huge impact. That's massive, and I think it undermines that complete trust bond between the surgeons and the companies.”

TAKEAWAY: Reducing the number of vendors and developing new ventures are among the ways hospitals are targeting supply-chain costs.

Thursday, January 17, 2013

Monumental regulatory fail: metal on metal hips


http://www.nytimes.com/2013/01/17/business/fda-to-tighten-regulation-of-all-metal-hip-implants.html?emc=tnt&tntemail1=y

After an estimated 500,000 patients in the United States have received a type of artificial hip that is failing early in many cases, the Food and Drug Administration is proposing rules that could stop manufacturers from selling such implants.
Under the proposal, which the agency is expected to announce on Thursday, makers of artificial hips with all-metal components would have to prove the devices were safe and effective before they could continue selling existing ones or obtain approval for new all-metal designs.



Joshua Borough for The New York Times

Some all-metal hip implants have failed prematurely, forcing thousands of patients to undergo operations to replace them.

Saturday, October 27, 2012

Found this in the mouse maze! Patient last to know.


 Being a patient advocate is like running in a maze designed to disorient and exclude.


Regina Holliday (patient advocate, artist) painted this while attending the PCORI patient-engagement workshop in DC today.  It is unreasonable of PCORI/FDA to expect any patient or advocate to demonstrate more tenacity or willingness to work productively.  This system is rigged.  I await my invitation to the December 4 PCORI meeting.

Posted: September 11, 2012  (FiDA highlight)
FDA device officials are pushing for a national postmarket surveillance monitoring system that emphasizes Unique Device Identifiers and their incorporation into electronic health records, device registries, modernized adverse event reporting and new methods to analyze postmarket information, laying out the plan in a paper released late last week and discussed at a public meeting Monday (Sept. 10). The head of the health law's comparative effectiveness institute expressed interest in participating in the initiative, which FDA hopes will extend beyond the agency.
Stakeholders also debated potential governance structures, eventually floating a public-private partnership. When pressed on the role the health law's Patient-Centered Outcomes Research Institute could play, PCORI Executive Director Joe Selby said he is particularly interested in involving patients and contributing analytic methods. “We’d be glad to be party to discussions like that,” he told and FDA official during the meeting. He said, however, there should be a business case made to each party, and it is more challenging to make the case for patients and health systems.
While industry, consumer and academic stakeholders lauded FDA’s effort, concerns emerged about off-label uses and access to the data, given issues with patient protections and company proprietary concerns. “The key is going to be implementation,” said Paul Brown, government relations manager with the National Research Center for Women and Families. He cited examples in the report that spurred concerns about the potential to incentivize off-label use as the data collected through postmarket surveillance could support new indications.
“Analysis of de-identified EHR data containing a unique device identifier demonstrates that within the practice of medicine, physicians have been treating patients with incontinence due to other causes -- and the data demonstrates the device is as effective as it is in patients with incontinence due to prostate surgery,” according to an example comparing potential future uses of the system to the current state where manufacturers must conduct clinical trials to expand labeled indications. “The company submits the analysis and (the Center for Devices and Radiological Health) approves an expansion of the labeled indication solely on the basis of the collected postmarket data.”
Brown warned that, depending on implementation, the system could provide an incentive for companies not to conduct clinical trials and potentially exacerbate problems with off-label promotion. Another device safety advocate, however, said using the postmarket data would allow for a real-world analysis of devices as many risks are unknown until products are available to a broader patient population.
Brown also took issue with FDA suggestions that postmarket data could be used in support of device down classifications, saying such information should also be used to support up classification if appropriate. Further, he said FDA should have access to information in registries to detect safety signals, an issue that also emerged as academic and industry stakeholders debated who would have access to the device data as it could affect hospitals and individual practitioners. Industry stakeholders also expressed concern that the system should not try to be “all things to all people.”
FDA device center director Jeffrey Shuren emphasized that the agency would leverage national and international registries, as opposed to creating a registry repository.
“Let me be clear, we don’t need registries for every type of medical device nor is it feasible or sustainable to do so,” he said. “And we don’t want to develop a central repository.” Individual repositories should remain such as it helps protect patient privacy, he said.
Thomas Gross, director of the device center’s office of surveillance and biometrics, said the agency has already facilitated the development of dozens of registries. With regard to modernizing adverse event reporting, Gross touted the use of triggers in electronic health records to automate the reporting and a medical app that is being piloted.
FDA device officials said they hope to release a finalized version of the plan by the end of the year. -- Alaina Busch (abusch@iwpnews.com)