Dear All,
PASA (NHS Purchasing & Supplies Agency) are currently revising/revamping our beloved PPQ (pre-purchase questionnaire) and have invited those of us who are involved to feedback on additions or design changes (if any) to the existing form.

The ebme Forum is the ideal medium for all the positive and constructive comments we can muster to improve the existing system and these will be tracked.

Key contact details are below should you wish to contact PASA directly outside of this forum for more detail.

Examples of some of the comments so far that are being considered for inclusion:

- addition of query to Suppliers wrt WEEE Directive requirements / compliance.

- anticipated working life of equipment

- price list of 10 most ordered and/or most expensive spares for equipment

- consideration of variable warranty periods (e.g. lasers) with warranty detail (exclusions)

----------------------------------------
EMAIL: Nigel.Champken-Woods@pasa.nhs.uk
Job Title: Clinical Specialist
Department: Medical & Surgical Equipment, PASA
ph 01844 216809
fx 01844 216809
----------------------------------------

Chris,
Does this device require consumables?
How much are they?
What are your service option / costs for 'return to base' planned maintenance, call outs/repairs?

I saw a service contract for £22K on an ultrasound machine a couple of week ago (won't name the hospital or supplier) absolutely ludicrous cost.

No wonder the tax payer is having to pay more in NI contribs

Sorry , I am rambling. This is a worthwhile subject that needs addressing. Well done and good luck to PASA for tackling this. I am sure the EBME community will help.

I have to admit that I’m not even sure what the current PPQ looks like! Are there any links available for a quick gander?

As a representative for the manufactures can I ask that due consideration is given to the person that has to fill these forms in.

In past revisions these forms have contained ambiguous questions, which are difficult to complete.

Also you should be looking for objective, rather than subject responsive.


To directly respond to Chris’s questions for inclusion;

addition of query to Suppliers wrt WEEE Directive requirements / compliance.
Make sure that this question is put in such as way that is binary answer.

anticipated working life of equipment
This is a little subjective, as working life, depends heavy on usage patterns, but I like that as it is.

price list of 10 most ordered and/or most expensive spares for equipment.
This not really a practical question to answer, as each hospital, will have different usage patterns. Also how do you complete this for new products?
Any response would just be a guess, favouring the lower cost items, and possibly never being update during the life of the PPQ. Highly subjective and giving little value.

consideration of variable warranty periods (e.g. lasers) with warranty detail (exclusions)
Good point, warranty details with exclusions should be attached.


On Johns’ points;

Do you provide a UK field service operation for the product; Yes/No

Do you provide a UK based bench service operation for this product; Yes/No

Does this device require consumables; Yes/No (Please attached a price list)
Do not ask the manufacture to workout the consumables cost, when you have not told them your usage patterns.

I also agree with a question about service contract and callout charges, at least an idea of these should be known upfront.


Some of my own suggestions;

As nearly all products these days have some form of software component;

Will all software updates during the warranty period be supplied free of charge, Parts & labour (without addition service contract); Yes/No

Will software updates after expiry of warranty be supplied free of charge, (parts only); Yes/No

Just my two penny worth.

Chilly

Sorry,
I've had to remove all these links as they are now obsolete and this post becomes meaningless.

I'd agree with John on the contract options, it would certainly save a lot of work in telephone calls if we knew up front what a contract might cost!

Also it would prevent companies from trying to sell goods in the UK without proper service provisions / support.

Chris

Thanks for the e-mail on this. I was at Carl Zeiss yesterday discussing their completion of a PPQ form for a PICO microscope system.

The PPQ is a fantastic medical devices management tool in the right hands. The form in fact dominates my life and my staffs too.

I will contact Nigel at PASA and hopefuly create a good dialogue over any revamp of the PPQ.

HUW, we produced an extension of the PPQ form some years ago, which we called the PPQ Supplement. Can I attached it to this particular topic for discussion. I can then explain its use and why it was produced, though this should be self evident.

Thanks.

Jim

Hi Jim,
Can you send it to me?
I'll see what I can do.
Cheers,
H.

Jim,
Could you email me your supplementary attachment please?

Many Thanks
Neal

Neal

Huw, is going to see if he can upload it to the EBME website for all to see.

I welcome comments of course, positive or otherwise.

If there are any problems, I will gladly e-mail a copy to you.

Jim

For Geoff Hannis and anyone else who would like to see current PPQ it can be viewed at the following :

http://www.pasa.nhs.uk/standardforms/ppq_june2003.doc

I hope this is of use and all your comments are most welcome and will all be reviewed.

