Safety or Secrecy: Implanted Medical Devices

New rules to end secrecy oversafety of medical implants

By Laura Donnelly, Health Correspondent, The Telegraph

7:50AM BST 09 Sep 2012  (FiDA blog highlight added)

The changes will mean that for the first time the public will be able to access details of the clinical research behind the products, and their safety record since coming on to the market.

The rules are being drawn up by the European Commission in the wake of the PIP breast implant fiasco and the scandal of metal-on-metal hips, which were found to poison the body and suffer failure rates of up to 50 per cent.

Under the current system, the clinical evidence to support devices, and the records of adverse incidents linked with them are kept behind closed doors.

Manufacturers must share some information with a "nominated body" of their choice, which authorises their products for use, yet it cannot be seen by the public, nor by independent scientists because of draconian European Union regulations.

British regulators run a voluntary system so surgeons can report concerns about medical devices, yet the EU confidentiality rules mean their data is not published, with patients and doctors told nothing - unless the situation deteriorates so badly that a safety alert is issued.

Last December it emerged that more than 40,000 British women received substandard breast implants, made by Poly Implants Protheses (PIP), with some made from industrial silicone, instead of the medical substance which had been authorised.

In January, The Sunday Telegraph disclosed that thousands of Britons had been given metal-on-metal hip implants which were found to poison the body, with some devices having failure rates of up to 50 per cent.

Weeks later, regulators the Medicines and Healthcare products Regulatory Agency (MHRA) issued a warning that 49,000 people with the implants should undergo checks throughout their lifetime and undergo further operations to replace the devices if problems were found.

The new proposals from the European Commission, due to be published within weeks, are expected to recommend that three directives on medical devices, passed during the 1990s, are rewritten.

Under the plans, a duty of confidentiality which is currently placed on all organisations which handle clinical data would be erased, in a bid to make the system more transparent.

The current rules were intended to protect the commercial interests of manufacturing companies, but safety campaigners and regulators believe they have gone too far in putting the interests of business ahead of patient safety.

Professor Sir Kent Woods, chief executive of the MHRA, which has called for the change, said: "The evidence should be out there – so that scientists can look at it, so that patients can look at it and so the public can look at it."

He said it had now become "widely accepted" in the pharmaceutical industry that companies had to make the data from their clinical trials public after drugs were licensed, and that reports of adverse reactions to drugs were documented and published.

Medical devices and implants should follow the same direction, he said.

Because of the single European market, devices used in this country can be manufactured elsewhere, then authorised by a "notified body" in any of the 27 EU member states.

That meant that in the case of the PIP implants, a company in Germany was responsible for the quality of devices produced in France and imported for use in 300,000 women around the world, including Britain.

British regulators the MHRA accredit the six notified bodies which operate in this country and can audit them to check their processes – but have little control over the quality of checks done abroad.

The MHRA has urged the European Commission to change the system, so that accreditation is done by representatives from several countries, in order to ensure that all countries are working to the same standards.

Prof Woods said he felt confident about the expertise of the organisations it inspects but said: "I can't be confident that notified bodies in every one of the 27 countries are working the same way".

He said the rules of a single market in Europe meant it was not possible for British regulators to check all the devices used in this country.

The MHRA is also calling for more rigorous standards to ensure that the clinical evidence to support the application for a licence is more consistently and robustly scrutinised.

The commission is considering how information should be better shared across EU member states, which Prof Woods said could have helped regulators to detect the PIP scandal sooner.

"If we had been able to easily share adverse incident data across Europe I think we would have picked up an increased signal about rupture rates – though not that the filler was fraudulent," he said.

The Commission is also considering whether an "implant card" should be given to all patients who receive an implant, with details of the date, name of device, batch, lot and serial number.

The MHRA said it became clear when problems arose over breast implants and metal-on-metal hip replacements that most patients given implants were not aware what type of device they had.

Sir Bruce Keogh, the Department of Health medical director, is leading a review of cosmetic surgery which is considering whether details of all operations should be held on a central register, to help detect problems with particular types of implants.

