Could Low Expectations By Rheumatoid Arthritis Patients Be Holding Them Back After Knee Replacement Surgery?

Main Category: Arthritis / Rheumatology
Also Included In: Bones / Orthopedics;  Rehabilitation / Physical Therapy
Article Date: 07 Nov 2011 – 1:00 PST

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Compared with osteoarthritis patients, individuals with rheumatoid arthritis who undergo total knee replacement surgery have lower expectations about their postsurgical outcomes, according to a new study by researchers at Hospital for Special Surgery (HSS) in New York City. These reduced expectations, which may be unnecessary, could cause some patients to slack on their postsurgical rehabilitation leading to worse outcomes, say doctors. The study will be presented November 7 at the annual meeting of the American College of Rheumatology.

“If rheumatoid arthritis patients are healthy enough to have surgery, they should really expect good outcomes. If patients have lower expectations, then maybe they don’t push their physical therapy, and perhaps don’t recover as well,” said Lisa Mandl, M.D. M.P.H., a rheumatologist at HSS who was involved with the study. “It would be a real shame if these patients could have significantly improved function, but for some reason they don’t attain it, perhaps connected to their expectations.”

Before this study, researchers had known that patients with rheumatoid arthritis (RA) who undergo a total knee replacement are often very satisfied with the surgery, even though they have inferior outcomes to patients with osteoarthritis who undergo the operation. Because satisfaction is determined not only by improvements in pain and function, but by fulfillment of pre-operative expectations, investigators set out to determine if the expectations of the two patient groups differed.

The researchers turned to the HSS Total Joint Replacement Registry, a prospective registry started in 2007 that includes, among other things, data on all patients who seek care at HSS for knee replacement surgery, also known as total knee arthroplasty (TKA). Because roughly 90 percent of patients who undergo TKA have osteoarthritis, they first used the registry to identify patients with RA. They then mined the registry to find osteoarthritis patients that matched these RA patients in terms of age, gender and function. Investigators gauged function using the Lower Extremity Activity Score (LEAS), a score that quantifies how much activity a person is capable of performing. The scale ranges from a person being confined to bed all day to participating in vigorous physical activity such as competitive level sports.

The researchers identified 62 RA patients and matched them to 124 osteoarthritis controls; 81.7 percent were women and the average age was 64.7 years. The average LEAS was 8.7, which corresponds to being able to walk around the house and for several blocks without assistance.

The investigators measured pain, stiffness and function prior to surgery, using a tool called the Western Ontario and McMaster Universities Arthritis Index (WOMAC), and found that patients with RA had worse scores. “Even when you try to match these patients to make them similar, it really does seem like this chronic disease makes these patients sicker, less happy, less functional and clearly they have worse expectations,” Dr. Mandl said.

The investigators measured patient expectations prior to surgery using a validated tool called the Hospital for Special Surgery Expectations Survey, with 100 being the highest score and 0 being the lowest. RA patients had a lower overall expectation score compared with osteoarthritis patients, 73.7 versus 79.8, a difference that was statistically significant (P=0.03) and clinically meaningful. Patients with RA also had statistically significant lower expectations for several individually measured items such as whether the surgery will improve the ability to walk short distances, improve the ability to go up stairs, improve the ability to perform daily activities such as household chores and improve the ability to exercise.

“When people report if they are satisfied, a lot of it is not just related to actual objective measures. It has to do with their expectations preoperatively. So, if you don’t expect much and you don’t get much, you could be pretty happy,” said Dr. Mandl. “You might have a person who says, ‘I would love to have this surgery and be able to get up and walk to the bathroom without pain.’ And when they have their surgery, they can get up and walk to the bathroom without pain, but maybe because that is all they expected, they kind of give up after that. They might not be optimizing their postoperative physical therapy.”

“Our rheumatoid arthritis patients have just come along extraordinarily in the last decade with, first, the widespread use of traditional medications and now the more widespread use of the potent biological medications,” said Susan Goodman, M.D., a rheumatologist at Special Surgery. “What we can do as doctors is ensure that we educate our patients properly. In the past, our rheumatoid arthritis patients didn’t do as well as other patients and those expectations were realistic, but I think times are changing. RA patients might think ‘oh, I’m never going to have great function, why am I pushing myself?’ That would be shortchanging themselves. Doctors should explain to RA patients that they should expect good outcomes.”

