Upcoming GAWDA Medical Gas Alert Teleconference on Tuesday, July 15th.

Certain GAWDA members have received an urgent notice from Western Enterprises regarding a recall of their RG3000 and RG4000 Series Valve Integrated Pressure Regulators (VIPRs, Grab-n-Go, etc.). Most units are not affected by this recall. Only the RG3000 and RG4000 units over 10 years old are included in the recall. See the handouts for an exact listing of affected units.

Unfortunately, this is a measure that will require some action on your part if you have supplied any of the affected units to your customers.

We are holding a special teleconference exclusively for GAWDA members to address the following:

• How to decide if this recall affects you
• Review of sample recall procedures you can adopt/revise to fit your situation. We have customized some procedures that will accommodate a device recall such as the Western Enterprises VIPR recall
• Q&A 

In addition, Western Enterprises will have a representative available to directly answer any questions.

If you are affected by this Western Enterprises VIPR recall, consider having someone from your company log onto the teleconference on Tuesday(7/15/14) at 11 AM EDT. The teleconference will be recorded in case this schedule is inconvenient.

Below are sample procedures to download.  The documents will be referenced during the teleconference

1. Recall Notification Supplement
2. Recall Notification Letter

Please contact us (amy@asteriskllc.com) if you would like further information about this notice or the meeting on the 15th. 

7/1/14 - Changes to policies on filling open mouthed dewars

Q – What is the latest information about filling liquid nitrogen in open topped dewars for dermatologists? 

A – This issue has been interpreted in contradictory ways in the past. Recently, the CGA Medical Gases Committee published a position statement about open topped dewars (PS-38-2014, Registration of Facilities Filling Open Topped Medical Nitrogen Dewars For Device Use).

The small open topped container should not contain a medical label but should include a product identification label. The position statement includes other clarifying information about container filling, personnel training and written procedures. The conditions under which you may fill these open topped containers without FDA registration are detailed in the position statement.

If you fill open topped dewars with medical liquid nitrogen, we recommend that you download the position statement from CGANet.com. Of course, this is available at no cost for participating GAWDA members.

The GAWDA Medical Gas SOP’s are being revised to recognize this new industry position.

7/1/14 Micro-Audit

1.    Authorized Procedures – Verify that your SOPs have been authorized in writing by your Quality Control Unit.
2.    Following SOPs – Be sure that your cylinder filling personnel are strictly following the authorized procedures. This is easily accomplished by taking a copy of the cylinder fill procedure to the manifold and watching the operator fill the cylinders.

6/1/14 – NADA Submissions Part 2

Q – What is the latest information regarding New Animal Drug Application (NADA) submissions for drug listings (June 2014)?

A – Since last month, the FDA has revised the animal drug listing procedures to reverse their prior procedures regarding Active Pharmaceutical Ingredients (API’s). You may now submit your drug animal listings is exactly the same manner as your human drug listings. The only differences are that you use the NDA number for human drugs and NADA numbers for animal drugs. You also select the type of drug listing you are submitting… human or animal. 

We recommend that you review and submit your human and animal drug listings to remove the “unapproved medical gas” statement from your online FDA drug listings. The following resources are available on the GAWDA.ORG website:
-    An 18 minute recorded teleconference about how to remove the “unapproved medical gas” statement from your online FDA drug listings: http://www.aws.org/GAWDA/audio/Medical_Gas_Update_20140131.WAV
-    Handouts and sample forms for the recorded teleconference: http://www.gawda.org/uploadedFiles/Site_Framework/Home_Page/FDA_Medical_Gas_Certification_Compliance_Alert_20140131.pdf

If you have any questions about this process or would like us to re-submit your drug listings, please contact amy@asteriskllc.com.

6/1/14 – Micro Audit

1.    Annual Records Review – Verify that you have looked at your records to determine if changes are needed in your medical gas program. This review can be easily completed and documented. Contact Tom if you need a form to document your annual records review.
2.    Electronic Registration and Listing – Be sure your electronic registration and listing is correct. Print out the web pages with your information below to document your compliance:
Facility Registration - http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm
Drug Listing - http://dailymed.nlm.nih.gov/dailymed/search.cfm

5/1/14 - NADA Submissions Part 1

Q – What is the latest information regarding New Animal Drug Application (NADA) submissions for drug listings?

A – The Center for Veterinary Medicine (CVM) has implemented additional validation procedures on medical gas drug listings for animal drugs. The agency believes that listings with NADA numbers should be classified as an Active Pharmaceutical Ingredient (API). We disagree with the Agency’s position and have formally notified the agency of our objections.

The API requirements cause significant disruptions in the listing process for animal drug gases. After resolving this issue with the FDA, we will let you know how to proceed.