Nigel Champken-Woods

PPQ Supplement A



>> Download PPQ Supplement A in PDF format



*************************************************


PPQ Supplement B



>> Download PPQ Supplement B in PDF format

Dear Nigel.Champken-Woods of PASA,

In this day and age of wonderous servers, databases and technology, how come PASA has not got a database of all companies PPQs ? Surely, with the NHS being the size that it is, there should be a database were the companies only have to up-load or up-date their PPQs once. The users could then log on and get any PPQ for any piece of medical kit! It would save the NHS tens of thousands of pounds in lost "person-hours" and save the individual companies money by writing PPQs once, which could be passed on to the NHS (I can dream, can't I ?).

Here's another idea, get an EBME dept. to run the database, and pay some of our guys and gals(techies) to check that the PPQs are fit to be on the database.

" What a time saver! "

O.k. guys and gals, what are the down sides? Please feel free to dismember this e-mail! After all, it's only an idea!

Eddie
Taking into account our wonderful civil service's competency in running major computer projects ie CSA, Passport Office etc. What makes you think PASA could do it.

Mind you the idea of an EBME Dept running it sounds good! At least we should know what is required.

Sorry Eddie, but your idea (of letting an EBME Dept. handle things) won’t generate enough jobs, Mate!

Eddie

PASA did look at the possibility of a database of companies PPQ's a few years ago but the task was almost impossible.

The number of PPQ's are almost infinite whilst resources are finite! Just think how many different pieces of equipment subject to PPQ's are bought by the NHS!

Perhaps a better way would be to request suppliers to post them onto their web-site. This is something we may investigate during this revision but even that has problems.

What do others think?

I think suppliers posting on their own sites is an excellent idea. we could then set up a central source of links to their ppq's from here.

Jim,
I think your PPQ is very good but doesn't cover any consumable (single use) or durable items. The cost of some these items can hit the Trusts revenue budget very hard over the life of the equipment. (£millions) (often equipment can be seen as a bargain because life costs are not considered in enough detail).

John, correct.
Certainly in Orthopaedics it is not un-common practice to have 'permanent' loan equipment on site as part of a 'deal' whereby the cost is tied into the consumables and how many are used over a period, etc.

This therefore means there is (potentially) a variable cost rather than a more measurable capital cost. Our Trust likes this because it appears cheaper initially, a little like leasing, however we have been stung further down the 'contract' road.

From a PPQ perspective therefore, we may ask all of the usual questions about Servicing, Training, Manuals, etc. which still apply, but the terms of the contract extend far beyond the initial purchase and a review date (in line with ISO9000's Contract Review) would be good to set at the beginning.

However, this very often falls into the realms of Supplies rather than EBME. I would be interested to know if you cross this boundary at Chester, Jim.

PS
Jim - this is a very useful document!

You can have the best form in the world, and ask a million questions if you like, but personally, I would need to ask “what use is made of all this information”? How intelligently is it acted upon, I wonder? If the answer to that one, is “very, thoroughly, expertly” etc., etc – then how come so much gash kit can be seen laying around our hospital?

If, for instance, the world’s most perfect questionnaire were to be handed to donkeys for processing, what would the result be (if you catch my drift)? Just hypothetically speaking, you understand.

We usually get the PPQs some time after the kit has been delivered. At least this lets us know that there is a piece of equipment somewhere that needs an acceptance check!

John

The commodity advisor from our Procurement Dept handles the costs that you highlight, with input from me as required. I have to say however that I show little interest in the cost of the consumables such as IV sets or syringes.

Unless of course I am playing one product off against the other and I then use the cost of consumables to benefit the cause.

Geoff, the forms as I said are a good management tool in the right hands.

Dicky, again it alarms me when our fraternity still quote such things as you have.
The PPQ form is a Pre-Purchase not a post purchase. Your medical devices management should not allow purchases until EBME have ratified and sanctioned such purchases.

The question is, who is not in control in your department, rather than who is.

Jim I could not agree with you more regarding pre and post purchase. But when a culture has grown over a number of years (decades) within a hospital wards/finance/purchasing system it is very difficult to break this, however good our medical devices management (ie us) is. The words head banging and brick wall come to mind.

I agree with Chilly Penguin. Some of the questions are very ambiguous.

