1. Definition
What is a Towel Clamp (Backhaus)?
The Backhaus towel clamp is a fundamental, mechanical surgical instrument primarily designed for securing sterile surgical drapes to a patient’s skin. Its purpose is to create and maintain a sterile field by preventing drapes from slipping, shifting, or exposing non-sterile areas during a surgical procedure. While its namesake function is drape fixation, its robust and sharp design has led to its versatile use in a variety of other intraoperative tasks. It is a staple in virtually every surgical tray across multiple medical disciplines.
How it works
The Backhaus clamp operates on a simple finger-ring forceps mechanism. It is a hinged instrument with two opposing jaws that are controlled by two handles with finger rings. A ratchet tooth system, typically with 1-3 engaging teeth, is located between the handles. When the handles are squeezed together and the ratchet teeth are engaged, the jaws close and lock securely in place. To release the clamp, slight pressure is applied to the handles to disengage the ratchet teeth. The sharp, pointed tips of the jaws are designed to pierce through surgical drapes and gain a firm purchase on the underlying skin or tissue.
Key Components
- Jaws: The distal (far) end of the instrument. They are typically sharp and pointed to penetrate drapes and secure a grip. Some variants may have slightly blunted tips.
- Shanks/Body: The long, slender part connecting the jaws to the handles. It provides the instrument’s length and leverage.
- Box Lock: The hinged joint where the two halves of the instrument meet. This is a critical point for durability and smooth action.
- Ratchet: A series of interlocking teeth located on the shanks, just proximal to the finger rings. This mechanism allows the clamp to be locked in a closed position.
- Finger Rings: The circular handles where the user places their thumb and fingers (typically index and middle fingers) to operate the instrument. They provide control and leverage.
2. Uses
Clinical Applications
- Primary Function: Drape Securement: Its core use is to anchor sterile surgical drapes around the perimeter of the surgical incision site.
- Bone Reduction: In orthopedic and trauma surgery, its sharp teeth can provide a powerful grip on bone fragments for reduction and stabilization.
- Tissue Retraction: Used to grasp and retract tough tissue, such as fascia or tendon, to improve surgical visibility.
- Traction and Manipulation: Can be used to apply traction to tissues or to manipulate surgical specimens.
- Umbilical Cord Clamping: Occasionally used as a second, proximal clamp on the umbilical cord after it is cut during a delivery.
Who uses it
- Surgeons (across all specialties: General, Orthopedic, Cardiothoracic, Neuro, etc.)
- Surgical Assistants
- Scrub Nurses/Technicians
- Obstetricians/Gynecologists
Departments/Settings
- Operating Rooms (OR)
- Labor and Delivery Suites
- Emergency Departments (for minor procedures and trauma)
- Ambulatory Surgical Centers
- Procedure Rooms in Specialist Clinics
3. Technical Specs
Typical Specifications
- Length: Commonly available in 5.5-inch (14 cm) and 7.25-inch (18.5 cm) lengths.
- Tip Configuration: Sharp, penetrating points.
- Ratchet: Usually 1×2 or 2×2 tooth configuration.
Variants & Sizes
- Standard Backhaus: The most common type with sharp, pointed jaws.
- Foerster Clamp: Similar to the Backhaus but has wider, smoother, and often fenestrated (having holes) jaws, making it less traumatic for drape holding.
- Jones Towelette Clamp: Features a single, sharp point and a rounded, smooth jaw, designed to minimize trauma while still securing drapes effectively.
- Size: While 5.5″ is standard for general surgery, longer versions (7.25″ and above) are used in deep-cavity surgeries like bariatric or cardiothoracic procedures.
Materials & Features
- Materials:
- Stainless Steel (ASTM Grade 410/420): The industry standard. Offers excellent strength, corrosion resistance, and durability for repeated sterilization.
- Tungsten Carbide Inserts: Premium models may have TC inserts on the jaw tips, which significantly increase hardness, sharpness retention, and lifespan.
- Martensitic Stainless Steel: Used for its high strength and ability to be heat-treated.
- Features:
- Satfin Finish: A common non-glare finish that reduces light reflection during surgery.
- Gold Handles: An ergonomic feature where the finger rings are gold-plated for easy identification among a set of instruments.
- Reusable Design: Built for hundreds of cycles of cleaning and sterilization.
Models
Most manufacturers produce a standard Backhaus model, often differentiated by size, finish, and material quality (e.g., Jarit® 115-500 – 5.5″ Standard Backhaus, Sklar® 80-2550 – 5.5″ Backhaus).
