Limited Availability of Naloxone Atomization Device

Message Details
Date Sent: 11/04/2016 02:58 PM EDT
Sender: Michigan Health Alert Network
Subject: Limited Availability of Naloxone Atomization Device

Message:
11/4/16​
To: Life Support Agencies, Medical Control Authorities, Hospitals
From: Bureau of EMS, Trauma, and Preparedness
RE: Limited Availability of Naloxone Atomization Device
There is a national supply chain problem in the Mucosal Atomization Devices (MAD®).  These devices are the primary device required for intranasal syringe administration of naloxone (Narcan).  First, there is a recall of specific lots of the devices based on a potential to ineffectively atomize the medication (see attachment).  This could result in a clinically significant under dosing of the medication resulting in ineffective reversal of the opiate overdose (i.e., failure to restore effective respirations).  Second, the manufacturer has suspended production of new devices until the atomization problem can be resolved.  At this time, we have been advised that manufacturing will not resume for another 4-5 weeks.  When delivery of devices will occur remains unknown.  We are unaware of an effective substitute device to permit intranasal syringe administration of naloxone.  
Considering the current opiate crisis, this problem with the device supply chain may have an important impact on EMS operations.  Therefore, the Bureau of EMS, Trauma and Preparedness offers the following recommendations:

1. All responders should constantly be reminded that effective bag-valve-mask ventilation continues to be the preferred initial treatment for opiate overdoses and can be used by BLS responders until ALS arrival.
2. Hospitals should immediately suspend non-EMS use of MAD® devices for non-EMS purposes (e.g., ENT, pediatric sedation/analgesia)
3. Life support agencies, MCAs, and hospitals, should immediately assess inventories of MAD® devices to identify lots that may be subject to the recall.
4. To the extent possible, life support units should have recalled devices replaced with non-recalled devices.
5. Return of recalled MAD® devices should be deferred until the supply chain is reestablished.
6. At this time, it is felt that if a non-recalled MAD® device is not readily available, intranasal administration of naloxone through a recalled MAD® device may be preferable to no administration at all, provided effective ventilatory support is provided.
7. To conserve MAD devices for MFR and BLS agencies, ALS and Limited ALS units and personnel should avoid administering all intranasal medications unless no other option (IM, IV, IO) is available. 
8. Redistribution of MAD® devices from ALS and L-ALS units to MFR and BLS units may be considered, if needed.
9. Consistent with the Naloxone Administration Procedure, MFR and BLS agencies should be reminded to not administer intranasal naloxone when ALS or L-ALS units are likely to arrive within 5 minutes, assuring effective ventilatory support is provided.
10. Preference for non-recalled MAD® devices should be given to MFR and BLS units likely to experience delayed or no access to ALS or L-ALS
11. Naloxone should NOT be delivered by syringe without the use of a MAD® device.
12. Each MCA should coordinate activities between life support agencies and hospitals.

If you have any questions or concerns, please contact Kathy Wahl @ wahlK@michigan.gov. 
 *** This alert is being sent to: Local Public Health EPC, Health Officer and Medical Director, BETP, Regional Epi and Regional Coalitions, EMS, MCAs, Hospitals and Emergency Management ***

​Attachments:

• MS - Teleflex Mucosal Atomization RASMAS letter 2.pdf
• MS - Teleflex Mucosal Atomization RASMAS letter 1.pdf