Renasys recall

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Anonymous said:
WOCN here...have been following the latest talk regarding the Renasys because I placed one of these on a patient only to find out afterwards about the FDA hoopla. This site, thank you very much, actually helped me when I went back to my office to try to find some information. I then called the company to ask why the product was being distributed despite the FDA order and got the run around. I was not pleased. The company has a DUTY to inform consumers of this action and not try to let the vacs slide by. The rep did not think it was an issue and had to be reminded about the "no distribution" statement. Since I applied the vac that makes ME liable as well which quite frankly pisses me off. Very irresponsible business practice. Fortunately, I was able to get back to the pt and remove the device. Incidentally, if this is the new and improved Renasys keep it, it's a piece of crap. This is a coming from a person who has had to apply NUMEROUS vac dressings and no I don't work for KCI.
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The Renasys is fine. There is nothing to worry about. It's all under control. Just use the Renasys and it will heal just like it always has before.
 








Anonymous said:
The Renasys is fine. There is nothing to worry about. It's all under control. Just use the Renasys and it will heal just like it always has before.
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"Fine" doesn't cut it. I wouldn't want the product placed on myself based on the comment, "The Renasys is fine" which implies maybe a middle of the road product. I bet if you were a patient with a large abdominal wound you'd want a top product not a fine product.
 








Anonymous said:
"Fine" doesn't cut it. I wouldn't want the product placed on myself based on the comment, "The Renasys is fine" which implies maybe a middle of the road product. I bet if you were a patient with a large abdominal wound you'd want a top product not a fine product.
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Well it's just fine for other hospitals. Maybe you are snobby.
 








Anonymous said:
yes, i got the letter and my customers are extremely angry. In case you did not see the letter, here you go.

June 20, 2014

Dear Valued Customer,

As a Smith & Nephew Negative Pressure Wound Therapy (NPWT) customer, I am writing to advise you that the FDA has requested Smith & Nephew to cease US commercial distribution and promotion of our RENASYS* systems until the company receives appropriate regulatory clearances or authorization to resume distribution.

In late 2013 we introduced a number of enhancements to the RENASYS NPWT Systems, responding to the needs of our customers. These improvements were implemented in line with our understanding of FDA regulations governing product enhancements. However, the FDA has recently notified Smith & Nephew that the product enhancements require premarket notification 510(k) and requested us to cease US commercial distribution until this matter is resolved.

Accordingly, Smith & Nephew has ceased shipping affected RENASYS products to customers. We do not believe that there are any risks associated with the continued use of RENASYS systems for those patients currently using these devices. We are working cooperatively with the FDA to address its concerns in order to resume distribution of RENASYS products as soon as possible.

We apologize for the disruption caused and want to reassure you that we remain committed to patient safety, the efficacy of our products and developing NPWT products that reduce the human and economic cost of wounds.

The distribution hold affects RENASYS systems. The PICO* Single Use NPWT systems are not affected.

If you have additional questions or concerns, please contact Smith & Nephew Customer Care Center at 1-800-876-1261.

Regards,

Francois Fournier
President, North American Advanced Wound Management

Smith & Nephew, Inc.
970 Lake Carillon, Suite 110
St. Petersburg, FL 33716
Customer Care Center
1-800-876-1261
www.smith-nephew.com
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Well Mr Fournier should now by now that all this spin doesn't pay!!!! No mention of the quality control, adverse events that the FDA took issue with! Yeah right Franswaa, BON D'EBARRAS
D'EGOUTED EMPLOYEE
 








































Anonymous said:
What is going to happen??? I need to know if I should take another job? Why the long wait???
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I would not hesitate to take another job. I worked with SNN NPWT for a few years and there is a serious mismanagement issue in upper management. I understand changing the pumps and kits to meet better serve your customers but to not file a 510k for the modifications is a serious issue. Plus you are constantly defending your product in the accounts you do have on a daily basis.

SNN managed to loose almost all their NPWT customers in about 4 weeks after the FDA restricted promotion and distribution. Major accounts like Banner health, Dignity health, and Kaiser. They managed to sink multimillion a year NPWT division in 4 weeks.

Another serious issue is the lack of home care distribution with Apria no longer supporting SNN renasys for patient discharges.

Even if they resolve the numerous issues cited by the FDA and resume distribution of renasys it won't matter because the damage is done to SNN NPWT reputation. People buy from reps and companies they trust.
 
































Anonymous said:
I would not hesitate to take another job. I worked with SNN NPWT for a few years and there is a serious mismanagement issue in upper management. I understand changing the pumps and kits to meet better serve your customers but to not file a 510k for the modifications is a serious issue. Plus you are constantly defending your product in the accounts you do have on a daily basis.

