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How can hospital beds support nursing staff in the ICU?

Article-How can hospital beds support nursing staff in the ICU?

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The ICU is one of the most challenging places to work in a hospital. Caring for and treating critically ill patients is as emotionally demanding as it is physically straining. Burdened with serious illnesses, patients in the ICU often need more attention than patients on regular wards. The nursing job has been complex and stressful before the Covid-19 pandemic started. However, since 2020, the challenges faced by ICU staff have increased exponentially.

While the number of Covid patients in ICUs across the world has been rising, especially during the 2nd and 3rd waves this past winter, staff still has to care for their “usual” patients with strokes, heart attacks, etc. on a daily basis as well. Many challenges in the ICU are based on the shortages of staff and protective gear and a hospital bed can not solve these fundamental problems. However, a hospital bed with the right functions can relieve nursing staff of some of the physical strain and stress in their day-to-day tasks surrounding the patient in bed.

Calculating the correct medication for the patient’s weight

Before administering medication to a patient, it is imperative to calculate the correct dose. For this, nursing staff needs to know what the different measurements used for drug dosages in healthcare are and how to convert between different units. However, that is not all, as medications can also be prescribed according to a patient’s weight.1 This will require additional calculations, but first poses the question: How much does the patient weigh?

A 2016 study showed that almost 20 % of patients are given a dose of medication that deviates from the recommended dose due to their body weight being incorrectly estimated.2 It would, therefore, be helpful to be able to determine the patient’s weight quickly and without strenuous repositioning. The new ICU bed Sicuro tera by Stiegelmeyer offers an optional integrated scale that determines the patient’s weight to the nearest 200 grams, if needed even to the nearest 100 grams. Treatment can progress unhindered, and the appropriate medication can be determined without any time-consuming weighing procedures or rough estimations.

Placing machines, wires and tubes where they are needed

In most cases, a patient in the ICU is connected to several different machines and devices with wires, tubes and cables to allow staff to monitor and track his/her progress, and to keep the patient alive. These may include ventilators, ECG devices, dialysis machines, monitors and syringe pumps, for example. And while some procedures take place in the patient’s ICU room, there are also incidents where a patient must be transported for a test, such as a CT or an MRI. Here it is important that portable devices that are critical for the patient’s treatment can be attached directly to the bed.

Stiegelmeyer’s ICU bed Sicuro tera has standard sliding rails almost all around the bed’s frame. Thus, attaching the needed equipment is not a problem. Numerous Stiegelmeyer accessories are also available to further assist with the attachment of medical equipment.

Physical strain

Positioning patients appropriately, especially if they are immobile, can be extremely strenuous for nursing staff. The most time-consuming task might be turning the patient from one side onto the other, to relieve the lungs and prevent pressure sores. In difficult cases, this may require up to five nurses and take several minutes – especially when numerous tubes and cables have to be attended to in the process.

In order to turn an immobile patient on a horizontal surface, nursing staff have to bend forwards and apply a great deal of force to either pull the patient towards them or push the patient away. The resulting strain applied to the nurse’s spine and back muscles is very unhealthy. Nurses suffer more from back disorders than any other occupational group – up to 75 % of those questioned in studies complained of pain. And the 2019 Health Report of the German health insurance company Techniker Krankenkasse stated that 20 % of sick days among nursing staff are due to disorders of the musculoskeletal system.3

However, the lateral tilting capability of the Sicuro tera ICU bed allows ideal positioning of the patient. Nursing staff can work in a more back-friendly and efficient way as the tilting mattress base takes over the task almost completely. It helps to turn the patient, even if he/she weighs up to 250 kg. If equipped with the optional double foot switch, the Sicuro tera bed makes positioning an ICU patient even more comfortable. While the nurse is adjusting the bed position, e. g. height or lateral tilt, with the foot, he or she has the hands free to look after any tubes and cables and to support the patient’s body if needed.

Emergencies

The day-to-day work on the ICU involves many stressful and emergency situations. A patient’s condition may deteriorate quickly at any moment, calling for almost immediate action. According to the current European Resuscitation Council Guidelines “defibrillation within 3–5 min[utes] of collapse can produce survival rates as high as 50–70%”.4 When the alarm sounds, it is therefore important that staff can quickly start CPR.

“The American Heart Association (AHA) 2010 guideline prioritizes placing the patient in the supine position to perform optimal CPR.”5 The mattress base of the ICU bed, therefore, has to be brought into a flat horizontal position with the safety sides lowered to grant optimal access to the patient. The Sicuro tera ICU bed allows staff to react in a rapid manner without much effort. The Protega safety sides can be lowered with one hand without any complicated mechanisms or catches. The mattress base automatically moves into the resuscitation position when the CPR buttons are pressed – almost twice as quickly than conventional hospital beds. Alternatively, it is also possible to lower the backrest manually by operating the emergency lever. The quickly removable headboard allows unencumbered access to the patient.

References

1 Wright K, Shepherd E (2017) How to calculate drug doses and infusion rates accurately. Nursing Times [online]; 113, 10, 31-34.

2 Barrow T, Khan MS, Halse O, Bentley P, Sharma P. Estimating Weight of Patients With Acute Stroke When Dosing for Thrombolysis. Stroke. 2016 Jan;47(1):228-31. doi: 10.1161/STROKEAHA.115.011436. Epub 2015 Nov 10. PMID: 26556826.

3 Dr. Thomas Grobe, Susanne Steinmann, aQua – Institut für angewandte Qualitätsförderung und Forschung im Gesundheitswesen GmbH, Göttingen. Gesundheitsreport 2019 – Pflegefall Pflegebranche? So geht’s Deutschlands Pflegekräften. Published by Techniker Krankenkasse

4 Gavin D. Perkins, Anthony J. Handley, Rudolph W. Koster, Maaret Castrén, Michael A. Smyth, Theresa Olasveengen, Koenraad G. Monsieurs, Violetta Raffay, Jan-Thorsten Gräsner, Volker Wenzel, Giuseppe Ristagno, Jasmeet Soar, on behalf of the Adult basic life support and automated external defibrillation section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015 Section 2. Adult basic life support and automated external defibrillation

5 Anez, Cristobal MD, PhD*,†; Becerra-Bolaños, Ángel MD; Vives-Lopez, Ariadna MD*,†; Rodríguez-Pérez, Aurelio MD, PhD‡,§ Cardiopulmonary Resuscitation in the Prone Position in the Operating Room or in the Intensive Care Unit: A Systematic Review, Anesthesia & Analgesia: February 2021 - Volume 132 - Issue 2 - p 285-292. doi: 10.1213/ANE.0000000000005289

Medical gas: sustaining life 

Article-Medical gas: sustaining life 

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Medical gases are being used in a variety of clinical settings, and their piped administration is a significant step forward in patient care. In the design, installation, commissioning, and operation of medical gas pipeline systems (MGPS), patient safety is paramount. The system must be operational 24 hours a day, with virtually no downtime, and its failure can be hazardous if not restored as soon as possible. There is a lack of knowledge among practitioners about the medico-legal implications of the MGPS. It is a highly technical sector; therefore, in-depth expertise is required to assure system safety.

