Breach Of Patients Safety By Using Of Medical Devices - Essay Example

How Patients Safety Is Compromised With The Use Of Medical Devices. Medical technology has undergone a sea change in the last two decades. With the aid of these, the previously fatal conditions are no longer fatal, and technological expertise applied through innovative devices now can do wonders. Consequently medical devices have become important parts of deliverables in medical care. With these, the critical care medicine has become very technically wonderful, but it is becoming increasingly dependent on medical devices and in many cases, the result is very promising in the sense that health of the individual and life of a critically ill person are saved by the use of these devices. Health Minister Lord Philip Hunt said “Medical devices play an increasingly important role in looking after patients wherever they are cared for. The booklet “Equipped to care” provides practical information on medical devices for health professionals, who will enhance patients care” (Department of Health 2000). Demographic factors, changing illness patterns and the concept of patients as consumers of healthcare will act as a driver to the delivery of care, where sophisticated device usage will become increasingly routine (Department of Health 2002). Medical devices have moved from being tools to support clinical practice to being an integral requirement in treatment delivery (Quinn 2000). However, use of medical devices is not entirely free of risk since sometimes they malfunction, or sometimes clients may have increased suffering from their misuse. Over the past 20 years, there has been significant development around medical device safety, from MHRA and the Department of Health. However, in the later years, available studies have been limited. Research articles were published in the early stages of development on the safety of use of medical devices and were reinvestigated some years later, in 2001 – 2003. For some time, there has been a shortfall of ongoing research, and tremendous advances in medical equipments at the same time, previous research were deemed unreliable. It is perceived that major devices of the earlier time are now considered as minor. The major devices being studied today would not have been foreseen in previous years. The evolving complexity of devices and the need for training have been highlighted (MDA 1998 cited in Quinn 2000). An example from Maidstone and Tunbridge Wells NHS Trust back in 1995 plastic tongue thermometers were used, and now, they have been replaced with tympanic thermometers. This essay will focus on the strategic importance of training around the modern day medical devices in an emergency care centre, analysing the research involving the given topic and degree of needing to change/to make changes. The term “medical devices” are all products, except medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability (MHRA, 2008). There are approximately 1,800 categories of devices, these categories host 10,000 medical devices with a potential of over 400,000 devices on the market at any given point in time (Pammolli et al 2005 cited in Weir) (please see appendix 1). This demonstrates the need of training and need for applications of strict principles of safety in practice. If the medical devices are used incorrectly, the resultant outcome can be fatal or at least may compromise the wellbeing of a patient. Due to the vast number of these available devices, their complexities and categories, the safety practice involved in this vast array of all medical devices, there is a dire need of the magnitude of training and competency of using such devices. The history of medical devices evolution and regulations related to the usage of these began in the mid 1990’s – a Europe-wide initiative. The Department of Health took great care in setting up the improvement of the safety principles and quality parameters of medical equipment. This was done by the subcommittee of the Medical Devices Directorate (MDD). Following this, it became the Medical Devices Agency in 1994, which then merged with its medicines counterpart in 2003 to become the MHRA (Medicines and Healthcare products Regulatory Agency). The role of the MHRA was to protect and promote public health and patient’s safety. This highlights the need for development regarding medical devices, as it has its own agency to address the ever growing advancements in this area. In 2000, the first ever booklet on medical devices was published “Equipped to care”. The booklet highlights roles and responsibilities of the healthcare professionals involved in safety principles with the use of medical devices. The other purpose of this booklet is to effectively support patient care and treatment (Department of Health 2000). The booklet was published as a guide around the subject “The safe use of medical device in the 21st century.” It stands alone as just a guide. However, it offered suggestions of areas that needed to be addressed to make a safer workplace but fell short on implicating how the suggested improvements could be implemented in practice. Although the booklet was published with good intentions when it was published, on distribution, it reached management/Trust board level, but failed to reach the shop floor the target user of the guide. As a professional in a very busy emergency care centre, this author has interacted with many colleagues in the department, and it is surprising to note that not one person was aware such a booklet existed. The National Health Standard Litigation Authority (2008) risk management states that “Any person operating diagnostic or therapeutic equipment must have a significant understanding of its use to do so in a safe manner.” As a result due to these shortfalls, the Trust is putting together a training package for every member of staff to complete to run alongside the “Equipped to care” booklet to meet the suggested guidelines. One must take part in appropriate learning and practice activities that maintain and develop the competence and performance (NMC 2007). The