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MEDICO-LEGAL ISSUES IN IRON EXTRAVASATION


Matt Fowler Registered Nurse

Matthew Fowler. Registered Nurse (1997). Consultant Advanced Clinical Practitioner. Advanced Practitioner for 10 years - Prescriber. University Lecturer. Doctorate Student.




Scott Harding-Lister Registered Nurse

Scott Harding-Lister. Registered Nurse (1995) and Non-Practising Solicitor (2013). Head of Practice. Critical Care & General Nursing Expert. University Lecturer & Clinical Educator.




Staining to right arm
Staining

Understanding iron extravasation: causes, prevention, and medico-legal implications.


Iron infusion therapy plays a pivotal role in modern medicine, particularly in the management of iron-deficiency anaemia. While it offers significant benefits, there are inherent risks associated with this treatment, including the potential occurrence of iron extravasation—an issue that raises medico-legal concerns within the healthcare industry.


In this comprehensive guide, Apex Health Associates, a specialist practice of medical and nursing experts, explores iron extravasation, its causes, prevention strategies, and the medico-legal implications involved.



A bag of dark brown fluid
Iron Infusion

What is an iron infusion and when is it necessary? An iron infusion is a medical procedure that involves the intravenous administration of iron-containing solutions directly into a patient's bloodstream. This method becomes necessary when oral iron supplements may not be effective or tolerated due to several reasons:


  1. Gastrointestinal issues: One of the primary reasons oral iron supplements may not be effective is gastrointestinal issues. Iron supplements, when taken orally, can often lead to side effects such as nausea, abdominal discomfort, constipation, or diarrhoea. These issues can deter patients from consistent use, reducing the effectiveness of the treatment.

  2. Limited absorption: Iron from oral supplements is absorbed in the small intestine. However, certain conditions like coeliac disease, inflammatory bowel disease, or surgical alterations in the digestive tract can hinder iron absorption, rendering oral supplements less effective.

  3. Low tolerance: Some individuals may have a low tolerance for oral iron supplements due to their taste, size, or frequency of dosing. This can result in non-compliance with the prescribed regimen.

  4. Chronic blood loss: In cases of chronic blood loss, as seen in gastrointestinal bleeding, heavy menstrual bleeding, or disorders like peptic ulcers, the rate of iron loss may exceed the rate of absorption from oral supplements. In such instances, intravenous iron infusion becomes essential to replenish iron stores more rapidly.

  5. Underlying health conditions: Patients with certain health conditions, such as chronic kidney disease, heart failure, or cancer, may require higher iron levels than can be achieved with oral supplements alone. Iron infusions offer a more efficient method of reaching the necessary iron levels.

  6. Rapid recovery needs: In some situations, rapid correction of iron deficiency is imperative, such as during pregnancy, surgeries, or treatments for specific medical conditions. Intravenous iron infusions can provide a quicker increase in iron levels compared to oral supplements.

  7. Medication interactions: Certain medications and medical conditions can interfere with the absorption of oral iron supplements, reducing their effectiveness. An iron infusion bypasses these potential interactions.

  8. Patient preferences: Patient preferences and lifestyle factors can also influence the choice between oral supplements and iron infusions. Some individuals may prefer the convenience and reliability of intravenous infusions over daily oral doses.

In summary, iron infusions are necessary when oral iron supplements are not effective or tolerated due to factors like gastrointestinal issues, limited absorption, low tolerance, chronic blood loss, underlying health conditions, the need for rapid recovery, medication interactions, or patient preferences. Iron infusion therapy provides a viable alternative to address iron deficiency and its associated health complications effectively.


Why is it given? Iron infusions are prescribed for various medical conditions, including chronic kidney disease, gastrointestinal disorders, pregnancy-related anaemia, and more. They are crucial for replenishing iron stores and addressing iron-deficiency anaemia.


What are the causes of anaemia, including iron deficiency? Anaemia is a condition characterised by a lower-than-normal number of red blood cells or a lower-than-normal amount of haemoglobin in the blood. It can result from various underlying causes, with iron deficiency being one of the most common and significant contributors.