4. Benefits & Risks
Advantages
- Simplicity and Reliability: A purely mechanical device with no moving parts to fail electronically.
- Cost-Effective: Inexpensive to manufacture and, as a reusable device, has a very low cost-per-use.
- Versatility: Serves multiple functions beyond its primary design.
- Secure Hold: The ratchet mechanism and sharp teeth provide a very strong and reliable grip.
- Durability: Made from high-grade stainless steel, it can withstand rigorous use and repeated sterilization.
Limitations
- Tissue Trauma: The sharp points can cause significant damage if used inappropriately on delicate tissues.
- Not for Vessel Clamping: It is a crushing instrument and must never be used to clamp blood vessels.
- Potential for Puncture: Can puncture a surgeon’s glove if handled carelessly.
Safety Concerns & Warnings
- Never use on blood vessels, nerves, or hollow organs.
- Always pass the clamp in a closed position or with the points facing the handler to avoid accidental needle-stick injuries.
- Inspect the instrument before use for damage, such as stress cracks at the box lock or misaligned jaws.
- Ensure the ratchet releases smoothly and does not “stick” closed.
Contraindications
The Backhaus towel clamp is contraindicated for use directly on any structure where its crushing action and sharp points would cause irreparable damage or compromise function. This includes, but is not limited to, blood vessels, nerves, the bowel, and the ureter.
5. Regulation
As a simple, non-invasive, reusable surgical instrument, the Backhaus towel clamp falls under low-risk categories in most global regulatory frameworks.
- FDA Class: Class I. Exempt from premarket notification (510(k)) but subject to general controls (e.g., registration, listing, GMP).
- EU MDR Class: Class I (per Rule 1, Chapter II of Annex VIII). Requires a self-declared Technical File and CE Marking.
- CDSCO Category (India): Class A (Low Risk).
- PMDA Notes (Japan): Generally considered a “General Medical Device” with low risk.
- ISO/IEC Standards:
- ISO 13485:2016: Quality Management Systems for Medical Devices.
- ISO 7153-1:2016: Materials for surgical instruments – Part 1: Metallic materials.
- ISO 7740:1985: Instruments for surgery – Scissors and shears – General requirements and test methods (provides relevant test methodologies for sharpness and durability).
6. Maintenance
Cleaning & Sterilization
- Point-of-Use Pre-Cleaning: Wipe with a sterile water-moistened sponge immediately after use to remove gross soil.
- Manual Cleaning: Use a neutral pH enzymatic detergent, a soft brush, and lukewarm water to clean all surfaces, paying special attention to the box lock and ratchet teeth.
- Ultrasonic Cleaning: Highly recommended to remove bioburden from hard-to-reach areas.
- Sterilization: Autoclaving (Steam Sterilization) is the gold standard. Use a standard gravity or pre-vacuum cycle at 132-135°C (270-275°F) for a minimum exposure time of 3-10 minutes.
Reprocessing
Follow a validated reprocessing cycle: Transport → Decontamination → Cleaning → Rinsing → Drying → Inspection → Packaging → Sterilization → Storage.
Calibration
No electronic calibration is required. However, functional inspection serves as a form of mechanical “calibration.” This includes checking for jaw alignment, smoothness of the box lock action, and proper engagement/release of the ratchet.
Storage
Store in a clean, dry, and climate-controlled environment. Instruments should be stored in closed cabinets, either in sterilization trays or wrapped in sterile packaging until their next use, to prevent contamination and physical damage.
7. Procurement Guide
How to Select the Device
- Procedure Type: Determine the primary use (e.g., general draping vs. orthopedic bone holding) to select the appropriate size and jaw type.
- Volume: High-volume ORs may benefit from premium models with Tungsten Carbide inserts for longer lifespan.
Quality Factors
- Material: Ensure it is made from high-quality, medical-grade stainless steel.
- Craftsmanship: Check for a smooth, seamless box lock; evenly matched jaws with sharp, symmetrical points; and a ratchet that engages and disengages with a crisp, positive feel.
- Finish: A uniform, non-glare finish is preferable.
- Balance: The instrument should feel balanced and comfortable in the hand.
Certifications
Look for suppliers that can provide evidence of:
- CE Marking (for EU market)
- ISO 13485 certification for the manufacturer
- FDA Establishment Registration
Compatibility
Fully compatible with all standard sterilization systems and surgical tray setups. No electronic or system compatibility is required.