FiDA blog comment: 

Tomorrow 9/10/12 the US FDA is conducting a webinar/public meeting on the issue of unique device identifiers UDI's for implanted medical devices.  The US government is liberating a substantial amount of 'big data' from Medicare for research.  Patient harm will be reduced and safe and effective implanted medical devices will be identified so that consumers can make informed decisions.  "Proprietary" information that endangers public health will be exposed.

Patients Informed: Reduce Joint Replacements

Shared Decision Making for Hip andKnee Replacement Candidates

SEPTEMBER 6, 2012

Jaan Sidorov, MD, MSHA, FACP

Posted 9/05/12 on the Disease Management Care Blog

Osteoarthritis (a.k.a “degenerative arthritis) of the hip and knee just… sucks. Characterized by activity-related pain in the affected joint, many otherwise physically fit persons have to resort to pills, injections and, finally, an appointment with an orthopedic surgeon to talk about joint replacement surgery.

What is less appreciated is that osteoarthritis can have a waxing and waning course with periods of relative remissions. What’s more, conservative treatment options can lessen or delay the need for surgery. Last but not least, the surgery itself involves months of recovery and the possibility of a nasty complication.

The primary care physician Disease Management Care Blog presided over this many times with its arthritis patients. It was generally reluctant to refer a patient to an orthopedic surgeon because it knew that the patients would be more interested in the potential benefits and pay less attention to the downsides of surgery.

Enter shared decision making (SDM). Defined as care that is respectful of and responsive to individual patient preferences, needs, and values and ensures that patient values guide all clinical decisions, the premise is that by giving patients the information they need, they’ll be able to ultimately determine the course of their care. That would include patients with severe hip or knee osteoarthritis who are thinking about surgery but who also need to consider the option of conservative management.

That’s why this just-published Health Affairs study is noteworthy. All the 27 orthopedic surgeons in the 5 Group Health Cooperative clinics introduced shared decision making (SDM) for patients who were being evaluated with knee or hip osteoarthritis. The intervention consisted of DVDs and booklets (from this company) that were ordered by the surgeon prior to an appointment. The materials could also be viewed on Group Health’s website at any time.

The study itself was quasi-experimental. To be included in the study, patients had to 1) have knee or hip arthritis, 2) ) be continuously enrolled in the Group Health Plan for 12 months prior to the orthopedic clinic visit and 3) have a visit itself that was first index visit by the patient for that problem being evaluated by that particular specialty.

Outcomes from the 18 months of the SDM intervention period (January 2009 through July of 2010) were compared to the observation period of January 2007 through July of 2008.

Recall that the surgeon had to proactively order the SDM prior to the visit. As a result, only 41% of the hip patients and 28% of the knee patients received the DVD, pamphlet or viewed the on-line materials.

Nonetheless, during the 6 months after the initial visit, the SDM patient population had 0.34 hip operations per 180 person-days (your DMCB offers an explanation of this counter-intuitive metric below*), compared to the control population of 0.46. The difference was statistically significant.

There was also a statistically significant reduction in knee operations: 0.09 per 180 person-days vs 0.16 per 180 person-days.

All the differences held up after the authors statistically adjusted for differences in age, sex, obesity, co-morbid conditions, use of prior x-rays, joint injections, insurance factors and the clinic site.

Like all good authors writing in a high quality journal, they point out that this research was not pristine. The comparison period may not have been a representative baseline and, from 2008 to 2009, other factors may have caused a drop in hip and knee surgeries.

Nonetheless, this is an example of a “real world” study that credibly demonstrates that when osteoarthritis patients are exposed to SDM, more will opt for conservative management. While that helps decrease health care utilization and ultimately costs, that’s not the most important point: the patients who really wanted surgery got it and the patients who were less sure about the benefits of surgery chose not to have it. What’s more, this didn’t involve a lot of expensive face-to-face care management, it involved some DVDs.

The DMCB cautions that this successful study was carried out in a highly integrated delivery system and may not be transferable to other practice settings. That being said, as Accountable Care Organizations struggle to meet their patients’ expectations and save money, this application of SDM may represent an important option.

