Health information technology has been touted as crucial to better healthcare, but a new report says an entirely new regulatory agency is needed to oversee this largely unregulated sector, which can also injure or kill patients if it’s not operating properly.

In pushing for a new oversight body, the respected Institute of Medicine, an independent research and advisory organization, is explicitly advising that the Food and Drug Administration (FDA) not be tasked with the job – a recommendation that is bound to be controversial.  [Read More]

FALLS CHURCH  The overall increase in the number of product recalls in 2010 may have been modest, but Pharmacy recalls jumped 33 percent according to statistics from RASMAS.

RASMAS collects and posts recalls and product safety notices for the healthcare industry. RASMAS statistics show that the number of product safety notices and alerts increased 4 percent over 2009. That 4 percent increase is identical to the increase in 2009. RASMAS released 3,317 alerts to its subscribers in 2010; an average of 64 per week. This compares to 62 alerts per week in the same 2009 period.

Bill Klein, RASMAS data manager, attributes the rise in the number of Pharmacy notices to the large number of over-the-counter drug recalls by McNeil Consumer Healthcare, the withdrawal of Propoxyphene (Darvon) and the recall of Lipitor for an “uncharacteristic odor”.

Another category of products showing a significant increase were Operating Room Products.  OR products include devices used for treatment and diagnosis in the OR as well as devices implanted in the OR such as hips or shoulders. RASMAS released 29 percent more OR product related notices in 2010.

It seems every year has a memorable food recall, Klein says. This year, Salmonella-contaminated food continued to make the list. Walnuts, hydrolyzed vegetable protein and eggs made headlines.

Below are statistics for RASMAS for 2010:

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One of the product safety alerts for 2010 was for Fisher Price Little People. Health Canada released an alert after yet another choking incident. Source: Health Canada Release

FALLS CHURCH - Recalls continue to be an ever-increasing time-expense on healthcare, according to mid-year statistics from RASMAS .

RASMAS collects and posts recalls and product safety notices for the healthcare industry. Between January and June 2010, RASMAS statistics show that the number of product safety notices and alerts increased 10 percent over the same period in 2009, as compared with a 4 percent increase from 2008 to 2009. RASMAS has released 1,752 alerts to its subscribers as of the end of June 2010; an average of 67 per week. This compares to 62 alerts per week in the same 2009 period.

Bill Klein, manager of RASMAS data, attributes the rise in the number of notices to to the large number of over-the-counter drug recalls by McNeil Consumer Healthcare and the numerous recalls of tainted food.

“It could be that the FDA or manufacturers are pushing out alerts at a faster pace,” says Klein. “In the past manufacturers and the FDA would identify a problem, conduct an investigation, and eventually the recall notice would be published in an FDA Enforcement Report.” But with the criticism over Tylenol and other issues, Klein believes that the FDA may be moving faster when there is a problem. “The Heparin recalls of 2008 were a wake-up call to the FDA and Congress,” says Klein.

When food recall statistics are excluded from the results, RASMAS data shows that general healthcare recalls have surged by over 15 percent. Klein reports that the busiest month for recalls this year was March, when healthcare facilities received 420 recall notices, compared to 286 recall notices issued in March 2009, a 47 percent increase.

Last year, peanut recalls were a major issue that negatively affected both consumers and the healthcare industry, Klein says. This year, other food issues have surfaced, including Salmonella-contaminated food ingredients.

