Drug & Device News

FDA Issues Guidance on Hospital Bed Design

Elderly patients in hospitals and nursing homes are prone to entrapment in their beds, which has resulted in a reported 413 deaths in the past 21 years. To study and combat this problem, the Food and Drug Administration (FDA), Veterans Administration, Health Canada's Medical Devices Bureau and representatives of several other groups formed an organization in 1999 known as the Hospital Bed Safety Workgroup (HBSW). Their recommendations have just recently been published in an FDA final guidance entitled 'Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment.' The final guidance offers suggestions for health care facilities on ways to assess the safety of their existing beds by identifying the locations of hospital bed openings that are potential entrapment areas. It also offers recommendations for how to choose new hospital bed systems. The guidance is available on the FDA's Web site at: http://www.fda.gov/cdrh/beds/.

Wyeth Held Accountable

Pharmaceuticals manufacturer Wyeth announced March 23 that the jury in the trial of four plaintiffs' claims against the company found it liable for harm caused by its diet drugs. The cases, argued in the Philadelphia Court of Common Pleas, led to awards to the plaintiffs in the bifurcated trial of $109,100, $88,700, $90,400 and $104,000. 'We are disappointed in the jury's verdict in this case and believe it was not supported by the evidence presented. In each instance, the only physicians claiming that the plaintiffs have an injury were hired by their lawyers,' said Mike Scott of Reed Smith, the attorney representing Wyeth. 'In the second phase of this case, we will show that Wyeth acted responsibly at all times and should not be held liable for any award to these plaintiffs.'

The company is also winning some cases, however, including two tried in the Philadelphia Court of Common Pleas in which a jury verdict was rendered just days before the four Wyeth case losses were announced.

After Two More Deaths, FDA Renews Warnings on Abortion Pill Use

Danco Laboratories, manufacturer of mifepristone (Mifeprex), the medical abortion pill, notified the FDA in March that it had received reports of two more deaths in conjunction with use of the drug. While neither the manufacturer nor the FDA could say if the deaths were caused by the use of mifepristone, the FDA immediately reminded all providers of medical abortion and their patients that there is a risk of sepsis when using the abortion pill. The signs of distress to look for are nausea, vomiting, or diarrhea and weakness with or without abdominal pain, and without fever or other signs of infection more than 24 hours after taking misoprostol. The agency also strongly recommends that patients showing possible signs of complications receive a complete blood count. Physicians who suspect infection should also consider immediate initiation of antibiotics to include coverage of anaerobic bacteria such as Clostridium sordellii. FDA information about Mifeprex can be found at: http://www.fda.gov/ cder/drug/infopage/mifepristone/default.htm

Tubing and Catheterizing Errors Prompt JCAHO Alert

The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) issued a Sentinel Event Alert on April 3, warning health care providers that tubes and catheters are often being used incorrectly, which can lead to serious injury or death. 'The basic lesson from the reported cases of tubing and catheter misconnection error is that if it can happen, it will happen,' said Dennis S. O'Leary, MD, president of JCAHO. 'Thankfully, many tubing misconnections are caught before the patient is injured, but these errors pose a real threat to patient safety that can be overcome through heightened vigilance and a systematic approach to avoiding misconnections.' The Alert advises health care organizations to: 1) avoid purchasing non-intravenous equipment with tubing connectors that permit connection with intravenous connectors; 2) test new tubing and catheter acquisitions for potential risks; 3) trace tubing from the patient to the point of origin before connecting new devices or infusions; 4) route tubes with different purposes in different (but standardized) directions; 5) make a check on tubes and catheters part of the standard operating procedure when patients are moved to new settings; 6) provide training on the risks of misconnection to personnel; and 7) tell patients and their families to report any concerns about their tubes and catheters to their caregivers. The Alert can be found at: http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_36.htm.