Q14 on decontamination causes us the most grief - particularly as it was altered to make it clearer that it referred to cleaning as well as sterilisation, but the date on the form wasn't changed, so a quick glance suggested it was the original version. The vast majority of manufacturers answer NO to this one - a response which should only apply to single use or single patient devices.

The other problem we have is the wrong person is filling the form in and signing it. My view is that it should be either someone technical, the specific product manager or the sales manager who signs - not the junior office clerk who hasn't the feintest idea what the equipment is (when you ring to ask why they haven't filled it in properly). This often goes hand-in-hand with the comment - "We don't usually get asked to complete this form." !

Surely ALL supplies departments send these forms out before placing an order ? ? ?

Just a comment regarding Eddie's interest in a PPQ Databases, that was made a little earlier in the posting.

We use a Web based, PPQ Authorisation Database in our Trust. It was written in the asp.net format. It has proved to be very useful and the ppq authorisation can be checked or printed off as necessary, with appropriate access rights. We are currently looking at the provision of storing the actual electronic PPQ document in the near future. Lack of time has sadly put a temporary halt to that part of the develpoment..!!

Brian.

Further to the development of the PPQ form.

Having spoken to Nigel Champkin-Woods for an update - I believe there is a working party meeting of EBME Managers next month in London to thrash out the final details of improvements (details to follow).

We have already specified a request for a 'Guidance Document' that would assist & pad out details of how the PPQ should be used / completed (not disimilar to a Work Instruction for those of an ISO mind). Specifically, I have issues with our Supplies department who believe that the PPQ should not be used for equipment that isn't strictly "purchased" in a capital sense (e.g. Equipment on long term loan, or as part of a 'deal' over consumables).

This approach has taken us backwards in our process as a Trust since we are risking possession of some 'ropey' equipment because the key principle of the PPQ has been subverted. However, watch this space.

Another development from PASA may be LESS focus in the PPQ on questioning training offered by Suppliers. I for one think this should be an area EBMEs ask about much more (ref: CNST) when equipment is purchased, not just for Technical Staff but for end users - i.e. "Do you as a Supplier offer Competency Based Training?" - If EBMEs do not cross-check the level of support we expect we stand to reap the consequences long after Purchasing have been involved.

It seems PASA are taking the view that this should be requested at the tender / contract agreement point - and I agree - but all too often Suppliers just do not deliver. So this is a vital question with far reaching consequences.

Any comments, or similar experiences welcomed.

---------------

This post is also really to encourage those of you who were intending to contribute to the PPQ debate to do so as soon as possible, either via this forum or by contacting Nigel directly. Thanks to all who all ready have / are. His details again:

----------------------------------------
EMAIL: Nigel.Champken-Woods@pasa.nhs.uk
Job Title: Clinical Specialist
Department: Medical & Surgical Equipment, PASA
ph 01844 216809
fx 01844 216809
----------------------------------------

I think PaSA should insist that PPQ's are completed by the suppliers senior technical staff and not their admin people. I spend too much time contacting them because the info is wrong, contradictory or confusing only to be told it was because the office junior filled it in.

Come on suppliers this is an official document which can form part of the sales contract.

Bioman,

I agree. The dilema appears to be that, although 'official', the PPQ is not legally binding unless it is included in the contractual / tender information .. (in my limited understanding).

This is precisely why the document (or the Guidance Notes for it) should state the intended use and best practice for both EBME's & Supplies/Hubs.

Even office junior's can use PCs nowadays to make things look 'official'. Shocking.

A step in the right direction to resolve this appears to be the concept of a centralised point for PPQs. PASA do not have resources to police this, but if the accountability was placed upon the Suppliers and a web-space was provided by PASA to provide hyperlinks to the correct / updated PPQs, that would be a move in the right direction.

I think EBME Managers would be very quick to highlight companies that weren't towing the line. A 'forum'/feedback space for this directly connected to the above would be valuable too.

mini-ebME.co.uk?

Hmmm.

Chris
I agree that it is mandatory that companies are asked prior to purchase if they provide training for end users or "Train the Trainer" courses.
It also helps if they can provide Quick User Guides and other such like training material.

I would definitely like to have some kind of Competency Training accreditation check on the PPQ.

In the same way we ask for Warranty details to be attached in writing.

Every company will say they do it, but many don't deliver when push comes to shove, even some of the bigger Companies we often have issues with.
(no names here)

ISO9000 accredited companies, however, should have training activity in their QA manual of course - this may be considered better evidence than the Salesman promising the moon & stars - perhaps we could ask for that at the PPQ stage.