training package that has been developed by this author by using a template designed by the Trusts medical devices group (2004, see appendix 2) for the department will be aimed at those medical devices that are not self explanatory. Some examples of such devices are infusion pumps, ECG machines and the like. These devices if used incorrectly could have fatal consequences. Lack of training is identified as a significant cause of device related adverse incidents (Quinn 2000). The medical devices such as the application of a bandage or plaster (non-life threatening) will not be included as they are self explanatory and is a versatile piece of equipment. Each piece of equipment will have a competency chart, which will cover the understanding of its use, the interpretation of its results, and the maintenance of the piece of equipment. To be competent one must demonstrate that he/she possesses the knowledge and skill required before using a device (Quinn 2000). To produce the above, the package will have to be verified by the trusts medical devices group to make sure it meets the required standards. Users of equipment should be asked to sign statements confirming that they have received and understood written and/or verbal instructions, and these should be maintained updated in case a legal case is brought against the use of such devices in case of a fatality (MHRA 2006). This in its self has drawbacks as every department/ward has been left to its own conclusion as to what questions need to be addressed to deem the user as competent, thus making a lack of continuity and uniformity of policies across the trusts. Another shortfall in developing individual training package within the department is that each training package has to be designed for each individual specialist area. What might be considered a highly complex piece of equipment in one environment might be considered routine ‘bread and butter’ equipment in another (Equipped to care 2000). The whole medical devices training programme for the trust will be an extensive product. The training will collaborate all the information gained about certain pieces of equipment to equip the user with a holistic overview of the device used. In a hypothetical statement the equipment a healthcare professional uses, the professionals will have to be an advocate for its correct and appropriate usage, and that is where the training staff needs to be questioned on equipment usage. The Staff needs to be diligent about continuing to use the devices in the way they were taught and not to use medical devices for something other than their intended use. Nurses can avoid common clinical problems with devices by understanding their proper use and the condition in which devices are not considered safe (Wagner 2002). As professionals, the nurses should be able to understand the equipment from the beginning to the end of its stage with the patient involved in needing to use it. Nurses’ responsibility does not end when their patient is no longer using a device. It is their individual responsibility to ensure that the correct procedures are followed (Murray 2001). This is applicable in the ways that the device is maintained, decontaminated and stored safely in the correct manner in which the standard of training has been set, since it is assumed that in the event of an emergency, equipment will operate as we expect it to do so (Murray 2001). In this model within the training, opportunity will be provided to prevent any misinterpretation of the required information to make the device work and how to use it effectively. The truth is that many of the technical functions of devices are not fully understood by nursing staff (Quinn 2000). On the other hand, with active demonstration every user will fully understand what the trust requires to deem a user as competent and safe, and not what the user considers as safe. The most frequently identified methods of initial learning were trial and error (self taught) and reading the user instruction manuals (McConnell 1995). Therefore, a benchmark has been set and continuity will flow through the trust. With technology changing faster than ever – instead of having one device to perform one task, an individual device can multitask to save time and money. Sometimes with this kind of instrument, safety could be compromised if users are unfamiliar with its numerous functions, results/readings and settings. The nurses must recognise these and work within the limits of their competences (NMC 2007). With the technological advances of programmable devices, human factors are more likely to cause device use problem (Wagner 2002). If a member of staff has not had training in all aspects of a particular device, they may unwillingly activate a section of the device which could cause harm to the patient. The fault most often lies not with the device itself, but with the professional who is managing it. It is essential that staff understand the function of any device before they use it (Health and Safety at Work Act 1974 cited in Quinn 2000) At least 90 % of respondents from a survey from a tertiary care hospital in a large Midwestern city indicated that when they first learned about the medical device, they learned how to operate it and its purpose and function (McConnell 1995). This survey shows that 10% of staff were unsure or had insufficient training of one form or another. This is unacceptable as any member of staff attempting to use a device on a patient should fully and completely understand its operation. Training should include technical and clinical needs of all medical devices. Understanding the technical risk associated with the use of devices enables the nurse to manage care safely and effectively (Quinn 2000). They should include understanding the principles underlying the use of devices, familiarity with the practical aspects of the devices they are likely to encounter and competence assessed in relation to the safe use of devices (MHRA 2008). NMC 2007 states that “You must have the knowledge and skills for safe and effective practice when working without direct