Thursday, October 29, 2015

NTSB criticizes tire recall process.

Coverage of the NTSB’s special investigation report on tire safety continues garnering significant media coverage. Rubber News (10/28, Moore) reports the agency has 11 recommendations to address the tire recall process. “The current tire registration process has proven to be ineffective in enabling tire manufacturers to compile complete and accurate customer contact information, which is vital to ensuring the success of a tire recall,” the NTSB said in the conclusions in its report. “We cannot change what happened in the past, and we cannot bring back the 539 fathers, mothers, sons, daughters and friends who lost their lives due to tire causes in 2013,” NTSB Chairman Christopher Hart said. “But action on today’s recommendations can help bring those numbers down in future years,” he added. The NTSB’s recommendations to the NHTSA call for changes to standards, recall, and safety requirements.
        KXAN-TV Austin, TX (10/28, Ricke, 119K) reports that according to the NTSB, “close to two million tires could be too dangerous to be on the road right now, but the system for recalling those tires is broken.” Some 500 people are killed and 19,000 injured in the US each year in crashed involving faulty tire. T. Bella Dinh-Zarr, NTSB Vice Chairman asked “Why can’t be service tech tell me if my tires are recalled?” to which NTSB Highway Safety Investigator Robert Squire answered, “The main reason for that is there’s no easy way to do it.”
        Landline Magazine (10/28, Fisher, 607K) reports the NTSB found the registration and recall system for tires “ineffective” and the tire industry provides “insufficient guidance on tire aging.” In its report, NTSB also “found that manufacturers’ registration process was ineffective,” the article reports. The NTSB however found that “more than 75 percent of all recalled vehicles have been serviced,” yet “the rate specific to tire recalls can be as low as 20 percent,” the article adds. The NTSB called on the NHTSA to streamline the way it lists recalled tires as it confuses website users.

        The story was covered on local television by KOIN-TV Portland, OR (10/29, 5:25 p.m. PDT, 29K), WCSC-TV Charleston, SC (10/28, 7:12 p.m. EDT, 27K) and WVTM-TV Birmingham, AL (10/28, 4:46 p.m. CDT, 13K). 

Wednesday, October 28, 2015

After a Delay of Years, Mazda Recalls 4.9 Million Vehicles
The New York Times
"As attention to auto safety intensified after General Motors’ admission last year that it had failed for a decade to disclose a deadly defect in millions of cars, many automakers have scrambled to address lingering safety problems.

This week, Mazda became the latest automaker to do so, revealing for the second time in three months that it had known about safety problems for years before alerting customers. In the latest case, Mazda announced that it was recalling 4.9 million vehicles worldwide, including 1.4 million in the United States, because too much grease in the ignition switch could cause a short circuit and possibly a fire.

The automaker knew about the problem seven years ago, according to a filing submitted this week to the National Highway Traffic Safety Administration. It took action only after Japanese regulators opened an investigation this year."

Important FDA Safety Communication

Nontuberculous Mycobacterium Infections Associated with Heater-Cooler Devices: FDA Safety Communication

