FDA Safety Notice Letter “Recommends The Continued Use Of Forced Air Thermal Regulation Systems During Surgery”

Does the August 30, 2017 FDA Medical Device Safety Notice Letter Impact the BAIR HUGGER MDL 2666 FORCED AIR WARMING DEVICES Litigation? 

3M™ Bair Hugger™ Blanket System

 

 

 

 

 

 

 

 

US Food & Drug Administration Healthcare Provider Notice, August 30, 2017

FDA Safety Information Notice: Forced Air Thermal Regulating Systems: Healthcare Provider Letter – Information About Use

08/30/2017 – Dear Health Care Provider Letter – FDA]

AUDIENCE: Surgery, Nursing, Anesthesia

ISSUE: The FDA is reminding health care providers that using thermoregulation devices during surgery, including forced air thermoregulating systems, have been demonstrated to result in less bleeding, faster recovery times, and decreased risk of infection for patients.

The FDA recently became aware that some health care providers and patients may be avoiding the use of forced air thermal regulating systems during surgical procedures due to concerns of a potential increased risk of surgical site infection (e.g., following joint replacement surgery). After a thorough review of available data, the FDA has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection.

Therefore, the FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted. Surgical procedures performed without the use of a thermoregulation system may cause adverse health consequences for patients during the postoperative and recovery process.

The FDA will continue to actively monitor this situation and will update this communication if significant new information becomes available.

BACKGROUND: Forced air thermal regulating systems, also called forced air warmers or forced air warming systems, are devices used to regulate a patient’s temperature during surgical procedures. Forced air thermal regulating systems use an electrical blower to circulate filtered, temperature controlled air through a hose into a blanket placed over or under a patient.

To determine if there is an increased risk of surgical site infection when forced air thermal regulating systems are used during surgery, the FDA collected and analyzed data available to date from several sources, including medical device reports received by the agency, information from manufacturers and hospitals, publicly available medical literature, operating room guidelines, and ventilation requirements.

RECOMMENDATION: FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted. As always, please follow the manufacturer’s instructions for use in the operating room/and or the post-operative environment.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

 

FDA Medical Device Safety Notice

“Official Notice Letter”

 Information about the Use of Forced Air Thermal Regulating Systems – Letter to Health Care Providers

August 30, 2017

Dear Health Care Provider,

The FDA is reminding health care providers that using thermoregulation devices during surgery, including forced air thermoregulating systems, have been demonstrated to result in less bleeding, faster recovery times, and decreased risk of infection for patients.

The FDA recently became aware that some health care providers and patients may be avoiding the use of forced air thermal regulating systems during surgical procedures due to concerns of a potential increased risk of surgical site infection (e.g., following joint replacement surgery). After a thorough review of available data, the FDA has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection.

Therefore, the FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted. Surgical procedures performed without the use of a thermoregulation system may cause adverse health consequences for patients during the postoperative and recovery process.

Forced air thermal regulating systems, also called forced air warmers or forced air warming systems, are devices used to regulate a patient’s temperature during surgical procedures. Forced air thermal regulating systems use an electrical blower to circulate filtered, temperature controlled air through a hose into a blanket placed over or under a patient.

To determine if there is an increased risk of surgical site infection when forced air thermal regulating systems are used during surgery, the FDA collected and analyzed data available to date from several sources, including medical device reports received by the agency, information from manufacturers and hospitals, publicly available medical literature, operating room guidelines, and ventilation requirements

As always, please follow the manufacturer’s instructions for use in the operating room/and or the post-operative environment.

FDA ACTIONS

The FDA will continue to actively monitor this situation and will update this communication if significant new information becomes available.

CONTACT US

If you have questions about this communication, please contact CDRH’s Division of Industry Communication and Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041, or 301-796-7100.

Sincerely,
/s/
William Maisel, MD, MPH
Deputy Center Director for Science
Center for Devices and Radiological Health
U.S. Food and Drug Administration

 

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Parties Nominate 34 Cases for Bellwether Trials in Bair Hugger Litigation

3M and the plaintiffs in the federal litigation over the the company’s Bair Hugger warming blanket have nominated 34 hip infection and knee infection lawsuits for potential bellwether trials (test cases).

The 3M Bair Hugger is used during surgical procedures to regulate a patient’s body temperature. During an operation, a portable heater/blower takes in and warms ambient air, which is then gently forced through a flexible plastic hose into a single-use, disposable blanket.