Iron deficiency anaemia (IDA): Iron deficiency anaemia occurs when the body lacks an adequate supply of iron to produce a sufficient number of healthy red blood cells. Haemoglobin, a protein in red blood cells, requires iron to carry oxygen from the lungs to the body's tissues and organs. When iron levels are insufficient, the body's ability to transport oxygen is compromised.


Causes of iron deficiency: Iron deficiency can be attributed to several factors:


  1. Inadequate dietary intake: A diet lacking in iron-rich foods, such as red meat, poultry, fish, leafy greens, and fortified cereals, can lead to insufficient iron intake.

  2. Blood loss: Chronic blood loss, either due to gastrointestinal conditions (such as ulcers or colon cancer) or menstrual bleeding in women, can deplete iron stores.

  3. Pregnancy and breastfeeding: During pregnancy and lactation, iron requirements increase to support both the mother and the developing foetus or nursing infant. If dietary iron intake is inadequate, deficiency can occur.

  4. Malabsorption: Certain gastrointestinal disorders, like coeliac disease and inflammatory bowel disease, can impair the body's ability to absorb iron from the diet.

  5. Surgery or trauma: Surgical procedures, injuries, or trauma resulting in blood loss can contribute to iron deficiency if not adequately managed.

Signs and symptoms of iron deficiency anaemia: Iron deficiency anaemia can manifest with a range of symptoms, which may include:

  • Fatigue and weakness

  • Pale skin

  • Shortness of breath

  • Rapid or irregular heartbeat

  • Cold hands and feet

  • Brittle nails

  • Headaches

  • Pica (craving non-food items)

  • Restless legs syndrome

Diagnosis and treatment: Diagnosis of iron deficiency anaemia typically involves blood tests to measure haemoglobin and iron levels. Once diagnosed, treatment strategies focus on addressing the underlying cause of the deficiency and replenishing iron stores. Treatment may include dietary changes, iron supplementation, or addressing the root cause of blood loss.


How common is IV iron administered? In clinical practice, the frequency of iron infusion therapy varies depending on the patient's condition and the healthcare provider's recommendations. It is commonly administered when other treatment options have proven ineffective. Intravenous iron infusion is a well-established practice throughout the UK.


How is it given? Iron infusions can be administered through various methods, including IV drip/infusion, or intramuscular injection. Different iron formulations are available, each with its own protocol. IM administration is very rare as there is a risk of brown staining around the injection site.


What is an extravasation injury? Extravasation refers to the unintended leakage of infused substances from a blood vessel into the surrounding tissues. In the context of iron infusion, extravasation can occur when the iron solution escapes from the vein and enters the surrounding tissue, leading to various types of injuries. These injuries can include:

Picture showing staining at the cannula site
Stained Arm - Cannula Site & Surrounding Tissue

  1. Brown (permanent) staining: This is sometimes referred to as an ‘iron tattoo’ and can be very substantial. Iron solutions have the potential to permanently stain the skin, leaving a brown or rust-coloured discolouration at the extravasation site and can spread throughout the limb. This staining can persist long after the injury has healed and may result in significant psychological distress for affected patients.

  2. Pain and swelling: Patients who experience extravasation often report significant pain and swelling at the infusion site. This discomfort can persist for an extended period and may require pain management interventions.

  3. Hematoma formation: Extravasation can cause the accumulation of blood under the skin, resulting in a haematoma. Haematomas can vary in size and severity, causing discomfort and cosmetic concerns.

  4. Psychological injury: Beyond the physical effects, iron extravasation can lead to psychological injury. Patients who experience permanent skin staining or scarring may suffer from reduced self-esteem, body image issues, and emotional distress.

  5. Infection risk: Any breach of the skin's integrity, as can occur with extravasation injuries, can increase the risk of infection. Healthcare providers must monitor and manage such injuries to prevent infections.

It is essential to recognise that iron extravasation can result in a range of physical and psychological injuries, from tissue damage and staining to pain, scarring, and emotional distress. Prompt detection and appropriate management are critical to minimise these adverse outcomes.


How common is extravasation during iron infusion? While iron extravasation is relatively uncommon, its incidence may increase due to various factors, such as the choice of venous access, the expertise of the healthcare provider, and patient-specific factors.