Panel Reports Its Findings to Guidant

The independent panel commissioned internally by Guidant Corp. to review its past handling of defibrillator malfunctions issued its 130+-page report March 21. In it, the group, chaired by Electrophysiologist Dr. Robert J. Myerburg, made several recommendations for change in procedures to the company. Among them are that a physician should be employed who will take primary responsibility for safety and performance issues. This person should also be aided by an external committee of experts who will evaluate product safety and make recommendations to the company when products fail or malfunction. Overall, the report's tone indicated that the panel felt the company had in many ways mismanaged its handling of evidence that its products could fail with catastrophic results. The panel urged Guidant and other similarly-situated device makers to put the needs of patients and doctors ahead of concern for 'the bottom line' by keeping them fully informed. The panel's full report can be viewed at: http://www.guidant. com/panel/panel.pdf.

New Tool Available for Detecting Cervical Pre-Cancer

The LUMA Cervical Imaging System, a system that can help detect a cervical cancer precurser, received FDA approval in March. The diagnostic system is manufactured by Medi-Spectra Inc. of Lexington, MA, and is intended to be used along with colposcopy, a high magnification evaluation of the cervix performed on women who have recently had an abnormal Pap test. MediSpectra's studies of its imaging system showed that it can detect additional cancer precursors missed by colposcopy. Of the 50 cases of pre-cancer detected in the study, colposcopy caught 41 cases of cervical pre-cancer, while LUMA caught the additional 9 cases that colposcopy had missed.

Laparoscopy Burns Make the News

An article in The New York Times shines a spotlight on a little-discussed danger associated with laparoscopic surgery: internal burns from the stray electricity escaping from cracked insulation in the laparoscopy wand. Feder, The New York Times, 10/17/06. The article, which profiles a woman suing her doctor, her hospital and the surgical device maker after she sustained injuries during a gynecological procedure, notes that one company, Encision, markets equipment that monitors for stray electrodes. In response to the publication of the Times article, Jack Serino, President & CEO of Encision, stated, 'We are pleased that Encision's technology to reduce the risk of serious complications from stray energy burns during laparoscopy has received this level of publicity and awareness.'

FDA Issues Guidance on Hospital Bed Design

Elderly patients in hospitals and nursing homes are prone to entrapment in their beds, which has resulted in a reported 413 deaths in the past 21 years. To study and combat this problem, the Food and Drug Administration (FDA), Veterans Administration, Health Canada's Medical Devices Bureau and representatives of several other groups formed an organization in 1999 known as the Hospital Bed Safety Workgroup (HBSW). Their recommendations have just recently been published in an FDA final guidance entitled 'Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment.' The final guidance offers suggestions for health care facilities on ways to assess the safety of their existing beds by identifying the locations of hospital bed openings that are potential entrapment areas. It also offers recommendations for how to choose new hospital bed systems. The guidance is available on the FDA's Web site at: http://www.fda.gov/cdrh/beds/.

Wyeth Held Accountable

Pharmaceuticals manufacturer Wyeth announced March 23 that the jury in the trial of four plaintiffs' claims against the company found it liable for harm caused by its diet drugs. The cases, argued in the Philadelphia Court of Common Pleas, led to awards to the plaintiffs in the bifurcated trial of $109,100, $88,700, $90,400 and $104,000. 'We are disappointed in the jury's verdict in this case and believe it was not supported by the evidence presented. In each instance, the only physicians claiming that the plaintiffs have an injury were hired by their lawyers,' said Mike Scott of Reed Smith, the attorney representing Wyeth. 'In the second phase of this case, we will show that Wyeth acted responsibly at all times and should not be held liable for any award to these plaintiffs.'

The company is also winning some cases, however, including two tried in the Philadelphia Court of Common Pleas in which a jury verdict was rendered just days before the four Wyeth case losses were announced.