Currently 1,343 lawsuits are consolidated before U.S. District Judge Joan N. Ericksen in MDL 2666, IN RE: Bair Hugger Forced Air Warming Devices Products Liability Litigation

Pursuant to Pretrial Order No. 17, the plaintiffs and defendants each identified 16 cases from the 150 cases randomly selected by the court on January 5, 2017. There is one overlapping case, making a total of 31 federal Bellwether Nominated cases. Additionally, consistent with the parties’ agreement to include Ramsey County, Minnesota cases, the plaintiffs and defendants each identified two cases from the related Bair Hugger cases filed in Ramsey County, Minnesota, on or before December 19, 2016.

There is one overlapping Ramsey County, Minnesota case, leaving a total of three Ramsey County Bellwether Nominated cases.

Infections following joint replacement surgery

Plaintiffs include patients who developed hip and knee infections following joint replacement surgery that involved use of the forced air warmer system. They assert that the Bair Hugger has a design defect that may cause the surgical site to come into contact with bacteria and other contaminants from the operating room floor. They further charge that the 3M Company has been aware of this risk for years, yet failed to make design changes or issue any warnings to the medical community.

The Bair Hugger system was developed by Arizant Healthcare, Inc., which was acquired by the 3M Company in 2006. Since its introduction in 1987, the apparatus has been adopted as the standard surgical warming system in thousands of hospitals throughout the U.S.

Co-Lead Counsel for Plaintiffs include:

  • Michael V. Ciresi and Jan M. Conlin of Ciresi Conlin LLP in Minneapolis, MN.
  • Ben W. Gordon, Jr. of Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor, Pensacola, FL.
  • Genevieve M. Zimmerman of Meshbesher & Spence, LTD., Minneapolis, MN.

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Federal Court to Select Pool of Bellwether Cases in Bair Hugger MDL

bair-hugger-infectionUS District Judge Joan N. Ericksen said she will randomly select 150 cases for bellwether trials from the 809 actions filed in In Re: Bair Hugger Forced Air Warming Products Liability Litigation – MDL No. 2666 in Minnesota.

Pretrial Order No. 15, issued on November 16, states that the cases will be designated on Dec. 23 from those that were filed in, removed to, or transferred to MDL No. 15-2666 (JNE/FLN) on or before Dec. 19, 2016.

After the parties submit relevant characteristics or categories to be considered, they will each select 16 cases from the pool of 150 for consideration for bellwether trials. Cases can be drawn from those filed in Ramsey County, Minnesota state court.

Deep joint infections

Bellwether nominations must be made by Jan. 20, 2017. Between then are March 1, 2017 the parties may conduct case-specific discovery, including collecting records from third parties. By March 1 the court will select up to eight of the Bair Hugger lawsuits for the final trial pool, with the first trial commencing on Nov. 6.

The 3M Bair Hugger is used during surgical procedures to regulate a patient’s body temperature. During an operation, a portable heater/blower takes in and warms ambient air, which is then gently forced through a flexible plastic hose into a single-use, disposable blanket.

Plaintiffs include patients who developed hip and knee infections following joint replacement surgery that involved use of the forced air warmer system. They assert that the Bair Hugger has a design defect that may cause the surgical site to come into contact with bacteria and other contaminants from the operating room floor. They further charge that the 3M Company has been aware of this risk for years, yet failed to make design changes or issue any warnings to the medical community.

The Bair Hugger system was developed by Arizant Healthcare, Inc., which was acquired by the 3M Company in 2006. Since its introduction in 1987, the apparatus has been adopted as the standard surgical warming system in thousands of hospitals throughout the U.S.

For more information see Court Approves Bair Hugger Plaintiff Fact Sheet and Medical Form.

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Pretrial Conference Set for 800+ Bair Hugger Product Liability Cases

bair-hugger-infectionUS District Judge Joan N. Ericksen set November 17 as the date for the Initial Pretrial Conference in Bair Hugger Forced Air Warming Devices Products Liability Litigation consolidated in MDL 2666 in Minneapolis.

Since the Judicial Panel on Multidistrict Litigation (“JPML”) created the multi-district litigation docket on December 11, 2015 in the District of Minnesota, the caseload has ballooned from 200 lawsuits to 809 today.

These cases involve the Bair Hugger Surgical Warming products, which are medical devices used to maintain patients’ normal body temperature and prevent hypothermia during surgery.