According to an article published by the Journal of Anesthesiology Clinical Pharmacology, gas pipeline breakdowns have been documented several times in the anesthesiology literature. Petty looked at pipeline-related mortality in the United States from 1972 to 1993 and found 26 deaths caused by crossed pipes, faulty connections, and supply errors.

The Anesthesia Patient Safety Foundation conducted a study that revealed a large knowledge gap among anesthesiologists about medical gas pipeline systems (MGPS), and a thorough grasp of information is required to ensure the system's safety. Several medico-legal cases over the last decade have compelled doctors to turn their attention to the system's practical direction. As a result, upholding safety requirements is critical from the main source in the manifold room through the final distribution point.

National Fire Protection Association 99 (US) and HTM 02-01 are the two main MGPS standards (UK). The International Standards Organization, the Compressed Gas Association, the Canadian Standards Association, and the British Standards EN 737 (BS EN 737) are among the others. Pipes should have Lloyd's certification according to BS 2871 and cylinders should fulfill American Society for Testing and Materials requirements.

The manifold room, which should be manned by qualified workers 24 hours a day, is the heart of the entire system. It should have an appropriate acoustic containment, as well as 100% generator backup and fire protection. In the case of an emergency, the site should be prominently marked for easy identification. It holds the control panel, which permits a flow rate of 3000 L/min at 4.1 bar from the vacuum insulated evaporator (VIE) and sends alarms to secondary panels positioned throughout the hospital.

Oxygen

Any medical unit's basic requirement is a constant supply of oxygen. There should be three separate supply sources, according to BS EN 737-3:2000. Primary, secondary, and a reserve source sufficient to fulfill demand if primary and secondary sources fail.

Two banks of D-type cylinders, each carrying a minimum of two days' supply, should be connected to a fully automated changeover control panel in the manifold room. As a fallback option, three days' worth of consumption should be maintained on hand.

Higher filling pressure is possible with aluminum or steel cylinders with a Kevlar or Carbon fiber outer shell, allowing for more storage. Cylinders should be checked every 5 years by the manufacturer. Furthermore, oxygen concentrators or pressure swing adsorber systems can provide FiO2 levels ranging from 0.95 to 0.97, with a paramagnetic oxygen analyser monitoring the levels.

Liquid oxygen is a cost-effective and simple way to store oxygen. The cryogenic liquid is kept in a VIE, which is generally 5 or 10 liters in size, though smaller Cryospeed™ vessels are also available.  After receiving regulatory permission from Nagpur's Fires and Explosives Act office, VIE should be installed in a high-security and fire-safe zone.

Compressed Air

It's utilised as a driving power for pneumatic drills (surgical air) as well as an inhalational gas (medical air). The plant must maintain a 3 KL/min flow at 8 bar, then lower the flow as needed. A flow rate of 80 L/min at 4 bar is required for medical air, while 350 L/min at 7 bar is required for surgical air.

The medical air quality should satisfy the European Pharmacopoeia's guidelines, which limit carbon monoxide levels to 5 ml/m3. Integral dryers, filters, and a dew point sensor keep the humidity below the 67 ml/m3 standard.

Vacuum and Anesthetic Gas Scavenging System

According to the Control of Chemicals Dangerous to Health Regulations 2002, anesthetic gases are substances hazardous to health unless they are provided to a patient in the course of therapy. A vacuum pressure of 300 mmHg is required at the terminal unit, with a flow rate of 40 L/min.

Both systems' exhausts should be carefully positioned away from windows and air compressor and ventilator intake. Anesthetic gas scavenging systems should include a canister system that catches wasted gases, filters them, and recycles them to reduce the greenhouse effect of anesthetic gases.

Overutilisation of healthcare services

Article-Overutilisation of healthcare services

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One of the biggest impediments for the delivery of high-quality healthcare is the prevalence of overuse/overutilisation of medical services. Overuse of medical services is identified as the top factor driving up medical costs and whilst the full impact of the pandemic is yet to be realised, medical costs in the GCC region are expected to be more than 8 per cent in 2021 (Willis Towers Watson, 2020).

Browsing through public media in the GCC region, supports the claim that local healthcare market suffers from significant high level of overutilisation, waste and abuse:

“The UAE Ministry of Health conducted a survey revealing that 28 per cent of respondents had been advised to undergo unnecessary tests, designed to inflate provider bills” (Stirzaker, 2017)

“UAE Authorities estimate around 5 per cent of claims are a result of abuse or fraud and are pushing up the cost of insurance premiums by 20 per cent to 30 per cent” (Willis, 2015)

Overuse occurs when doctors admitted patients when this may not be required, keep patients in hospital longer than may be needed, use a higher level of care than may be indicated as well as order greater numbers of often more expensive tests than are medically necessary. Some practices in particular drive-up costs, even though they appear to have no explicable basis, and this global problem also exists in the GCC region - “89 per cent of physicians admitted that there is an overuse in the UAE” (Pharmacy Practice, 2010).

Some estimates suggest that a fifth of mainstream clinical practice brings no benefit to the patient at all (Chassin MR and Galvin RW, 1990). Overuse of unneeded services can damage patients physically and psychologically and can harm health systems by wasting resources and deflecting investments in both public health and social spending (Cheung A, 2009).

The last few years have been difficult for local healthcare organisations already before the COVID-19 pandemic. Cashflow problems lead to consolidations and bankruptcies, and companies will have to resort to new initiatives to assure their financial viability and to lower their claims costs. When looking at the main reason for the increase in claims costs, a study by Willis Limited, concluded that

“Overuse of care through medical practitioners recommending too many services” and “insured people seeking inappropriate care” are the two most significant factors driving medical costs.

Healthcare market players in the GCC region (Healthcare insurance providers and TPAs) are aware of the risks and challenges that overutilisation brings and strategies to tackle cases of fraud and abuse are constantly being updated and implemented. However, despite many processes, systems and analytical tools, significant rates of overutilisation are still evident in the private healthcare system.

If overutilisation is so well documented, has high awareness levels and is being tackled by endless efforts and initiatives, how come it is still so widespread in the GCC area?

MedRev (Medical Reviews International), an Ireland-based utilisation and clinical reviews organisation is tackling the global issue of healthcare overutilisation. MedRev, through a combination of Artificial Intelligence technology, analytics, and its network of medical specialists, helps healthcare organisations to lower overutilisation levels and improve outcomes quality. According to the author, healthcare insurers and their TPAs are barking up the wrong tree when attempting to lower overuse and abuse levels. The focus is almost exclusively on payment eligibility and processing of “correct and proper” cases.