For those of you who are involved in training - your thoughts / experiences?? Does the delivery match the promise?

NOTE: see THIS POST also.

Hi,

I'm not that familiar with the legal status of the PPQ within the framework of purchasing and what measures can be taken, post-purchase, if a manufacturer/supplier apparently mis-represents information on a PPQ that has been examined/passed prior to payment being authorised so please bear with me.

I assume that in this circumstance the PPQ forms part of the purchase contract between the NHS and the supplier of any services or equipment and as such the supplier would be "in-breach of contract" if any information on the PPQ were inaccurate or deliberately mis-represented for whatever reason. Is this its intention or is it there solely to guide the decision whether to purchase or not?

Obviously there are grounds to reject a purchase based on the information in the PPQ prior to purchase, however, based on the fact that a lot of PPQs are received after the purchase has in fact been completed, as Dicky states, does anyone have any opinions on what sway purchasers would have regarding the information that's in the PPQ and whether this is, realistically, likely to influence a purchase that has gone through or not? Has anyone any experiences they would be willing to share?

If there are problems with the information in the PPQ then this might prevent purchase of a particular product, if it's assessed prior to purchase, but where does the purchaser stand if the PPQ is later made available but not obtained before a specific purchase (does a PPQ have to be attached to every purchase, prior to purchase just to be "safe" - even if it's a repeat purchase of a particular model of equipment).

Given problems with the PPQ, obtained retrospectively, would there be reasonable grounds for either returning equipment, claiming some form of compensation or a refund or, in some cases, could the deal be "reversed", i.e. can it be sent back to the supplier? More generally speaking, i.e. regards contracts in general, not just concerning PPQs, in what situations would either of these approaches be justifed?

Another issue is what's the legal status of PPQs that are modified locally - do the "enhanced" requirements of PPQs such as that provided by Jim Gavin give any more protection to the purchaser by "padding" the specification? Certainly they do enhance the requirements and tie-down the specification of requirements for a range of aspects affecting servicing in my opinion but I was wondering what other's thoughts are on this.

I suppose what I'm asking is whether anyone knows if there's a definitive statement of the intention of the PPQ, its legal status, the role it plays in the purchase, contractually, whether this applies nationally (or whether its contractual status, if it has any legally speaking, depends on legal advice obtained by each trust, locally).

It'd be interesting to hear if anybody out there has actually had to take recourse with manufacturers using the information in the PPQ to backup their case. Bottom line is that I'm wondering what peoples views are on what the PPQ is, what it's intended to do and how effective it is at facilitating it. Any feedback, including that from our colleagues in supplies departments, would be welcomed. Thanks.

The PPQ is a legally binding document, if formally used as part of a purchase and both partys are aware of that fact. Best method is to have it mentioned as a reference in the contentent of the tender and offical order.
Ihave had to mebtion factors effected in the past involving PPQ to suppliers. Once they know you arent kidding with anyt action you may take involving the completed PPQ they usually dont mess you arround.
The important part (i'm told) is that you have to ensure the supplier knows that the PPQ prented is being used as part of the conditions of purchase.

Dear all

Many thanks for your comments there was some very useful comments and these will be included in the new document where applicable.

I will post a note when new document is available for comment

Thanks again for your input

Hi folks,
I enforce the PPQ requirement in this Trust. Before any new medical device is accepted for use, loan or trial, a PPQ is required to arrive on my desk in time to allow investigation of the facts quoted.
Without a completed PPQ, deliver is rejected. However, we live in the real world and know that some devices still get through, but we are winning. A number of companies now send a PPQ in anticipation of any trial / loan date.
The PPQ requirement is clearly stated in the Trust's Medical Devices Policy.
regards
Pete

At a recent medical devices group meeting, the subject of PPQs was debated. There were a number of comments about its fitness for purpose (the latest copy I have been able to find is dated June 2003) and this tends to be what most suppliers still use as a standard form. I note from previous correspondence on this thread that there was talk in 2006 of revising it, but I've never seen anything more up to date. Does anyone know who (if anyone) has ownership of this document, now that it's not PASA? Do any hospitals issue supplementary questions alongside the PPQ?

They are now managed by a company called BiP Solutions on behalf of the DoH and can be found here
They are now dated 2011 but do seem very familiar on first sight.
RoJo

Thanks Rojo,
Am I looking in the right place? I can only see indemnity documentation on the link that you posted.