|Year : 2008 | Volume
| Issue : 5 | Page : 581
Price of Poor Quality ! Misleading Epidural Catheter Gauge and Missing Graduation Marks on the Catheter (A Case Report)
Senior Consultant and HOD, Dept. of Anaesthesia, Tata Motors Hospital, Jamshedpur-831004, India
|Date of Acceptance||20-Jul-2008|
|Date of Web Publication||19-Mar-2010|
44, Beldih Lake Flats, Dhatkidih, Jamshedpur-831001, Jharkhand
Source of Support: None, Conflict of Interest: None
Epidural anaesthesia with catheter is very useful technique in modern anaesthesia armamentarium. It is safe, flexible and useful for postoperative analgesia and thus cost effective technique. However, if quality of component(s) (epidural catheter) is poor, it may result in higher incidence of technical failure and inconvenience to operator and harm to patients. We have reported few incidences where the epidural catheter was of poor quality. Our suggestion is that we should use only quality products although the cost may be marginally high but they are more cost effective and safe.
Keywords: Epidural, EPICATH™, Epidural catheter, Kinking, Poor quality, Romsons®
|How to cite this article:|
Jadon A. Price of Poor Quality ! Misleading Epidural Catheter Gauge and Missing Graduation Marks on the Catheter (A Case Report). Indian J Anaesth 2008;52:581
|How to cite this URL:|
Jadon A. Price of Poor Quality ! Misleading Epidural Catheter Gauge and Missing Graduation Marks on the Catheter (A Case Report). Indian J Anaesth [serial online] 2008 [cited 2020 Aug 4];52:581. Available from: http://www.ijaweb.org/text.asp?2008/52/5/581/60680
| Introduction|| |
In developed countries the adherence to quality standard is mandatory and slight deviation can leads to forceful withdrawal of that product from market  . In Indian scenario, although regulations for quality standards are present, however they are not strictly implemented. We have reported here a 'poor quality product' EPICATH™ an epidural catheter manufactured by an Indian company Romsons® (Romsons Scientific& Surgical Industries (P) Ltd. Agra, India)).
| Case-1|| |
A 24-yr-female was scheduled for labour analgesia by epidural. In sitting position with due asepsis epidural space was localized by 18G Tuohy needle at L2/L3 level using loss of air technique. Two ml saline was injected through Tuohy needle and 18G epidural catheter was inserted. During advancement of catheter it was noticed that there was no markings[Figure 1] for assessment of insertion length, and there was no clue that how far we have to insert to know that 3-4 cm is inserted. The Tuohy needle along with catheter was removed. Epidural space was relocated and a new catheter with proper markings was inserted again.
| Case-2|| |
A 51-yr-old male patient with fracture right neck femur and compound fracture right tibia was posted for decompression hip screw(DHS) right hip and close nailing tibia. Epidural space was localized at L3/L4 level by 18G Tuohy needle and loss of resistance to air. The plan was to insert epidural catheter (18G) up to III mark at hub so II mark would possibly at skin. This is a common practice to insert the catheter little more than the distance to be kept in epidural space (3-4cm) and that pull it out to desired level. During insertion it was noticed that mark I was at 10cm instead of mark II[Figure 2]. It means that if we inserted catheter 3-4cm in epidural space, would result in 8-9 cm insertion and which might have caused difficulty during insertion as well as removal. This catheter was changed and new 18G catheter with proper markings was inserted.
| Case-3|| |
A 78-yr-old male patient with fracture right hip posted for DHS surgery. He was known case of coronary artery disease, hypertension and diabetes mellitus. Combined spinal epidural anaesthesia with single space two needle technique was planned due to difficult spinal anatomy. Spinal block was given with 26G Quinckie needle by right Para median approach at L2/ L3 in sitting and 1.2 ml 0.5% heavy bupivacaine was given. Epidural space was identified with 18G Tuohy needle at similar level and approach as spinal using LOR with air technique. 18 G epidural catheter was tried to insert in epidural needle. However it was not possible to insert it beyond the hub. A new 18G catheter was inserted and procedure was completed. On later examination it was found that the catheter size was 16G instead of 18G, as it was written on the pack. Similar incidence has occurred three times in one month with same type of catheter.
| Discussion|| |
Epidural analgesia with catheter technique is an excellent choice as it provides a desired level of block with less amount of local anaesthetic solution and catheter acts as conduit to provide extended duration of anaesthesia and postoperative analgesia. The epidural needles are sized (Gauge) in such a manner that allows to pass a same size (Gauge) of epidural catheter in to epidural space i.e. a 18G catheter can be passed through 18G epidural needle. The marking of epidural catheter indicate catheter length from its tip i.e. I mark appears after 5cm from tip, then every cm is marked along with markings like II, III and IV at every 5cm. The size of epidural needle and catheter can be easily identified as it is always printed on their respected pack. To avoid confusion of compatibility combined pack (epidural needle and epidural catheter in one pack) are commercially available. However, due to their high cost we use Tuohy needle and epidural catheter available in market as separate units. We have been using epidural catheter of different brands (B.D, Portex, B-Braun) for many years and never faced such problems before.
The misleading gauge (wrong gauge printed over pack labeling) has been reported in literature , , however the wrong markings and no markings on epidural catheter [Figure 1] and [Figure 2] which shows a poor quality control of the product are never reported.
We were using Romsons catheter due to its lower cost and easy availability in market. The cost (MRP) of each EPICATH is Rs. 144. However, we had to open two catheter (Rs. 144+Rs.144=Rs.288) every time in all these patients. The cost of other catheter is Rs. 220 to Rs. 280. Other than the reported problems we often faced the kinking of this catheter either during insertion or after it is fixed on the patient, which results in failure of technique  . At the end we realized that this particular brand is not cost-effective and we had to pay THE COST OF POOR QUALITY by higher complication rate, technical failure and harm to the patients. This is against our principle of anaesthesia e.g. Primum non nocere "First, do no harm."
We must use the epidural catheter of reputed brands because, low cost EPICATH™ (Epidural catheter) manufactured by ROMSONS ® has poor quality control and results in technical difficulties and higher incidence of complications.
| References|| |
|1.||FDA Recalls. Manufacture Recall Archives ;11: August 7, 2002 - December 25, 2002. (www.mdiconsultants.com). |
|2.||Rucklidge M W M. Orlikowski C E P. Misleading epidural catheter gauge. Anaesthesia 2002; 57:501-521. |
|3.||Bajaj P, Raiger L, Raman V. Kinking of epidural catheter- a case report. Indian J Anaesth 2003; 47:53-54. |
[Figure 1], [Figure 2]