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Description: good afternoon ismp, my name is (b)(6) and i have been an enteral feeder - 'tubie' for the past 3 years due to side effects of my treatment for head and neck cancer 10 years ago.First of all, a big thank you to your watchdog organization for all you do to advocate and help ensure that safe medication procedures are the backbone of all medical care, be in the doctor's office or in the hospital.I have just read your december 17, 2015 medical safety alert about enfit and am {and have been} extremely concerned about the impact that this new enteral design for feeding tubes will have on all users of such a device.From my perspective, and those of every tubie i know, there are simply too many safety and feeding flow problems that come with this new design to make it viable.In particular, i note the following: an unacceptable dead space of 0.15ml exists in the connector for 20ml syringes or less, the smaller bore size in the connector would significantly decrease the flow rate for a normal feed.The smaller bore size would definitely create clogging for crushed medication and all blenderized food.The tiny screw type connector would be nearly impossible to fully clean after a feeding.The tiny screw connector would make it extremely difficult for anyone with less than full dexterity to hook up.The fact, admitted by (b)(4), that no 'real use' field testing of the design was done on blenderized foods.The fact that enfit's male pt connector cannot be safely connected to a foley bag.The fact that enfit's female syringe and formula delivery set misconnects with trach tubes.The fact that the smaller bore would make it virtually impossible to fully clean both the syringe and feeding tube.The fact that enfits screw type lock connector heightens the risk of pulling one's g-tube out of the stomach during a feeding accident because there is no slip connection device of the sort which exits on current feeding tubes.The fact that while enfit is touted to make feedings safe, in effect what it does is exactly the opposite.All these problems became even more evident at the (b)(6) summit conference on enfit in (b)(6).I was an invited 'tubie patient' presenter at this conference, which was attended by dietitians, clinicians, mfrs, the fda, (b)(6), (b)(6), tubies, and folks from (b)(6).It became quickly apparent that gedsa's attempt to 'sell' their design fell on more than a few deaf ears, even though the stated reason for this summit was to forge a consensus between the mfrs of enfit and the end users of the product.In addition, prior to this conference, two of the largest mfrs of medical supply devices, bd and medtronic/covidien, had withdrawn their support for the current design of enfit.Furthermore, at the conference, dr.(b)(6), director of home parenteral and enteral nutrition at the (b)(6), made two very salient points.First, that his clinic's survey of their 'tubies' made it clear that 50+% of their pts used blenderized real food nutrition rather than/or along with formula feeding, and 80% of pts indicated a desire to eventually make blenderized real food a part of their diet; and second, the current dosage of enfit would make the use of blenderized food very problematic because of its reduced inner bore connectors.Dr.(b)(6) abstract of his study, published in pubmed, reads as follows: source: pubmed abstract, use of long-term enteral nutrition (en) has increased dramatically in the united states.It has been the authors' experience that most home en (hen) pts use blenderized tube feeding (btf) in addition to commercial en.There are limited resources available for pts interested in btf, and studies evaluating safety and effectiveness are limited.The authors conducted a prospective cross-sectional study (n = 54).Age >18 years, f/u in hen clinic, prescribed commercial en.Participants were provided the survey at hen f/u appointments after receiving hen for at least 3 weeks.Median age (range) was 60.5 (22-87) years with 42.6% females (n = 23).Btf was used by 55.5% of pts (n = 30).Most (57%; n = 31) received hen for >6 months.Btf use was a median of 4 (1-7) days per week.Most common reasons for using btf were as follows: it is more natural (4.3%), like eating what their family does (3.3%) and tolerate btf better (30%).In pts who use btf, 80% reported maintaining goal body weight.Btf resulted in significantly less reported nausea, vomiting, bloating, diarrhea, and constipation compared with commercial en.This is the first study to evaluate btf use in an adult hen population.More than 50% of our pts used and approx 80% expressed a desire to use btf if provided with adequate info.With new connection tube changes coming in the near future, adequate adapters for bft need to be developed.In 2015, american society for parenteral and enteral nutrition.The fourth paragraph in your december 17 alert really grabbed my attention when it stated that (b)(6) had found through testing that tubies who used 20fr feeding tubes would find that there was no difference between the flow rate of formula food and blenderized food.Why did it 'jump out' at me you may ask? for the simple reason that during the (b)(6) conference, soon after dr.(b)(6) made this statement, (b)(4) admitted that it had not done any comparative testing for blenderized foods.I, and the other tubies in attendance, just sat there with our mouths agape, how had the enfit design made it this far (the iso vote on enfit was supposed to begin on december 3, but was called off for no stated reason) without being a usable medical device, critical to the very existence of tens of thousands blenderized food tubies, children and adults alike? additionally, the fourth paragraph stated that (b)(4) 'had engaged' with (b)(6) and some pts (b)(6) represents.Well, i certainly have not been 'engaged'.After checking with the other invited tubies who were at the conference, they had not been engaged either.And nothing we have received from (b)(4) mentions any 'engagement' with them either.I don't know how this sounds to you, but it sure seems to me that (b)(6) (which was originally formed specifically to promote the acceptance of enfit) is playing games, running on fumes, or both.Either way, i think they are trying to pull the wool over everyone's eyes in order to get their product on the market as quickly as possible.Which i find especially deplorable because they are directly dealing with people's lives with this highly problematic device.Thank you for listening to all this and thank you for whatever you can do to ensure that if any enfit product does make it to market that it is properly designed to serve all tubies, from those babies who could be given the wrong dosage of medicine to those blenderized food tubies who have been forced, through no fault of their own to take nutrition for the rest of their lives through a feeding tube.Sincerely, xxxx.Medication administered to or used by the pt: no.Pt counseling provided: (b)(6).
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