SNN managed to loose almost all their NPWT customers in about 4 weeks after the FDA restricted promotion and distribution. Major accounts like Banner health, Dignity health, and Kaiser. They managed to sink multimillion a year NPWT division in 4 weeks.

Another serious issue is the lack of home care distribution with Apria no longer supporting SNN renasys for patient discharges.

Even if they resolve the numerous issues cited by the FDA and resume distribution of renasys it won't matter because the damage is done to SNN NPWT reputation. People buy from reps and companies they trust.
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I wouldn't be too surprised if they pulled out of the US market altogether
 








I just want to thank everyone for the info in this thread. I was debating on taking a job in this division until I read all of this. Looks like I'll be looking elsewhere. Good luck to everyone.
 
















I am a DermaScience/Medi-Honey rep being romanced by my recruiter for an AWD position that is open. I was told the S&N FDA issue is close to being resolved and should not be too concerned. Is this accurate and is there something in place to take care of the reps with guaranteed commissions until this is straightened out? Please advise to what is really going on at this time.
 








Anonymous said:
I am a DermaScience/Medi-Honey rep being romanced by my recruiter for an AWD position that is open. I was told the S&N FDA issue is close to being resolved and should not be too concerned. Is this accurate and is there something in place to take care of the reps with guaranteed commissions until this is straightened out? Please advise to what is really going on at this time.
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Hope this recent letter helps. Your recruiter is wrong. Read closely what the President stated in his letter. If you don't understand, have someone read this from the hospital and get their opinion.

Just trying to help my friend. Good luck.


July 15, 2014

By Facsimile and Federal Express

Re: Smith & Nephew, Inc.’s RENASYS™ Negative Pressure Wound Therapy Systems (NPWT)

Dear Customer :

As you know, the FDA recently requested Smith & Nephew to obtain additional regulatory
clearances through the premarket notification 510(k) process with respect to certain design
modifications made to the RENASYS NPWT product line in late 2013. Those changes were made in response to customer feedback. At the time the changes were made, we followed our internal procedures and determined that a new clearance was not required. In June, the FDA advised us that such clearance would be required to market the modified RENASYS products. (The original products went through all of the required FDA processes before being
introduced commercially.) We have complied with the FDA request to cease commercial
distribution of the RENASYS product line in the United States until the additional
clearances are obtained.

Subsequent to the request, we raised concerns with the FDA about potential patient
continuity of care, and access to care, issues resulting from the cessation of distribution.
The FDA acknowledged that some institutions and homecare providers may experience an acute shortage of RENASYS products to the detriment of patient care and authorized the limited distribution by Smith & Nephew of these products under a Certificate of Medical Necessity (CMN) program. Details of the CMN program are available from your Smith & Nephew representative or our Customer Care Center.

I am writing to update you on further developments relating to RENASYS systems in the
United States. Smith & Nephew is working collaboratively with the FDA to secure clearance for the modified RENASYS systems. It is now apparent to us that the 510(k) clearances for these products will take longer than we had expected – at least three months and probably longer.

Moreover, in a recent discussion with us, the Medical Director of a regional durable medical
equipment Medicare Administrative Contractor (MAC) expressed his belief that, until the
additional 510(k) clearances are obtained, the modified RENASYS products do not meet the
minimum threshold for eligibility for Medicare coverage – clearance by the FDA. He did not
believe that he has the discretion to decide otherwise, although CMS could make a
determination that additional flexibility is warranted under the circumstances. (Medicare and
other government payors generally do not cover medical devices that are not cleared for
marketing.) We understand the MAC Medical Director shared his thinking with the other DME
MACs. Given the complexity of this issue, we are in the process of contacting the CMS central office in Baltimore to discuss this situation and, if the guidance changes, we will
communicate that to you.

In the meantime, we recommend that you furnish this information to, and consult with, your
reimbursement/billing experts about billing for the use of RENASYS products on federal
health care program patients, such as Medicare, Medicaid, TRICARE, VA and DOD patients, and also federal employee health benefits program patients.

Additionally, you may wish to consult with your reimbursement/billing experts regarding
commercial payors who may also consider the FDA’s communication relevant to assessing
coverage. In the light of these uncertainties, customers should consider transitioning patients to an alternative NPWT device.

We deeply regret the disruption caused by this situation and will continue to assist you as
best we can. If you have any questions, please call the Smith & Nephew Customer Care Center at 1-800-876-1261.

Sincerely,

Francois Fournier
President, North America Advanced Wound Management
 
















So are reps getting paid something to bridge them over for the few months until business resumes? Or is the 60k base all you might me stuck with for an indefinite period of time? It would seem terrible to penalize a hard working sales force for something they have absolutely nothing to do with...
 








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