COMPLIANCE WITH WHAT?

FOREWORD
Keith Jones of NARC and I disagree on a number of issues that's why he's so useful as an editorial peer. Not the least of these are the points raised by this article, Keith has a solid grounding in the mechanics of the new European standards system whilst I am more concerned with implementation of such a system as it relates to rescuers at grass roots level.

Keith considers that the whole issue is too complex to be covered in the slightly confrontational style here but I would counter that rescuers are faced right now with a legal/liability/insurance issue which cannot wait the length of time it would take for the usual bureaucratic processes. During the proofing of this article we therefore decided to run this as a debate so that we can address some of the issues now rather than wait for the next issue. Your comments are most welcome. - Ade Scott

INTRODUCTION
K: Early in 1995 a strange mark began appearing on products used in sport and industry (and rescue). manufacturers of all kinds of safety related products were preparing to meet the requirements of EU Health and Safety Directive 89/686. From the 1st of July in that year it became illegal for manufacturers to sell Personal Protective Equipment (PPE) without a CE mark. What does this mean? Well, PPE is defined as equipment worn or held to protect against hazards. And a CE mark indicates a product meets the requirement of the Directive. Broadly speaking, this means it must satisfy general health and safety requirements: give adequate protection as intended, be comfortable, compatible with other items, be issued with user instructions, be manufactured under a process controlled by a quality system, AND conform to any EN standards, IF they exist for the PPE in question. It is possible to CE mark a product for which no standard exists if it satisfies the general requirements of the Directive.

When the EN standards were drafted for items used to protect against falls, a distinction was made (rightly or wrongly) between similar products used for sport or industrial purposes. Karabiners are a good example. 'Rescue' was not identified as an activity requiring a set of standards in its own right and there is a case to be made for not doing so. Paradoxically, there is a debate at the moment as to whether products intended for rescue should be classified as PPE at all. Confused? So are we all, and it is still the case that few manufacturers distinguish between products intended for single or multiple person loads. However, the 'nature' of the CE mark is perhaps not important. All CE marked equipment is issued with clear user instructions and these give performance characteristics of the item, indicate its behaviour when used in conjunction with other items and, importantly, usually indicate dangerous methods of use. Most rescuers should be competent enough to judge whether the loads which might be placed on equipment in a given situation are excessive. If this might be the case, the system should be rearranged so that excessive loads do NOT occur. It could (and should) be said that one of the primary goals during a rescue should be to eliminate the possibility of excessive loading occurring within the system.

A: But we need to differentiate between the general CE marking of a product (which has much to do with quality control procedures) and the product's strict adherence to a specific EN standard. Many products carry a CE mark but no identifying EN standard because there is no current standard. The examples used in this article will refer to rope rescue products but the principles will be true in many other areas of rescue.

The question is; if you purchase a piece of equipment with a CE mark and compliance with an EN standard is that EN standard actually relevant to your requirements - eg. is the ascender certified for only that activity or is it suitable for use in hauling systems or as a tensioning device and is it acceptable for two-person loads? Rescue itself is a grey area for the standards committees and has yet to be fully addressed, indeed it is now looking as if rescue items may be specifically precluded from standards and certification requirements.

K: If rescuers feel that the ENs are insufficient to describe their needs they could put forward a case explaining why these standards are deficient and suggest criteria against which a 'rescue' harness might be judged. In many ways 'rescuers' are in an identical situation to all persons who work at height, all of whose equipment might be called upon to perform a rescue function. But it might be worth waiting for the outcome of the PPE / non debate currently taking place within CEN committees.

A: At the moment European rescuers are unable to purchase or use products without a CE mark and this means that many small specialist items from small specialist companies, particularly outside of Europe are prohibited. Many folk feel that this is fair enough arguing that if the product is good enough and if the manufacturer were keen enough on entering the European market they would stump up the money, meet the necessary quality control criteria and have the equipment tested to the relevant standard. This is questionable since the outlay for each product is not inconsiderable and the rescue market, as compared to the sport and industrial market is relatively small. Also a product's country of origin will almost certainly require adherence to their own standard which is a cost in addition to that required by European Norm Standards so it is never simply a case of paying for one standard since they are rarely mutually regarded.