Increased risk of infection

Plaintiffs’ counsel argue that peer-reviewed medical literature in international journals such as the Journal of Bone & Joint Surgery reveal problems with forced-air warming devices in general, and demonstrate an increased risk of infection with the Bair Hugger device specifically. The plaintiffs allege they developed infections as a result of the use of the Bair Hugger products and allege causes of action relating to the product’s design, development, manufacture, testing, regulatory approval process, and marketing. Plaintiffs further allege 3M Company and Arizant Healthcare, Inc. have fraudulently and intentionally concealed knowledge about the dangers associated with

The plaintiffs allege they developed infections as a result of the use of the Bair Hugger products and allege causes of action relating to the product’s design, development, manufacture, testing, regulatory approval process, and marketing. Plaintiffs further allege 3M Company and Arizant Healthcare, Inc. have fraudulently and intentionally concealed knowledge about the dangers associated with

The plaintiffs allege they developed infections as a result of the use of the Bair Hugger products and allege causes of action relating to the product’s design, development, manufacture, testing, regulatory approval process, and marketing. Plaintiffs further allege 3M Company and Arizant Healthcare, Inc. have fraudulently and intentionally concealed knowledge about the dangers associated with use of these products.

Defendants contend that plaintiffs will never be able to prove that their surgical site infections were caused by the Bair Hugger warming system. Defendants contend that, in each of the studies upon which plaintiffs’ lawyers rely, the authors themselves explicitly acknowledge that their studies do not establish that the Bair Hugger warming system causes surgical site infections. Defendants further respond that, to the contrary, the body of peer-reviewed scientific literature proves that the Bair Hugger warming system is safe and effective in maintaining normal body temperature during surgery. Defendants assert that since the Bair Hugger warming system’s entry into the market more than 25 years ago, it has safely warmed more than 200 million surgical patients.

For more information see Court Approves Bair Hugger Plaintiff Fact Sheet and Medical Form.

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Court Approves Bair Hugger Plaintiff Fact Sheet and Medical Form

bair-hugger-infectionUS District Court Judge Joan N. Ericksen for the District of Minnesota approved a Plaintiff Fact Sheet as well as procedures to use it in 3M Bair Hugger Forced Air Warming Products Liability Litigation — MDL No. 2666, where 700 cases are filed, charging that it causes deep hip and knee infections.

The Sept. 27 order specifies that each plaintiff must serve defendants’ lead counsel electronically with a completed 22-page Fact Sheet and a signed medical authorization within 90 days. New plaintiffs, or those who have their cases transferred to the MDL, also have 90 days after the filing of their complaint/short-form complaint, or completed transfer.

The Judicial Panel on Multidistrict Litigation created the MDL on December 11, 2015, when only 14 cases were pending. The plaintiffs allege that the device is defective in two respects:

  1. The device affects airflow in the operating room, causing bacteria from the operating room floor to be deposited into the surgical site.
  2. The internal airflow paths of the device’s blower can become contaminated with pathogens that can then be expelled into the operating room.

Deep joint infection

The actions present common issues about the development, manufacture, testing, regulatory approval process, and marketing of the Bair Hugger blanket. The plaintiffs developed a deep joint infection after hip or knee implant surgery. 3M is accused of ignoring the flaw for years, and of failing to make design changes or provide appropriate safety warnings to the medical community.

The Bair Hugger surgical warming system was brought to market in 1987 by Arizant Healthcare, Inc., which was acquired by the 3M Company in 2008. For further information, see Study: Contamination Increased 2000x With Bair Hugger Warming Blanket.

Starting in November 2016, the regularly scheduled status conferences shall be held on the third Thursday of each month.

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700 Cases Filed in Bair Hugger Surgery Blanket Product Liability Litigation

bair-hugger-infectionThe US Judicial Panel on Multidistrict Litigation reported that 700 product liability lawsuits have been filed as of Sept. 15 in federal court in Minnesota against 3M Company involving its Bair Hugger forced-air warming blanket used in hip or knee surgery.

The docket is In Re: Bair Hugger Forced Air Warming Products Liability Litigation – MDL No. 2666. It was created in December 2015 when there were only 14 cases pending.

The actions share factual issues arising from allegations that plaintiffs developed serious infections during their orthopedic surgeries due to the introduction of contaminants into their open wounds as a result of the use of a Bair Hugger system.

The plaintiffs allege that the device is defective in two respects:

  1. The device affects airflow in the operating room, causing bacteria from the operating room floor to be deposited into the surgical site.
  2. The internal airflow paths of the device’s blower can become contaminated with pathogens that can then be expelled into the operating room.

Deep joint infection

The actions present common issues concerning the development, manufacture, testing, regulatory approval process, and marketing of the Bair Hugger blanket. The plaintiffs developed a deep joint infection after hip or knee implant surgery. 3M is accused of ignoring the flaw for years, and of failing to make design changes or provide appropriate safety warnings to the medical community.

