The House Energy and Commerce Health Subcommittee’s draft bill would significantly weaken device safety oversight and should be rejected by Congress, according to Consumers Union, the policy and advocacy arm of Consumer Reports. While the Senate Health, Education, Labor and Pensions Committee’s draft bill provides some additional protections for patients once devices are on the market, it misses the opportunity to enact a clear process for preventing unsafe devices from being sold in the first place.

The medical device industry has been pushing Congress to scale back oversight of implants and other devices, which it claims is necessary to promote innovation and make it easier to get new devices approved. But according to the new Consumer Reports poll, 82 percent of Americans believe that preventing safety problems is more important than limiting safety testing in order to prevent delays and encourage innovation.

The vast majority of medical devices do not require proof that they have been clinically tested and found to be safe and effective prior to being cleared by the FDA for distribution or sale. Instead, the FDA is limited to review only whether the device is similar to one already on the market. Ninety-one percent of the Consumer Reports poll respondents said each implant should be safety tested before being sold even when similar implants were in use, and 68 percent of those respondents thought they “definitely should” be safety tested.

Current law allows the FDA to approve a new device that is similar to an existing device even when the existing device has been recalled because of safety problems. So far, the medical devices industry has succeeded in lobbying Congress to keep this policy in place – neither the House nor Senate discussion drafts address it. However, 71 percent of the poll respondents said that a new device should not be allowed to be sold based on its similarity to an existing implant that has a safety problem or has been recalled.

Ninety-four percent of poll respondents indicated that medical device makers should be required to do long-term monitoring of implants if there are safety concerns or problems with a particular device. Existing law gives the FDA only limited authority to require such long-term safety monitoring.

Similarly, 95 percent of respondents said that effective consumer protections for medical implants should include a nationwide system for tracking medical implants so patients can be notified about safety problems or recalls. No such system currently exists in the U.S. even though it was required by Congress’ previous reauthorization of the law.

Sixty-six percent of respondents indicated a high level of concern about the safety decisions or recommendations made by expert committees that included doctors who had current financial relationships with medical device makers. Industry lobbyists have been pushing lawmakers to weaken current rules designed to prevent such conflicts of interest. The Senate and House discussion drafts remove current caps on the percentage of expert committee members that can be granted waivers if they have a conflict of interest, a provision championed by consumer advocates five years ago.

One additional finding of the poll was that 17 percent said they had a medical implant and 47 percent have a family member or close personal friend with one. These findings reflect the large number of Americans using medical implants that could pose a risk of significant harm if they break, leak, stop functioning or disintegrate.

“Our poll shows that Americans support common sense reforms that would help improve medical device oversight and keep patients safe,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project. “The vast majority of the public wants strict requirements that ensure new implants are safe and effective.”

Consumers Union’s Safe Patient Project has called on Congress to require more rigorous safety testing before medical implants and life sustaining devices are allowed on the market and to establish a better system for monitoring devices after approval, including a national system for notifying doctors and patients when safety problems arise. For more details, see the Safe Patient Project’s Improve the Safety of Medical Devices fact sheet.

The Consumer Reports National Research Center conducted a nationally representative telephone survey about medical implants such as artificial joints and heart stents between February 9-12, 2012. The poll included 1,000 U.S. residents (18 and older) and was fielded by vendor ORC International. Respondents were asked their opinions about the safety, level of concern and consumer protections related to medical implants. The margin of error is + / – 3.0 percentage points at a 95 percent confidence level.

As measured by the S&P Healthcare Economic Commercial Index, healthcare costs covered by commercial insurance plans increased by 7.05% over the year ending January 2012, down from the +7.11% reported for December 2011. Growth rates in Medicare claim costs rose by 2.40%, as measured by the S&P Healthcare Economic Medicare Index, down from the +2.52% reported for December. The Professional Services Index’s annual growth rate also decelerated from its +5.37% December 2011 rate, increasing by 5.13% in January. The broad Hospital Index’s annual growth rate increased slightly to 5.03% in January from its +4.99% December pace.