How to prevent iron extravasation? Preventing iron extravasation is paramount to ensuring patient safety during iron infusion therapy. Healthcare providers must take proactive measures to reduce the risk of this potentially serious complication. Here are key strategies for preventing iron extravasation:


  1. Patient assessment: Conduct a thorough assessment of the patient's medical history, including any prior adverse reactions to intravenous infusions. Assess the patient's veins for suitability and accessibility, considering factors like vein size, integrity, and patency.

  2. Vein selection: Choose an appropriate vein for venous access. Larger, more robust veins are preferred for iron infusion to minimise the risk of extravasation. Avoid veins that are fragile, sclerosed, or have signs of thrombosis.

  3. Informed consent: Prior to the infusion, obtain informed consent from the patient, explaining the procedure, its potential risks, and the signs of extravasation to watch for. Encourage patients to report any discomfort or unusual sensations promptly. It is essential that patients are informed about the risks of an iron infusion (ref: Montgomery -v- Lanarkshire). It is good practice for patients to be given oral and written advice.

  4. Proper needle insertion: Ensure that a skilled healthcare professional inserts the intravenous catheter or cannula. Proper insertion technique minimises the risk of vein injury and subsequent extravasation.

  5. Secure the catheter: Once the catheter is in place, secure it with appropriate dressings and adhesive materials. This helps prevent accidental dislodgment and maintains vein integrity.

  6. Monitor the infusion site: Continuously monitor the infusion site throughout the procedure. Look for signs of extravasation, including swelling, pain, redness, or the formation of a haematoma. Address any concerns immediately.

  7. Patient education: Educate the patient about the importance of reporting any discomfort, pain, or unusual sensations at the infusion site. Provide clear instructions on what to do if extravasation is suspected.

  8. Regular check-ins: Periodically check the patient during the infusion to ensure their comfort and the absence of signs of extravasation. Frequent assessments contribute to early detection.

  9. Checking place of the catheter: Prior to starting the iron infusion, healthcare providers should flush and check the catheter is in the right place by flushing and ensuring there is no abnormal signs.

  10. Immediate response to signs: If any signs of extravasation are observed, stop the infusion immediately. Disconnect the infusion line and assess the extent of extravasation. If it occurs, follow local protocols for extravasation management. Due to the permanent staining of the iron, it may be that the plastics team is involved as soon as possible so they can assess and formulate a treatment plan.

  11. Documentation: Thoroughly document the iron infusion procedure, including patient assessments, informed consent, the choice of venous access, the infusion process, and any incidents of extravasation. Accurate and comprehensive documentation is essential for medico-legal purposes.


By implementing these preventive measures, healthcare providers can significantly reduce the risk of iron extravasation during infusion therapy, enhancing patient safety and mitigating potential medico-legal issues.


Medico-legal issues involved Iron extravasation can have serious medico-legal implications. Patients who experience an extravasation injury may consider pursuing legal action against healthcare providers, alleging negligence or improper care. Such cases may result in significant legal consequences and financial settlements.


Reporting and documentation In cases of iron extravasation, thorough and accurate documentation is crucial. Healthcare providers should promptly report any incidents, document the circumstances, and maintain records of patient education and informed consent.


Best practice and guidelines To minimise the risk of iron extravasation, healthcare providers should adhere to best practices and guidelines. This includes following industry standards, ensuring adequate training, and staying informed about advancements in infusion therapy. The organisation should have detailed and clear policies for staff to follow. Staff must be well trained on the administration of the drug, potential consequences and what to do when an extravasation occurs.


Conclusion Iron deficiency, often resulting in iron deficiency anaemia, is a widespread medical condition with various underlying causes. Understanding these causes is crucial for healthcare providers when determining the appropriate treatment and intervention strategies. Iron infusion therapy serves as a valuable tool in the management of iron deficiency, but it must be administered carefully to mitigate the risk of complications like iron extravasation.


Apex Health Associates has specialist expert witnesses who can assist with producing a medico-legal opinion.


This article is produced for educational purposes and is not clinical or legal advice.

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