According to Dr. Mandl, doctors should assess patients’ preoperative expectations. “If they are concerned that patient’s expectations are not in line with what they would predict, then doctors should recalibrate what the patient is hoping for, so that they can get the best result they can,” she said.

Dr. Mandl says the study also makes her wonder if patients with RA are not choosing to have surgery because they don’t think it will make a difference.

RA is an autoimmune disease that causes joint swelling, pain and fatigue among other symptoms. Osteoarthritis is caused by the normal wear and tear of the aging process; it can be encouraged by a high impact injury or obesity.

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Reducing Disease Flares By Tweaking Withdrawal Of Rheumatoid Arthritis Medications Before Surgeries

Main Category: Arthritis / Rheumatology
Also Included In: Bones / Orthopedics
Article Date: 07 Nov 2011 – 1:00 PST

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As guidelines recommend, doctors appear to be stopping anti-TNF medications before surgery, but may be doing so far sooner than is necessary, according to a new study by researchers at Hospital for Special Surgery. These medications are used to treat a variety of inflammatory diseases, including rheumatoid arthritis, and better timing of withdrawal prior to surgery might minimize the risk of disease flares.

“We need to do more studies to see if more pharmacologically-based timing of when you hold these medications – maybe tie it more to their half life – might potentially decrease rates of postoperative flares,” said Lisa Mandl, M.D. MPH, a rheumatologist at HSS. She is principal investigator of the study that will be presented on Nov. 8 at the American College of Rheumatology’s annual meeting.

Anti-tumor necrosis factor (anti-TNF) medications are increasingly being used in patients with rheumatoid arthritis (RA) due to their effectiveness. Because these medications suppress the immune system, guidelines recommend stopping anti-TNF therapy before any type of surgery. Few studies, however, have examined what happens in actual practice or the effect of stopping medications on patients.

To investigate the issue in knee replacement surgery, a common surgery in RA patients, researchers utilized data from the HSS Total Joint Replacement Registry. This prospective registry started in 2007 includes, among other things, data on all patients who seek care at HSS for a total knee replacement (TKR). “Other institutions may have similar registries, but we do such a high volume of surgeries that other people might take decades to get what we do in a few years. We have large numbers and it is a contemporary registry, so it’s not 10,000 patients over the last 20 years. It is 20,000 over the last five years,” Dr. Mandl said. The database gives doctors a snapshot of what is happening in present day practice.

Through a retrospective chart review of patients in this registry who had undergone a TKR between June 2007 and May 2010, HSS researchers identified 194 patients with RA. Cases were identified by medical billing code (ICD-9) or self-report, and then confirmed by chart review; 86 (41.4%) used anti-TNFs, predominantly etanercept (Enbrel), adalimumab (Humira), and infliximab (Remicade). When investigators checked the charts, they found that 86 percent of them documented that anti-TNFs should be held and 74 percent identified a specific stop time.

While the recommended stop time should have been based on the half-life of the medications (how long the medicines stay in the body), the data did not show this to be the case. For individuals on etanercept, which has a half-life of 3 to 5.5 days, the average stop time was 2.4 weeks prior to surgery. For adalimumab, which has a half-life of 1.4 to 2.9 weeks, the average stop time was 4.6 weeks. For infliximab, which has a half-life of 1 to 1.7 weeks, the average stop time was 4.9 weeks.

All patients in the HSS Total Joint Replacement Registry receive a six-month adverse events survey and, for this study, an additional survey was sent to patients if they had not yet replied to maximize response rates. Study participants also received an RA specific questionnaire that collected information such as how long they had been impacted by the disease and whether they had any arthritis flares after surgery.

Investigators analyzed self-reported flares within one month of surgery as well as six-month adverse events, including surgical site infection, pulmonary embolism, deep venous thrombosis, re-operations, and infections such as pneumonia. They found no statistically significant difference in adverse events between patients who received anti-TNFs and those who did not. The self-reported RA flare rate was higher in the anti-TNF groups (22.4% vs. 16.9%), although this difference was not statistically significant (P=0.47).