*The DMCB interprets “180 patient days” as one patient being followed for the entire 6 months of the study. If that’s correct, the average SDM knee patient referred to a Group Health orthopedist had a 34% chance of getting surgery versus a 46% chance in the prior control group. For the knee patients, it was 9% vs. 16%.

Application for PWP Travel Scholarship

Steven Baker

Application for Travel Scholarship to the Partnership With Patients Summit 2012

Four years ago (9/29/2008) my implanted right elbow failed and I began advocating for patient rights to access medical records, for identification, registry and post-market research on implanted medical devices.  My efforts brought me in contact with medical device manufacturers, hospital trustees, the state Attorney General, my Congressional Representatives, journalists, consumer organizations and the FDA.  My situation is common to most harmed patients: the medical harm causes permanent disability which disrupts/ruins established careers forcing productive individuals onto fixed income without adequate medical care.  I am committed to attending Partnership With Patients, but a scholarship would be both an endorsement of my efforts and would relieve some of the constant financial pressure I experience.  I intend to continue to work for federal public policy legislation and public health education on this topic and learn from and share with others about social media tools and effective communication strategies that will strengthen the shared mission of protecting all patients from medical harm.

 How Patients Can Apply for a TravelScholarship

Tuesday, August 28th, 2012 at 11:58 pm  

Are you a patient who would like to apply for a travel scholarship to the Partnership With Patients Summit?

We will be awarding 10 scholarships of $500 each. Here are details and how to apply:

Write a (no more than) 500 word essay of why you should be granted a travel scholarship to attend the Partnership With Patients Summit. Why should you be the person who receives the scholarship? What can you offer to the people you connect with? What can they offer you? What do you hope to do with what you learn?

If you have your own blog, then post your essay on your blog, and tweet the link to Regina Holliday
(@ReginaHolliday) or post the link on her Facebook page

If you do not have your own blog, then send the post, contained in an email (not attached) to Regina. She will post your essay here on the Partnership with Patients website.

Submit Your Post By Email!

Deadline for submission is midnight, pacific time, September 8, 2012.

The essays will be reviewed by the committee at the Society for Participatory Medicine and winners will be notified by September 16.

Good luck!

Register by September 5: FDA Medical Device UDI webinar

Public Meeting-Strengthening the National Medical Device Postmarket Surveillance System, September 10, 2012

The Food and Drug Administration (FDA) is announcing a public meeting entitled: “Strengthening the National Medical Device Postmarket Surveillance System.” The purpose of this meeting is to solicit public feedback regarding FDA’s proposal to strengthen the national medical device postmarket surveillance system.

•                Date, Time and Location 

•                Federal Register Notice

•                Agenda

•                Registration

•                Contact Us

Date, Time and Location

This meeting will be held September 10, 2012, beginning at 9:00 a.m. - 4:00 p.m. at the following location:

Greenbelt Marriott
6400 Ivy Lane,
Greenbelt, MD 20770
301-614-8202

The meeting will be available by Webcast.

Agenda

Available soon.

Registration to Attend the Meeting

If you wish to attend this meeting in person, you must register online by September 10, 2012. If you wish to view this meeting by Webcast, you must register by close of business on September 5, 2012.

There is no fee to register for the meeting and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

If you wish to make an oral presentation during an open comment session at the meeting you must indicate this at the time of registration. FDA requests that presentations focus on the areas defined in the Federal Register Notice. You should also identify which discussion topic you wish to address in your presentation and you must submit a brief statement that describes your experience and/or expertise relevant to your proposed presentation. In order to keep each open session focused on the discussion topic at hand, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak.

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Joyce Raines, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, WO-66 Room 4319, Silver Spring, MD 20993, 301-796-5709, FAX: 301-847-8142, email: Joyce.Raines@fda.hhs.gov, no later than September 5, 2012.

