Que The Doors; "This is the end"...

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Anonymous said:
http://www.medicaldevicedaily.com/servlet/com.accumedia.web.Dispatcher?next=MDD_Alert10142014b
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Inside the Beltway: Zoll warning hints FDA wants user studies for wearable defibs





By Mark McCarty







Washington Editor

Zoll Medical (Chelmsford, Massachusetts) had an uncomfortable May-June inspection of its plant in Pittsburgh, the site of manufacture of the LifeVest wearable external defibrillator, which resulted in seven citations, including one addressing validation of the device's use. FDA said the device was not adequately validated under simulated or actual use conditions, but this was just one of several citations suggesting the agency is concerned that such devices have not been adequately tested in real-world use situations for the range of patients who will use the devices.

Zoll has snared only one other warning of recent vintage, a June 24, 2011, warning citing the firm's plant in Chelmsford for manufacture of external defibrillators. This warning contained two well-detailed citations addressing procedures for non-conforming product and verification of battery life, one of a series of FDA actions dealing with automated external defibrillators in the past few years.

The most recent letter to Zoll made mention of a redacted number of complaints of inappropriate shock "in which noise artifact and/or vibration were caused by various daily activities." However, the agency cited two other problems in addition to the validation issue associated with noise and vibrations, including a risk analysis that did not control for "lifestyle activities causing high noise artifact and/or vibration." The third sub-finding in this citation again took aim at the risk analysis, which the agency said did not "consider the use of the device in patients with cognitive and/or physical limitations," providing the example of "numerous complaints" in which "the device was supplied to patients even though they could not interact with the device as intended."

The problems cited in this context included complaints that patients "did not understand or know how to properly operate the device due to their physical and/or cognitive disabilities." In each case, FDA said the firm's response to the findings on the form 483 would be evaluated in a subsequent inspection, suggesting the agency found the responses reasonably assuring that Zoll addressed the problems.

The noise/vibration issue fed a citation for corrective and preventive action (CAPA), which stated that no CAPAs were undertaken to address those problems. The warning letter stated that Zoll had opened no CAPAs for the problems associated with patients who were unable to properly use the devices due to physical/cognitive disabilities as well. However, FDA also said Zoll had received "numerous complaints document that bystanders are interacting with the device, during cardiac events of patients, preventing treatment [from being] delivered."

Issues associated with medical device report (MDR) mandates also populated the warning letter, with the by-now commonplace citation that the company's procedures did not properly define the terms "became aware" and "caused or contributed." However, the term "malfunction" is now apparently on the list of confusing regulatory terminology for device makers as well. As was the case with the other citations, FDA said Zoll's response would be evaluated in the next inspection.

FDA cited Zoll for lack of documentation demonstrating that senior management had attended all management review meetings in 2013 and 2014. Zoll declined to comment for the record.
 




































Let's put this in perspective... it's a "warning" letter that was received several months ago, so obviously Zoll responded or action would have been taken by taken by now. I think what it shows, however, is that the executive team clearly don't know what they're doing. Some of these are basic violations that someone reasonably should have been able to recognize. This isn't IBM. It's a medical device company, and just because it's got a circuit board doesn't mean you run it like IBM. These are human beings and you're dealing with the FDA. WEl come to the big leagues ladies and gents. You want to be a big medical device firm? Well you gotta start acting like one, namely, play by the FDA's rules. And while I'm at it, fix the foolish quota algorithm (Actually, algorithm is too strong because its not an algorithm. Its an average using false assumptions). It's ridiculous at best. Hire a consulting firm with all the Medicare money to fix what's wrong.
 






One of these days (soon) they will find out THEY don't run the show. A company is only as good as there employees and when we talk they don't give a crap about what we say. This is what happens when a small company grows so fast in little time, without adjusting there rules. The A-holes sitting behind desks think they made this company,,,WRONG. Why is ML still in charge he clearly cannot handle the company (per all the posts) an has so many violations at corporate office. So funny even Doctors are seeing through your BS and writing articles. Stop thinking your a Bad ass and untouchable, arrogance is so unattractive and equals ignorance..
There is upper management on here telling us to "get to work and stop bitching" LOL LOL ya maybe corporate needs to take there own advice and start working on the company protocol and making it so OIG and FDA doesn't shut us down. I WILL predict there will be a LARGE tun over in management as soon as Asahi Kasei catches wind of this cluster FU**. Japanese will put an end to your money hunger don't give a crap for workers mentally! You wont be able to talk your way out of this mess. I think Zoll has the government handbook on how to run a business, cover up and lie....
 






Anonymous said:
Let's put this in perspective... it's a "warning" letter that was received several months ago, so obviously Zoll responded or action would have been taken by taken by now. I think what it shows, however, is that the executive team clearly don't know what they're doing. Some of these are basic violations that someone reasonably should have been able to recognize. This isn't IBM. It's a medical device company, and just because it's got a circuit board doesn't mean you run it like IBM. These are human beings and you're dealing with the FDA. WEl come to the big leagues ladies and gents. You want to be a big medical device firm? Well you gotta start acting like one, namely, play by the FDA's rules. And while I'm at it, fix the foolish quota algorithm (Actually, algorithm is too strong because its not an algorithm. Its an average using false assumptions). It's ridiculous at best. Hire a consulting firm with all the Medicare money to fix what's wrong.
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Read the letter. Zoll has not responded appropriately or at all to questions that were imposed. Keep this in perspective. You were in pharm. A warning letter is never good. The important thing here is that Zoll is under the microscope.
 