Date Issued: October 15, 2015
  • Health Care Providers who use heater-cooler devices
  • Hospital staff who are responsible for operating and maintaining devices
  • Infection Control Practitioners
  • Infectious Disease Specialists
  • Surgeons
  • Perfusionists
  • Operating Room Managers, Directors and Staff
  • Risk Managers
Medical Specialties: Cardiothoracic Surgeons, Cardiovascular Surgeons, Orthopedic Surgeons, Neurosurgeons, General Surgeons, Anesthesiologists, Infection Control, Infectious Disease Physicians, Intensive Care Physicians
Product: All heater-cooler devices. Heater-cooler devices provide heated and/or cooled water to 1) oxygenator heat exchangers, 2) cardioplegia (paralysis of the heart) heat exchangers, and/or 3) warming/cooling blankets.
Purpose:The FDA wants to heighten awareness about infections associated with heater-cooler devices and steps health care providers and health facilities can take to mitigate risks to patients.
Summary of Problem and Scope:Heater-cooler devices are used during cardiothoracic surgeries, as well as other medical and surgical procedures to warm or cool a patient to optimize medical care and improve patient outcomes. Heater-cooler devices include water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or transmit bacteria through the air (aerosolize) through the device’s exhaust vent into the environment and to the patient.
Through the FDA’s analysis of adverse event reports, the medical literature, and information from national and international public health agencies, we are aware that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedures. NTM organisms are widespread in nature and can be found in soil and water, including tap water sources. They are typically not harmful, but in rare cases may cause infections in very ill patients and/or in individuals with compromised immune systems.
Between January 2010 and August 2015, the FDA received 32 Medical Device Reports (MDRs) of patient infections associated with heater-cooler devices or bacterial heater-cooler device contamination. Twenty-five of these MDRs were reported to the FDA in 2015. Some reports describe NTM infections related to cardiothoracic surgeries, but other reports do not specify the procedure the patient was undergoing. Eight reports were related to 3 events describing patient infections occurring in U.S. health care facilities. The remaining 24 reports involved health care facilities outside the United States, most of these in Western Europe. In some cases, patients presented with infections several months to years after their surgical procedures. It is important to note that half of the 32 reports submitted to the FDA describe bacterial contamination of the heater-cooler device without known patient involvement or infection. The FDA is not aware of NTM infections acquired by hospital staff.
It is possible that some cases have not been reported to the FDA. It is challenging for a health care facility, health care provider, manufacturer, or patient to recognize that infections, particularly NTM infections, may be associated with the use of or exposure to a particular medical device. The FDA continues to evaluate reports through follow up with health care facilities and manufacturers to determine which factors may have contributed to the reported events.
Recommendations for Health Care Facilities and StaffIn addition to following standard precautions, the FDA recommends that facilities and staff using heater-cooler devices consider implementing the following measures to reduce risk to patients:
  • Strictly adhere to the cleaning and disinfection instructions provided in the manufacturer’s device labeling. Ensure you have the most current version of the manufacturers’ instructions for use readily available to promote adherence.
  • Do not use tap water to rinse, fill, refill or top-off water tanks since this may introduce NTM organisms. Use only sterile water or water that has been passed through a filter of less than or equal to 0.22 microns. When making ice needed for patient cooling during surgical procedures use only sterile water or water that has been passed through a filter of less than or equal to 0.22 microns. Deionized water and sterile water created through reverse osmosis is not recommended because it may promote corrosion of the metal components of the system.
  • Direct the heater-cooler’s vent exhaust away from the surgical field to mitigate the risk of aerosolizing heater-cooler tank water into the sterile field and exposing the patient.
  • Establish regular cleaning, disinfection and maintenance schedules for heater-cooler devices according to the manufacturers’ instructions to minimize the risk of bacterial growth and subsequent patient infection.
  • Develop and follow a comprehensive quality control program for maintenance, cleaning, and disinfection of heater-cooler devices. Your program may include written procedures for monitoring adherence to the program and documenting set up, cleaning, and disinfection processes before and after use.
  • Immediately remove from service heater-cooler devices that show discoloration or cloudiness in the fluid lines/circuits, which may indicate bacterial growth. Consult your hospital infection control officials to perform the appropriate follow up measures and report events of device contamination to the manufacturer.
  • Consider performing environmental, air, and water sampling and monitoring if heater-cooler contamination is suspected. Environmental monitoring requires specialized expertise and equipment to collect and process samples, which may not be feasible in all facilities.
  • Health care facilities should follow their internal procedures for notifying and culturing patients if they suspect infection associated with heater-cooler devices.
  • Submit a report to the manufacturer and to the FDA via MedWatch, as described below, if you suspect heater-cooler devices have led to patient infections.
FDA Activities:The FDA is actively engaged with stakeholder groups to better understand the causes and risk factors for transmission of microbial agents associated with these devices and to develop strategies to minimize patient exposure. Our ongoing activities include:
  • Working with health care facilities and professional medical societies to understand their experiences with heater-cooler devices.
  • Evaluating information about documented and potential infections from multiple sources, including medical device adverse event reports submitted to the FDA, the medical literature, international public health agencies and federal partners.
  • Collaborating with medical device manufacturers to review their existing cleaning and disinfection protocols provided in the instructions for use for currently marketed devices.
FDA continues to actively monitor this situation and will provide updates as appropriate.
Reporting Problems to the FDA:Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with the use of medical devices. Health care providers should submit voluntary reports of infection transmission associated with heater-cooler devices or reports describing difficulty following the manufacturers’ instructions for use to the agency via the Medical Device Reporting (MDR) process. If a health care provider suspects bacterial contamination of the heater-cooler device following use, we encourage the health care provider to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Additional Resources:
Centers for Disease Control and Prevention. Non-tuberculous Mycobacterium (NTM) Infections and Heater-Cooler Devices. Safety Alert. October 2015.
Sax, H.; Bloemberg, G.; Hasse, B.; et al. Prolonged outbreak of Mycobacterium chimaera infection after open chest heart surgery. disclaimer icon Clin Infect Dis. 2015 Mar 11.(Abstract)
Falkinham JO.; Pruden A.; Edwards M. Opportunistic Premise Plumbing Pathogens: Increasingly Important Pathogens in Drinking Water.disclaimer icon Pathogens 2015;4(2):373-386.
Contact Information:If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.