Contact Us

For questions regarding workshop content please contact:

Anita Rayner 
Center for Devices and Radiological Health 
Food and Drug Administration 
10903 New Hampshire Avenue, WO-66 Room 3316 
Silver Spring, MD 20993 
301-796-6002 
email: anita.rayner@fda.hhs.gov

or

Danica Marinac-Dabic
Center for Devices and Radiological Health 
Food and Drug Administration 
10903 New Hampshire Avenue, WO-66 Room 4110 
Silver Spring, MD 20993
301 - 796-6689
e-mail: danica.marinac-dabic@fda.hhs.gov

Page Last Updated: 09/04/2012 

Thalidomide & Failed Implants-Egregious Harm

German Drug Maker Apologizes to Victims ofThalidomide

By JOHN F. BURNS

Published: September 1, 2012  New York Times  (FiDA highlight added.)

LONDON — Decades of campaigning by victims of thalidomide, a morning sickness drug, have taken a new turn, with the first apology in 50 years to the victims and their families by the drug’s German manufacturer — and an incensed rejection of the apology as too little and too late from many of those it was intended to placate.

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The apology was issued Friday by Harald Stock, chief executive of the Grünenthal Group, a family-owned pharmaceutical company that marketed the drug in the 1950s and early 1960s. It was withdrawn in 1961 after it was linked to birth defects, including shortened arms and legs, and in some cases no limbs at all, that campaigners say affected 10,000 babies around the world, mostly in Australia, Canada, Europe and Japan.

The apology came in a speech Mr. Stock delivered in the Rhineland town of Stolberg, the company’s base, at the unveiling of a thalidomide memorial, a bronze statue of a limbless child.

Addressing the victims and their families, he said the company wished to “apologize for the fact that we have not found the way to you from person to person for almost 50 years.

“Instead, we have been silent, and we are very sorry for that.”

According to an English translation of his remarks that appeared on Grünenthal’s Web site, he added, “We ask that you regard our long silence as a sign of the shock that your fate caused in us.” As for the company’s delay in moving beyond its previous expressions of regret for marketing the drug to a direct apology to the victims, he said that in recent discussions with victims and their families, “we learned how much it is publicly desired that we express our deep regrets to those affected by thalidomide.”

Although thalidomide was never approved for use by pregnant women in the United States, some victims are American.

One is Berrisford Boothe, 51, an associate professor of art at Lehigh University in Bethlehem, Pa., who described himself in a telephone interview as one of 26 known American thalidomide victims. He said he had been born with severe disabilities in both hands and one arm, and described his life as a “long and isolated journey.”

Now, he said, Grünenthal, shaken from a half century of denial by a class-action lawsuit in Australia, had made “some kind of statement that they are emotionally connected to our suffering. They’ve had 50 years to make billions of dollars while we struggled and our parents committed suicide. And now, they’re apologizing for not saying anything. How dare they do that and think it’s going to be enough?”

Mr. Stock said the company had carried out all the tests on thalidomide before it was marketed that were possible given the scientific knowledge available in the 1950s.

But the storm of protest the apology provoked from thalidomide victims and groups that represent them suggested that it had done little to assuage the anger and hurt accumulated over decades of campaigning for a full acknowledgment of thalidomide’s harm, and for more generous compensation.

“It is over 50 years on since the thalidomide tragedy — why now?” said Freddie Astbury, chief consultant at Thalidomide U.K. Agency, which represents people in Britain, where nearly 500 victims survive. He said British victims had received some compensation from the government and from distributors of thalidomide, but not enough.

Mr. Astbury, 53, who was born with no arms and no legs, said he believed that one reason for Mr. Stock’s speech was greater global awareness of issues affecting the disabled, manifested by the success of the Paralympic Games in London.

He pointed, too, to the Australian lawsuit, which legal experts say can result in new compensation awards for thalidomide victims running into tens of millions of dollars.

“We are glad the apology has been made,” he said. “But when you are disabled, it costs a lot of money. We are in our 50s, we need care. We need adaptations in our houses and cars, for starters. So if they’re serious, let’s get around the table and talk financial help.”

He added: “We didn’t ask to be born this way.”

Sandy Macaskill contributed reporting.