Looking at the narrower sub-indices, the Professional Services Medicare Index hit a two-year low of +3.32% in January 2012, down from +3.73% in December 2011. The Hospital Medicare annual growth rate increased in January at +1.56%, it was up from its +1.48% December level. The Professional Services Commercial Index decelerated to +6.02% in January from +6.15% in December; and the Hospital Commercial Index marginally decreased to +7.84% in January from +7.85% in the previous month.

Proton beam radiotherapy can accurately deliver targeted radiation doses with complete proton energy absorption at predictable tissue depth, thus allowing precise radiation delivery adjacent to critical structures and lower radiation doses to healthy structures. The availability of proton therapy has remained very limited however, due to the enormous cost, large footprint, and technical complexity of traditional proton therapy systems.

The Unilife investor relations app for iPhone allows users to navigate the Company’s investor relations materials, as well as receive a stock quote and other important stock information. Developed and powered by KCSA Strategic Communications, the Unilife app features the latest press releases and SEC filings as well as background information, videos and presentations from the Company.

To be added to the Unilife investor email list, please email investors@unilife.com or go to the Unilife website at http://ir.unilife.com/alerts.cfm.

Become a Unilife fan and follow the Company on Facebook at http://www.facebook.com/unilifecorp

Unilife Corporation (NASDAQ:UNIS / ASX: UNS) is a U.S. based developer and commercial supplier of advanced drug delivery systems. Unilife collaborates with pharmaceutical and biotechnology companies seeking innovative, differentiated devices that can enable or enhance the delivery of injectable drugs and vaccines supplied in either a liquid stable or lyophilized form. The Unifill syringe, the world’s first and only prefilled syringe with fully integrated safety features, sits at the leading edge of this diversified portfolio. In addition to prefilled and hypodermic safety syringes with automatic, user-controlled needle retraction, Unilife has other proprietary technology platforms including drug reconstitution delivery systems, auto-injectors, auto-infusion pump systems and specialized devices for targeted organ delivery. Unilife’s global headquarters and state-of-the-art manufacturing facilities are located in York, PA. For more information on Unilife, please visit www.unilife.com

HealthSouth is the nation’s largest owner and operator of inpatient rehabilitation hospitals in terms of revenues, number of hospitals, and patients treated and discharged. Operating in 27 states across the country and in Puerto Rico, HealthSouth serves patients through its network of inpatient rehabilitation hospitals, outpatient rehabilitation satellite clinics and home health agencies. HealthSouth’s hospitals provide a higher level of rehabilitative care to patients who are recovering from conditions such as stroke and other neurological disorders, orthopedic, cardiac and pulmonary conditions, brain and spinal cord injuries, and amputations. HealthSouth can be found on the Web at www.healthsouth.com .

Our contingency plans will be immediately activated, and we will make every effort to meet our customers’ needs with minimal disruption.

We have demonstrated a deep commitment in helping fight prescription drug abuse. We work hard to actively prevent drug diversion and have spent millions of dollars to build a system of advanced analytics and on anti-diversion specialists. We have stopped distributing to hundreds of pharmacies determined to pose an unreasonable risk of diversion. The majority of those pharmacies still maintain their DEA registrations to dispense controlled medicines. We have also collaborated with industry experts to create programs to educate young people, parents, teachers and communities about medication safety and the dangers of prescription drug abuse.

We have genuine respect for the work of the DEA, but effectively addressing prescription drug abuse requires a very different approach than does the war on illicit drugs. We want to work collaboratively with all participants in the drug supply chain – including regulators, pharmaceutical manufacturers, distributors, pharmacists, doctors and boards of pharmacy – to combat this serious nationwide issue. We want to be part of a new, more effective solution to stop prescription drug abuse, without disrupting legitimate use.

SOURCE Cardinal Health

Crothall’s CES division will continue to focus on safety, risk management, technical support of medical devices and clinical technologies, financial stewardship, and management of healthcare technologies that are integrated and interoperable.

