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| REVIEW ARTICLE |
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| Year : 2016 | Volume
: 9
| Issue : 3 | Page : 247-250 |
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Are extravasation injuries “Negligence”?
Neeraj Nagpal1, Nimisha Nagpal2
1 Chairman and Managing Trustee, Medicos Legal Action Group Trust (Regd) and Director Hope Gastrointestinal Diagnostic Clinic, Chandigarh, India
2 Junior Resident, Department of Ophthalmology, Govt Medical College, Chandigarh, India
| Date of Web Publication | 21-Dec-2016 |
Correspondence Address:
Dr. Neeraj Nagpal
#1184, Sector 21-B, Chandigarh
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/2349-5006.196335
Recent High Court and Supreme Court judgments have awarded large compensations for complications arising out of intravenous treatment. Extravasation of fluids and drugs is the most common complication of any medical procedure worldwide. Extravasation injury leading to gangrene occurs rarely and is due to factors related to patient characteristics, underlying disease, and the type of drug which is being injected. Human error rarely may be contributory to development of the extravasations and injury resultant thereof, but to label all of these complications as negligence by the application of “res ipsa loquitur” has serious consequences. High compensation risk for a complication which is faced universally by all doctors has the potential to raise the cost of this simple procedure. Keywords: Compensation, extravasation, gangrene, intravenous
How to cite this article:
Nagpal N, Nagpal N. Are extravasation injuries “Negligence”?. Indian J Health Sci Biomed Res 2016;9:247-50 |
| Introduction | |  |
Insertion of an intravenous (IV) cannula is probably the most frequently performed medical procedure in the world. In excess of 1,000,000 Intravenous infusions are given every day globally. Keeping adverse events and complications of these procedures to a minimum is important for the patients who receive them and also for the health-care establishment in which they take place.[1] Extravasation injury is defined as the damage caused by the efflux of solutions from a vessel into surrounding tissue spaces during IV infusion. The damage can extend to involve nerves, tendons, and joints and can continue for months after the initial insult. If the treatment is delayed, surgical debridement, skin grafting, and even amputation may be the unfortunate consequences of such an injury.[2]
| Review of Literature | | |
The reported incidence of extravasation ranges from 10% to 30%.[3] Both infiltration and extravasation are risks of IV administration therapy involving unintended leakage of the solution into the surrounding tissue and the consequences of both range from local irritation to amputation.[4] In cancer therapy, experts estimate that it accounts for up to 6.0% of all adverse events associated with treatment.[5] However, when one considers that adverse events with cancer therapy are quite common, the absolute number of extravasations which take place is significant.[6]
The American Society of Anesthesiologists Closed Claims database revealed that IV catheters were an important source of liability for anesthesiologists, approximately half of which resulted from extravasation of drugs or fluids.[7] A study which investigated extravasation over a 5-week period in a UK hospital established an incidence of 39% in adults, almost double that of previously published reports.[8] Two percent of the Medical Defence Union cases involving anesthetic-related events between 1970 and 1982 (excluding deaths) were due to extravasation injuries.[9]
Swelling of the area around the insertion site is a very common phenomenon seen in virtually 70% of patients who are receiving prolonged IV fluids and drugs. This swelling may be due to infiltration or extravasation. Infiltration is the inadvertent leakage of nonvesicant solution from its intended vascular pathway (vein) to the surrounding tissues. Infiltration is usually seen as a benign event as it generally does not lead to tissue necrosis; however, a large volume of infiltrate can cause compression of nerves and acute limb compartment syndrome, resulting in long-term disability.[10] However, extravasation which is inadvertent administration of a vesicant fluid or solution into surrounding tissues has the potential to cause blisters, severe tissue injury (skin/tendons/muscle), or necrosis after escaping from the intended venous pathway.[4],[10],[11]
All infiltration and extravasation injuries are not however due to faulty technique of cannulation by doctors and nurses. Some of the most common patient factors known to increase the risk of extravasation are listed below:[12],[13],[14] small blood vessels (e.g., infants and young children); fragile veins (e.g., elderly, cancer patients); hard, sclerosed veins; mobile veins; impaired circulation (e.g., cannula sited on side of mastectomy, lymphedema, noninvasive blood pressure (BP) cuff above the cannulation site); obstructed vena cava (elevated venous pressure can cause leakage); preexisting conditions (e.g., diabetes, peripheral circulatory conditions such as Raynaud's syndrome and radiation damage); obesity. Risk of extravasation increases if patient has trouble reporting early symptoms (e.g., sedated, confused, or decreased sensation due to neuropathy). Prolonged hospitalization with need for repeated cannulation, multiple attempts at cannulation, bolus injection, or injections under high flow, all increase the risk of extravasation. Even in prolonged domiciliary patients where cannulation is done for prolonged duration for repeated injections, thrombus formation in the vein proximal to site of cannulation causes drug to extravasate around the cannulation site due to decreased flow in the vein, and hence, increased pressure on injection. IV drug or fluid characteristics determine type and extent of injury, following extravasation which is more, especially with the use of mannitol, phenytoin, antibiotics (erythromycin), and anesthetic agents (propofol, thiopentone). Tissue injury can be caused by hyperosmolarity (mannitol, sodium bicarbonate), vasoconstriction (adrenergic drugs), cytotoxicity (phenytoin, chemotherapeutic drugs, potassium salts), infusion pressure, and altered regional anatomy.[15],[16],[17],[18]