Recall Themes in 2010

Some major types of recalls in the first half of this year:

• Toys and Cribs: While cadmium tainted Shrek glasses from McDonald’s made the news this year, some older recall issues have not been resolved. Health Canada issued a reminder notice that Fisher Price “Little People” manufactured prior to 1991 should be discarded, because they can be lodged in a child’s throat. Health Canada has become aware of the death of a 10-month-old child resulting from the use of one of these older products. The death occurred after an older “Little People” figure became lodged in the child’s throat. Drop Side and Fixed Side Cribs were also subject to numerous CPSC and Health Canada recalls this year. These recalls highlight the issue of millions of recalled products that remain in homes and on shelves because recall announcements were missed.
• HVP and Salmonella: Contaminated or possibly contaminated food continued to be a big issue in 2010. The recalls this year include Salmonella-contaminated HVP (Hydrolyzed Vegetable Protein) supplied by Basic Food Flavors of Las Vegas, Nevada. Another contributor to recalls was Salmonella-contaminated pepper from the Mincing Overseas Spice Company.
• Imports: Some drugs made overseas had issues with quality. Claris Lifesciences recalled intravenous Metronidazole, Ondansetron, and Ciprofloxacin due to “floating matter” which could be an indication of lack of sterility or contamination. The Indian manufacturer Aurobindo Pharma Limited, Andhra Pradesh recalled Sertraline HCL Tablets, 100 mg. because a foreign tablet of Zolpidem Tartrate Tablets, 10 mg, was found in a bottle.
• Undeclared Ingredients, Out of Specification: A number of recalls this year have been for ingredients that were not declared. For instance, JTM Foods Inc. of Erie, Pennsylvania recalled marshmallow treats because of undeclared colors FD&C Yellow #5 and Yellow #6.  Many recalls were for drugs “out of specification” for various parameters such as stability and expiration date. PL Developments, Inc. of Westbury, NY recalled over 1.4 million bottles of Ketotifin eye drops in March because they were out of specification for pH.
• Market Withdrawals: Pfizer pulled the drug Mylotarg (gemtuzumab ozogamicin for injection) used for the treatment of relapsed acute myeloid leukemia. Pfizer took the action at the request of the FDA after results from a recent clinical trial raised new concerns about the product’s safety and the drug failed to demonstrate clinical benefit.

Below are statistics from RASMAS for the first half of 2010:

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All Recalls/Alerts Per Month Released By RASMAS

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All Recalls/Alerts per Month by RASMAS, Excluding Food

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Breakdown of RASMAS Alerts by Subject Area, January-June 2010

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WASHINGTON, D.C. – When the public needs to know about unsafe food, the federal government releases announcements about contaminated foods on its website, FoodSafety.gov. The information comes from the two agencies that inspect food, the Food and Drug Administration (FDA) and the United States Department of Agriculture’s Food Safety and Inspection Service (FSIS).

FSIS is part of the U.S. Department of Agriculture, and tracks meat, poultry and processed egg products produced in federally inspected plants. FDA, part of the Department of Health and Human Services, issues notices for other food products.

The Food Safety Alerts & Tips widget, seen at right, combines all the food  recalls, market withdrawals and safety alerts from the FDA and FSIS, as well as tips and research.

Food Safety Widget. Flash Player 9 is required.

Healthcare providers often receive their alerts from a recall service, such as the RASMAS. For consumers concerned about the safety of specific food items, below are the main pages where the most recent food safety cases are listed:

• Current Recalls and Alerts from FSIS
• FSIS Recall Case Archive (searchable by year)
• FDA Food Recalls and Safety Alerts

Find out more

You can the latest news on health safety and recall from RASMAS’ Bill Klein on Twitter at twitter.com/RASMASrecall. Or you can follow our headlines via RSS feed.

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FALLS CHURCH – The book Glitch: The Hidden Impact of Faulty Software by Dr. Jeffrey Papows details the perils of software bugs, a common reason for both consumer and medical recalls.

The book is a sweeping critique of these computer errors, including how these “glitches” relate to cyberterrorism and computer networks. One particular danger area from software error is in medicine and in particular, radiology. The book cites the radiology-related recall statistics of Bill Klein, Principal at Noblis. RASMAS statistics show that over 48 percent of radiology recalls were a result of software problems. Some physicians estimate that one out of 20 patients receives lethal doses of radiation.