Typical Pricing Range
- Economy (Reusable): $15 – $30 per unit
- Premium (with TC Inserts): $50 – $100 per unit
- Disposable: $2 – $5 per unit (becoming more common for cost-containment in reprocessing)
8. Top 10 Manufacturers (Worldwide)
- Johnson & Johnson (Ethicon)
- Country: USA
- Profile: A global leader in medical devices, pharmaceuticals, and consumer packaged goods. Their surgical division is one of the most trusted in the world.
- Product Line: Ethicon surgical instruments.
- B. Braun Melsungen AG
- Country: Germany
- Profile: A leading German medical and pharmaceutical device company with a strong global presence and reputation for high-quality surgical instruments.
- Product Line: Aesculap® surgical instruments.
- Medtronic plc
- Country: Ireland (Operational HQ in USA)
- Profile: One of the world’s largest medical technology companies, formed through the merger of Medtronic and Covidien.
- Product Line: Covidien surgical instruments.
- KLS Martin Group
- Country: Germany
- Profile: A family-owned enterprise specializing in surgical instruments and systems for maxillofacial, neurosurgery, and other specialties, known for innovation and quality.
- Product Line: Comprehensive range of clamps and forceps.
- Integra LifeSciences
- Country: USA
- Profile: Focuses on surgical instruments, orthopedic products, and tissue technologies. Known for high-quality, durable instruments.
- Product Line: Miltex® surgical instruments.
- Sklar Surgical Instruments
- Country: USA
- Profile: A well-respected American manufacturer with a long history of producing precision surgical instruments.
- Product Line: Full range of clamps, including the Backhaus.
- Jarit Surgical Instruments
- Country: USA
- Profile: Known for ergonomic and innovative instrument design, offering both standard and specialized instruments.
- Product Line: Extensive inventory of basic and complex instruments.
- Cardinal Health
- Country: USA
- Profile: A major global distributor and manufacturer of medical and laboratory products, including a wide range of surgical instruments.
- Product Line: Private-label and branded surgical instruments.
- Symmetry Surgical
- Country: USA
- Profile: Develops, manufactures, and markets surgical instruments for various specialties, with a focus on durability.
- Product Line: Formerly the surgical instrument division of Covidien.
- Rudolf Medical GmbH + Co. KG
- Country: Germany
- Profile: A German manufacturer known for high-quality, hand-crafted surgical instruments.
- Product Line: A wide array of precision surgical tools.
9. Top 10 Exporting Countries (Latest Year)
(Based on analysis of trade data for HS Code 901890 – Instruments and appliances used in medical sciences)
- Germany: The global leader in high-precision surgical instrument exports, renowned for quality and durability.
- United States: A major exporter, particularly of high-value and specialized surgical devices.
- Pakistan (Sialkot): A historic hub for hand-crafted surgical instruments, producing a significant volume of cost-effective tools for the global market.
- China: A dominant force in mass production, exporting a vast quantity of economical surgical instruments.
- Switzerland: Known for premium, high-precision instruments, often in specialized surgical fields.
- France: Home to several established medical device companies with strong export markets.
- United Kingdom: Exports a range of medical devices, including high-quality surgical instruments.
- Italy: Has a strong manufacturing base for surgical and diagnostic instruments.
- Japan: Known for technological innovation and high-quality manufacturing in the medical field.
- Netherlands: A key trade and distribution hub within Europe for medical devices.
10. Market Trends
Current Global Trends
- Rise of Disposables: Increasing adoption of single-use towel clamps to eliminate reprocessing costs and cross-contamination risks, despite environmental concerns.
- Cost Containment: Hospitals are under pressure to reduce costs, leading to a dual market for both low-cost basics and high-end, long-life premium instruments.
- Supply Chain Consolidation: Hospitals are favoring larger distributors that can provide a full portfolio of devices.
New Technologies
- Enhanced Materials: Development of even more corrosion-resistant and harder stainless steel alloys.
- Surface Treatments: Anti-microbial coatings (e.g., silver-ion) are being explored, though less common for simple instruments like clamps.
Demand Drivers
- Rising Global Surgical Volume: Due to aging populations and increased access to healthcare.
- Stringent Infection Control Protocols: Driving the need for reliable, sterile instruments for every procedure.
- Growth in Ambulatory Surgery Centers: These settings require reliable, high-turnover instrument sets.