After Two More Deaths, FDA Renews Warnings on Abortion Pill Use

Danco Laboratories, manufacturer of mifepristone (Mifeprex), the medical abortion pill, notified the FDA in March that it had received reports of two more deaths in conjunction with use of the drug. While neither the manufacturer nor the FDA could say if the deaths were caused by the use of mifepristone, the FDA immediately reminded all providers of medical abortion and their patients that there is a risk of sepsis when using the abortion pill. The signs of distress to look for are nausea, vomiting, or diarrhea and weakness with or without abdominal pain, and without fever or other signs of infection more than 24 hours after taking misoprostol. The agency also strongly recommends that patients showing possible signs of complications receive a complete blood count. Physicians who suspect infection should also consider immediate initiation of antibiotics to include coverage of anaerobic bacteria such as Clostridium sordellii. FDA information about Mifeprex can be found at: http://www.fda.gov/ cder/drug/infopage/mifepristone/default.htm

Tubing and Catheterizing Errors Prompt JCAHO Alert

The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) issued a Sentinel Event Alert on April 3, warning health care providers that tubes and catheters are often being used incorrectly, which can lead to serious injury or death. 'The basic lesson from the reported cases of tubing and catheter misconnection error is that if it can happen, it will happen,' said Dennis S. O'Leary, MD, president of JCAHO. 'Thankfully, many tubing misconnections are caught before the patient is injured, but these errors pose a real threat to patient safety that can be overcome through heightened vigilance and a systematic approach to avoiding misconnections.' The Alert advises health care organizations to: 1) avoid purchasing non-intravenous equipment with tubing connectors that permit connection with intravenous connectors; 2) test new tubing and catheter acquisitions for potential risks; 3) trace tubing from the patient to the point of origin before connecting new devices or infusions; 4) route tubes with different purposes in different (but standardized) directions; 5) make a check on tubes and catheters part of the standard operating procedure when patients are moved to new settings; 6) provide training on the risks of misconnection to personnel; and 7) tell patients and their families to report any concerns about their tubes and catheters to their caregivers. The Alert can be found at: http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_36.htm.

Panel Reports Its Findings to Guidant

The independent panel commissioned internally by Guidant Corp. to review its past handling of defibrillator malfunctions issued its 130+-page report March 21. In it, the group, chaired by Electrophysiologist Dr. Robert J. Myerburg, made several recommendations for change in procedures to the company. Among them are that a physician should be employed who will take primary responsibility for safety and performance issues. This person should also be aided by an external committee of experts who will evaluate product safety and make recommendations to the company when products fail or malfunction. Overall, the report's tone indicated that the panel felt the company had in many ways mismanaged its handling of evidence that its products could fail with catastrophic results. The panel urged Guidant and other similarly-situated device makers to put the needs of patients and doctors ahead of concern for 'the bottom line' by keeping them fully informed. The panel's full report can be viewed at: http://www.guidant. com/panel/panel.pdf.

New Tool Available for Detecting Cervical Pre-Cancer

The LUMA Cervical Imaging System, a system that can help detect a cervical cancer precurser, received FDA approval in March. The diagnostic system is manufactured by Medi-Spectra Inc. of Lexington, MA, and is intended to be used along with colposcopy, a high magnification evaluation of the cervix performed on women who have recently had an abnormal Pap test. MediSpectra's studies of its imaging system showed that it can detect additional cancer precursors missed by colposcopy. Of the 50 cases of pre-cancer detected in the study, colposcopy caught 41 cases of cervical pre-cancer, while LUMA caught the additional 9 cases that colposcopy had missed.

Laparoscopy Burns Make the News

An article in The New York Times shines a spotlight on a little-discussed danger associated with laparoscopic surgery: internal burns from the stray electricity escaping from cracked insulation in the laparoscopy wand. Feder, The New York Times, 10/17/06. The article, which profiles a woman suing her doctor, her hospital and the surgical device maker after she sustained injuries during a gynecological procedure, notes that one company, Encision, markets equipment that monitors for stray electrodes. In response to the publication of the Times article, Jack Serino, President & CEO of Encision, stated, 'We are pleased that Encision's technology to reduce the risk of serious complications from stray energy burns during laparoscopy has received this level of publicity and awareness.'