Drug & Device News

Embattled heart-health device maker Guidant Corp. announced on July 18 that is was voluntarily recalling certain of its pacemakers. A seal within the recalled devices can leak, allowing moisture to affect the electronic circuits. This defect can cause the pacemakers to fail to provide pacing or can cause a rapid heart rate. Other unexpected device behaviors are also possible. The problems may occur without warning and can lead to loss of consciousness as well as possibly heart failure and death. All the devices being recalled were manufactured between Nov. 25, 1997 and Oct. 26, 2000.

As of July 11, Guidant had received reports that 69 pacemakers may have failed because of the leakage. Twenty of the devices were confirmed to have stopped providing pacing output, resulting in loss of consciousness in five patients. Guidant also received reports of two patients who had sustained pacing at a rapid rate. A patient whose device exhibited sustained pacing at a rapid rate was admitted to the hospital and later died. The device problem could not be confirmed as leakage since the device was not returned. Approximately 18,000 of the affected devices remain in service in the United States and an additional 10,000 are in service in other countries.

Baxter Healthcare Recalls Infusion Pumps

Baxter Healthcare Corp. of Deerfield, IL, has initiated a worldwide recall of all models of its Colleague Volumetric Infusion Pumps because they can shut down while delivering critical medication and fluids to patients. Baxter has received six reports of serious injury and three reports of death associated with this shut-down problem. The affected models are: 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, and 2M8163R.

In addition to the shut-down problem, the device may fail in two other ways: 1) Users may inadvertently press the on/off key instead of the start key when attempting to start an infusion; and 2) Disconnecting or connecting the pump from the hospital monitoring system while the pump is powered “on” can result in a failure code, requiring the infusion to be restarted.

JCAHO Warns About Mistakes in Giving Chemo Drug

Patients undergoing chemotherapy to fight leukemia and lymphoma are sometimes accidentally injected with a powerful cancer-fighting drug in an incorrect way that results in death or permanent paralysis, according to an alert issued July 14 by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).

The drug vincristine has been widely and successfully used to treat cancer for many years, but the JCAHO's Sentinel Event Alert patient safety newsletter reports that the drug is sometimes mistakenly administered in the sac around the spinal cord (intrathecal) instead of intravenously. The intrathecal injection of vincristine can be the result of a single error or a series of mistakes in a medication system. These errors have continued to occur despite repeated warnings and extensive labeling requirements and standards.

“This tragedy is so preventable — yet there have been many cases reported in the media of patients being injected with vincristine intrathecally,” said Michael R. Cohen, R.Ph., M.S., Sc.D., president, Institute for Safe Medication Practices, in a statement. “These cases are especially tragic because the patients experience paralysis and a slow and extremely painful deterioration, which in nearly all cases results in death.”

To reduce the risk of “wrong-route” errors involving vincristine, the JCAHO newsletter recommends that health care organizations: 1) Dilute the drug in such volume that it prevents intrathecal administration; 2) Clearly label all vincristine syringes with the warning: “Fatal If Given Intrathecally. For IV Use Only. Do Not Remove Covering Until Moment of Injection;” 3) Prevent intravenous and intrathecal medications from being dispensed or administered at the same time, in the same place; and 4) Have at least two caregivers conduct a “time out” before the patient receives vincristine to independently confirm the correct patient, the correct drug, the correct dose, and the correct route for administering the drug.

Step Taken Toward Approval of Silicone Breast Implants

On July 28, the FDA issued an approvable letter to Mentor Corporation for their application for silicone gel-filled breast implants. Federal law prohibits the government from discussing the specific contents of the letter, but an approvable letter is one of several intermediate steps in the FDA review process of new products. Previously at their April 2005 meeting, the General and Plastic Surgery Devices Advisory Committee voted 7-2 that Mentor's application was “approvable with conditions.” This letter does not mean that the device is approved for marketing in the United States at this time.

FDA Issues Health Advisory for 'Morning After' Pill

The Food and Drug Administration (FDA), which is investigating recently reported serious adverse events associated with mifepristone (trade name Mifeprex', also known as RU-486, or the “Morning After” pill), issued a public health advisory July 19 highlighting the risk of sepsis when undergoing medical abortion using Mifeprex and misoprostol in a manner that is not consistent with the approved labeling. Between Septem-ber 2003 to June 2005, four deaths were blamed on these drugs. The bacteria thought to have caused the fatal infection has been identified in two of the cases. The other two cases are under investigation by the FDA in cooperation with the Centers for Disease Control and Prevention, state and local health departments and the manufacturer of Mifeprex. Doctors are urged to have a higher level of suspicion for sepsis in their patients taking Mifeprex. The FDA, which has of late been accused of “sitting on” information about possible drug dangers, seems to be taking a more open attitude about informing the public and health care community when drug problems occur. Dr. Steven Galson, Acting Director of the FDA's Center for Drug Evaluation and Research, said in a statement released along with the warning about Mifeprex, “The FDA is committed to sharing emerging drug information with the public and we believe it is important to share with healthcare providers and patients the latest serious reports of infection associated with this drug that we have received.”