Papows raises a number of questions about the errors including:

“Is it realistic to expect radiation physicists to become experts in computer programming, and vice versa? Just how much training goes into ensuring that hospital staff have mastered the use of the technology? How can software developers create more error-free programs?”

The book is the second business tech book authored by Papows; his first was Enterprise.com: Information Leadership in the Digital Age. Papows is best known for his work as president and CEO of Lotus Development Corporation where he is credited for his work with Lotus Notes.

To find out more about the book, see www.glitchthebook.com; you can follow Papows’ Twitter feed at twitter.com/glitchthebook

FALLS CHURCH – Curious about the safety or official recall status of a drug or product? A half dozen agencies handle recalls in the U.S., depending on the type of recall.  Across the globe, other agencies post their recalls and safety alerts online.

The first place for consumers to go in the U.S. to find out about the official status of a government recall is Recalls.gov, which is a search page of the entire U.S. government’s recall sites. The site, (snapshot seen at right) includes links to separate databases at the following agencies:

• The Consumer Products Safety Commission (CPSC) handles recalls of toys and consumer products
• Food and Drug Administration (FDA) provides alerts, recalls and warnings on foods, drugs, medical devices and cosmetics
• The United States Coast Guard’s (USCG) recall section includes all marine and boating products, including engines, life jackets and other water related items
• The United States Department of Agriculture (USDA’s) Food Safety Inspection Service (FSIS) initiates food recalls
• Environmental Protection Agency (EPA) emissions recalls are for notices related to pollution standards
• The Environmental Protection Agency’s (EPA) pesticides site includes pesticides and agricultural products
• The National Highway Traffic and Safety Administration (NHTSA) website includes recalls of vehicles, car equipment, child restraint devices and tires

International Recall Sites

As supply chains have become increasingly complex and interconnected, some recalls have been international in scope. Below are some official recall sites from around the world:

Canadian Recall Sites

• Public Health Agency (PHA) of Canada has a Road Safety Recalls Database that handles auto recalls
  
• Canadian Food Inspection Agency (CFIA) search page
• Health Canada’s Product Safety Programme (PSP) has a page for Consumer Product Recalls. It is searchable by keyword and year.

European Union

• RAPEX is the European Union’s rapid alert system for all dangerous consumer products, with the exception of food, pharmaceutical and medical devices
• The European Medicines Agency (EMA) of the E.U. has a web page with links to individual European state government pharmaceutical agencies

Asia/Oceania/Australia

• Australia’s Therapeutic Goods Administration (TGA) regulates drug recalls and notices
• The Australia Competition and Consumer Commission (ACCC), regulates consumer products in Australia; search on their Product Safety Recalls Australia page
• New Zealand Food Safety Authority (NZFSA) tracks food recalls in New Zealand
• Hong Kong Centre for Food Safety monitors food recalls in the Hong Kong Special Administrative Region

Are there other official agencies we ought to list? Please add them in the comments section below.

A view of Methodist Charlton Medical Center of Dallas. The hospital's Outpatient Diabetes Program educates the public about diabetes.

DALLAS - What’s the key to the safe use of the glucose monitor?

Simplicity.

“Our culture is so fast paced, the simpler the better,” says Mary W. Frank, RN, CDE (Registered Nurse Certified Diabetes Educator) at the Outpatient Diabetes Program based at Methodist Charlton Medical Center. Frank teaches patients at the Texas hospital’s diabetes education center, training patients on how to monitor and live with the disease.

Millions are affected. The International Diabetes Foundation estimates that some 285 million worldwide have diabetes; the American Diabetes Foundation estimates that in the U.S. there are about 23.6 million with the disease, with only 18 million or so of them diagnosed.

For those who work professionally to educate the public, the main issue, after treatment, is making sure that patients can both afford the equipment and are able to use the equipment safely. For instance, with a 75-year-old patient, Frank is happy to have him find his count through a simple glucose monitor, rather than a more complex monitor that is not used regularly.

