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Posts Tagged ‘medical gas’

Making Sense Of DOT & FDA Regulations

Tuesday, May 22nd, 2012

Making Sense of FDA & DOT RegulationsRegulations can be not only hard to keep track of, but hard to make sense of at times, whether it’s FDA medical gas regulations, DOT driver regs, OSHA or other standards. Thankfully for GAWDA members, the association has enlisted its consultants to help simplify this Sisyphean task.

Yesterday, two of GAWDA’s consultants delivered a regulatory update for members. Rick Schweitzer, Government Affairs, Human Resources & Legal Consultant, updated members on the latest driver regulations, including hours of service, EOBRs and the Certified Medical Examiners Registry.

There seem to be quite a few regulations up in the air as it relates to drivers in the gases and welding industry. One such issue is the tank vehicle definition. FMCSA quietly redefined its definition of tank vehicle in a way that would have required distributors hauling cylinders or tanks above a certain quantity to obtain a tank vehicle endorsement, even if the trucks are not carrying hazardous materials. With the rule having faced a great deal of criticism, Schweitzer reports that FMCSA will reconsider the tank definition. There’s only one problem. Several states have already started enforcing the new definition (they were not required to enforce it until 2014), creating confusion and an additional burden. It may be within their right, but is it fair for states to enforce a rule that’s under review?

There’s also quite a bit of regulatory anticipation on the medical gas side, as reported by FDA, Medical Gases and Specialty Gas Consultant Tom Badstubner. As I’ve mentioned in previous posts, there have been discussions about whether medical gases should be regulated differently than other drugs. But aside from the regulatory uncertainty of medical gases, distributors of food-grade gases face an increasingly uphill terrain. As Badstubner explained, food gas distributors are now being looked at as food producers, and as such, are inspected as though they ran a bakery. This means distributors may need to keep logs of cleanliness and check for infestations much like a bakery.

I’m only skimming the surface of the regulatory issues at hand. As Schweitzer and Badstubner pointed out, part of members dues’ pays for access to the consultants. So if you have regulatory questions, they are a great resource. GAWDA’s consultants also each write a regular column in Welding & Gases Today, which are all available online. Find answers to your regulatory questions in the Consultants’ Corner Archive.

GAWDA Gives Medical Gas Act A Push

Friday, May 11th, 2012
Medical Oxygen

More than a million patients in the U.S. use medical gases like oxygen every day.

Over the past week, GAWDA members rallied to provide some additional support to the Medical Gas Safety Act. In the past, I wrote about the congressional hearing on medical gas and the Medical Gas Safety Act. The problem facing the industry is that medical oxygen, nitrogen and other medical gases are subject to the same regulations as pharmaceutical drugs, despite having very distinct manufacturing processes. There are also issues with the FDA requiring an approval process for medical gases as drugs.

GAWDA Medical Gas Consultant Tom Badstubner explains that the proposed Medical Gas Safety Act would approve medical gases as drugs and provide exemption from user fees. The bill would require FDA to work with the industry to modify the existing regulations to address the differences between medical gases and traditional drugs.

To help the medical gas industry’s cause, GAWDA sent letters to members of Congress and the Senate with the names of 185 GAWDA members who stepped up to support the message on short notice. The letter to Chairman Fred Upton and Ranking Member Henry Waxman explains, “The unique manufacturing and distribution process for medical gases is distinct from any other class of drug products and does not fit well into the current Food and Drug Administration (FDA) regulatory process. For example, the use of expiration dating may be appropriate for other pharmaceuticals but unnecessary and likely costly for medical gases like oxygen, whose effectiveness does not expire with time.”

Within the next few months, the bill (formally H.R. 2227) will be voted on in both houses. On May 10, the House Energy & Commerce Committee voted 46 to 0 to send the legislation to the full House for a vote. The Senate Committee on Health, Education, Labor and Pensions previously voted to send the bill to the Senate floor.

Badstubner says there are some hurdles ahead, but it is looking more and more likely that the initiative will succeed. Great work to the GAWDA members who stepped up to support the message to Congress and the Senate. This is a perfect reminder of the importance of an association to bring industry members together to respond quickly to issues that can have a long-lasting impact on everyone.

Congress Talks About Medical Gases

Friday, March 9th, 2012
Congressional Hearing on Medical Gases

LifeGas President Michael Walsh testifies before Congress.