Guidant Recalls Leaking Pacemakers

Embattled heart-health device maker Guidant Corp. announced on July 18 that is was voluntarily recalling certain of its pacemakers. A seal within the recalled devices can leak, allowing moisture to affect the electronic circuits. This defect can cause the pacemakers to fail to provide pacing or can cause a rapid heart rate. Other unexpected device behaviors are also possible. The problems may occur without warning and can lead to loss of consciousness as well as possibly heart failure and death. All the devices being recalled were manufactured between Nov. 25, 1997 and Oct. 26, 2000.

As of July 11, Guidant had received reports that 69 pacemakers may have failed because of the leakage. Twenty of the devices were confirmed to have stopped providing pacing output, resulting in loss of consciousness in five patients. Guidant also received reports of two patients who had sustained pacing at a rapid rate. A patient whose device exhibited sustained pacing at a rapid rate was admitted to the hospital and later died. The device problem could not be confirmed as leakage since the device was not returned. Approximately 18,000 of the affected devices remain in service in the United States and an additional 10,000 are in service in other countries.

Baxter Healthcare Recalls Infusion Pumps

Baxter Healthcare Corp. of Deerfield, IL, has initiated a worldwide recall of all models of its Colleague Volumetric Infusion Pumps because they can shut down while delivering critical medication and fluids to patients. Baxter has received six reports of serious injury and three reports of death associated with this shut-down problem. The affected models are: 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, and 2M8163R.

In addition to the shut-down problem, the device may fail in two other ways: 1) Users may inadvertently press the on/off key instead of the start key when attempting to start an infusion; and 2) Disconnecting or connecting the pump from the hospital monitoring system while the pump is powered “on” can result in a failure code, requiring the infusion to be restarted.

JCAHO Warns About Mistakes in Giving Chemo Drug

Patients undergoing chemotherapy to fight leukemia and lymphoma are sometimes accidentally injected with a powerful cancer-fighting drug in an incorrect way that results in death or permanent paralysis, according to an alert issued July 14 by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).

The drug vincristine has been widely and successfully used to treat cancer for many years, but the JCAHO's Sentinel Event Alert patient safety newsletter reports that the drug is sometimes mistakenly administered in the sac around the spinal cord (intrathecal) instead of intravenously. The intrathecal injection of vincristine can be the result of a single error or a series of mistakes in a medication system. These errors have continued to occur despite repeated warnings and extensive labeling requirements and standards.

“This tragedy is so preventable — yet there have been many cases reported in the media of patients being injected with vincristine intrathecally,” said Michael R. Cohen, R.Ph., M.S., Sc.D., president, Institute for Safe Medication Practices, in a statement. “These cases are especially tragic because the patients experience paralysis and a slow and extremely painful deterioration, which in nearly all cases results in death.”

To reduce the risk of “wrong-route” errors involving vincristine, the JCAHO newsletter recommends that health care organizations: 1) Dilute the drug in such volume that it prevents intrathecal administration; 2) Clearly label all vincristine syringes with the warning: “Fatal If Given Intrathecally. For IV Use Only. Do Not Remove Covering Until Moment of Injection;” 3) Prevent intravenous and intrathecal medications from being dispensed or administered at the same time, in the same place; and 4) Have at least two caregivers conduct a “time out” before the patient receives vincristine to independently confirm the correct patient, the correct drug, the correct dose, and the correct route for administering the drug.

Step Taken Toward Approval of Silicone Breast Implants

On July 28, the FDA issued an approvable letter to Mentor Corporation for their application for silicone gel-filled breast implants. Federal law prohibits the government from discussing the specific contents of the letter, but an approvable letter is one of several intermediate steps in the FDA review process of new products. Previously at their April 2005 meeting, the General and Plastic Surgery Devices Advisory Committee voted 7-2 that Mentor's application was “approvable with conditions.” This letter does not mean that the device is approved for marketing in the United States at this time.