Health Behavior News Service - Rising Cost of Inpatient Care Linked to Medical Devices and Supplies

Health Behavior News Service - Rising Cost of Inpatient Care Linked to Medical Devices and Supplies

By Glenda Fauntleroy, Contributing Writer
Research Source: Health Services Research
Health Behavior News Service

Inpatient hospital treatment accounts for the largest proportion of health care spending in the U.S., with the use of diagnostic imaging services such as MRIs, frequently implicated as the probable cause.  A new analysis finds that the biggest expense may not be imaging technology but from supplies including medical devices, such as stents and artificial joints. “One of the take-away messages for hospitals is that they should examine their own data in closer detail to explore the costs that are rapidly rising and have a better understanding for the underlying reasons,” said lead author Jared Lane Maeda, Ph.D., of Truven Health Analytics in Washington, D.C.

The study, released in Health Services Research, used the 2001 and 2006 Healthcare Cost and Utilization Project State Inpatient Databases and Medicare Cost Reports for community, non-rehabilitation hospitals in nine states. The researchers conducted a cost analysis on more than 10.2 million patient discharges for various conditions. 

At 24.2 percent of costs, “supplies and devices,” (defined as the “supply items required for patient care”) were the leading contributors to the increase in average cost per discharge. Intensive care unit charges contributed 17.6 percent, and room and board for a semiprivate room was 11.3 percent. Imaging, such as CT scans, and other advanced technological services contributed just 4.9 percent. The significant growth in the mean cost per discharge of supplies and devices suggests they should be examined more closely. 

Caroline Steinberg, vice president of Trends Analysis for the American Hospital Association, said the group supports comparative effectiveness research to determine whether new drugs and devices are both clinically and cost effective.  

“This is an area where more research is needed,” she added. “And as for increased use of the intensive care unit, that is consistent with the trend towards older and sicker patients.”

Maeda added that payers might consider negotiating discounts in areas of care and cost that are growing quickly

Article Discussion

» Ken Maddock 8/30/2012 10:22 AM I'm glad that people are starting to focus on things other than the overuse of tests and provider inefficiency as the drivers of healthcare costs. While there is undoubtedly additional room for improvement in those areas, the costs providers have to pay for equipment, supplies, services, and software are a very large part of the reason for increased healthcare costs. Providers of equipment, supplies, services, and software charge what the market will bear, and the market will bear a lot because healthcare providers have few options, none of them inexpensive. It baffles me why so many people fail to see this as a problem. I want to be clear that I'm not opposed to those who provide services, equipment, software, and supplies making a profit. Obviously they need to make a profit to remain in business. It's the inequity between healthcare provider margins and supplier margins that have to be addressed somehow. The current model isn't sustainable.

» Joleen Chambers 8/30/2012 12:51 PM I have been a Patient Advocate for the past four years. I have testified twice at FDA/CDRH Town Hall meetings (TX-3/10/11 and CA 9/22/11 about the high number of failed implanted medical devices. When these devices fail, they place patients in medical and legal purgatory because of poor federal public policy. The FDA approves most of them through 510(k) that does not require clinical testing or post-market follow up. The IOM report 7/29/11 stated that this practice must end. There is no product warranty and no objective information that allows patients to make a good decision. Furthermore, the device industry is powerful politically and has entitlements that prevent patients from accessing trial by jury and fair compensation. The FDA/CDRH Orthopedic Panel Patient Representative is non-voting.

.

# # #

TERMS OF USE: This story is protected by copyright. When reproducing any material, including interview excerpts, attribution to the Health Behavior News Service, part of the Center for Advancing Health, is required. While the information provided in this news story is from the latest peer-reviewed research, it is not intended to provide medical advice or treatment recommendations. For medical questions or concerns, please consult a health care provider.

Reach the Health Behavior News Service, part of the Center for Advancing Health, at hbns-editor@cfah.org or (202) 387-2829.