There is an over-reliance by self-administered insurers and the TPAs on data analytics and automated software solutions that authorise health insurance cases almost exclusively based only on data factors. Sophisticated systems are deployed to look at correlation between services rendered and tariff codes charged, they look for trend outliers based on predictive modelling, they check prices, billing and coding issues utilising data mining tools, and using behavioural analytics and claims adjudication rules. Professional teams and Special Investigating Units / Forensic teams are involved only when a case deviates from the pre-defined data rules and is flagged as outlier.

According on MedRev’s international experience of reviewing tens of thousands of cases, if the question of medical necessity is posed, about 40 per cent of the reviewed cases are determined as Medically Inappropriate, they fail to deliver best clinical outcome to patients and are wasting funds to the system. This means that four out of 10 patients undergoing medical procedure would have been better off by an alternative course of action. This is a global average for a whole wide range of orthopaedic, cardiovascular, oncology and neurology procedures, amongst others.

Considering the amount of effort and systems used to approve cases and the fact that overutilisation still exists, it’s easy to conclude that the current processes are falling short of effectively tacking overuse, and a new approach should be implemented to deliver better results and long-lasting impact.

According to MedRev, what physicians do and how they render medical services determine the quality and efficiency of healthcare, wellbeing of patients and a country’s healthcare costs. Considering physicians’ unique and central role in medical care, this is where change needs to happen, based on a new approach that changes physicians’ practice and behaviour.

Physicians are as sensitive to performance feedback as any other profession, and when they know that their work is reviewed by a peer specialist – they positively change their practice by tighter adherence to clinical standards and higher consideration for conservative care.

The process behind this is where high-volume of cases are reviewed individually by specialty-matched physicians to determine if services provided were necessary based on evidence-based literature and established standards of care. Independent specialists that are external to the cases authorisation process, are best at reviewing the quality of the proposed care and determining its medical necessity. Their written reports are an effective structured approach that delivers an immediate positive impact on the treating physician’s practice and behaviour.

This approach has been implemented in several international markets and the results are consistently positive, according to MedRev’s client’s experience. This is a subtle cost-effective method which is effective in reducing overutilisation levels, improving patients’ safety and promoting good healthcare practice.

Gulf region market players are well aware of the problems and challenges that overutilisation brings and are investing considerable resources in tackling overuse. In the post-COVID-19 period, healthcare insurers and TPAs will have to focus their attention on implementing the right processes and methodologies, rather than expect better results from managing the same processes time and again.

Based on international best-practice combined with local physicians’ network, this approach of external specialists’ reviews for medical necessity will deliver better patient’s outcome, reduce overutilisation levels and lowers healthcare costs for the benefits of patients, insurers and the market as a whole.

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Nir Kaminer

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.

Staged reconstruction of post-traumatic hand deformities

Article-Staged reconstruction of post-traumatic hand deformities

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Hand surgery is a challenging specialty. It needs precision and combines knowledge and skills of orthopaedic, neuro, plastic and vascular surgery. Hand anatomy is very complicated, structures are small and biology of healing is very often discouraging. We cannot overestimate the necessity of a healthy and functional hand. It enables us to live our lives with full potential. For every human being upper extremity is needed in everyday life, to eat, to write, to perform in their profession. Every part of the hand is important too, every finger has its functions, with the thumb being especially valuable. Every nerve, even the smallest, is responsible and involved in most of our activities. Every joint and its movement adds to the precision of our skills.

Unfortunately, hand injuries often have severe consequences and very often are quite complex. Hand anatomy is such that even a simple fracture can be accompanied with tendon, nerve or blood vessels injury. Posttraumatic deformities which hand surgeons face in their practice are often very challenging and difficult to treat. How to help the patients? How to restore the proper function of the hand? It is so extremely important to restore the possibility for precise movements, powerful grip and decent range of motion. Unfortunately, very often biology works against the patient.

Hand injuries are very well known for their common complications. The biology of healing is such that stiffness develops very quickly and insidiously. The more severe and extensive the injury, the more probability for loss of function, precise movements and grip strength. That is why the problem of surgical hand reconstruction is a real challenge for the surgeon and the patients. Very often we have to perform several procedures, reconstructions and even teno- or arthrolysis to resolve adhesions and scars, which are the result of previous surgeries. So far we cannot predict the healing. Some patients will heal without excessive scarring and adhesions, some will develop them very quickly.

The decision and planning of the whole treatment is a real challenge. It requires not only surgical skills of the surgeon but also a lot of involvement and understanding from the patients. When we discuss the treatment plan, it may be discouraging for the patient to hear about few surgeries combined with periods of physiotherapy. It all takes a long time and patience. The result is not always predictable but most of the times rewarding and resulting with the patient getting his/hers hand back. Before the treatment, the proper set of expectations is important together with very close cooperation between patient, surgeon and physiotherapist. This is teamwork, for sure.

Different stages

When we plan the treatment, the most important thing is to analyse the initial injury. The proper physical examination gives the idea of how much of hand function is lost. The quality of modern diagnostic imaging is very high and together with initial physical examination, gives a good understanding of what needs to be repaired and what cannot be.

There is no specific algorithm of how and when to start but usually the first stage are bones and joints, to provide a basis for the rest of the structures and movement. Most of the bony deformities can be treated with osteotomies and fixations. With the use of new anatomic plates and screws, bone grafts and different kinds of bone substitutes, we can restore the proper alignment of the bone and have a stable fixation to allow early rehabilitation.

Very often injuries involve the joints, which become arthritic or even completely damaged. Almost all joints of the hand and wrist may be either fused or replaced. With the help of modern implants, the replacement is quite easy and reliable and gives a decent range of motion. When it’s necessary we combine the osteotomy and joint replacement in the first reconstructive procedure. The joint may be also addressed with arthroscopy to fix the ligament, to assist with bone fixation or to remove the adhesions and scarring which block the proper movement. The new small arthroscopes can reach even the smallest of hand joints.

The next stages usually involve reconstruction of tendon and nerves. Few weeks or months after injury, all damaged or cut tendons are not suitable for simple repair. Already they are retracted or not viable. Usually we use silicon rods to deal with this problem. We insert the rod and wait a few weeks to allow the body to recreate tendon sheath and obtain the space for a graft. Next step is to replace the rod with a tendon graft. This approach enables active range of motion and good function of the hand.

For the nerve reconstruction, we can either repair them in a separate stage or to combine it with the first stage of tendon reconstruction. We can obtain good help with recovery and prevention of neuromas, using neuro tubes to protect repair sites. To set the order of reconstruction is always a challenge and there is no one protocol of how to do it. Surgeon choice and experience is a key.

For the whole treatment and all stages of reconstruction, patients’ compliance is extremely important. They have to accept months of treatment and the necessity of strict protocols of exercises, physiotherapy and muscle strengthening. Psychological factors play an important role – the more trust in the treatment, the better the result is.

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Dr Katarzyna Papiez

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.