supervision.” However, the trust has a legal obligation to provide necessary training in terms of both visual and documentary evidences. Good records are important in effective device management (MHRA 2008). Having the opportunity to integrate both theory and practice in teaching/training sessions, the nurses then become a competent practitioner (Morgan 2005). In spite of this, evidence will only be valid from the day it is assessed, and hence there would be no guarantee on another day and time the users will not commit an error, since there may be external and environmental factors which could inhibit the users’ performances. The variables are the physical and mental states of the user and teacher and anxiety levels and home/work circumstance depending on the acuity of the patient treated. Medical device use can cause more than 75% of staff nurses to feel stressed (McConnell 1995). Nevertheless if a learning environment is not of an optimum standard, it can inhibit the whole learning process (Boud 1988). A time and a place away from the department should be allocated for initial training of a medical device; this gives opportunity for a group discussion, role-play and hand- on exploration without interruption or pressure from the department. This will coincide with MNC 2007 standards of conduct, performance and ethics, which suggests working effectively as part of a team. The nurses must be willing to share their skills and experience for the benefit of their colleagues. However, in practice, medical devices are used when professionals are under pressure from workloads, and this in itself is a potential cause of an accident to happen. It was suggested that all nurses, even those who would not normally handle a pump, should receive basic skills training, so they would know how to cope in an emergency situation (Richardson 2003). NMC states that “You must keep your knowledge and skills up to date throughout your working life.” The procedure for prevention of the above is for the trust to maintain continuous assessment to make it a valid tool for usage. This is an ongoing process and needs to be achieved by the trust on an annual basis; however, to make it completely valid, training should be performed under different circumstances to make sure the performance remains at an optimum level of safety. On reflection, this cannot be seen as practical because the training will be a long drawn out process, and each individual works under different levels of pressure. Also practically where annual training is undertaken, there is nobody to assess the competency of the assessor, as once the device is installed in the department, it is not up to the manufacture of the device to ensure standards of competency in training are adhered to. Regardless of thorough training and user cautions, medical device use problems happen and harm for the patients may result. Human error can occur when psychological and physical human factors, such as stress, interruptions and information overload are involved during medical device usage (Wagner 2002). Patient’s safety is not merely protected from the department/ward through teaching. It is addressed on a managerial level through application of managerial principles. The trust is liable to cover the medical device issue – they produce the policy which nurses follow, but in addition, they cover the underlying issues such as guide/deal with maintenance of medical devices, purchasing and risk management. Minimising the risk with medical devices is dealt by using a systematic approach to purchasing, deployment and maintenance, repair and disposal of medical devices – meeting appropriate standards of safety, quality, performance and effectiveness. It is increasingly evident that unless healthcare organisations start to address risk management issues, significant financial penalties might be incurred, not the least through medical negligence claims (Bourn 1997, Spring & Prince cited in Quinn 2000) The Trust across the board have limited the types of devices that can be purchased and used, so they have hold of overall safety and standards, and they can be maintained. The MDA has published comprehensive guidance on rationalising a number of different devices (MDA 1998 cited in Murray 2001) and encourages limiting the number of devices used. The MHRA guideline allows health care organisations to make their own selection of medical devices for different procedures. The selection can only be made by the staff who are appropriately trained. This is done to prevent inflexibility in any other member of staff choosing the most suitable devices for its purpose. If all these can be adopted, then staff and the Trust are seen to be proactive in preventing harm from medical devices. However, each year about 400 people are killed or seriously injured in adverse incidents involving medical devices. In any hundred reports involving pumps, nearly half are of over-infusions, with 80% due to user error rather than a fault with the device (Equipped to care 2000). This can lead to a serious deterioration in health of the patients, the necessity for medical and surgical intervention or unreliable test results which could lead to an inappropriate diagnosis. The consequences of these incidents can be devastating for the patient and their families as well as for the health care professionals involved (Murray 2001). An adverse incident can arise from shortcomings in the device, its accessories, its operating instructions, user practice, servicing and maintenance and conditions of use (MHRA 2008). Quinn (2000) states that the risk, function and management issues associated with devices need to be viewed collectively if safe practice is to be achieved. Healthcare professionals have the expertise to improve patient care by reporting actual and suspected problems with medical devices (White et al., 1998). Professionals are at a point and position to actively monitor, report problems and adverse incidents related to medical devices, thus playing a critical role in ensuring patient safety (Beyea, 2002). Nevertheless, staff can only do this if