Fiat Chrysler issues recalls.

NBC News (10/28, 3.32M) reports that Fiat Chrysler Automobiles “said Tuesday it is recalling 86,046 Ram trucks and 93,895 Jeep Cherokee sport utility vehicles for two different safety issues.” FCA “said the recall of certain 2015-2016 Ram 1500 pickups produced between mid-June and late September this year is to inspect and replace rear axles,” the article reports. This comes after an internal investigation found axle shafts on some trucks could “overheat and trigger the anti-lock brake system warning light, leading to component fracture and possible wheel separation,” the article adds. Meanwhile, the recall targeting certain 2015 Jeep Cherokee SUVs “is to replace air-conditioning lines that may have been installed close to the engines’ exhaust manifolds, posing a fire risk,” the article continues.
        The Detroit News (10/27, Shepardson, 545K) reports that the automaker launched its investigation into the issue after two owners complained to the NHTSA, citing incidents involving smoke and fire. FCA “told NHTSA it has 31 reports of low-mileage failures in new Ram pickups,” the article reports. Earlier this year, “Fiat Chrysler agreed to a record setting $105 million, three-year consent decree with NHTSA for failing to properly carry out 23 recall campaigns covering more than 11 million vehicles,” the article adds.
        The story was also covered by the AP (10/27) and Reuters (10/27, Ajmera

General Motors announces third recall.

The CBS Evening News (10/27, story 10, 0:25, Pelley, 5.08M) reported, that after General Motors attempted two repairs that failed, it announced Tuesday a third recall of nearly 1.3 million 1997-2004 cars. “Oil leaks have started fires in more than 1300 of these cars after they were supposedly fixed by dealers,” CBS reported.
        ABC World News (10/27, story 11, 0:15, Muir, 5.84M) reported that GM is in fact recalling 1.4 million older vehicles, including “the Chevy Impala, Pontiac Grand Prix and more.”
        The New York Times (10/28, Jensen, Subscription Publication, 11.64M) reports that the recall is in fact the fourth for GM and is targeting 1.4 million vehicles, including about 1.3 million in the US. Alan Adler, a GM spokesman, said that associated malfunctions resulted in 19 minor injuries, as well as damage to some structures, such as garages. All models involved have a 3.8-liter V6 engine.” The models covered are the 1997-2004 Pontiac Grand Prix; 2000-4 Chevrolet Impala, 1998-99 Lumina and 1998-2004 Monte Carlo; 1998-99 Oldsmobile Intrigue; and 1997-2004 Buick Regal,” the article reports. The NHTSA received complaints from some customers, including the owner of a 2001 Buick Regal.

        The story was also covered by the AP (10/27, Krisher). 

