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Helpful MCN Healthcare Resources
Hospira notified the public of a nationwide recall of seven lots of Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL) to the user level due to a glass defect located on the interior neck of the vial. The defect was identified during a sample inspection where the glass vial contained visible embedded metal particulate. Free-floating metal particulates were also identified in vials upon further analysis.
Injected particulate matter may result in local inflammation, phlebitis, and/or low level allergic response through mechanical disruption of tissue or immune response to the particulate. Additionally possible responses include occluded capillaries and/or granulomatous formation, most likely in the lungs although long term clinically meaningful impact is low if a patient has normal lung function. While extremely rare, embedded stainless steel may put a patient at risk from MRI (strong magnetic field exposure) as particulate, if in the lung, could potentially dislodge and be pulled through tissue.
The affected lots were distributed nationwide to distributors/wholesalers, hospitals and clinics from August 2013 through December 2013. On April 2, 2014, Hospira notified its customers via recall letter that the company had implemented corrective actions to the manufacturing process to prevent recurrence. See the Press Release for a listing of affected lot numbers.
Customers have been advised to check inventory and immediately quarantine any affected product. In addition, customers should inform potential users of this product in their organizations of this notification. Affected product should be returned to Stericycle, which can be contacted at 1-877-272-2158 (M-F, 8 a.m. - 5 p.m. ET).
Read the MedWatch safety alert, including a link to the press release, at the link below.
FDA Issues Safety Communication about Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy
Laparoscopic power morcellators are medical devices used during different types of laparoscopic surgeries. These can include certain procedures to treat uterine fibroids, such as hysterectomy or myomectomy. Morcellation refers to the division of tissue into smaller pieces or fragments and is often used during laparoscopic surgeries to facilitate the removal of tissue through small incision sites.
When used for hysterectomy or myomectomy in women with uterine fibroids, laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus. Health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids. Based on currently available information, the US Food and Drug Administration (FDA) discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.
Recommendations for Health Care Providers:
- Be aware that based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids.
- Do not use laparoscopic uterine power morcellation in women with suspected or known uterine cancer.
- Carefully consider all the available treatment options for women with symptomatic uterine fibroids.
- Thoroughly discuss the benefits and risks of all treatments with patients.
- For individual patients for whom, after a careful benefit-risk evaluation, laparoscopic power morcellation is considered the best therapeutic option:
o Inform patients that their fibroid(s) may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis.
o Be aware that some clinicians and medical institutions now advocate using a specimen "bag" during morcellation in an attempt to contain the uterine tissue and minimize the risk of spread in the abdomen and pelvis.
The FDA has instructed manufacturers of power morcellators used during laparoscopic hysterectomy and myomectomy to review their current product labeling for accurate risk information for patients and providers. Additionally, the FDA will convene a public meeting of the Obstetrics and Gynecological Medical Device Advisory Committee to discuss: 1) the clinical role of laparoscopic power morcellation in the treatment of uterine fibroids, 2) whether surgical techniques and/or use of accessories, such as morcellation/specimen bags, can enhance the safe and effective use of these devices, and 3) whether a "boxed warning" related to the risk of cancer spread should be required for laparoscopic power morcellators.
See the Safety Communication for additional information.
Class I Recall of ARKON Anesthesia Delivery System with Version 2.0 Software by Spacelabs Healthcare
Spacelabs Healthcare is recalling the ARKON Anesthesia System with Version 2.0 Software due to a software defect. This software issue may cause the system to stop working and require manual ventilation of patients. In addition, if a cell phone or other USB device is plugged into one of the four USB ports for charging, this may cause the system to stop working. The Spacelabs ARKON Anesthesia Delivery System is used in hospital operating rooms. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The primary users of this device are qualified physicians.
Serial numbers of units distributed in the U.S. ARKN-000011, ARKN-000016, ARKN-000017, ARKN-000019, ARKN-000020, ARKN-000021, ARKN-000022, ARKN-000023, ARKN-000024, ARKN-000025, ARKN-000026, ARKN-000027, ARKN-000028, ARKN-000029, ARKN-000030, and ARKN-000031
This defect may cause serious adverse health consequences, including hypoxemia and death. Spacelabs Healthcare received one report related to the software defect. Affected products were manufactured and distributed from March 18, 2013 through June 17, 2013. Sixteen units were distributed to hospitals in North Carolina and South Carolina.
Spacelabs Field Service personnel are contacting customers affected by this recall to schedule a free software update installation that may resolve this issue. Until the software updates are installed, Spacelabs Healthcare provided the following recommendations for health care facilities with ARKON Anesthesia Delivery Systems:
- If you continue to use your ARKON Anesthesia System, Spacelabs recommends that you do NOT save spirometry loops until Spacelabs has remedied the software defect. The error is triggered by the combination of a spirometry loop save and a change in waveform configuration.
- Advise users NOT to use the USB ports until after your ARKON software is updated.
- If the error does occur, the user will hear a buzzer and a warning icon will appear on the main display screen. We recommend that the user switch to emergency oxygen and manually ventilate the patient until such time as they can safely remove the system from patient use.
- If you cycle power, the system will reboot in roughly 3 minutes and recover from the above software anomaly and mechanical ventilation can continue.
For questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.
Read the MedWatch Safety Alert at the link below.
Featured Policy Library Manuals
MCN's NEW Ambulatory Surgical Center/Outpatient Surgery Department Policy and Procedure Manual is cross referenced to TJC standards, AAAHC standards and CMS regulations. Policies and procedures meet AORN and CDC recommendations and guidelines. This comprehensive reference guide has over 290 policies and procedures that are ready to customize to your organization. See also the Administrative Manual for Ambulatory Care Facilities and the Ambulatory Services EOC Manual.Read more »
MCN's Central Service Policy and Procedure Manual provides over 200 proven, up-to-date policies and procedures in a ready-to-customize format. This manual is cross referenced to federal regulations, as well as Joint Commission and NIAHO standards. References used include AAMI Recommended Practices, IAHCSMM Central Service Technical Manual, ASHCSP Training Manual for Health Care Central Service Technicians and AORN Recommended Practices.Read more »
MCN's Post Anesthesia Care Policy and Procedure Manual is a comprehensive resource that covers the latest "hot topic" regulatory and patient safety issues that are relevant to PACU! This manual includes administrative, operational, functional and patient-centered policies and procedures. Policies and procedures are cross-referenced to CMS regulations, Joint Commission standards and NIAHO standards.Read more »