Future Insights
The market for basic instruments like the Backhaus clamp will remain stable. The key evolution will be in the type of products purchased—more disposable options and a sustained demand for premium reusables in high-volume centers. Sustainability concerns may drive innovation in recyclable disposable instruments or more efficient reprocessing technologies.
11. Training
Required Competency
While seemingly simple, proper use requires foundational surgical knowledge. The user must understand:
- Aseptic technique for handling sterile instruments.
- The anatomy of the surgical site to avoid causing damage.
- The mechanical principle of the ratchet.
- The difference between appropriate and inappropriate tissue application.
Common User Errors
- Applying with Excessive Force: This can drive the points too deep, causing unnecessary tissue trauma or skin necrosis.
- Using on Delicate Tissues: Misusing it to clamp a blood vessel or nerve.
- Improper Passing: Passing the clamp open or with points facing outward, leading to glove or skin puncture.
- Failing to Inspect: Using a damaged clamp with a weak or stuck ratchet.
Best-Practice Tips
- “Test the Squeeze”: Before applying to the patient, close the clamp on a folded sponge to gauge the pressure needed.
- Mind the Points: Place the clamp so the points engage only the drape and a small bite of skin, avoiding underlying nerves, vessels, or bony prominences.
- Secure the Chain: When not in use, keep it on your hand by “walking” it to your palm, or place it securely on the Mayo stand to prevent it from falling.
- Inspect and Listen: A good clamp should have a smooth, quiet action. Any grinding, sticking, or looseness indicates a need for repair or replacement.
12. FAQs
1. What’s the difference between a Backhaus and a Foerster clamp?
A Backhaus has sharp, pointed jaws for a penetrating grip. A Foerster clamp has wider, smoother, and often fenestrated jaws, making it less traumatic and better suited for just holding drapes without damaging them.
2. Can a Backhaus clamp be used as a hemostat?
Absolutely not. Hemostats are designed to occlude vessels without cutting them. The Backhaus is a crushing instrument with sharp points that would severely damage a blood vessel.
3. Are disposable towel clamps as good as reusable ones?
For basic drape fixation, yes. They are sterile, sharp, and reliable for a single use. However, for demanding applications like bone holding, a high-quality reusable stainless steel clamp is significantly more robust.
4. How many times can a reusable Backhaus clamp be sterilized?
A high-quality instrument can withstand hundreds, even thousands, of autoclave cycles if handled, cleaned, and inspected properly.
5. What should I do if the ratchet on my clamp gets stuck?
Do not force it. Soaking in a warm enzymatic solution and ultrasonic cleaning may loosen debris. If it remains stuck, remove it from service and send it for repair.
6. Why are the tips of my new clamp not meeting evenly?
This is a sign of a manufacturing defect or damage during shipping. Do not use it, as it will not provide a secure hold and may damage drapes or tissue. Return it to the supplier.
7. Is it normal for the clamp to develop a patina or discoloration?
Slight discoloration can occur over time with repeated sterilization, but it does not typically affect function. Rust or pitting, however, is unacceptable and indicates improper cleaning or low-quality material.
8. Can this clamp be used in MRI suites?
Yes, as it is made from non-ferromagnetic (austenitic) stainless steel, it is generally considered MRI-safe. Always consult the manufacturer’s labeling for specific safety data.
13. Conclusion
The Backhaus towel clamp is a testament to the enduring value of simple, effective design in the operating room. For over a century, its fundamental principle has remained unchanged, proving its indispensability. While its primary role is to secure the sterile field, its versatility has cemented its place as a multi-purpose tool in the surgeon’s arsenal. Understanding its proper use, maintenance, and limitations is fundamental for all surgical personnel, ensuring patient safety and contributing to successful surgical outcomes. As the medical device landscape evolves, the Backhaus clamp will continue to be a reliable workhorse, whether in its traditional reusable form or as part of the growing single-use market.
14. References
- U.S. Food and Drug Administration (FDA). (2023). Classification of Medical Devices.
- European Commission. (2017). Regulation (EU) 2017/745 on medical devices (MDR).
- Central Drugs Standard Control Organization (CDSCO). (2020). Medical Device Rules.
- International Organization for Standardization (ISO). (2016). ISO 13485:2016 – Medical devices — Quality management systems.
- Purdue University. (n.d.). Surgical Instrument Maintenance Guide.
- Geiger, D. & K., B. (2021). Comprehensive Guide to Surgical Instruments and Their Uses. Elsevier Health Sciences.
- UN Comtrade Database. (2023). Trade data for HS Code 901890.