Monday, October 26, 2015

York Hospital Patients May Have Been Exposed to Bacteria

WellSpan York Hospital is warning patients who had open-heart surgery at the hospital over a three-and-a-half-year period that they may have been exposed to bacteria.

Friday, October 23, 2015

Defective air bags being sold online.

Bloomberg News (10/23, Plungis, 2.66M) reports that “an underground market is growing” online for unauthorized replacements for Takata’s recalled air bags. Jennifer Timian, chief of the NHTSA’s recall management division, said that the agency has “learned of defective air bags for sale on EBay Inc,” according to the article. She said that consumers should only buy replacement air bags from authorized dealers. Timian is quoted as saying, “Under no circumstances should a person purchase an air bag off the Internet, or from a salvage yard or any other unauthorized source.” 

Mazda recalling 1.36 million vehicles in the US over ignition switches.

The AP (10/22) reports that Mazda “is recalling 4.9 million older vehicles worldwide, including 1.36 million in the US, because ignition switches could overheat and catch fire.” The recall involved “the 1990-1996 323 and Protégé, the 1993-1998 626, the 1993-1995 929, the 1993-1997 MX-6, the 1989 to 1998 MPV and the 1992-1993 MX-3.” 

Wednesday, October 21, 2015

Toyota to recall 6.5 million cars over power window issue.

Reuters (10/21, Kim) reports that Toyota Motor Corp on Wednesday announced it will recall some 6.5 million vehicles globally over a defect in the power window switch in some models. In the US and North America, 2.7 million such vehicles will be subjected to repairs in a bid to fix the issue concerning the power windows. 

Monday, October 19, 2015

        GM recalls more than 3,000 trucks, SUVs for new ignition switch defect. USA Today (10/17, Gardner, 5.23M) reported online that General Motors announced Friday that it would be recalling “about 3,300 large pickup trucks and SUVs” due to newly discovered ignition switch defects. This comes but “a month after agreeing to pay $900 million to settle criminal charges” related to the earlier faulty switch problems. In this new case, some GM trucks “have ignition lock gears with an outer diameter that is larger than specifications, making them difficult to turn.” 

GM adds vehicles to Takata air bag recall.

USA Today (10/18, Snider, 5.23M) reports in continuing coverage on the addition of 395 General Motors vehicles to the Takata air bag defect recall. The problem, according to the NHTSA is that the air bags “may rupture when deployed, causing possible serious injury or death.”
        The AP (10/18, Krisher) reports that the global issue of “exploding Takata air bag inflators” has now “spread to newer vehicles, this time hitting a small number of 2015 General Motors cars and SUVs.” On Saturday, GM announced the recall of “more than 400 vehicles” due to potentially faulty side bag inflators that can “rupture and send shrapnel into drivers and passengers,” according to documents posted with NHTSA. As the AP points out, the Takata question “continues to widen with no end in sight.” NHTSA’s Gordon Trowbridge comments that “All Takata-made ammonium nitrate inflators are within the scope of our investigation,” adding that the agency “will take action” should it find “that additional recalls are necessary.”
        MLive (MI) (10/18, Al Hajal, 739K) reports that the number of recalled vehicles was “395 vehicles of six different models,” bringing the number of recalled vehicles with Takata airbags to “more than 19 million.”

        WIMS-AM South Shore, IN (10/17) also reported online. 

Wednesday, October 7, 2015

Medical malpractice rates “essentially flat” in 2015.

Medscape (10/7, Lowes, 232K) reports on a survey of medical malpractice rates by the Medical Liability Monitor finding that rates were “essentially flat” for 2015 in “three bellwether medical specialties” namely, obstetricians/gynecologists (up 0.6 percent), internists (up 0.5 percent), and general surgeons (down 0.2 percent). Rates fell in the Northeast, West, and Midwest, but were up 0.9 percent in southern states, with Texas, North Carolina, and Georgia having 5 percent increases. The report also found that 71 percent of rates were the same in 2015 as in 2014, 12 percent were lower, and 17 percent were increased. Decreases outnumbered increases in every year since 2006 until this year.