“At least in this relatively small sample, it doesn’t look like there are any increases in infections or blood clots or other problems that go along with these anti-TNFs, which is comforting for patients who are on these drugs who are going in for surgery,” Dr. Mandl said.

She said that more work should be done to evaluate if the half-lives of the medications should be considered more carefully when determining when to pull the drugs from patients before a procedure. “Maybe we won’t have to stop patients so early,” Dr. Mandl said. “We need to think a little bit more about how we hold them to optimize how patients do after surgery.”

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Study Finds No Savings From Using Commercial Disease-Management Programs For Medicare Patients

Main Category: Medicare / Medicaid / SCHIP
Article Date: 04 Nov 2011 – 3:00 PDT

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At a time when everyone is looking for ways to reduce health care costs in America, using commercial disease management programs to reduce the fee-for-service Medicare costs associated with chronic conditions among senior citizens seems like a practical approach.

Rather than managing chronic conditions with traditional care that includes physicians and clinical visits, commercial disease-management models rely on teams of health coaches, usually in remote call centers, to enhance beneficiaries’ knowledge and ability to care for themselves as well as coordinate services across providers.

Unfortunately, commercial disease management models did not reduce hospital admissions or emergency room visits or result in cost savings in a study of nearly 250,000 Medicare patients conducted by researchers at RTI International for the Centers for Medicare and Medicaid Services.

The study is published in the Nov. 3 issue of the New England Journal of Medicine.

“While this would appear to be an innovative way to reduce Medicare expenditures, managing the care of older patients through telephone contact or an occasional visit does not achieve the cost savings Congress had hoped for when it mandated the Medicare Health Support Pilot Program,” said Nancy McCall, ScD, a senior health economist at RTI International and the study’s lead author. “Our results suggest that for such programs to be effective, they would need to be supplemented by intensive, costly, personal clinical attention.”

The study, which included almost 250,000 patients randomly assigned to a commercial program for disease management or usual care, found that commercial disease-management companies had no success in reducing hospital admissions or emergency room visits among fee-for-service Medicare beneficiaries and had only limited success in improving the processes of care.

The results also showed that commercial disease-management programs achieved only modest improvements in quality-of-care measures and had no demonstrable reduction in the use of acute care or the costs of care.

The researchers suggest that the commercially based disease-management model may not work for Medicare, in part because the care of older, chronically ill patients is difficult to manage. They are more likely than younger people to have new acute conditions such as stroke, pneumonia or a hip fracture.

The authors also found that the health coaches in the disease-management program were not integrated into the patient’s primary health care team, which hindered their ability to interact directly with the patient’s primary care providers and facilitate changes in medical care plans made by the primary care provider.

As part of the Medicare Modernization Act of 2003, Congress required the Centers for Medicare and Medicaid Services to test the commercial disease management model in the fee-for-service program.

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Schedule Your Appointment with Block Scientific at the Clinical Lab Expo 2011 in Atlanta, July 26-28

Block Scientific is attending the Clinical Lab Expo 2011, the largest clinical lab exposition in the world to be held from July 26–28. The venue is the Georgia World Congress Center in Atlanta, GA.

Reported to be the most-attended show of its kind every year, the Expo saw more than 700 companies participating in 2010. More than 20000 participants, including lab directors, managers, administrators, supervisors, and researchers are expected to attend the 2011 Clinical Lab Expo, making it a unique event for showcasing their products and services.

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If you are looking at recertified equipment, your ideal option is to buy from a well known dealer that specializes in selling such devices. Reliable dealers will ensure that the used equipment they buy is put through a well-organized refurbishment process so that it functions like new. Stringent quality control will ensure that these products are revamped in a way that they meet original manufacturer specifications.

Budget – Consider your budget when you invest in expensive lab equipment. If you have budget limitations, buying recertified equipment is an ideal option as they are available at prices much lower than new, but work efficiently.

Accessories – Many of the dealers provide parts and accessories along with the products they sell. If you are buying chemistry lab equipment, make sure that spare parts are available as also reagents, controls and consumables.