K: When a European standard is accepted, it becomes what is known as 'harmonised'. This means it is accepted by all EC member nations as equivalent to their own national standard. This has meant that the concept of national standard has to some extent become meaningless as far as equipment specifications are concerned - Europe is singing from the same song sheet. This is unfortunately not the case for non-European manufacturers who could be faced with the requirement to satisfy two standards.

A: Regardless of how or why a non-European manufacturer has decided not to attain CE conformity the user could be deprived of a vital piece of equipment or at the very least equipment which is superior to that which is available with a CE mark. Rescuers can get around this by arranging their own risk assessment and testing program in order to prove the products ability to function for the use to which it is going to be subjected. But this is time consuming, will probably incur additional expense, requires a degree of expertise and may be difficult to convince senior officers or those holding the purse strings that this is preferable to buying products already CE marked. Before Petzl bought Rock Exotica it was not possible to buy a smooth profile cam with a CE mark despite the fact that these are the only devices able to handle high loads (hauling and tensioning). We could, however, happily purchase any of the toothed ascenders because there are many with a CE mark and compliance to EN567 which bears no relevance to high load rescue work! One of my key concerns is that litigation and accountability in rescue is overtaking the 'Good Samaritan' defense for rescuers. In the event of an accident either operationally or during training any lawyer worth his salt is going to ask - why were you using that piece of equipment? Was it designed for the use to which you subjected it? If not did you test to see if it could cope? Does the manufacturer support your use of it in this manner? Was there a more suitable piece of equipment?

DOES RESCUE EQUIPMENT NEED TO BE CE MARKED?
K: The Personal Protective Equipment Regulations 1992 specify that all PPE used at work must carry the CE mark. It is likely that a large majority of rescuers would be classified as at work.

A: Still the subject of some debate but I would say essentially NO. There are two reasons for this - firstly rescue equipment may soon officially be classified to be outside the remit of the whole CE process and therefore any suitable rescue equipment may be used by rescuers. And secondly it is already the case that a rescuer can use non-CE marked products providing they can show that it is suitable for the purpose.

K: It is possible that the HSE might not disapprove of the use of non-CE marked items provided it could be shown they are fit for purpose and provide a reduced risk in comparison to a similar CE marked item.

A: This could be problematical in that it may involve some testing of the product and there may be a time and cost implication unless specific testing has already been undertaken by the manufacturer. SRT in Australia for instance already publish test results for rescue loads and will fully support their product's use for rescue. Keith believes that risk assessment alone without full testing may be sufficient but we would need to see something in writing from HSE to provide true legal protection. Nevertheless with the above points in mind I would contend that any organisation currently requiring that only CE marked products be purchased are acting only in accordance with their own protocols and not necessarily a national safety requirement.

K: The phrase 'organisation's internal protocol' is meaningless in the UK when discussing the Personal Protective Equipment at work regulations. Protocols cannot rescind national laws!

A: Possibly naïve but surely it must if national law does not take account of a special circumstance eg rescue. A lawyer would hopefully be able to answer this but I suspect that it would have to go all the way to a court decision for true clarification.

To add to the confusion there is also a loop-hole allowing use of non-CE marked 'components'. A component is part of

an overall CE marked system and in this way individual items such as pulleys or descenders can be introduced onto the market as part of a hauling system or an emergency escape system. Once purchased however, the component should not be used outside of the system.

K: Non CE marked components can only be used in a system if the whole system is CE marked

A: Another question for European rescuers purchasing only CE marked products is, are you buying the best tools for the job or are you being forced to purchase inappropriate or even inferior items? Were it the case that products across the world carried the CE mark unless they were of insufficient quality or functional ability to comply this would be an excellent arrangement but like the superior Betamax video format it'll only be a winner if everyone plays. If we reach a saturation point where everyone who's going to comply has done so and we still have 40% of world products outside the fold then rescuers or more importantly their 'rescuees' are getting a bum deal. And it is clear that rescue as a distinct

discipline from industry and sport is not being properly addressed in the establishment of EN standards. Indeed it could be said that there exists the potential for catastrophic equipment failures if rescuers purchase and use equipment which meets such sport and industrial standards without addressing the outer envelope loading potentials which exist in rescue.