Personalised prosthetic and orthotics in digitised world

Article-Personalised prosthetic and orthotics in digitised world

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As we, all know there are 7.5 billion of us living on this planet. Our shapes and forms are very close to each other, but we cannot find two that are identical. Under the skin, the functional anatomy and physiology differences are even greater. Loss of a limb or even small loss of function results in automatic compensation by body and mind resulting even greater differences between any two individuals with disability. The body machine of all aims at comfort and confidence and assistive technology is deployed in rehabilitation pathways to restore lost function to this aim.

This is the main reason personalised medical devices are tailor made to individuals and match their specification of disability. This will produce much better outcomes and in the long run provide good health economics and quality of life.

How many of us still remember the one shoe or one shirt that fitted our body so well that we search for that feeling and re-experience. The purpose of my talk at Arab Health is to discuss how to achieve this experience in prosthetic and orthotic. To get to provision of such an integrated product and service, we need to lay technological foundations and commercial demonstration of proof of concept as well validate and verify the vision before proceeding to larger investment.

Digital health acceptance plays a crucial role on the change of infrastructure. Fortunately, COVID-19 created the condition to accelerate this by user’s, payers and multi-disciplinary professionals.

To enable manufacturing of the Movement Assistive Devices (MADs) some key objectives need to be met. A Total Body Avatar will need to be created to store personalised information about the MAD’s user, gathered using state-of-the-art scanning tools. MovAiD will also advance engineering solutions to enable automatic generation of a personalised design of the MADs. To enable fabrication of morphologically- and kineto-dynamically tailored parts, advanced manufacturing solutions, including additive manufacturing will be developed. Since the design, production and assembly tasks will vary between consecutive MADs, an integration platform for their management will be formed to ensure that the production process is conducted in automated and timely manner.

The long-term vision of MovAiD is to promote development of smart, innovative and low-cost solutions and technologies, with a view on enabling emergence of new-generation Movement Assistive Devices as well as increasing the competitiveness of the European manufacturing industry. Such devices will bridge the gap between exoskeletons and classic orthotic devices, representing highly personalised solutions and featuring morphological and kinematic characteristics tailored the needs of the industry.

The Paralympic Games in London in 2012, and then in Rio later, have propelled more disabled athletes into the limelight than any games before. We have seen some astonishing success stories, resulting in the biggest medal haul of the Paralympic Games to date.

In recent decades, the most fascinating events featured lower limb amputees running on composite blades. The speed afforded by the prosthetics was amazing. The blades used in the Paralympic Games are designed with extreme sports in mind, but they are not ideal for the numerous challenging situations of daily life. Amputees must instead change between different prosthetic limbs for different purposes.

Today, our research focus lies in overcoming these everyday challenges. During the course of a typical day, a person takes a huge variety of different steps, makes numerous small movements and undertakes hundreds of complex tasks. When it comes to developing a device that can replace a missing lower limb, every motion must be considered.

The integrated prosthetic limb called ‘Linx’ is designed for people with amputations above the knee. The robotic limb has both a knee joint and a foot joint that are controlled by microcontrollers. The Linx limb is unique, mimicking natural Muscular skeletal control because both the knee and the foot can ‘talk’ to each other. In all previous prosthetics, knee and foot joints were developed separately and worked in isolation.

The need for a ‘translator’

The biggest challenge faced was developing a system that would allow the joints to communicate to each other. Let us imagine, for example, that one speaks English and the other speaks French. To make them work together, we needed to develop a ’translator’ that could understand both languages. One of my core tasks on this project was to develop the translator that holds the whole system together, and then develop additional limb functionalities.

Linx is the first commercially available system, which features communication between its joints. By communicating as a whole, the limb can react in a coordinated way to changes in gait. This offers the wearer greater stability when descending a ramp and while standing still.

True servitisation is a future reality for now. The beauty of the MovAiD framework is its holistic approach to integrate product and service provision. It considers the overall information and process flow. It is developing technologies to capture body shape and movement, undertaking musculoskeletal modelling to optimise forces acting inside and on the body of an individual wearing a MAD. Through computer simulation, the framework can optimise how a MAD performs, designs tools to define its shape, place the joint mechanisms correctly and automatically define the stiffness of the material it is made of. Then, the MAD design is sent to local and central additive manufacturing machines to create its actual design. But the MovAiD framework does not stop there. It also provides monitoring and support post-fitting. Therefore, working towards the vision of a true servitisation.

We are faced with societal challenges due to ageing populations, rising social and healthcare costs, a lack of qualified personnel in certain industrial sectors, and workplace-related injuries. MovAiD investigates how technology and additive manufacturing can address some of these challenges. This cross-disciplinary project develops technologies for manufacturing passive and highly personalized wearable equipment to assist disabled children, the elderly, and workers in their everyday lives.

Non-invasive technology is used and designed and developed in conjunction with our clinicians. Products that are clinically proven and tested to return users as close as possible to their “pre-event” activity levels whilst minimising cognitive cost, maximising symmetry, allowing users to get their lives back.

Under the current medical device’s regulatory framework, custom-made medical devices are exempt from the requirement to be included in the EU Medical Device Regulation and Australian Register of Therapeutic Goods (ARTG). Since the introduction of the exemption, the technology and manufacturing processes used to produce medical devices have changed dramatically. Higher risk custom-made medical devices, including orthopaedic implants, are now available and their continued supply under the custom-made medical device’s exemption, without independent oversight, is not appropriate.

Custom Build P&O is a patient matched device leading to Adaptable P&O, which is the next objective in personalised P&O. The pathway is clearly to offer a patient-matched medical device – an adaptable medical device at cost and speed of other mass-produced medical devices.

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Sir Saeed Zahedi 

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.

Combined MPFL and MPTL reconstruction for medial patellar instability

Article-Combined MPFL and MPTL reconstruction for medial patellar instability

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Lateral patellar dislocation is a common cause of anterior knee pain and instability especially in young athletes. Several ligaments, the action of muscles and the shape of the trochlear groove act as patella stabilisers, and the medial patellofemoral ligament (MPFL) is considered the major medial restrictor. The MPFL works in association with the medial patellotibial ligament (MPTL) and the medial patellomeniscal ligament (MPML). Patella alta, a large Q angle, a hypoplastic lateral femoral condyle and congenital ligamentous laxity are associated to recurrent patellar dislocation.

Anatomy, imaging, and biomechanical characteristics of the MPFL have been well described, but less is known about the MPTL and MPML. The MPTL is located 13.7 mm distal to the joint line and 3.6 mm proximal to the distal border of the patella, 9.4 mm distal to the joint line, and in line with the medial border of the medial tibial spine. When choosing a graft for reconstruction, it must be considered that the MPTL is stiffer than the MPFL. The MPTL and MPML, though considered secondary stabilisers, exert an important role in maintaining joint stability, especially in the final phases of extension, opposing the lateral traction of the quadriceps.

