COVID-19 FAQ FOR HEALTHCARE PROFESSIONALS
SynchroMed™ II Targeted Drug Delivery Therapies (ITB, Malignant Pain, Non-Malignant Pain) and COVID-19
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SynchroMed™ II Targeted Drug Delivery Therapies (ITB, Malignant Pain, Non-Malignant Pain) and COVID-19
This resource provides information on questions that Medtronic has received related to targeted drug delivery (TDD) therapies and the COVID-19 pandemic.
Medtronic's product labelling states:
Patients must return to the clinic for refills at the prescribed times. Failure to return for refills at the prescribed times can result in the actual flow rate of the pump being less than expected, resulting in a loss of or change in therapy, which may lead to a return of underlying symptoms, drug withdrawal symptoms, or a clinically significant or fatal drug underdose. Failure to return at the prescribed times can also damage the pump, requiring surgical replacement.
However, the COVID-19 disease has caused many unique situations that can affect the availability of refill drugs and facilities in your area, the ability of the patient to travel, or where the patient is living. The healthcare provider and/or care team should maintain contact with their patients. Consider contacting your patients well in advance of planned refills to identify and mitigate any concerns.
There are options that you can consider:
Contact your Medtronic field representative or refer to the Medtronic TDD websites (see the Additional Resources section of this page). In case of any technical questions, contact our U.S. Patient and Technical Services Team: (800) 707-0933.
In response to COVID-19, Medtronic has created an FAQ webpage for patients.
Note: Changing drug concentration and adjusting other medications are medical management decisions based on the clinical judgement of the physician and discussion with the patient.
If you have questions about programming or maximum refill interval, please contact US Patient and Technical Services Team: (800) 707-0933.
Follow COVID-19 guidelines which can be found on the World Health Organization (WHO) and Center for Disease Control (CDC) websites. There may be additional COVID-19 guidelines or requirements that may be in place from your local authorities.
To clean and disinfect the Communicator for COVID-19:
When cleaning the communicator and USB connector cable, use the following guidelines (per product manual):
Full cleaning instructions can be found in Communicator Guide 8880T2.
Cleaning instructions for the Clinician Programmer/Tablet (per tablet manufacturer, Samsung®*):
Warning: To use the nonsterile programmer system components in a sterile field, place a sterile barrier between the patient and system components to prevent infection. Do not sterilize any components of the programmer system. Sterilization may damage the components.
Samsung®* Customer Service has informed Medtronic that Lysol®* or Clorox®* wipes would be appropriate for cleaning.
The CDC has published guidance to help assess the risk of exposure to COVID-19 for healthcare professionals. One factor for determining risk is close contact with infected patients.4
Medtronic field representatives can provide education and technical support related to TDD therapies. Due to health care licensing laws, Medtronic sales representatives cannot change patient pump infusion settings even with a physician order.
Medtronic field employees, who work with customers in hospital settings, are collaborating with healthcare providers in new ways — like video chat for technical support — to make every effort to reduce exposure to COVID-19. In situations where employees continue to work in clinical settings, we are following the WHO, CDC, and local hospital guidance to prioritize safety while helping doctors, nurses, and patient care teams.
Lioresal®* Intrathecal (baclofen injection) websites (by Saol Therapeutics):
Prialt®* (ziconotide) intrathecal infusion website (by TerSera):
Infumorph®* (morphine sulfate injection) website (by Hikma):
Boxed Warnings for Lioresal®* Intrathecal (baclofen injection), Infumorph®* (morphine sulfate injection) and Prialt®* (ziconotide) (for reference)
Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.
Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at apparent risk (e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information (see WARNINGS).
For more information, including BOXED WARNING, refer to Lioresal Intrathecal (baclofen injection) prescribing information, and the SynchroMed™ II brief statement.
Risks with Neuraxial Administration
Because of the risk of severe adverse reactions when INFUMORPH is administered by the epidural or intrathecal route of administration, patients must be observed in a fully equipped and staffed environment for at least 24 hours after the initial (single) test dose and, as appropriate, for the first several days after catheter implantation [see WARNINGS AND PRECAUTIONS (5.1)].
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of INFUMORPH. Monitor for respiratory depression, especially during initiation of INFUMORPH or following a dose increase. Patients must be observed in a fully equipped and staffed environment for at least 24 hours after each test dose and, as indicated, for the first several days after surgery [see WARNINGS AND PRECAUTIONS (5.2)].
Addiction, Abuse, and Misuse
INFUMORPH exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing INFUMORPH, and monitor all patients regularly for the development of these behaviors and conditions [see WARNINGS AND PRECAUTIONS (5.3)].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of INFUMORPH during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS AND PRECAUTIONS (5.4)].
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see WARNINGS AND PRECAUTIONS (5.5), DRUG INTERACTIONS (7)]
PRIALT is contraindicated in patients with a preexisting history of psychosis. Severe psychiatric symptoms and neurological impairment may occur during treatment with PRIALT. Monitor all patients frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness. Discontinue PRIALT therapy in the event of serious neurological or psychiatric signs or symptoms.
Medtronic and Medtronic logo are trademarks of Medtronic. Third-party trademarks ("®*") belong to their respective owners. All other brands are trademarks of a Medtronic entity.
US Department of Health and Human Services. Waiver or Modification of Requirements Under Section 1135 of the Social Security Act. Public Health Emergency Website. https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx; March 13, 2020. Accessed: April 7, 2020.
Medtronic data on file.
Center of Disease Control and Prevention. Cleaning and Disinfecting your facility. Coronavirus Disease 2019 (COVID-19) website. https://www.cdc.gov/coronavirus/2019-ncov/community/disinfecting-building-facility.html. April 1, 2020. Accessed: April 7, 2020.
Center of Disease Control and Prevention. Interim U.S. Guidance for Risk Assessment and Public Health Management of Healthcare Personnel with Potential Exposure in a Healthcare Setting to Patients with Coronavirus Disease (COVID-19) website. https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html. March 7, 2020. Accessed: April 7, 2020.