Sites most often implicated in extravasation injuries include the dorsum of hand and foot,[19] ankle, antecubital fossa,[20] and near joints or joint spaces [21] where there is a little soft tissue protection for underlying structures.[22] The phenomena involved in the evolution of tissue damage following drug extravasation are (a) vasoconstriction and ischemic necrosis; (b) direct toxicity; (c) osmotic damage; (d) extrinsic mechanical compression by large volumes of extravasated solutions; (e) superimposed infection; (f) compartment syndrome which develops when interstitial pressure of a given muscular compartment exceeds the capillary perfusion pressure; (g) gangrene.[23],[24]
| Legal Scenario in India | | |
In a recent case, a young 2-year-old girl with microcephaly, seizures, pneumonia, and septic shock was treated with IV fluids and antibiotics through cannula on dorsum of the right hand. Later, the right radial arterial line placement for arterial BP monitoring was done in view of persistent shock. Discoloration and swelling were noted in fingers of the right hand during hospitalization. Doppler and angiography were done which revealed no flow beyond brachial artery, diffuse spasm of all vessels, and an aberrant subclavian artery. Heparinization, elevation of limb, vasodilator infusion, fasciotomy, and right cervical sympathetic nerve blockade were all done. Later, after demarcation of gangrene occurred, amputation was done. The National Commission considered that “since the hospital failed to rule out the possibility of having caused cyanosis on account of cannulation or arterial invasion, this is a case where res ipsa loquitur (negligence speaks for itself) applies” and awarded compensation which was later enhanced four times by the Honorable Supreme Court. It is gleaned from the discussion that the Courts felt that in this case inadvertently someone injected drugs or antibiotics through the arterial line instead of the veinous cannula. If that was so, it is an outright case of negligence as decided by the Honorable Supreme Court earlier in the landmark case of Shantha et al. versus Indian Medical Association.[25] Gangrene had started in the fingers and then spread proximally. The ulnar artery also became blocked leading to gangrene in its area of distribution. Going by these facts it would support the version of the hospital that it was septicemic shock plus extravasation of a vesicant solution from venous cannulation on dorsum of hand which started the cascade of events which lead to gangrene and amputation and not inadvertent intraarterial injection of drug.[26]
In another recent case decided by the Bombay High Court, a young man was brought to a municipal hospital in Mumbai with cerebral malaria and meningitis with altered sensorium. He has been given IV fluids, mannitol, eptoin, and antibiotics through cannula placed in the dorsum of the right hand. Due to extravasation of drugs, discoloration and swelling of hand were noted next day. Amputation of fingers and thumb was done after 2–3 weeks. The Bombay High Court applied the principle of “res ipsa loquitur” to award a compensation of Rs. 10 lac with interest from the date of filing claim total working out to Rs. 2,182,500 only.[27]
| Discussion | | |
Both these cases highlight the problem of high compensations awarded for negligence resulting in the loss of fingers/arm due to the complications of IV cannulation for IV fluid and medications. As shown earlier, extravasation of fluids or drugs is probably the most common complication of any medical procedure worldwide. In case of extravasation, which episode will resolve uneventfully and which will lead to gangrene and amputation is usually based on factors related to patient characteristics, underlying disease, or the drug being injected. Negligence of the cannulating junior doctor or nurse may also rarely be the cause of extravasation injury, especially if multiple attempts to cannulate have been made in a patient who has never been cannulated before and should have been cannulated easily in first attempt. Negligence would also be assumed if, after trying to cannulate larger proximal vein, the doctor cannulates a smaller distal vein and injects drugs which then extravasates through the venipuncture sites proximally. Negligence of healthcare provider is obvious if neither is the complication recognized in time nor are steps taken to treat it. However in the case decided by Supreme Court titled Manipal Hospital vs Mr Alfred Benedict, the error was promptly recognized and all steps possible to rectify the situation were taken. Despite the prompt recognition and proper treatment the limb could not be salvaged and court declared the hospital negligent and awarded compensation. The one aspect of this judgment which bears analysis is in the question whether the occurrence of a recognized and common complication of a medical procedure is negligence per se.