To restore the stability of the PF joint, surgeons need to consider the patient’s skeletal maturity to avoid distal femoral physis injury, the recommended treatment, in patients with normal bony morphology, is ligamentous reconstruction. This involves MPFL reconstruction with procedures to improve alignment and congruence of the PF joint, although it should be considered that isolated MPFL reconstruction produces good results, with low complication rates are obtained with combined MPTL and MPFL reconstruction. At present, no studies compare the outcomes of isolated MPFL reconstruction with isolated reconstruction of the MPTL, or combined reconstruction of both ligaments. Combined MPFL and MPTL reconstruction may improve outcomes compared to isolated reconstructions of either of them, and/or decrease the need for other procedures, such as tibial tuberosity osteotomies (TTO), reducing surgical morbidity.

Probably the first technique to manage patellar instability was the Galeazzi procedure, described in the 1922, using a semitendinosus (ST) transfer. This procedure continued to be performed even in 1998, when the precise anatomical location of the insertion of MPFL was reported. Rillmann et al. described a transfer of the medial portion of the patellar tendon (PT). Both surgical techniques are analogous to a MPTL reconstruction. Many other authors reported their results with these techniques, with or without the reconstruction of the MPFL (e.g., lateral retinaculum release, TTO, Roux–Goldthwait). In the early 2000s, following the introduction of the isolated MPFL reconstruction, MPTL reconstruction alone fell out of favour. However, in the last few years, several techniques have been described for the combined MPFL and MPTL.

An adequate tensile strength and length of the graft and similar stiffness to the original ligaments are the most important features for an ideal graft in combined reconstruction. The most commonly used grafts in the knee include the quadriceps, patellar, semitendinosus, and gracilis tendons: all provide adequate strength in reconstruction procedures. However, because the MPTL is stiffer than the MPFL, the use of a stiffer graft for the MPTL than for the MPFL can be considered.

A recent PRISMA systematic review analysed nine studies regarding the combined reconstruction of MPFL and MPTL reporting that eight studies had used hamstrings autografts, such as the gracilis tendon, preserving their tibial attachment. Only in two studies had free tendon ends been fixed in the tibia, and one used the medial portion of the patellar and quadriceps tendons using anchors to fix the grafts at the femoral and tibial attachments. In three studies, anchors were used to secure the grafts to the femur, while in one study the free end was looped and sutured to the adductor magnus tendon, and in other three studies an interference screw were used to fix the grafts to the femoral tunnel, with the proximal end of the grafts employed to reconstruct the MPFL.

Complications include wound infections, knee effusion, quadriceps atrophy, subjective instability and limitation of the range of motion (ROM). Three studies reported no complications in a total of 67 patients. Management of patellar instability with combined reconstruction of the MPFL and MPTL lacks level I evidence, which compares surgical techniques and biomechanical principles behind the mentioned techniques. Bitar et al. compared operative and nonoperative management for recurrent patellar instability, with better subjective outcome after surgical treatment with MPFL reconstruction. The use of femoral soft-tissue fixation for MPFL reconstruction reduces surgical morbidity with no inferior outcome in term of patellar stability, patellar tracking and subjective clinical outcome when compared with screw fixation.

Combined reconstruction of the MPFL and MPTL is receiving increasing interest, probably a consequence of new anatomical, biomechanical, and histological studies which report that the MPTL is a true ligament, with specific biomechanical proprieties important for patellofemoral tracking and stability. Furthermore, this combined reconstruction can improve outcomes if compared with isolated MPFL reconstruction, reducing surgical morbidity and decreasing the need for bony procedures such as TTO in patients with borderline patella alta/lateralized force vector, and the use of trochleoplasty in patients with moderate dysplasia.

Rehabilitation protocols, reported in the available scientific literature, are different, and vary from restrictive (progressive weight bearing with a brace locked in extension for two weeks) to partially restrictive (full weight bearing with crutches and isometric quadriceps strengthening, progressive increase of ROM to 0°–90° within sixth weeks).

Routine reconstruction of both MPFL and MPTL may become a part of the algorithms used for the management of patellar instability, but, at present, because a meta-analysis was not possible, we can only conclude that good clinical outcomes were achieved by combined MPFL and MPTL reconstruction.

Given the lack of randomised controlled trials and the low number of studies, we are unable to define the ideal situation for combined MPTL and MPFL reconstruction. Probably, the indications suggested by Hinckel et al., such as subluxation in extension, instability in flexion, knee hyperextension with ligamentous laxity, and skeletal immaturity with associated risk factors, supported by anatomical and biomechanical studies, may be used, at least until stronger clinical evidence is available.

In conclusion, the available scientific literature regarding combined MPTL and MPFL reconstruction suggests that this procedure leads to favourable clinical outcomes with minimal morbidity, supporting its use as a valid surgical alternative for the management of recurrent lateral patellar dislocations and clinical instability. However, the quality of the scientific articles available is variable, from low to high, and appropriate RCTs are needed to understand the adequate indications for surgery in case of patellar instability.

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.

Painful knee osteoarthritis and iliotibial band syndrome, a new approach

Article-Painful knee osteoarthritis and iliotibial band syndrome, a new approach

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Osteoarthritis (OA) can be viewed as structural and functional failure of synovial joints, the pathophysiological response of a synovial joint to mechanical insult, and the attempt of the joint to repair the damage caused by local abnormalities in force/unit area. The abnormalities in cytokines, degradative enzymes, toxic radicals and the like, which are being studied as the cause of OA, are rather the result of this attempted repair. Therefore, thinking about OA is moving from biochemistry of the particular cartilage to the mechano-biology of the whole joint. OA is joint failure rather than a disease and joint failure is driven by abnormal joint loading of the knee.

OA is clearly a multi factorial disease and the aetiopathogenesis includes local factors (trauma, misalignment, overloading, muscle weakness around joints etc.,) general conditions (old age, female sex, obesity, physical activity level) together with genetic susceptibility. The relative contribution of these factors, and their importance for development and progression of Knee OA with possible implications for sub grouping remains to be clarified. There were only two ways of looking at joints affected by OA: X-ray or gross anatomy, that obsession with pathology, X-rays and cartilage damage, which was led from the UK, and that stretched from the 1950s to the beginning of this century. During the years of focus on articular cartilage, fundamental research into OA was dominated by biochemists and cellular biologists who did wonders in sorting out the biology of cartilage, but largely failed to understand that OA is primarily a mechanical problem.

The hallmark symptom of knee OA is pain, yet the aetiology of pain in OA is not entirely clear.

Since cartilage has no vascular, lymphatic, or sensory supply, the primary pathologic abnormality in OA (hyaline cartilage loss) could occur without pain and it is clear that the severity of the joint damage on the radiograph bears little relation to the severity of the pain experience. According to multiple researches and articles the most prevalence and consistent signs from all the MRI findings in painful knee osteoarthritis (anterior cruciate ligament rupture with or without meniscal lesions, Cartilage defect, Osteophytes, large bone marrow lesion, active synovitis, hypertrophy and joint effusion), are active effusion/synovitis and large bone marrow lesions BML (often associated with effusion and some degree of synovitis) suggesting these features may indicate the main aetiopathology of painful knee osteoarthritis compared with patients with no symptoms.