Warranty – To ensure lasting performance, check out whether the medical equipment you purchase comes with proper warranty. When it comes to used products, check whether they have parts warranty.

Shipping and return policy – It is advisable to go through the shipment terms and conditions, return policy, charges and other related details to avoid complications that could arise during transport. If you notice that the product is damaged on delivery, notify the dealer immediately.

Post-purchase service – When you choose a supplier, consider post-sales support offered. A reliable dealer would offer in-house service and repair, customized on-site annual service contracts, Preventive Maintenance (PM) service contracts, and ongoing personal support services.

There are numerous medical equipment suppliers in the US. When buying medical laboratory equipment, find a one-stop-shop that can offer you all need at reasonable prices.

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Type 1 Diabetes Prevented In Mice

Main Category: Diabetes
Also Included In: Multiple Sclerosis;  Arthritis / Rheumatology;  Preventive Medicine
Article Date: 02 Nov 2011 – 1:00 PDT

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Researchers at the University of Colorado School of Medicine have found a specific molecule that can prevent the development of type 1 diabetes in mice and has a similar effect on human cells from diabetic patients.

The findings, published in the latest edition of The Journal of Immunology, signal a new and promising direction in the fight against type I diabetes along with other autoimmune disorders like rheumatoid arthritis, multiple sclerosis and celiac disease.

Aaron Michels, MD, an assistant professor of pediatrics and medicine, working with George Eisenbarth., MD, Ph.D., executive director of the Barbara Davis Center for Childhood Diabetes at the CU School of Medicine, tested a series of molecules before finding one that stopped diabetes from developing in mice bred to get the disease.

“We found that when you put specific molecules into specific structural pockets you can block the formation of diabetes,” said Eisenbarth. “We are basically throwing a monkey wrench into the machinery.”

The researchers were looking for small molecules capable of occupying pockets along a protein binding groove. Some of the molecules got into these pockets and inhibited the presentation of insulin to immune cells while others enhanced it.

Type 1 diabetes is characterized by the body’s inability to manufacture insulin because its own immune system is attacking it. The incidence of the disease has doubled in each of the last two decades.

Michels and Eisenbarth found that the compound Glyphosine enhanced insulin presentation and prevented diabetes in mice genetically modified to develop type 1diabetes. It had the same effect on human cells. The mice remained disease-free as long as they received daily injections of the compound. It was not as effective on mice that already had diabetes.

The molecules used in the research were obtained with the assistance of the University of Florida College of Medicine in Gainesville.

“Our role was to screen a large chemical library to identify drug candidates for prevention of type 1 diabetes,” said David Ostrov, Ph.D., associate professor of pathology, immunology and laboratory medicine at the University of Florida. “We developed a novel screening method that pinpoints very specific areas of a protein that is genetically associated with type 1 diabetes.”

Using a supercomputer, Ostrov’s lab ran tests on 139,735 drug candidates to see which were most likely to bind on the four critical pockets of the protein.

“Not only does this provide a new way to change specific immune responses in a manner that is beneficial for diabetes, this shows that we may be able to modify specific immune responses for other autoimmune diseases,” Ostrov said. “This is also relevant to cancer and infectious diseases where it would be beneficial to modify specific immune responses rather than in a general way.”

Michels said that based on the two and a half year study, it would be feasible to genetically screen individuals likely to develop type 1 diabetes and begin a therapy regimen using these compounds to prevent the onset of the disease. Right now, doctors can predict who will get type 1diabetes about 90 percent of the time.

“This technique would also apply to other autoimmune disorders like arthritis and celiac disease,” Michels said. “The principals are the same.”

The next step is to focus specifically on human cells to try and develop new therapies for clinical use. That could be at least five years away.

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Scientists Discover Link Among Spectrum Of Childhood Diseases – Hard-To

Main Category: Arthritis / Rheumatology
Also Included In: Genetics;  Pediatrics / Children’s Health;  Immune System / Vaccines
Article Date: 02 Nov 2011 – 1:00 PDT

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An international collaboration of scientists, including researchers at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), a part of the National Institutes of Health, has identified a genetic mutation that causes a rare childhood disease characterized predominantly by inflammation and fat loss. The research suggests that the disorder, named chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperature (CANDLE), actually represents a spectrum of diseases that have been described in the literature under a variety of names. More importantly, since no effective treatment for this disease currently exists, the findings may have uncovered a possible target for future treatments.