they are aware when things are wrong. Another possible reason for suspected underreporting is the ‘fear factor’ – disciplinary action, the traditional response to mistakes, is counterproductive in such circumstances (Quinn, 2000). This is where education and continual assessment play important parts. The primary causes of incidents with medical devices include inappropriate management procedures and use, inadequate instructions, servicing, maintenance, training, documentation such as missing service history, incompatible ancillary equipment such as leads and infusion sets, shortcomings in the manufacture and lack of policies for disposal and replacement (MHRA 2006). Staff is accountable for reporting and identifying faulty equipment. NMC 2007 states that “you must act without delay if you believe that you, a colleague or anyone else may be putting someone at risk.” In Maidstone emergency care centre, to the best of this author’s knowledge, there has been no recollection of any adverse incidents with a medical device. It is reassuring to know this; however, it could stem from the fact that the staff may be unaware of reported incidents or how to report an incident or what needs to be observed to then be able to report an incident or it could be due to insubordinate staff that are becoming slapdash in their approach and put the equipment in the corner and wait for someone else to sort the problem out. This then has repercussion that patient’s safety is at risk as an underlying cause for not functioning efficiently has not been rectified. As professionals, the nurses are personally accountable for actions and omissions in their practice and they must be able to justify your decisions (MNC 2007). Undoubtedly this is prevalent in the department due to work pressure, lack of spare time and other priorities taking precedence. Staffs do put signs on equipment with “not working” or “broken” but this statement is lacking in vital information to get the equipment repaired/rectified. The problem may be something very simple which could be resolved and out in the department serving a patient instead of sitting dormant. This is where the training in checks and maintenance on a basic level is paramount, especially more so when the issues with faulty equipment arises out of hours. The safety features on many devices are usually enough to ensure that most problems associated with equipment are prevented or addressed (Quinn 2000). There is no set solution for this problem as every individual department is responsible for decontamination of equipment, reporting and safe guarding whilst awaiting collection for repair. The best possible solution may be a central holding area where faulty equipment can be stored until collection. The department sending the equipment for repair must fill out an online or hard copy form of decontamination, name of professional delivering the equipment, the problem (which could be tick boxes) and the department sending it so the maintenance team can follow the equipments history and contact for more information if necessary. But to achieve this, it would cost money, but in the long run, lives could be saved and legal cost reduced. In addition to this and to enable the maintenance team/infection control team to review past history of the device, a bar code system could be introduced to the device which could be scanned and the entire history could be retrieved from a computer database. Records should provide evidence of what the device is and where it came from, its serial number/batch number, the maintenance record and any training carried out on how to use it properly (MHRA 2008). With the computer database, it should also include a copy of the manufacturer operating manual, as instruction should be available at all times (Murray 2001). The staff would be responsible for entering the patient’s hospital number who will require the use of the device. The staff using the logging system would also be required to scan a barcode which is personal to them. This barcode would contain information relating to the member of staff. It would also include whether the staff was trained and signed off as a competent user, or if found to be the cause of a fault on a certain device through the misuse. It could highlight the need for additional training and the department involved could be subsequently billed for the repair cost. However, it would not stop the staff member from using the said piece of device but it could alert a member of the device management team to follow up and train the staff involved if necessary. This system is already in practice using a barcode reader within the emergency care centre at Maidstone with a departmental blood gas machine which is used by the whole hospital. Due to the high volume of traffic using this machine because of its availability (by using the temporary access barcode), untrained professionals are attempting to operate this device and the consequences are that its being damaged on numerous occasion rendering the device useless and patients health is at risk through lack of diagnosis results. The temporary access barcode was initially set up for a short period whilst training was undertaken but as the training uptake has been poor due to staff attitude, time constraint and availability of the trainer, this has prevented the removal of the barcode rendering the barcode system open to exploitation. It’s indisputable that to safeguard a staff-patient relationship, there is a fundamental requirement for the prevailing needs to develop appropriate training strategies, thus encountering gray areas with some medical devices where there has been inadequate or non-existent information. Providing a high standard of practice and care at all times (MNC 2007) will have a positive outcome with all involved in the standardized delivery of care and to control negligent payments. Staff need to be assertive and competent in their work conduct and question where necessary. They will become a confident, competent and skilled professional user with selective medical devices in their work environment. Read More