In the early 1980s, histopathological analysis of OA synovium demonstrated abundant inflammation in the majority of OA patients. While traditionally considered primarily a disease of hyaline cartilage with associated bone involvement, caused by overload or overuse, the pathophysiology of OA development is now appreciated to be more complex. Mounting evidence suggests that synovitis and the resultant pro-inflammatory mediators are important in the pathogenesis of OA with effects on articular cartilage. Modern imaging modalities such as magnetic resonance imaging (MRI) and ultrasound have confirmed a high prevalence of ‘macroscopic’ inflammation and have supported the role of synovitis as an active component of the OA process, associated with both pain and structural progression.

Products of cartilage breakdown released into the synovial fluid are phagocytosed by synovial cells, amplifying synovial inflammation. In turn, activated synovial cells in the inflamed synovium produce catabolic and pro-inflammatory mediators that lead to excess production of the proteolytic enzymes responsible for cartilage breakdown, creating a positive feedback loop. The data presented strongly suggest that synovitis is involved in OA symptoms and progression, and thus represents an important target for therapeutic intervention. Most of recent the research targets what is termed anti synovitis, a new term currently. The site of infiltration of the synovia is of obvious relevance as one of the most densely innervated structures of the joint is the white adipose tissue of the fat pad, which also show evidence of inflammation and can act as a rich source of inflammatory adipokines. Synovial causes of pain include irritation of sensory nerve endings within the synovia from osteophytes and synovial inflammation that is due, at least in part, to the release of prostaglandins, leukotrienes, proteinases, neuropeptides and cytokines.

In a large study conducted by Division of Rheumatology, Orthopaedics and Dermatology, School of Medicine, University of Nottingham, UK, 147 women and 152 men ≥40 years old were randomly selected to establish “normal” ranges for synovial thickness, effusion detected by ultrasound (US), determine cut-offs associated with knee pain (KP) and radiographic knee osteoarthritis (RKOA) in the community. The conclusion: US effusion and Synovial Hypertrophy but not Power Doppler Scan are common, but differ by gender, in community-derived people without painful knee.

OA Iliotibial band friction syndrome (ITBFS)

This is an inflammatory overuse disorder affecting soft tissue, interposed between the iliotibial band and the lateral femoral condyle, caused by chronic friction (Muhle et al., 1999). An anatomic study disclosed a fibrous anchorage of the iliotibial band to the femur preventing rolling over the epicondyle; as a result, ITBFS was found to be caused by increased pressure to the richly innervated, vascularized fat and loose connective tissue beneath the tract (Fairclough et al., 2006, 2007). Either ITBFS has been shown to cause lateral knee pain in athletes, it may be a consequence of gait changes induced by knee OA and may occur together with symptomatic knee OA (Hill et al., 2003)

During the routine practice in cases with advanced isolated medial osteoarthritis (with subsequent genu varum) presence of MR signs of ITBF have been noted:

Vasilevska’s group studied patients with osteoarthritis of the medial compartment of the knee and found a high incidence of iliotibial band friction syndrome. Reduced medial joint space created a varus knee deformation, thus putting extra tension into the iliotibial band. Vasilevska stated that ITBF is an unrecognised cause for lateral knee pain with medial compartment knee osteoarthritis.

Greater trochanteric pain syndrome (previously known as trochanteric bursitis) may also reflect altered biomechanics of the ITBF, that explain the frequent association of trochanteric pain syndrome with knee pain and mistaken as sciatica like pain.

Pelfert and others have reported the occurrence of ITBFS subsequent to repair of the anterior cruciate ligament,

Farell emphasised that ITBFS usually occurs as a result of overuse. If, however, the patient has certain anatomical conditions (leg length discrepancies, varus knee alignment or excessive pronation and external tibia rotation of more than 20 per cent), he/she will be more inclined to experience ITBFS.

Conclusion

Advanced reduction of cartilage thickness combined with severe degeneration of the meniscus at the medial compartment probably leads to biomechanical changes, and varus knee alignment, which may be the cause for iliotibial band syndrome. A latest statement for the so frequent presence of MR signs of ITBF in patients with medial compartment knee osteoarthritis, give us a right to put this entity in the list of an important associated entities with knee osteoarthritis. We should always think about it as the reason for lateral posterior knee pain in those cases.

As a result of the above research, we adopted in our clinic a simple clinical approach:

After detailed history taking, clinical and radiological examination including MRI if visible and always ultrasound examination with Power Doppler Scan, we grouped patients into two categories:

The first group, so called WET Knee had active synovial reaction, hypertrophy and large effusion seen with the US Power Doppler Scan and/or large bone marrow lesion seen in MRI. This group’s aetiology of pain was mostly due to advanced osteoarthritic active intra-articular lesions. This would be treated accordingly.

The second group, so called DRY KNEE within all age groups, showing or not showing all signs of radiological varus medial compartment osteoarthritis. They had no active synovial reaction or effusion confirmed by US Power Doppler scan or there were also no large bone marrow lesions seen by the MRI if visible and had lateral and posterior knee pain, occasionally radiating down to the outer aspect of the leg or else up to the trochanteric region, including the back of the hip region as it is frequently associated together and often mistaken as sciatic pain. We treat them as an Iliotibial band syndrome as well as trochanteric pain syndrome, using local steroid injection (triamcinolone acetonide 40 mg) and a magnesium supplement. The majority of our patients felt immediate pain relief, along with improved mobility of the joint.

Note: Some cases are equivocal having mild synovitis with little effusion as well severe signs and symptoms of ITBF. We treat them first as ITBF, which is simple procedure and follow up them next visit. Often time’s patients improve, otherwise we address the case as an intraarticular cause and deal with it accordingly.

It is our belief that there are considerable number of patients receiving unnecessary treatment, due to incomplete detailed history taken, incomplete examination and investigation done by the health provider, who is usually distracted by easy readily diagnosis of clinically and radiologically apparent signs of severe osteoarthritis.

References available on request

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Dr Abaza is a Consultant in Orthopaedic Surgery, Fellow of the Royal College of Surgeons in Glasgow (UK). He is also a Member of the A.O. Alumni Association (Switzerland). He was trained in Switzerland, Austria, France and U.S. He has worked in Al Jazeera Hospital and Sheikh Khalifa Medical City for 24 years, and in Al Mafraq Hospital from 2005 to 2010. Dr. Abaza has experience in Traumatology. His main interest is in the hand and upper extremities surgery, as well as Paediatric Orthopaedic Surgery. He has multiple publications in reputable scientific online magazines, and he is also an active reviewer for the British Medical Journal Case Reports for the past three years.

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.