The collaboration began when NIAMS rheumatologist Raphaela Goldbach-Mansky, M.D., started seeking the cause of inflammatory skin lesions, fat loss and fevers in two of her young patients. At a scientific meeting, she learned about recent publications by two other research groups – one led by dermatologists Antonio Torrelo, M.D., from the Boy Jesus Hospital, Madrid, and Amy Paller, M.D., from Northwestern University, Chicago, and the other led by Abraham Zlotogorski, M.D., from the Hadassah-Hebrew University Medical Center, Jerusalem – describing similar conditions. She immediately located the publications’ authors and emailed them that same night.

“It turned out they had found each other and were looking for a genetic cause and additional cases,” said Dr. Goldbach-Mansky. “I contacted them with a case report with pictures and they sent me theirs.”

Based on the clinical presentation and, particularly, the unusual skin lesions seen in the children, the researchers suspected that the children must have the same disease. Subsequent analyses – involving biopsies, blood tests and genetic testing – confirmed their suspicions. All but one child had at least one mutation in a gene called PSMB8, which had been recently identified in three adult patients with a disease called joint contractures, muscle atrophy and panniculitis-associated lipodystrophy (JMP).

PSMB8 is one of more than 20 components involved in making a cellular structure called a proteasome, which recycles proteins from cells that are stressed or dying.

“When the proteasome doesn’t function, there is a buildup of protein waste products in the cells – much like if your trash wasn’t picked up each week, it would accumulate in your driveway,” said Dr. Goldbach-Mansky.

The one patient without the mutation had a blood profile that was identical to the ones who did, and showed the same accumulation of waste products in the cells seen in children with the genetic mutation. Blood tests also showed high levels of an inflammatory chemical called interferon gamma-induced protein 10 (IP-10) that is stimulated by interferons. The chemical is produced in response to some infections, and the group suspects that it also may be produced in the cellular stress response.

The discovery, which is described in Arthritis Rheumatism, unifies several different diseases into one spectrum of proteasome-associated autoinflammatory syndromes, said Dr. Goldbach-Mansky. She hopes that these findings will enable doctors to identify more children who fit into this spectrum of difficult-to-treat disorders so that they can develop a better understanding of the disorders and their treatment.

Despite the best treatments currently available – which, in most cases, consist of high doses of steroids – children with these disorders continue to lose fat and suffer metabolic changes that lead to a range of problems, including loss of muscle mass, dilated heart muscles and cardiac arrhythmias. Treatments for other inflammatory diseases have little, if any, effect on the prognoses of these diseases. The group’s findings, however, suggest new therapeutic targets.

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HealthWatch: Feds Urged To Dump ‘Flawed’ Medical Device Review

WASHINGTON (AP) – The government should abandon a 35-year-old system for approving most medical devices in the U.S. because it offers little to no assurance of safety for patients, a panel of medical experts concludes in a report Friday.

The surprise recommendation from the Institute of Medicine panel calls for a massive reworking of how the government regulates medical devices, a $350 billion industry that encompasses everything from pacemakers to X-ray scanners to contact lenses.

The 12-member group’s advice, commissioned by the Food and Drug Administration, is not binding. But it could signal a new era of tighter standards for medical device manufacturers, who have long benefited from less safety scrutiny than their peers in the drug industry.

FDA requires that most new prescription drugs go through clinical trials to prove that patients fare better after receiving medication. Most devices only have to show that they are similar to devices already on the market. Only a handful of truly new devices must undergo extensive testing to prove they are safe and effective.

In a highly unusual move, the FDA said Friday that it disagreed with the group’s recommendations, but would hold a public meeting to discuss them. The FDA has already been working for more than a year to make the 510(k) process more predictable and less bureaucratic, efforts that would go to waste if the system is abandoned.

“FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches,” said FDA’s device director Jeffrey Shuren, in a statement.