Health Services Research is the official journal of the Academy Health and is published by John Wiley & Sons, Inc. on behalf of the Health Research and Educational Trust. For information, contact Jennifer Shaw, HSR Business Manager at (312) 422 2646 or jshaw@aha.org. HSR is available online at http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)1475-6773/

Maeda JL, Raetzman SO, Friedman BS. (2012). What hospital inpatient services contributed the most to the 2001 to 2006 growth in the cost per case? Health Services Research. Online Aug. 29.

Millions of Medical Device Recalls

LINK

PRESS RELEASE

Aug. 21, 2012, 9:43 a.m. EDT

Over 123 Million Medical Device Units Recalled in Second Quarter of 2012, Reaching an Eight-Quarter High, According to the ExpertRECALL Index

Consumer Product Safety Incidents Jump 35 Percent; Slight Uptick in Food Recalls  

INDIANAPOLIS, Aug. 21, 2012 /PRNewswire via COMTEX/ -- 

FiDA highlight added

More than 123 million units in the medical device category - which includes products like knee replacements, syringes, gels used in ultrasound procedures, dental implants, and products used in heart surgery - were recalled during the second quarter of 2012, according to the quarterly ExpertRECALL(TM) Index released today.

While the number of medical device recalls governed by the U.S. Food and Drug Administration (FDA) declined 13 percent compared with the previous quarter, the number of products affected by such announcements reached an eight-quarter high, breaking 100 million units for the first time since the third quarter of 2010. Food recalls increased 19 percent when compared with the previous quarter, while the rate of recalls affecting consumer products and pharmaceuticals remained largely unchanged.

When compared with the previous quarter, the ExpertRECALL Index found that 35 percent more consumer product safety incidents were reported to the U.S. Consumer Product Safety Commission (CPSC), resulting in 154 injuries and two deaths. While recalls of all children's and infant products reached a six-quarter low during the second quarter of 2012, recalls of child nursery equipment and supplies increased by 60 percent. Recalls of toys decreased 80 percent from the first quarter to the second quarter.

"The fact that more than 120 million medical device units were affected by recalls last quarter cannot be ignored, particularly because it comes during a time when America's 50 million aging Baby Boomers are placing increasingly high demand on life-saving medical devices," said Mike Rozembajgier, vice president of recalls at Stericycle ExpertRECALL. "The growing importance of this product category means that companies need to have a comprehensive recall plan in place that can be deployed within the blink of an eye and can effectively protect their customers and brand. Manufacturers, suppliers, hospitals and retailers must also continue to stay diligent in their efforts to ensure product and consumer safety in an ever-changing environment, particularly in light of FDA's recent proposals to track certain medical devices."

The ExpertRECALL Index also found that 80 percent of pharmaceutical products recalled during the second quarter of 2012 affected prescription medications.

Forty percent of food recalls were initiated due to undeclared allergens or other allergen concerns, the lead food recall cause, which continues an eight-quarter trend. Salmonella contamination, the presence of Listeria monocytogenes and other foodborne illness concerns combined also accounted for nearly 40 percent of food recalls.

"It is critical that FDA- and CPSC-regulated industries follow the agencies' requirements and guidelines to assure that they are met, thus diminishing the likelihood of a violative product and subsequent recalls," said former FDA Senior Recall Coordinator Willie Bryant, a Stericycle consultant. "Additionally, every regulated firm needs to be prepared with a vetted Standard Operating Procedure in place for recalls so that it is ready when that unexpected recall develops."

The 2012 second quarter ExpertRECALL Index is the only report that aggregates and tracks cumulative recall data from the CPSC and the FDA. Stericycle ExpertRECALL compiles the ExpertRECALL Index from data issued by the U.S. Food and Drug Administration and the Consumer Product Safety Commission. The ExpertRECALL Index report is available online at http://www.expertrecall.com/recallindex .

About Stericycle ExpertRECALL(TM) Stericycle ExpertRECALL(TM) is the industry leader in managing consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. Stericycle ExpertRECALL streamlines the entire product recall process and manages Notification & Response, Processing & Tracking, and Compliance & Reporting for a variety of companies. For more information, visit http://www.expertrecall.com .

SOURCE Stericycle ExpertRECALL