No child should be deprived the chance to hear

Article-No child should be deprived the chance to hear

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Hearing loss is the most common sensory abnormality, affecting 3 – 11 per cent of children. The incidence of congenital bilateral sensorineural hearing loss (SNHL) is 1.4 – 3 / 1,000 live births. This is suspected to be double in our region. The incidence of Auditory Neuropathy Spectrum Disorder (ANSD) is estimated at 10-15 per cent of children with a SNHL (Berlin CI, et al. 2010). Interestingly, 6-28 per cent of cases of ANSD are due to hypoplastic cochlear nerves (Buchman CA, et al. 2006).

Cochlear nerve hypoplasia was first described by Shelton et al (1989). The nerve diameter varies in normal-hearing subjects; therefore, it is the relative size, in relation to the facial nerve, that determines hypoplasia (Zanetti D, et al. 2006).

The term cochlear nerve dysplasia (CND) has been used to refer to both hypoplasia and aplasia. According to Bamiou et al (2001), cochlear nerve (CN) hypoplasia is often associated with a syndrome, while Levi J et al. (2013) reported 56 per cent prevalence of comorbid conditions (e.g., Congenital cardiac anomalies) and 50 per cent chance of inner ear abnormalities.

There is no universal criterion for diagnosing of CND. Levi J et al (2013) defined CND as <50 per cent of the size of the adjacent facial nerve. On the other hand, Kutz et al. (2011) argued that nerve absence on imaging does not rule out presence of some fibres, which could be traveling with other nerves. As advised by Pagarkar et al. (2011) diagnosis should be based on a combination of MRI, CT, and audiogical findings.

The optimal treatment of patients with CND is controversial and depends on whether there is complete absence of nerve fibres or hypoplasia. As there is a high prevalence of malformations and comorbidities in these patients, the assessment of the audiological development of these children after cochlear implantation (CI) is quite difficult.

So, should we deny the patients with CN aplasia the chance for hearing? Does the evidence support implanting the affected children?

Though old reports like, Goeverts, PJ. et al 2003, showed that patients with CN aplasia did not benefit from CI use, many other reports gave hope for these children. Relying only on radiological assessment may lead to false decision regarding implanting these patients, as it is quite possible that some nerve fibres actually exist, making CI a useful option (Kutz et al 2011).

The language outcomes and predicative factors of implanted patients with CND was studied on 50 patients (89 ears – 64 of them had aplasia on MRI) by Birman CS, et al 2016. Interestingly 96 per cent showed intraoperative CI evoked EABR response. Overall, 73 per cent were able to use some spoken language.

Children with CN aplasia were able to develop some speech understanding (CAP 5–7) in around 50 per cent of the children and use verbal language as their main mode of communication in 35 per cent of them. On the other hand, children with CN hypoplasia did better, as 90 per cent could attain some speech understanding and 80 per cent used verbal language as their main mode of communication.

At this year’s Arab Health conference, I will discuss one of my patients who suffered from CN aplasia on one side and CN hypoplasia on the other side. This lovely 5-year-old girl presented with bilateral profound sensori-neuronal hearing loss and speech delay despite continuous use of hearing aids and receiving regular sessions of speech therapy. The child did not have previously any work up. This was done on presentation and radiological studies revealed the CND.

As CI is a potential hope for her to restore some hearing, this was performed on the left side (where CN hypoplasia is). She did well postop and better than expected. Four months after activation of the implant, the parents were keen to go for the right-side implantation despite radiological evidence of CN aplasia. However, there was audiological findings pointing to the presence of some CN fibers on the right side. This encouraged us to agree on implanting this side and the postop result was quite satisfactory.

My message to the medical community and to the society at large, is to do comprehensive assessment early after confirming the hearing loss in a child. This will clarify the underlying cause and help putting a plan for early intervention to restore hearing. As medical development continues there will be less and less children that will remain deprived from the gift of hearing. 

References available on request

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Dr Mohammed Bitar

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.

Communication first – push now, save lives

Article-Communication first – push now, save lives

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As communication errors may lead to more than 70 per cent of medical errors, our hospital decided to improve communication in risky situations by using technology. The goal is to improve communication and reporting in risky situations to be under 5 minutes.

Time frame: 5 months

Approach: Our hospital developed a novel mobile application that will help in reducing the risk of medical errors through rapid reporting and ensuring prompt response to these situations by utilising one of the lean approaches, JIDOKA, which will enable staff to stop the line when they feel there is a risk of patient harm. The mobile application named “safety push” is to be used by healthcare professionals to report risky situations such as shortage of staff that may lead to patient harm. For example, when there is no staff to perform double checks, these events will be reported to supervisors and upper management in order to ensure fast and prompt response.

Target population: Healthcare workers

Stake holders: Nursing department, medical administration, quality department, information management.

Background

As per the results of a hospital patient safety culture survey, the main area for improvement, out of the 10 survey topics, according to the hospital staff was communication.

More than 50 per cent of the hospital staff reported that they have issues in reporting patient safety issues to their supervisors, and when we started interviewing them to elaborate more about this issue, they responded that it usually takes too much time to have response from supervisors.

Prolonged communication and reporting in risky situations led to adverse events such as medication error due to skipping the double check step.

Average reporting time in risky situations should be 40 to 60 minutes using the conventional occurrence variance reporting (OVR) method.

Methods

The “safety push” mobile application is a rapid way of communication that can be used by healthcare professionals to report risky issues and receive immediate response.

Approach: The IT department’s capabilities was used to develop a novel mobile application, which was created in collaboration with nursing administration, medical administration and quality department using the lean concept of “JIDOKA”, so the application would help the staff to stop the line and report risky situations and receive immediate response.

When hospital staff finds themselves in a risky situation, they can open the mobile application on their mobile phone and press the red button named: “push”, then enter their location and contacts. The notification will then go to their direct supervisor and top management.

The direct supervisor will visit the location once the notification is received and rectify the situation. If he was not able to deal with it, then the hospital director, medical director, nursing director or quality director will be notified accordingly.

After rectifying the issue, the quality department will call for a meeting to define the root causes of the problem and suggest a remedy for correction.

The new remedy will be communicated with the frontline staff, and they will receive training on it to prevent recurrence of the same problem again.

Goals: Improve communication, increase staff empowerment, ensure patient safety.

Timeframe

  • Project initiation (developing the mobile application design, preparing flowcharts for mobile application process of response) 1 week
  • Mobile application development: 2 months.
  • Pilot in critical areas (Intensive care unit, paediatric intensive care, neonatal intensive care, operation rooms, and Haemodialysis): 1 month.
  • Data collection and analysis: 2 weeks.
  • Full implementation and refinements: 1 month
  • Target population: All healthcare professionals.

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Challenges

  1. Developing a functional mobile application: It was addressed using the skills of one of our IT employees who had the required skills to develop the application.
  2. Launching the application may lead to an unauthorised use from outside the hospital: This was addressed by limiting the access to the application by logging in using hospital username and password.