“I just want him to test, and write in a log book,” says Frank, who mainly works with Type 2 and gestational patients, as well as the occasional Type 1 patient. “This is what the number is, and done.”

For many patients whose affinity for technology is greater, there are numerous glucose meters that come with software and connection cables in order to download results over time. The new Bayer model Contour USB ditches the cables altogether and plugs right into the USB port of a computer. With the more advanced products, users can then plot their numbers on a graph, which Frank says is the most helpful way to manage the disease.

Strip Safety

Diabetes supplies such as blood glucose monitors and insulin pumps are sophisticated devices that require the patient to perform frequent calibration and maintenance, as well as check for recalls. The devices also have many components and supplies such as lancing devices, docking stations, test strips, control solutions, tubing, batteries and an operations guide. The strips are the area where there can be the most problems, says Frank. She reminds us that they are made, transported and sold by “real people. ”

“Strips can be damaged by heat, cold and humidity,” says Frank. The key to success is to understand their limitations; most home meters test within a 10 to 15 percent accuracy rate. “It’s not the lab,” says Frank, “but a whole lot better than not testing.”

To ensure consistent results, most meters have a small bottle of control solution for the strips. A patient should test the meter using the solution, and if the results are not correct, they should shake the solution and test it again. The bad news; in some states, and where test trips are often sold as prescription items, you cannot take them back to where you got them, says Frank. Instead, you need to contact the manufacturer, which will often supply replacements overnight.

One other area of problems with strips is with coding. In some models, the user must tell the meter which batch of strips they will be using. Newer models have eliminated this, but each step puts in the possibility for error.

Patients often assume that calling the company’s 1-800 number will be time consuming, but Frank says she has found that major manufacturers have been very responsive with customer service. “Brand names have people 24/7,” says Frank. “Then they overnight them new strips.” In addition, because the money is made with strips, not meters, manufacturers often send out free meters.

Frequent Recalls, Safety Notices

Recalls are common, with 11 recall notices for meters and infusion pumps in 2010 so far, many from the nation’s best-known makers. While a user may become proficient in the maintenance and use of these devices, they should be aware of any manufacturer notifications of operational changes, maintenance changes, and device recalls due to defect. Recalls generally fall into three areas; below are a few types of recalls that have come out this year:

• Software issues: Johnson & Johnson’s Animas recalled their “ezManager” Max, a type of diabetes management software.  It would not load onto Apple Macintosh computers. In addition, Animas’ OneTouch Ping Insulin Infusion Pump had a software malfunction that disallowed users to download, view and print information.
• Possible Inaccurate Results: During testing, Abbott Diabetes Care discovered that there were FreeStyle Lite Blood Glucose Test Strips that could generate low blood glucose readings.
• Design issues: Nipro Medical Corporation recalled their GlucoPro Insulin Syringes because needles could detach from the syringe. If the needle became detached, it could become stuck in the insulin vial, and push back into the syringe, or remain in the skin after injection.

In recent years, tens of dozens of recalls and bulletins that cover several million devices and their supplies have been released by the FDA and manufacturers. RASMAS keeps track of these recalls for hospitals.  These recalls and bulletins cover operational warnings, calibration, device defects or potential malfunctions, user manual changes, calibration problems, and device supply defects. The consumer also has a resource, the FDA:

• FDA Recall Page: The FDA’s Recalls, Market Withdrawals, and Safety Alerts page has a searchable box where you can type in the name of your product to find out if it has been recalled.
• The American Diabetes Association has excellent resources on glucose monitors and infusion pumps, including a download of manufacturers, models and features.

Learn About Your Glucose Monitor

The individual websites of manufacturers provide information on safe operation in general, as well as any of the latest safety warnings. Below is a list of some of the top manufacturers in the U.S. market. Note that there are some manufacturers that sell store-branded diabetes equipment to grocery, drug and discount chains.

