|
|
Joined: Mar 2003
Posts: 36
Visionary
|
OP
Visionary
Joined: Mar 2003
Posts: 36 |
Hi Just had a read through the Updated guidance MHRA (April 2014) on one of the other topics. In Managing medical devices 8.1 Maintenance and repair it states - Frequency and type of planned preventive maintanance should be specified in line with the manufacturers instructions and taking account of expected usage and environment it is used in. The Resmed S9 user guide states - service and maintenance of the device generally should not be required during the 5 year design life of the machine. All our machines are used in the community and some will need servicing every 12 months but othrs could be seen every 2 years. Any advice on this would be appreciated.
|
|
|
|
|
Joined: Feb 2004
Posts: 14,798 Likes: 71
Super Hero
|
Super Hero
Joined: Feb 2004
Posts: 14,798 Likes: 71 |
My interpretation of "current thinking" (MHRA ... as well as various international sources of guidance [such as ECRI, and US Army TB MED-750, for example]) is that the idea is for Tech Support Agencies ( aka EBME Departments, biomed shops and what-have-you) to set their own "prudent" PM frequencies based upon "all things considered"*, but carry out PM more frequently if that is what the manufacturer decrees. As I have stated many times before, my own default PM interval for all equipment would be 180 days (that is, six-monthly). Or are these users in the community especially well known for looking after "their" equipment?  Meanwhile, I believe that ECRI says "12 months" for CPAP units. * "Risk", clinical environment, no back-ups, general conditions of use, manufacturers recommendations, government mandates, legal considerations (real or imagined), "tradition" ... and all the rest!
|
|
|
|
|
Joined: Jan 2005
Posts: 8
Newbie
|
Newbie
Joined: Jan 2005
Posts: 8 |
The machine should be serviced yearly. These are the reasons:
1. The pressure can be out of tolerance and will need either or both pressure and flow calibration. This means some patients may be receiving less or more than their precription pressure setting.
2. Unless you give your patient additional tubing, mask and filters, these will need replacement at least once a year and most especially, the filter.
Last edited by ernestowu; 08/01/15 6:49 PM.
|
|
|
|
|
Joined: Mar 2003
Posts: 36
Visionary
|
OP
Visionary
Joined: Mar 2003
Posts: 36 |
Thanks for the replies looks like every 12 months then
|
|
|
|
|
Joined: Jul 2002
Posts: 2,020
Hero
|
Hero
Joined: Jul 2002
Posts: 2,020 |
The pressure can be out of tolerance and will need either or both pressure and flow calibration. Ernestowu What facts is this statement base on when the manufacturers say that it does not need to be service at this frequency? May be they have very stable transducers that do not require such frequent calibration. You should not just bandy about comments without basing them of something, especially when there is evidence to the contrary. Robert
Last edited by RoJo; 13/01/15 4:01 PM.
|
|
|
|
|
Joined: Feb 2004
Posts: 14,798 Likes: 71
Super Hero
|
Super Hero
Joined: Feb 2004
Posts: 14,798 Likes: 71 |
Evidence? What evidence? How will you (we) know if the kit never gets checked? 
If you don't inspect ... don't expect.
|
|
|
|
|
Joined: Jul 2002
Posts: 2,020
Hero
|
Hero
Joined: Jul 2002
Posts: 2,020 |
The Resmed S9 user guide states - service and maintenance of the device generally should not be required during the 5 year design life of the machine. Presumably the company have done tests to back this up.
My spelling is not bad. I am typing this on a Medigenic keyboard and I blame that for all my typos.
|
|
|
|
|
Joined: Feb 2004
Posts: 14,798 Likes: 71
Super Hero
|
Super Hero
Joined: Feb 2004
Posts: 14,798 Likes: 71 |
The same could be argued about any claim regarding any piece of kit, from any manufacturer. You'll be saying next that we shouldn't be doing PM at all! Never presume - or assume - anything; after all, "Assume makes an Ass out of U and Me"!  My argument would go something like this:- how can anyone claim that something won't occur within five (or any other number) of years, unless that period has already passed, and it can be shown that the "event" didn't happen! Has the kit in question been around "in the community" for five years? That's what PM is all about ... preventing failures.  Lastly, and out of interest, does the thing carry a five-year warranty?
|
|
|
|
|
Joined: Jan 2005
Posts: 8
Newbie
|
Newbie
Joined: Jan 2005
Posts: 8 |
Rojo
I am very surprised to hear your comments. You and I know that machines can go out of tolerance and the only way to find out are during regular checks despite what the manufacturer says.
I work on the machine and other machines daily as we run a CPAP clinic at my place of work. I did not want to go in details and since you want evidence, here are they:
Last year, I condemnned more than 5 of the ResMed S9 machines as they failed both pressure and flow calibrations. In all these 5 units, the pressures were either more or less than 3cmH20 of the patients pressure. When the pressure is out of tolerance, you have to perform pressure calibration and at times flow calibration as well before the machine gives the required pressures. If the patients had not brought their machines to be serviced yearly, they would have continued either receiving less or more pressures.
I also had to peform both pressure and flow calibrations for more than 10 machines as the pressures were out of the prescription pressure settings.
I hope you know the consequences when the patients are not receiving the correct pressure or receiving more than the required pressure? The purpose of the CPAP is to open the airways for patiens suffering from Obstructive Sleep Apnoea. For example, if the pressure required to open the airwave is less, the patient's airway will not be opened enough and this will cause the patient to snore.
You said there is evidence to the contrary and I would be glad if you could throw more light on that.
Last edited by ernestowu; 14/01/15 6:07 PM.
|
|
|
|
|
Joined: Jul 2002
Posts: 2,020
Hero
|
Hero
Joined: Jul 2002
Posts: 2,020 |
I was just stirring the pot a bit to stimulate debate. So many people say we must follow manufacturers instructions and service periods to the letter and will not lengthen service periods when they seem to be too frequent or just an excuse to sell service parts. But here we have the opposite. On the face of it, it seems you just use and forget this piece of equipment. But as you have found risk and experience based servicing seems to be appropriate here. Let the debate continue. Robert Sorry if it seemed to be a personal slight.
My spelling is not bad. I am typing this on a Medigenic keyboard and I blame that for all my typos.
|
|
|
|
1 members (daisizhou),
4,139
guests, and
15
robots. |
|
Key:
Admin,
Global Mod,
Mod
|
|
|
Forums26
Topics11,248
Posts74,481
Members10,358
| |
Most Online37,242 Apr 12th, 2026
|
|
|
|