The Bair Hugger surgical warming system was brought to market in 1987 by Arizant Healthcare, Inc., which was acquired by the 3M Company in 2008. For further information, see Study: Contamination Increased 2000x With Bair Hugger Warming Blanket.

In pretrial order No. 13 on Sept. 9 the court set out an amended scheduling order governing discovery, proposals for short form complaints and plaintiff fact sheets, and setting the first bellwether trial for November 6, 2017. The next status conference will be held on October 13, 2016. Starting in November 2016, the regularly scheduled status conferences shall be held on the third Thursday of each month.

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Bair Hugger Blankets Made by 3M May Increase Risk of Infection

By Kay Van Wey, Board Certified in Personal Injury Trial Law by the Texas Board of Legal Specialization

Kay Van Wey
Attorney Kay Van Wey

There is concern in the medical community about Bair Hugger® Therapy used during surgeries involving implants because these surgeries often carry a high risk of contamination. According to multiple studies, the forced-air warming systems could possibly carry a higher risk for contaminating surgical sites than other warming methods.

Litigation against 3M has been consolidated in Bair Hugger – MDL 15-2666 Forced Air Warming Devices Products Liability Litigation.

Bair Hugger Therapy works by using temperature management systems that force warm air throughout to prevent and treat hypothermia in patients during surgery. Hypothermia during surgery can lead to blood loss, infections and prolonged hospital stays.

The blankets were invented by Dr. Scott D. Augustine, and they are sold along with warming units and accessories through his company, Augustine Biomedical and Design. Bair Hugger® Therapy is used on more than 180 million patients since being introduced in 1988. More than 80 percent of hospitals in the United States use them today.

Dr. Augustine now states that the blankets should not be used in patients who have had implants (including knee and hip implants and artificial heart valves) because they can potentially spread bacteria linked to infections.

FDA Not Recalled Bair Hugger® Blankets

The FDA still hasn’t issued a recall of these medical devices even though many adverse effects have been reported to them. Most reports involve burns from prolonged exposure to heat during surgery or cold air blowing during surgery when the device malfunctioned.

Patients who have developed an infection after surgery that involved the use of Bair Hugger® Therapy have filed lawsuits against the manufacturers, claiming they knew about the risk and attempted to conceal evidence. Compensation for damages, medical expenses, pain and suffering, lost wages and punitive damages could be awarded.

 

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3M Lawyers Intimidate Bloggers who Report about Bair Hugger Surgical Blankets

bair-hugger-infectionIn an effort to stifle free discussion about the Bair Hugger surgical blanket, attorneys for 3M are sending threatening takedown demands to bloggers who write about the litigation involving the medical device.

There are so many product liability cases against 3M, maker of the blanket, that the federal courts created MDL 2666 (multi-district litigation docket) in US District Court in Minnesota. The cases charge 3M with wrongful conduct in designing, manufacturing, and marketing a defective product.

More than 50,000 Bair Hugger units are currently in use across the country. About 217 Bair Hugger lawsuits are now pending in the MDL, all filed by hip and knee replacement patients who allegedly developed serious post-operative deep joint infections due to the use of the forced air warming blanket during their surgery.

Promoting a defective product?

For example, according to the lawsuit Tracy Adams Crawford v. 3M Company, CASE 0:15-cv-03777:

The hot air produced by Bair Hugger accumulates under the surgical drape covering the patient and escapes from under the surgical drape below the level of the surgical table or at the head end of the surgical table. This escaped air creates air flow currents that flow against the downward air flow of the operating room. As this warmed air rises, it can deposit bacteria from the floor of the surgical room into the surgical site.

In a June 1997 letter to the Food and Drug Administration (“FDA”), the 3M admitted that “air blown intraoperatively across the surgical wound may result in airborne contamination.” Defendants addressed this flaw in their products by making further misrepresentations to the FDA.

Rather than alter the design of their product or warn physicians of the dangers associated with the Bair Hugger, as numerous studies confirm, Defendants have chosen to “double down” on their efforts to promote their defective product.

Cheap intimidation tactic

Recipients of the 3M letter consider it a cheap intimidation tactic designed to violate free speech rights. The letters say:

We are writing because your organization, through its website and other channels, is making blatantly false advertising claims in an effort to generate leads for attorneys interested in pursuing claims against the 3M™ Bair Hugger™ patient warming blanket. These advertisements are damaging the goodwill and reputation of our client.

These claims violate various state and federal laws, including the Lanham Act; Section 5 of the FTC Act; state and common law product disparagement, unfair competition, and consumer protection laws; and attorney advertising ethics regulations.

Therefore, we hereby demand that your organization immediately cease sponsoring these advertising claims, and any others that make false or misleading claims about the Bair Hugger system.

