ShangRing Circumcision Device

Target SDGs

Market Suggested Retail Price

$15.00

Target Users (Target Impact Group)

Small and Medium-sized Enterprises, Public Sector Agencies, NGOs

Distributors / Implementing Organizations

Manufactured by Wuhu Santa Medical Equipment Technology Co. Ltd, distributed to health clinics and hospitals.

Competitive Landscape

Direct competitors include Prepex Circumcision Device.

Regions

Sub-Saharan Africa

Countries

China, Kenya, Uganda, Zambia

Manufacturing/Building Method

The ShangRing is mass produced in China by Wuhu Snnda Medical Treatment Appliance Technology Company Limited.

Intellectural Property Type

Patent

User Provision Model

The device is available at health clinics and hospitals to surgically trained medics. It can also be purchased via online retailer

Distributions to Date Status

600,000 units have been used since 2005. Over 3,000 men have participated in clinical studies in China and Africa between 2007 and 2013.

Design Specifications

The ShangRing is a disposable circumcision tool that helps health care providers with limited training to perform circumcision. The device consists of two parts (rings). The outer ring consists of two halves that are hinged together at one end with a ratchet closure. Hemostasis is realized by the pressure applied by the interlocking rings which minimizes bleeding and eliminates the need for sutures. The device must remain on the penis for 5-7 days.

The device is made from plastic, with a weight of 2.5 – 8.5 grams. ShangRign is commercially available in China in 32 sizes, ranging from 9-42 mm in diameter, for use with neonates to adults. The device is pre-sterilized.

Technical Support

The ShangRing must be used by properly surgically trained physicians. Training DVDs, manuals, and curriculum are being developed.

Replacement Components

The device is single-use.

Lifecycle

The device is sterilised by gamma radiation (Cobalt-60 exposure) and has a shelf life of 3 years. It is strictly non-reusable.

Manufacturer Specified Performance Parameters

The manufacturer claims that circumcision with the ShangRing is safer and more acceptable to patients than conventional surgical circumcision methods. Additional performance targets include: • No sutures necessary • Rapid procedural time (2 to 5 min) • Less bleeding • Frenulum is well preserved • Low complication rate • Excellent cosmesis • Easy to teach and learn • High satisfaction among medical providers and patients

Vetted Performance Status

Results from Chinese studies have demonstrated that the Shang Ring is both safe and easy to use. The first report of the Shang Ring in the literature was from a study conducted by Peng et al. who reported low rates of complication among 1,200 Shang Ring circumcisions. Similarly low complication rates were seen in a series of 328 men circumcised with the Shang Ring in another Chinese study by Cheng et al.. A third study by Li et al. conducted in China comparing Shang Ring circumcision with the dorsal slit technique found significantly fewer complications, lower pain levels during and after the procedure, and higher participant satisfaction among participants circumcised with the Shang Ring. Average Shang Ring circumcision times (excluding administration of local anesthesia), were reported in the Chinese studies to be between 3-5 minutes with patient satisfaction rates over 98. Since 2008, a series of studies using the Shang Ring for adult MC have been carried out in Africa according to guidelines established by WHO for clinical evaluation of new devices for adult MC. Results from the studies conducted to date in Africa demonstrate that the Shang Ring has an excellent safety profile, supporting results of Shang Ring use in China and indicating that the Shang Ring could facilitate rapid roll-out of MC for HIV prevention in Africa. The African experience shows that the Shang Ring is easily used by trained non-physicians, which would facilitate task shifting, and is strongly preferred by providers and well-liked by men who have participated in the studies. The vast majority of participants in studies in Africa as well as China have reported few problems and little disruption to daily life while wearing the device. The significantly shorter procedure time for Shang Ring circumcision would allow for many more procedures to be done in a given time frame compared to conventional MC techniques.

Safety

The ShangRing is non-reusable. It should be only used by surgically trained health care providers.

Complementary Technical Systems

None

Academic Research and References

Compliance with regulations

The ShangRingTM has obtained FDA (510K) clearance in the US, and CE Mark from the European Union and ISO 13485 certification.

Evaluation methods

Randomized controlled trials tracking user feedback, healing time, blood loss, infection rate and complication rate.

Other Information

Video presentations of the ShangRing™ surgical technique have been presented in various conferences and received awards for excellence.