Approximately 32,000,000 invasive surgeries are performed annually in the US alone. Wasting of leftover surgical supplies, needle-stick accidents, and instruments left inside the patient are preventable daily incidents that greatly increase the cost of surgeries. With the shift to reimbursements per entire procedure, such unnecessary costs directly impact hospitals’ profitability. To minimize this wasteful expense, improve the surgical technician’s workflow, cut down on needle-stick accidents and completely prevent leaving needles inside the patients, Drexel University biomedical engineers have developed a Suture Saver, an automatic desktop device that addresses all these needs and is very easy to operate.
Market opportunity
A systematic UCSF study has demonstrated that about 13% of disposable surgical supplies are unnecessarily wasted in the operating room, at annual cost of about $2,900,000 per neurosurgical department. These include sutures that come prepacked with needles sealed in sterile packages. All potentially required packages are opened before the surgery to avoid delays on opening them during the procedure. After the surgery leftover sutures are thrown away because they cannot be re-sterilized and resealed. The resulting waste, according to an unpublished study from the Hahnemann Hospital in Philadelphia, amounts to between 39,000 and 94,000 opened but unused sutures, causing additional cost for the hospital of $200,000 to $500,000 annually from the leftover sutures alone.
More than 600,000 suture-related needle-stick injuries are reported each year nationally; this statistic does not include urgent care and emergency management systems. Over 5,000,000 health care professionals are at risk of needle-stick injury, which risks direct exposure to blood borne pathogens of the patient. Approximately 40% of needle-sticks occur after the needle usage, and 15% occur after the needle disposal. The average cost to the hospital per needle-stick is over $5,000. For a large hospital system the costs of treatment and addressing suture-related needle-sticks are estimated to exceed $4 million per year.
Instruments left in the patient after the surgery are considered a “never event”, which still happens between 3,000 and 6,000 times a year. While the incidence of these events is relatively low, their consequences for the affected patients are severe2, leading to an average additional $60,000 cost of repeat surgery to remove the instrument, and the corresponding litigation expenses for the hospital often ranging between $200,000 and $500,000 per occurrence. Most frequently, the instrument left in a patient is a surgical sponge, and systems for tracking sponges have been developed and deployed, completely eliminating the occurrences of sponges being left in patients after surgery. Unfortunately, no equivalent system for tracking surgical needles exists. Currently, needles are counted manually before and after the procedure, typically after the surgery site is closed. In many cases, post-operative X-ray imaging is used to ensure that no instruments are left inside the patient, leading to unnecessary exposure to radiation and repeat surgery, which could be avoided if a better needle-tracking system was available.
Collectively, these adverse events and associated costs present a significant unmet need and cost burden for the hospitals. With more than 5,500 hospitals and 33,000 operating rooms, a solution for reducing adverse events and enabling cost savings presents a significant market opportunity. To address this unmet need and reduce the associated hospital costs, Drexel’s biomedical engineers have developed a Suture Saver, an automatic dispenser of sutures that counts dispensed needles & sutures, and safely disposes of used needles while assuring that no needles are left in the patient.
Technology description
The Suture Saver is an easy-to-operate benchtop device that dispenses desired sutures with a push of a button and automatically counts dispensed and used needles and provides for their safe disposal.
A surgical technician can operate Suture Saver with minimal training. After consulting the surgeon on the required suture types, surgical technician loads the sterile suture packages into Suture Saver. When a particular suture is requested by the surgeon, the surgical technician pushes one button and the Suture Saver dispenses and automatically opens the package with the requested suture. This way, only the required suture packages are opened, and all unused packages remain sealed and sterile. The Suture Saver contains an internal drive mechanism that grips the flaps of the suture package and opens it in as the package is being ejected through the front panel of the device. Customization of the package flaps and the matching grip mechanism can be a differentiating factor in the very competitive $1.8B sutures market enabling the “razor and razor blade” approach to marketing.
Used needles are disposed of into a special receptacle in the Suture Saver that receives the needle and drives it inside the device where it is automatically sealed it in a plastic package that can be safely disposed without the risk of a needle-stick injury.
The Suture Saver is equipped with two needle counting mechanisms: one counts dispensed needles when a fresh suture is ejected, while the second one counts the needles deposited into the receptacle. By keeping track of both counts the Suture Saver ensures that no needles are left inside the patient and alerts the surgical technician of any needle count mismatch. The Suture Saver can be set to prevent dispensation of a new suture until the previous has been disposed of or if a needle count mismatch exceeds a preset number for procedures where several needles/sutures can be used at once.