If you are a follower of mine on Twitter, you may have noticed that there was a Congressional hearing about medical gas regulations on Thursday, March 8. Among the many issues discussed were the regulatory challenges facing medical gas manufacturers and distributors. The underlying problem is that medical gases like oxygen, nitrogen and carbon dioxide are currently subject to the same regulations as pharmaceutical drugs, despite entirely different manufacturing distribution processes. Many in the gas industry believe that FDA needs to develop regulations that are targeted at medical gases specifically.

The industry has made a lot of progress on this front recently, as evidenced by the proposed Medical Gas Safety Act (HR 2227), introduced by Rep. Lance and cosponsored by members from both sides of the political aisle. The Congressional hearing was another step forward, as the industry was given a forum to plead its case. The Compressed Gas Association was represented by LifeGas president Michael Walsh.

In watching the hearing, I was shocked to learn that gases like oxygen are considered “unapproved drugs” in some venues. The problem, as Walsh explained, is that many customers are scared off by the “unapproved” label, causing them to cancel orders. The Medical Gas Safety Act would help resolve this by creating a process for medical gases to gain approval.

Another issue is expiration dates, which some government agencies attempt to enforce on medical gases. Walsh says, “Oxygen is an element of the periodic table. By its basic properties it will never expire.” Overall, Walsh was extremely well spoken. Let’s hope Congress and the FDA agree. You can read Walsh’s initial testimony here, or view the discussion in the video below.

From here, the next step for CGA is lobbying to have the Medical Gas Safety Act included with the Prescription Drug user Fee Act (PDUFA). At this point, there is a chance that FDA could attempt to block this effort, but there is hope. Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at FDA, also testified at the hearing. Dr. Woodcock said the FDA would be willing to work with CGA and industry manufacturers to come to a mutually beneficial solution. We’ll see what happens from here.

What do you think: Should the FDA adopt separate regulations for medical gases? How is your business affected by the current lack of specific medical gas regulations?

If you missed the Twitter chat yesterday, you can catch up by checking out hash tag #medicalgas.

View the Congressional hearing below or watch it on YouTube. It’s kind of a long one, but worth watching the discussions about medical gas.

Proof That Economic Recovery Is Here

Tuesday, October 5th, 2010

On Monday, I attended an economic trends webinar called “Recovery—Are We There Yet?” presented by Jeff Dietrich, an economist with the Institute for Trend Research. He offered encouraging news about the direction of the economy over the next year. Perhaps most important, he says we are not headed for a double-dip recession, or a W-shaped recession. The recovery may not be quick, but it is actively happening.

Also of note, Dietrich says medical equipment and supplies production is one of the strongest sectors the U.S. economy. This is good news if you supply medical oxygen and other gases. While U.S. industrial production rates dipped to around -14% year-over-year at the worst part of the recession, medical production never went below 0%. He projects a 4.5% increase for 2011.

Medical Equipment & Supplies Production
More good news: customers have money to spend. The problem is they are cautious about spending it. Through the recession, customers have been stashing their money, building their personal savings up to record levels. During normal economic levels, Americans keep somewhere around $250-300 billion in their personal savings. Through the recession, personal savings hit levels upwards of $900 billion, and they currently rest at $650 billion. Dietrich says an additional $4 trillion is available in credit cards and home equity line of credit loans. This means that as the economy returns to normal levels, customers will have money to spend. That’s good news for all of us.

Personal Savings

World Cup: Is the Oxygen Working?

Tuesday, June 15th, 2010

As you watch the world cup matches, I hope you are keeping an eye on the teams that used oxygen masks, chambers and tents in their preparations (See entry: Can Oxygen Spur World Cup Success?). The players are saying the altitude is negatively affecting their endurance, so the question is whether these preparations have made any difference. The big litmus test was England (oxygen user) vs. USA (non-oxygen user). At first glance, you might think the oxygen was a non-factor. If anything, England under-performed against the US squad. The 1-1 score line certainly suggests there was no difference.

Upon closer inspection, though, I would argue in favor of the oxygen. The US team started slow and England took advantage, scoring in the 4th minute! Using oxygen masks was all about adapting to the high altitude. Whether it was because of the thin air, the US certainly needed more time to get accustomed.

At the end of the game, England looked fresher than the US, who had several players dragging. The oxygen may have played a part in their conditioning, and there is little question that England was in better condition as a team.

The other two teams that made news with their use of oxygen chambers are Japan and Korea. And guess what? Both teams won their opening matches. Japan beat Cameroon 1-0, while the Korea Republic defeated Greece 2-0.

As the tournament wears on, I suspect the oxygen will have less impact as teams grow accustomed to the thin air. But for now, the damage is done. What could have been a dramatic win for the US is a satisfactory draw, leaving little margin for error. Will someone please send them some oxygen?