Interestingly, this does not seem to affect the human drug listings. We recommend that you continue to re-list your medical gases with the NDA (for humans) number in order to remove the “unapproved medical gas” statement from your drug listings

5/1/14 – Micro Audit

1.    Dead Ring Test – Verify that the dead ring test is actually being performed on high-pressure steel oxygen cylinders. Of course, the dead ring test should not be performed on aluminum cylinders. This simple item has appeared in recent FDA audits.
2.    Certificate of Analysis (CoA) – Be sure that the CoAs you receive for your bulk medical product and for your Servomex span/zero gas cylinders have the following mandatory items:
•    Name and address of the calibration standard supplier
•    Name of the product
•    Lot number or unique identification number specific for each cylinder
•    Analytical methodology used to assay the calibration standard
•    Actual analytical results (for example, 99.9 percent nitrogen)
•    The responsible person’s signature and the date signed

4/1/14 - What are the FDA issues around security?

A – The FDA does not have the same type of security regulations as the DOT. However, there are several security related issues.

Drug Storage
The 2003, Draft Guidance for Industry - Current Good Manufacturing Practice for Medical Gases summarizes the FDA thinking and regulations about medical gas security:

B.    Security

Medical gas manufacturers are wholesale distributors who are subject to the requirements of § 205.50 - Minimum requirements for the storage and handling of prescription drugs and for the establishment and maintenance of prescription drug distribution records.

All facilities used for medical gas distribution must be secure from unauthorized entry (§ 205.50(b)(1)).

Entry into areas where medical gases are held must be limited to authorized personnel (§ 205.50(b)(1)(iii)).  We recommend areas where nitrous oxide is held be especially secure.

The security requirements of § 205.50(b) apply to all facilities used for medical gas distribution.  FDA interprets this regulation to include all facilities where loaded medical gas delivery trucks are parked prior to making deliveries, including at an employee's home when a loaded medical gas delivery truck is driven there and parked overnight for early morning runs.

A manufacturer could use an alarm system to secure the building and keep loading docks secure, rather than open and easily accessible.

Keep in mind that the Draft Guidance does not carry the same authority as the underlying regulations. However, it does represent the last published agency thinking about security and medical gases.

Nitrous Oxide
The FDA does not define “especially secure” storage areas for nitrous oxide. The Compressed Gas Association has published excellent guidelines for storing and securing nitrous oxide. GAWDA members can sign up for free access to these CGA resources. For further details, see:
•    CGA G-8.3, Safe Practices for Storage and Handling of Nitrous Oxide
•    CGA P-50, Site Security Standard
•    CGA P-51, Transportation Security Standard for the Compressed Gas Industry
•    CGA P-52, Security Standard for Qualifying Customers Purchasing Compressed Gases

Though not all items will apply in all cases, consider the following:
•    Inventory control systems to detect theft or loss
•    Access controls
•    Property fencing
•    Secondary fencing for nitrous cylinders and bulk storage
•    Lockout devices to secure valves on bulk storage
•    Security systems, alarms, etc.
•    Procedure to determine if a customer is legitimate

4/1/14 – Micro Audit

1.    Annual Record Review – Verify that you have conducted and documented an annual records review for your medical gas production facility. Contact tom@asteriskllc.com for a sample form to easily document this requirement.

2.    Food Receipts – Be sure that your food gas bulk receipt paperwork documents that you are receiving food or beverage grade product into your bulk tanks which are used to produce food gases (especially CO2 and N2) 
3.    Food Lot Numbers – Be sure you are using lot numbers on food grade gases. You must also have a lot number record of food gas shipments. This lot number record may be kept electronically.

3/1/14 – Unapproved Medical Gas Part 2

Q – Why does my Drug Listing have the “Unapproved Medical Gas” warning statement? How can I remove this statement?
A – Medical gases, like oxygen, have been in use for well over a hundred years…. Even before the creation of the FDA. The FDA has approved many drugs over the years… but the common medical gases were never actually formally approved.
Several years ago, we began to see statements on our medical gas listings that said “unapproved medical gas”. Other safety warnings were also placed on the listings that could have been a concern to consumers. 
 
Just recently, the FDA has established a process to remove these “unapproved” statements and warnings. On January 31, 2014, we conducted an 18-minute teleconference explaining how to remove the “unapproved medical gas” warning statement from your listing. You can get the teleconference handout and sample forms/letter from: http://www.gawda.org/uploadedFiles/Site_Framework/Home_Page/FDA_Medical_Gas_Certification_Compliance_Alert_20140131.pdf

You can also listen to a recording of the consultants teleconference about Medical Gas Certification on the GAWDA home page. You can reach it here: http://www.aws.org/GAWDA/audio/Medical_Gas_Update_20140131.WAV