Major monitor manufacturers/brands/models include:

• Abbott Diabetes Care
• AgaMatrix, makers of the WaveSense line
• Arkray, maker of the Glucocard
• Bayer Diabetes Care, makers of the Contour and Breeze
• Bionime, makers of the Rightest
• Diabetic Supply of Suncoast’s Advocate Duo
• Diagnostic Devices, maker of the  Prodigy Meter
• Entra Health Systems
• Fifty50 Medical
• ForaCare
• GlucoCom’s Codefree
• Infopia USA makes brands that include Eclipse, Envision and GlucoLab
• Lifescan makes the OneTouch
• Nipro Diagnostics
• Nova Biomedical makes the Nova Max
• Roche, maker of Accu-Check
• U.S. Diagnostics, maker of Acura, EasyGluco, Infiniti and Maxima
• Walmart, distributor of the ReliOn

For more information: Methodist Health System has a whole section of resources and information on diabetes on their website. See www.methodisthealthsystem.org

FALLS CHURCH – It’s an old maxim of politics and public relations that bad news often gets released on a Friday, when newsrooms are understaffed, and investors are otherwise occupied.

The ostensible reason? Companies and government agencies release news that could affect a stock price on a day when the market and most consumers are not tuned in.

Recall notices are one bit of news that seems to get the Friday treatment. In 2010, major recalls for Kellogg’s cereal, Tylenol and Toyota all have been issued on Fridays. But is this true statistically? And is this true with recalls related to healthcare?

Bill Klein, a Principal at Noblis’ RASMAS , compiled statistics from 2009 that show more notices are released on Fridays. His research, compiled from RASMAS’ extensive data on healthcare recalls, shows Friday and Wednesday are the most popular days for the government and companies to release these types of notices.  Notices fall into categories such as Public Health Notices, Recalls, Field Corrections and Market Withdrawals.

“It’s an interesting phenomenon that we noticed some time ago,” says Klein, who supervises the database at RASMAS . The RASMAS database includes both federal and private alerts and is one of the most extensive alert databases in the country, including over 19,400 alerts since 2004.

Klein resists drawing any conclusions from the data, as each recall notice or alert has different origins.

“It may be a function of how the regulatory agencies do business or conscious decisions made by the manufacturers,” says Klein.

Studies Show Friday Bias

More formal economics studies have shown the effects of Friday announcements. Stefano DellaVigna, an associate professor at the Department of Economics, University of California, Berkeley has studied the issue along with Joshua M. Pollet, then of the Department of Finance, University of Illinois at Urbana-Champaign. Their paper, “Investor Inattention and Friday Earnings Announcements” discussed the effect of the Friday release of earnings data at companies.

RASMAS statistics show that Friday was the most popular day for announcing recalls in 2009, with 24 percent of recalls announced on Fridays. However, Wednesday was a strong runner up, with 23 percent of recalls released mid-week. Overall, recalls tend to get released toward the end of the week, with only 15 percent of releases sent out on a Monday.

The issue of a recall notice has repercussions in hospitals. When notices arrive during off hours such as holidays or weekends, staff must scramble to respond. On average in 2009, there were 62 recall notices each week, according to RASMAS data.

Editor’s Note: Do readers have any thoughts on when recall notices arrive, and the reasons they tend to arrive at the end of the week? Leave a reply at the end of the story.

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NEW LONDON, CT – Founded in 1912, Lawrence & Memorial Hospital is a non-profit, community-focused hospital in New London, Connecticut, just off Long Island Sound. The 280-bed hospital with approximately 2,300 staff adopted RASMAS in 2007.

The hospital’s regional footprint includes a stand-alone emergency room, the Pequot Health Center, hospital-owned physician practices, a dialysis clinic, an outpatient surgical center and a sleep center operated in conjunction with the local Hilton. Specialty practices at the hospital include the Community Cancer Center and a location of the Joslin Diabetes Center, affiliated with Harvard Medical School. (more…)