Anonymous said:
Read the letter. Zoll has not responded appropriately or at all to questions that were imposed. Keep this in perspective. You were in pharm. A warning letter is never good. The important thing here is that Zoll is under the microscope.
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The fact that Zoll, an engineering firm, run by engineers familiar with quality measures (e.g. ISO/Lean/Six Sigma) does not have established quality measures in place FOR YEARS is laughable.The engineering dept is about the size of sales which is absolutely amazing from a cost perspective. The fact that the letter highlights both internal (manufacturing) and external (marketplace) severe issues of defect do not bode well. The letter was a warning to "Please respond and advise of changes". The changes will be monitored and site inspected with future non-compliance issues bearing $$$$ fines. Do you honestly think that this culture will be able to respond appropriately and consistently enough to the external issues noted? For cripes sake we can not even investigate a death properly even when notified. I am sure a revision in "2x2" may be thought of as a satisfactory response but, somehow I don't think the FDA will feel the same in the longrun. Prediction: Once the DMEPOS bill is signed (not completely necessary but would speed up the following), we are reviewed and lose at a minimum the Primary prevention indications and reimbursement takes significant hits. 2.) a significant fine that sends a strong message to the marketplace-medical providers will see liability and constrain use, fine will be mentioned in 10-Q and analysts will smell blood 3.) AK will get concerned! 4.) AK/Zoll will spin-off LifeVest but retain global rights 5.) Futures-HF indication (lol) and "acoustic sensors" will never reach market. In hospital version will be spun out to Hospital Capital Reps. 5.) Reimbursement will decline. 6.) Attrition/lay offs will occur to cut costs and maintain +/neutral revenue balance. The crunching you will hear will be the screws tightening down on the bones of the company!
 






Nostradamus could not have predicted any better!!
I have already heard from other company's that there are a lot of Zoll reps looking or asking about any openings in the field. Better get it while you can, they are filling up fast.. Were all running for higher ground.
 






Most Zoll reps are looking to get out all the time. The letter sweetens the pot so to speak and puts a fire underneath our feet to get out fast. Quite honestly, some of the issues in the letter are spot on and I don't see anything happening to address these issues, such as a large majority of inappropriate treatments and not having anything in place to keep bystanders from pressing the buttons. We all know that there have been issues with this and even a death/s with a bystander pushing the buttons when the patient needed treatment. These are big issues that should have been addressed a long time ago along with the issues of lack of reporting timely. Oh what a tangled web we we've when we set out to deceive!
 






Anonymous said:
The fact that Zoll, an engineering firm, run by engineers familiar with quality measures (e.g. ISO/Lean/Six Sigma) does not have established quality measures in place FOR YEARS is laughable.The engineering dept is about the size of sales which is absolutely amazing from a cost perspective. The fact that the letter highlights both internal (manufacturing) and external (marketplace) severe issues of defect do not bode well. The letter was a warning to "Please respond and advise of changes". The changes will be monitored and site inspected with future non-compliance issues bearing $$$$ fines. Do you honestly think that this culture will be able to respond appropriately and consistently enough to the external issues noted? For cripes sake we can not even investigate a death properly even when notified. I am sure a revision in "2x2" may be thought of as a satisfactory response but, somehow I don't think the FDA will feel the same in the longrun. Prediction: Once the DMEPOS bill is signed (not completely necessary but would speed up the following), we are reviewed and lose at a minimum the Primary prevention indications and reimbursement takes significant hits. 2.) a significant fine that sends a strong message to the marketplace-medical providers will see liability and constrain use, fine will be mentioned in 10-Q and analysts will smell blood 3.) AK will get concerned! 4.) AK/Zoll will spin-off LifeVest but retain global rights 5.) Futures-HF indication (lol) and "acoustic sensors" will never reach market. In hospital version will be spun out to Hospital Capital Reps. 5.) Reimbursement will decline. 6.) Attrition/lay offs will occur to cut costs and maintain +/neutral revenue balance. The crunching you will hear will be the screws tightening down on the bones of the company!
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Don't forget the cognitive issue that the FDA mentions. Several patients that have recently had cardiac surgery, previous stroke or even slite dementia due to age will fall into this category. Just imagine having to have a cognitive function test performed by a health care provider and then documented by that provider before the vest is put on. Here comes the nightmare. Nice job Zoll. Keep burying your head in the sand and hope it goes away! Looks like you could have used all the cardiac experienced reps that left because of your idiotic policies! Try digging your self out with inexperienced managers and pharm reps.
 






Anonymous said:
Don't l patients that have recently had cardiac surgery, previous stroke or even slite dementia due to age will fall into this category. Just imagine having to have a cognitive function test performed by a health care provider and then documented by that provider before the vest is put on. Here comes the nightmare. Nice job Zoll. Keep burying your head in the sand and hope it goes away! Looks like you could have used all the cardiac experienced reps that left because of your idiotic policies! Try digging your self out with inexperienced managers and pharm reps.
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"Hey Doc this is ding dong at Zoll, we can not approve until we get a cognitive progress not or test result. Can you fax that over?"

MD response, "Sorry, what did you say?"...outcome MD requests consult which gets done two days later (after the weekend). Cardiology gets dressed down for LOS increases and whacky consult requests.
Even if we get "notes in", imagine the cluster of incompetence and signature log requests lol.
 












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