The report arrives as the FDA fends off pointed criticism from manufacturers who say the agency has become too slow and bureaucratic in clearing new devices, driving up costs for companies and forcing some out of business. Despite the relative speed of the 510(k) process, they point out that some devices still get tied up in red tape, ultimately reaching the U.S. market two years after launching overseas. In the past year, companies have taken their arguments to Capitol Hill, where lawmakers have grilled FDA officials over device reviews.

The device industry’s chief lobbying group immediately dismissed the proposal as “a disservice to patients and the public health.”

“The report’s conclusions do not deserve serious consideration from the Congress or the Administration,” said Stephen Ubl, president of the Advanced Medical Technology Association. “It proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven and unspecified new legal structure.”

The Institute of Medicine panelists, mostly doctors and researchers, appear to have overwhelmingly sided with public safety advocates who have argued for years that devices used to treat and detect illnesses must undergo real medical testing.

The FDA sought the group’s advice as it updates the system used to clear more than 90 percent of devices in the U.S. The so-called 510(k) system was created by Congress in 1976 to grant speedy approval to devices that are similar to products already on the market. The pathway was originally intended as a temporary method to grandfather in devices that had been used for decades. Instead it has become the standard tool to launch new medical implants.

The IOM generally recommends ways to improve or modify government programs, but in an unexpected move the panel said 510(k) approvals are “flawed” and should be eliminated completely.

“A system was put in place 35 years ago that does not really assess safety and effectiveness,” said panel chair David Challoner, former vice president of health affairs at University of Florida. “We need something different for the next 35 years. We’re dealing with a whole new world: new technology, new materials and new data.”

Challoner and the other panelists recommend the FDA develop a new system based on safety metrics and tracking device failure rates in the real world. He said better tracking of device complications could take the place of premarket testing, which would be financially unfeasible if applied to all new devices.

The group stresses that medical devices cleared through the pathway are not inherently unsafe—most probably are safe—but the approval system itself provides little assurance to doctors and patients.

The 510(k) system is popular among manufacturers because it is a faster, cheaper path to market than the review process for first-of-a-kind devices, which must undergo rigorous medical testing. Hip replacements, CT scanners and drug pumps are among the devices cleared by 510(k).

As generations of devices have been cleared year after year, FDA critics say dangerous devices that pose real risks to patients have slipped through because they vaguely resemble products approved decades ago.

“Originally there was this idea that the 510k would wither away and over time more and more new devices would go through the more onerous path. But instead there are more devices cleared this way than ever,” Dr. Diana Zuckerman, director of the nonprofit National Research Center for Women Families, said in an interview Thursday.

Earlier this month Zuckerman and other safety advocates critics seized on new reports of painful complications with pelvic surgical mesh as the latest example of the shortcomings of the abbreviated review system. Reports of pain, bleeding and infection with the implants are up 500 percent since 2008 among women who’ve had surgery to support the pelvic wall. The FDA cleared the device for that use in 2002 via 510(k). Similar safety issues have plagued metal-on-metal hip implants in recent years.

The IOM’s 245-page report will strengthen FDA’s hand against a multimillion-dollar lobbying effort by medical device manufacturers. But it also poses a host of challenges for the agency, including how to design and pay for a more comprehensive medical device system.

About 4,000 devices are cleared every year under the 510(k) system, while just 50 devices are approved under the more stringent system that requires human testing. It costs the FDA roughly $800,000 per device when utilizing the more rigorous system.

The IOM is a nonpolitical group of experts that advises the federal government on medical issues.

For months, medical device lobbyists and executives have downplayed the legitimacy of the IOM panel, pointing out that none of them have experience working in the device sector.

Like most panels convened by the agency, the group that drafted Friday’s paper consists mostly of academics and researchers from institutions like Harvard University and the National Institutes of Health.

Dr. Jeffrey Lerner, who has studied medical technology for over 25 years, said device makers are still coming to grips with a new regulatory environment that demands greater safety—often at the expense of profits.

“The device industry tends to take the position that their industry is competitive enough already and that anyone wanting to make it tougher is trying to do them real harm,” said Lerner, who is president of the Emergency Care Research Institute. “The bottom line is that everybody has got to make adjustments in an era in which technology is changing and public expectations are changing.”