“Our healthcare customers are already receiving the benefits of our full clinical technology solution,” Steve Carpenter, president of Crothall Healthcare’s facilities management divisions, explained. “We are updating our name to better reflect everything we have to offer in this area of expertise. Our managers and technicians have the skill sets and certifications necessary to perform any service expected from a clinical equipment solutions provider, as well as our commitment to provide the training and resources necessary to keep these skills current.” Chief among the program’s continuing highlights are:

Healthcare Technology Asset Management Solutions
Capital Asset Management Services
Asset Tracking (RTLS) Solutions
Assistance with New Equipment Planning/Purchasing
Customized Policy and Procedures
Regulatory Agency Inspection Support/Preparation
In-Service Education
Quality Management and Improvement
Quality Audits and Reports
Equipment Disposition Assistance
Regional and Corporate Support
Device Integration/Interoperability Analysis/Assistance
Collaboration with IT to Effectively Manage Networked Medical Devices

In October 2011, the Health Council of Canada held a national symposium on patient engagement. Patients, representatives from patient organizations, provincial and federal government representatives, researchers, health system administrators and health care providers shared their perspectives on patient-centred care.

A strong message from participants coming out of the symposium is the need to have patient engagement as a performance goal.

The patient experience should be measured at all levels of the health care system. The measurements should be used to set targets for higher quality care that is in keeping with patient experiences and expectations.

An equally strong message echoed by participants is the need to shift from a provider-focused to patient-centred care. To allow patients to take a more active role in their health care, governments and health care providers must shift the way health care is delivered to focus on patient-centred care. Patient-centred care concentrates on relationships that are a two-way exchange of information: patients are empowered, providers are willing to listen to them, and decisions are made as a team.

A recent report released by the Health Council of Canada, How Engaged are Canadians in their Primary Care: Results from the 2010 Commonwealth Fund International Health Policy Survey , revealed that only 48% of Canadians feel involved in and are actively participating in their own health care. This means less than half of Canadians are taking a more active role in maintaining their health, oftentimes leading to increased satisfaction with their care. Engaged patients better understand and know more about their care, which leads to better use of health care services and resources. The symposium reinforced these findings.

Dr. Thomas is a board certified orthopaedic surgeon who has practiced in the U.S. Air Force and private practice prior to working in the insurance industry. He has practiced in the United States and Great Britain, and more recently has worked with various insurance companies providing orthopedic expertise for technical and reimbursement issues.

Prior to joining MCRA, Dr. Thomas served as a Medical Director at Aetna Health Plans, Bravo Health, Lincoln Financial Group, Blue Cross Blue Shield Tennessee, and Unum.

Physicians commonly use radiotherapy to treat squamous cell carcinoma of the oropharynx (back of throat). Current standard-of-care treatment is called intensity-modulated radiotherapy, or IMRT. IMRT allows physicians to “sculpt” radiation to fit the anatomy of individual patients. Although appealing, this technique has a crucial Achilles’ heel – it is based entirely on a CT or MRI scan taken before actual treatment begins. Since a typical course of radiation treatment for oropharynx cancer lasts 6-7 weeks, standard IMRT cannot compensate for common changes that take place in a patient’s body during this time, such as weight loss, shrinkage of tumor, or gradual movement of normal tissues. Recent work suggests that the inability of standard IMRT to keep up with these changes may lead to unanticipated toxicity, or potentially worse, missing of tumor.

For this new trial, which was conducted at the University of Texas M.D. Anderson Cancer Center, investigators started patients on standard IMRT. They then took CT scans while patients were lying in the radiation treatment room each day so they could monitor changes in tumor and normal tissues during the entire course of treatment. Through computerized techniques, the investigators “adapted” (thus the name “adaptive radiotherapy”) treatment if they noticed significant tumor or body changes that could affect quality of treatment. Most strikingly, the group found that most patients required only one, or at most two adaptions of IMRT to maintain treatment quality.