Impact

Results: After piloting the app in critical areas, the reporting time reached an average of 1 minute 36 seconds. This is instead of the 40 to 60 minutes it would take using the OVR method.

There was an improvement of in the staff feeling safe as well, which was reported during leadership patient safety rounds.

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Spread and sustainability

A control plan was developed with the following steps:

  1. Continuous monitoring of application use by healthcare professionals with periodic quarterly training by quality department and IT department.
  2. Hotline (7272) was created to receive any suggestions or problems from users.
  3. Periodic (annual) mobile application update or when needed by IT department.

Value and innovation

The novel mobile application will help in reducing the risk of medical errors through rapid reporting and ensuring prompt response to these situations utilising one of the lean approaches to enable. the staff to stop the line when they feel there is a risk of patient harm.

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Engagement

Project team

Sponsor: Director of medical affairs.

Leader: Nursing director

Facilitator: Quality section head

Members: IT programmer, medical director, head nurses from critical areas

Engagement approach: Ensuring all stakeholders participation during the developing phase and incorporating their inputs in the mobile application, ensure proper training and continue gathering and applying suggestions from end-users.

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Dr Mohamed Elfaiomy

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.

Entering the RNA era of therapeutics

Article-Entering the RNA era of therapeutics

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On 12 October 1768, the first smallpox vaccination was given by Edward Jenner to an era that would save billions of lives from life-threatening infections, reduce disability, and stir up an economic revolution. On 11 December 2020, the FDA allowed using the first mRNA vaccine, creating a paradigm shift no less critical than Edward Jenner’s act. Instead of introducing live attenuated, inactivated, or subunit of viruses, we can introduce an innocuous chemistry strip to produce a surface protein found in a virus to produce immunity to infection. The chemistry, the mRNA, does not enter the cell’s nucleus and cannot cause any harm to the body. (Figure 1)

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Figure 1. Ab mRNA vaccine is a nucleotide sequence wrapped in a lipid coat of a nano size that allows quick penetration of the cell wall. Once it enters the cell, the lipid coat is removed, and the mRNA strip goes through a ribosome that produces the spike protein found on the surface of viruses. This protein is pushed out of the cell and returns to the Golgi apparatus if it had not already gone through it. The Golgi apparatus attaches a market (MHC class peptide) like a flagpole to invite the body’s immune system to attack the protein and produce long-term immunity. The mRNA strip simply gets destroyed. There is no impact on the DNA, or any genes present in the nucleus where the mRNA cannot enter.

It was the COVID-19 pandemic that forced the companies to create mRNA and the FDA to evaluate it. The safety and efficacy of the mRNA vaccines were way above any other vaccine ever produced.

All future vaccines will not be based on mRNA and prevent infections as the traditional vaccines do but to prevent hundreds of diseases of the immune system for which there are no therapies available or possible. This is truly a moment of revolution in the history of medicine. We will soon prevent Addison disease, Celiac disease-sprue (gluten-sensitive enteropathy), Dermatomyositis, Graves disease, Hashimoto thyroiditis, Multiple sclerosis, Myasthenia gravis, Pernicious anaemia, Reactive arthritis, Rheumatoid arthritis, Sjögren syndrome, Systemic lupus erythematosus, and Type I diabetes.

One question that is often asked is, “why was the mRNA vaccine not approved sooner?” While the RNA research dates back to the 1990s, it took 20 years to develop the technology of stable in vitro synthesis to produce RNA, to develop a technology to introduce the mRNA in the body by using nanoparticles in a lipid formulation and to establish formulations that will protect the highly unstable mRNA molecule. The big pharma, totally comfortable with their existing vaccine programmes, were in no hurry to invest in a new technology fearing regulatory constraints. This is all now history.

The safety of mRNA vaccines is assured because their production does not require toxic chemicals or cell cultures that could be contaminated with adventitious viruses, the common risks associated with all other vaccine platforms.

The RNA technology can be developed very fast; for example, Moderna developed the mRNA used in its COVID-19 vaccine within four days after receiving the genome sequence of the corona virus’s surface protein from the NIH that provides these data in the public domain.

A traditional path to develop an mRNA vaccine is shown in Figure 2.

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Figure 2. The traditional process of mRNA vaccine development and commercial production. Growing the DNA in a bioreactor allows the production of an unlimited quantity of DNA at a meagre cost—one reason why mRNA vaccine can always be produced at a meagre price. The vaccine synthesis takes place in test tubes eliminating many risks of contamination with biological entities.

However, a newer approach uses PCR to produce sufficient mRNA to test the vaccine before entering the commercial stage that will significantly reduce the cost of development and time to market in the future (Figure 3).

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Figure 3. A novel approach to develop mRNA vaccines. It involves using the PCR technology to eliminate several time and cost-consuming steps besides removing all possible contaminants. However, today, this technology is only available for small-scale production sufficient to produce enough mRNA to test safety and efficacy. Since the exact sequence of the mRNA is known, there is little risk in switching over to the commercial plasmid-based technology in the future. This dual-stage model is highly recommended for emerging companies to reduce their time to market significantly and at an extremely low cost. All steps described above can now be outsourced to several eligible CROs, eliminating the need to establish an in-house laboratory.

New vaccines

Some of the immediate targets for mRNA vaccines:

  • Influenza vaccine based on stalk domain as a long-term or permanent vaccine against influenza.
  • STD vaccine against HIV and HPV (contains multiple rRNAs)
  • Diabetes protection vaccine against the six strains of Coxsackie B (CVB) virus.
  • Antigens to produce antibodies against rogue antibodies: autoimmune disorders to prevent Parkinson’s disease, Alzheimer’s, and multiple sclerosis.

Advise to developing countries

Development and manufacturing of mRNA vaccines are straightforward and definitive because we can sequence the mRNA that we propose to us precisely and thus confirm the consistency of its batches—this had never been possible with any other vaccine in the past. With ample financial resources on hand, it should not take more than 24 months to develop and launch a new vaccine.

Today, the world is striving to get the mRNA vaccines against COVID-19. They will be aiming to get a vaccine to prevent diabetes. Given the ready technology, my suggestion is to all countries to initiate their mRNA vaccine production that does not require a significant capital investment and become self-sufficient, not just for the vaccine needs of today but for the future as the new era of medicines has just been opened.

Today, we have an opportunity to permanently eradicate the diseases that never had any treatment possible like autoimmune disorders; we have an opportunity to be self-sufficient in vaccine production without unaffordable investments of the past, and today, it is the day for the governments to make commitments to their citizens for a safe and productive life by producing their modalities and not depend on any other country to assist. COVID-19 is not the last pandemic—it pays to understand that we need to be ready for tomorrow.

References available on request

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Prof. Niazi is an adjunct professor at the University of Illinois in Chicago and Chairman of RNA Therapeutics, a U.S. company providing turnkey technology to produce mRNA vaccines. He owns more than 100 biotechnology patents and has authored over 100 research papers and 60 major technology books.

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.