If “res ipsa loquitur” is to be applied to declare negligent all extravasations and injuries resultant from it, then the procedure of IV fluid therapy needs to be placed at same pedestal as any surgery. Cost of any medical procedure reflects the risk involved in the procedure since the risk of financial compensation of this magnitude has the potential of increasing the cost of this simple procedure manifold for all patients. In the Bombay High Court Judgment, since the hospital was a Government Municipal Hospital where treatment is provided free or at a very subsidized cost. The implications of this judgment for private hospitals are worrisome. These are not isolated cases. In a decision by the State Commission, Tamil Nadu, a sum of Rs. 10,40,000 was awarded in a similar case where the child was admitted for fever and cough and given IV fluids through cannula placed in the foot. There was swelling and discoloration of the foot, and later, five fingers of the foot had to be amputated.[28]
With repeated movement after some time, even in a correctly placed IV cannula, the opening in the vein may enlarge and cannula entering the vein, through it, may no longer remain snugly fit. If then, the vein becomes thrombosed proximal to the cannulation site, it leads to decreased or no flow in this vein, and when an injection is given through the cannula, the drug may flow backward and escape into surrounding tissues through the space between the cannula and the orifice.
The Honourable Supreme Court in a case titled K Sharma vs Batra Hospital & Medical Research Centre has defined negligence as omission to do something which a reasonable man would do, or doing something which a prudent and reasonable man would not do. The Court also held, that to prosecute a person, the negligence to be established must be culpable or gross and not the negligence merely based upon an error of the judgment.[29] Backward flow of a drug or IV fluids and extravasation into the surrounding tissues are invariably frequently witnessed by all doctors and nurses. Medical professionals can only be expected to be vigilant and initiate prompt measures to manage it once it occurs. In the Medical world, occurrence of extravasation or injury thereof would not be regarded as negligence, but failure to recognize it or take remedial measures would probably be considered negligent. This is irrespective of consequence of the extravasation whether finally amputation is needed to be done or spontaneous resolution occurs. If a doctor chooses conservative management for extravasation injury instead of amputation and patient ultimately needs amputation, this would again not be negligence on part of a doctor. The Supreme Court Judgment stated clearly that merely because the doctor chooses one course of action in preference to the other one available, he/she would not be liable if the course of action chosen by him/her was acceptable to the medical profession.
| Conclusions | | |
Extravasation of IV fluids and drugs is an extremely common complication and injuries resultants thereof mostly do not occur due to negligence of the doctor or the nurse. Recent court decisions have however considered these injuries as outright negligence and awarded hefty compensation. It needs to be realized that the court decisions are given based on arguments placed on record and relevant literature or expert opinion presented to it. It is up to the affected party or medical associations to seek legal redressal if some judgment goes against what is proper as per medical teaching. Unfortunately, such judgments frequently slip under the radar for the medical community in India till it is too late. Even publication of this article is an acknowledgment of the problem which should initiate debate and possible solutions. The Professional Associations need to come out with standard operating procedures (SOPs) for various medical situations. If a doctor adheres to the SOP and an adverse event occurs, then if he/she faces charges of alleged negligence, he/she should have a set of guidelines issued by a professional body which can be produced in court in his defense. A white paper on extravasation injuries by the Plastic Surgeon's Association is sorely needed if similar adverse judgments are to be avoided.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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