ASSUMPTION IS THE MOTHER OF ALL...
Perhaps the biggest problem is that some are under the impression that if a product has a CE mark their organisation is legally 'safe' to use that equipment for rescue. This is clearly nonsense, in fact it is dangerous nonsense. Take the case of the Petzl Shunt - a rope safety device with a CE mark (pertaining to an ascender standard not a fall arrest standard) which is in use with a number of UK Fire Service teams as a second line backup device. The Shunt has never been sanctioned for rescue use by Petzl and nobody is ever going to stand up in a court of law and defend its use for rescue. If your organisation uses a Petzl Shunt as a back-up to a possible two person load you are contravening the manufacturers intended use and if you have an accident you are exposing your organisation and perhaps individual rescuers to litigation. This is not the only example but it is particularly evident in rope rescue and it is not the fault of the manufacturers. In this instance it is the training agencies which have picked up on equipment or techniques without fully investigating the consequences of worst case scenarios and have passed these on to their classes safe in the knowledge that a CE mark is all that is demanded of the end-user. To a new recruit the training agency is God and anything they pass on will be taken on board and accepted as gospel. The Shunt is a good example - but don't get me wrong, I have always advocated a degree of acceptable risk in rescue and I believe that the Shunt represents an acceptable risk (purely in terms of the likelihood of it failing when subjected to a rescue load - I have other reservations about its use in rescue). It is simply that we can longer accept such risks on legal grounds which expose the user, team/service or maybe even the original training agency to damaging litigation.

K: I fully agree that training agencies must be fully aware of the loading parameters of the equipment with which they train, but there is a limit to which a training agency can be 'expert' above and beyond the prevailing wisdom of the time. The choice of which item to use for a particular purpose is informed by many influences; common usage, historical trends, performance tests, manufacturers instructions and various interpretations by users and rescuers so we all contribute to the learning process and we all tend to choose the items which are probably best for the job. The HSE would probably describe this approach as 'goal orientated' the goal always being the reduction of risks. Guidelines are not always as clear as we might wish.

A: The CE mark is unquestionably a valid indicator of minimum quality despite what the official definitions say - ask 90% of rescuers and they'll say that they're buying CE marked gear because they think it meets a certain quality standard. This may be true to some extent albeit accidental but even with a CE mark your equipment still needs to be tested for rescue use or more particularly the specific use to which you're going to put it. If you can get the manufacturer to undertake this testing on your behalf or to put in writing that it is suitable for the use to which you are going to put it (making sure to include all worst case scenarios which is where failures are most likely to occur) then it does not matter whether the equipment carries a CE mark or not. Remember a CE mark will not cover your butt in the event of an accident and subsequent court battle unless it can been additionally supported by rescue relevant testing and data. If the manufacturer will not support your use of their device then you cannot use it CE mark or no CE mark without comprehensive self testing.

K: the common spectre of 'court battle' is not really a good arguing point. There are few if any such battles and the courts will probably be more interested in suitability for intended purpose than in a marking?

A: I hope you're right. But the last couple of years has seen a radical surge in negligence awareness - take for example the number of advertisements by law firms asking "have you been involved in an accident - if so we can help you get compensation" . Now we are exposed not only to litigation from a casualty or a casualty's family which is indeed a rare event but from team members themselves who may be injured during training or on jobs. Up to now we've relied on good will but I do not believe that the spectre of court battle is an invalid arguing point. I believe it is a very real risk and so must many other rescue agencies because we all seem to be filling in masses more accountability paperwork these days than we did just a few years ago!

K: This debate arose accidentally from a proof reading exercise but I think it is an excellent impromptu way to open the worm can. I hope we can burrow into these complicated issues in more detail in the future.