Date: Fri, 12 Jul 2002 11:32:25 -0500

Subject: Re-use of external fixator components

I know we have visited this issue before, but I have a company rep trying to scare my hospital into a policy of single use for ex fix clamps, even if they ve only been on a week as a temporary fixator. Does anyone know of any law or FDA rule or regulation, or any case law that clearly requires single use only of ex fix components ( not pins or wires, of course)? With Federal Register citation, or case law reference, please.

Jeff

Jeffrey O. Anglen MD FACS
Chief, Orthopaedic Trauma Service
Columbia, MO

Date: Fri, 12 Jul 2002 12:51:59 -0400

From: cbjhome

No I do not. The only problem with multiple uses is charges or billing. Since the device is not "new" you must charge a rental fee, not a purchase fee. I have gone over this in depth with the hospital without problems.

Cliff Jones

Date: Fri, 12 Jul 2002 16:57:46 +0000

From: b.meinhard

Texas Sw presented a study at the OTA a couple of years ago and they had been recycling ex fix products (not pins) and had no failures or problems in over 5 years. We have been doing the same and recently have begun usng a reprocesing company "Vanguard ", which saves us over 1 million $ each year. They inspect and sterile reprocess these items and others as well. Their liability coverage is $24 million per event and they have never had a claim. They charge 50% the cost of a new item to the hospital, and if the item cannot be reprocessed, it is discarded.

bpm

Date: Fri, 12 Jul 2002 13:32:35 -0400

From: Keith, Erin

The answer is it depends on the originally cleared labeling for the ex fix clamps. If the device was cleared for marketing as a single use only device then the use of the ex fix clamp in this case falls into the area of reprocessing single use devices. The FDA does regulate this.  There is information regarding Reuse of Single Use devices and Reprocessor (third party and hospital) requirements on the FDA (Center for Medical Devices and Radiological Health) website. Go to www.fda.gov/cdrh. When you are there select the topic index. Choose the letter "R" scroll down to "Reuse" Hope this helps.

Erin Keith
Materials Engineer
Orthopedic, Physical Medicine and Anesthesiology Devices Branch
DOE III
Office of Compliance
Center for Devices and Radiological Health
US Food and Drug Administration

Date: Fri, 12 Jul 2002 12:50:13 -0500

From: Anglen, Jeffrey

Thanks, there is a lot of information there and it is helpful, but I cannot find anything specific about external fixation components. A lot of the policies about single use devices seem inane when applied to an external fixator bar to bar clamp that may have been in place a couple days. Surely the FDA didnt mean to include these components in this policy just because the company decides (for profit reasons) to label their product single use only? This would bankrupt some already tenuous trauma hospitals, at a time when trauma centers are still closing and there are many areas without trauma center care because of financial problems. How would we go about seeking a clarification with regard to specific devices or situations?

Jeff

Jeffrey O. Anglen MD FACS
Chief, Orthopaedic Trauma Service
Columbia, MO

Date: Fri, 12 Jul 2002 14:08:17 -0400

From: Benedetti Gary E LtCol 74 MDOS/SGOSO

I don't know if my two sense will help, but.....

Agovernment lawyer once told me that a surgeon, based upon one's medical judgment that it is safe and effective, can use products in an "off-label" manner on-in patients; however, the physician assumes a greater liability if there are problems with the "off label" use. But you know how government lawyers are......

Regards,

Gary E. Benedetti, LtCol, USAF, MC, FS
Orthopaedic Trauma Surgery

Date: Fri, 12 Jul 2002 18:32:53 -0400

From: Brian McCardel MD

Doug Dirschl, now at Oregon, has written and presented extensively on this topic (e.g. OTA 96). He would be a good resource for you.

BRM

Date: Sat, 13 Jul 2002 00:23:19 -0400

From: William Obremsky

Jeff,

Doug Dirschl's article is in J of Trauma 11:471,1997. It dealt w/ cost issues and mechanics of re-use. We wrote another article that has been accepted to J. Ortho Trauma that looks at mechanical wear of the clamps. I have not looked at the data in awhile , the lab and photographic analyis showed no significant wear w/ 3 uses of the clamps. More than that showed increased wear. I could send you the article if you want.

Bill Obremskey