Despite the mounting litigation, 3M argues, “there are numerous studies confirming the safety of the Bair Hugger system and its effectiveness in reducing surgical bleeding, decreasing post-operative heart attacks, reducing the risk of infection, shortening the recovery time, and improving patient comfort.”

Attorneys who have a client who was injured by a Bair Hugger blanket may find sample product liability complaints online at Mass Tort Nexus.

For further reading see Study: Contamination Increased 2000x With Bair Hugger Warming

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Study: Contamination Increased 2000x With Bair Hugger Warming Blanket

bair-hugger-infectionBy Susan Schaefer

The use of Bair Hugger forced-air warmers during surgery creates convection currents that capture particles below the surgical table, lifting them into the sterile surgical field, according to research recently published by orthopedic surgeons. The waste heat radiating through the surgical drape induced the formation of tornado-like vortexes of rapidly spinning air near the surgical site. The vortexes sucked contaminated air from the operating room floor and deposited it over the surgical wound.

2,000 times more contaminant particles were found in the air over the wound with Bair Hugger warming than with air-free HotDog conductive warming. With HotDog patient warming, only 1,000 particles per cubic meter of air were present. With Bair Hugger warming, the particle count was 2,174,000 per cubic meter, an increase of 217,300%.

Torso-style disposable blankets

Concerned by convection currents produced by hot-air warming devices, orthopedic surgeons A.J. Legg and A.J. Hamer from Northern General Hospital in Sheffield, United Kingdom, compared the torso-style disposable blankets of 3M’s Bair Hugger system with the reusable, air-free HotDog conductive warming system. The surgeons released particles below the surgical table and then measured how many were transported to the surgical site. Neither surgeon has any financial relationship with either of the products studied.

The study was published in the February issue of The Bone and Joint Journal and entitled “Forced-air patient warming blankets disrupt unidirectional airflow.”

Dr. Scott Augustine, inventor of both products studied, stated, “Such a massive increase in airborne contamination is obviously a safety issue in contamination-sensitive surgeries. In joint replacement surgery, for example, a single airborne bacterium can cause a deep joint infection.”

Periprosethetic joint infections are often catastrophic: immense pain and suffering, permanent disability and an enormous cost to the hospital.

“Every joint infection is a disaster—both for the patient and the system,” said Dr. Augustine. “The process is horrific: ex-plant the joint, prolonged hospitalization, 6-8 weeks of IV antibiotics and then—assuming no amputation—re-implant the joint. The average cost is around $100,000.” More than 12,000 of these infections occur each year in the US, a rate that some see as a significant public health problem.

A study conducted by other orthopedic surgeons and published in November 2011 in the Journal of Bone & Joint Surgery positively linked Bair Hugger warming to increased joint replacement infections. The surgeons showed that their deep joint infection rate dropped 74% when Bair Hugger warming was discontinued.

“While Bair Hugger has served most surgical patients well for the past 25 years,” said Dr. Augustine, “these two studies along with three others recently published clearly show that hot-air warming has unintended consequences and should never be used during total joint replacement surgery. Contamination of the sterile surgical field is a serious risk to patient safety.”

The BJJ article follows several other recently published, peer-reviewed studies in the Journal of Bone & Joint Surgery (Br), the American Journal of Infection Control, Anaesthesia, Orthopedic Review and Anaesthesia & Analgesia relating to the potential contamination of surgical sites by forced-air warming devices.
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The BJJ study may be found at http://www.bjj.boneandjoint.org.uk/content/95-B/3/407.short?rss=1&cited-by=yes&legid=jbjsbr;95-B/3/407&related-urls=yes&legid=jbjsbr;95-B/3/407.

Citations to other studies mentioned in this article:

Albrecht M, Leaper D et al. Forced-air warming blowers: An evaluation of filtration adequacy and airborne contamination emissions in the operating room. Am J Infect Control 2011;39:321-8.

Leaper D et al. Forced-air warming: a source of airborne contamination in the operating room? Orthopedic Rev. 2009;1(2):e28.

McGovern et al. Forced-air warming and ultra-clean ventilation do not mix. J Bone and Joint Surg-Br. 2011;93(11):1537-1544.

Legg et al. Do forced air patient-warming devices disrupt unidirectional downward airflow? J Bone and Joint Surg-Br. 2012;94-B:254-6.

Belani et al. Patient warming excess heat: The effects on orthopedic operating room ventilation     performance. Anesthesia & Analgesia July 2012 (prepublished online).

Dasari et al. Effect of forced air warming on the performance of operating theatre laminar flow ventilation. Anaesthesia 2012;67:244-249.

 

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