The Problem

There are over 1.5 million reported needlesticks per year in the United States alone, with a 100% under reporting rate. Thousands of health care workers contract hepatitis B, C or HIV annually. The incidence of HIV and Hepatitis C in heavily populated foreign countries is epidemic.

The Solution

Percuguard ^TM is a patented, protective finger guard for the prevention of injuries which penetrate the skin of health care providers and thus invite contamination by blood-borne bacteria and viruses.

This inexpensive plastic medical device is designed primarily for dental health care workers to prevent accidental injury during administration of anesthesia using a syringe. Percuguard is designed to be worn over a latex glove. It is intended to prevent the transmission of Hepatitis B, C etc and HIV from patient to healthcare worker. Currently, there are only limited and restrictive, safe and effective protective devices and procedures, for the prevention of these injuries in Dentistry. This device targets an unaddressed area where inadequate protection results in needlestick injuries. For liability purposes, Percuguard is colorized to indicate the protective portion as separate from the part of the device that keeps it comfortably on the finger.

Percuguard is unlike any other device in that it develops a concept, wholly new…in puncture resistant personal protective equipment. This device is protective on the back side of the finger and elastic on the palm side, yet open at the fingertip to allow for the critical necessity of tactile sensitivity while administering anesthesia by syringe with the other hand. The device may be inverted.

Prototypes have been designed and tested. Upon clinical evaluation, minor additional design modifications have been established as necessary to bring this device into optimal clinical performance. Special plastics engineers have been contacted to address ergonomic designs and mass production capabilities.

Prior (Competing) Solutions

Other solutions have had limited success. One such earlier attempt was the use of mechanically engineered syringes with retractable needles. This solution does not entirely prevent accidental needlesticks to the health care worker, since their exposed finger or thumb is in such close proximity to the exposed contaminated syringe tip.

Retractable needle systems called Mechanically Engineered Syringes (MES) contain a single carpule (capsule-like vessel containing the local anesthetic) and once that injection is terminated the device must be discarded. MES for the most part are single-carpule only and cannot be reloaded. Dentistry requires the usage of multiple carpules with multiple injections per patient necessitating reloading of additional carpules with each syringe needle. Therefore, the cost of administering using MES is proven unacceptable in Dentistry because the cost is prohibitive.

Prior finger guard solutions introduced to the market proved ineffective for the following reasons, among others:

*They provide little additional protection from needle penetration, e.g. latex gloves;

*Penetration resistant devices cause unacceptable loss of manual dexterity and tactile sensitivity.

The current standard of care is the double latex glove, which of course will not stop a needle.

Supported by Patents and Cleared by the FDA

Our team was able to create and reach a standard for puncture resistance using the most commonly used needles. The hallmark of this device is that we have found the softest, thinnest and most flexible material which adequately prevents needlestick penetration. It is necessary, while administering anesthesia, for healthcare personnel to maintain tactile sensitivity with the finger tip of the endangered hand. We helped define what an accidental needlestick force could be.

FDA (510K) was obtained after our team established a new standard of puncture resistance, replacing the existing ANSI standard, using 27 gauge and 20 gauge needles. In conjunction with the University of Texas Dental Branch Biomaterials Department, our team consisted of acclaimed Biomaterials expert John Powers PHD, Associate Dean of the University of Texas Dental Branch, Milton Marshall PHD, toxicologist, and Nicole Meyers grad student in bioengineering.

This device, as per FDA, is single use only and is required to be discarded after use (not re-sterilized). The “single use only” device is sterilizable by irradiation or gas but can NOT be sterilized by heat.

JOURNAL OF CLINICAL ENGINEERING

In the Spring, 2001 issue of the JOURNAL OF CLINICAL ENGINEERING, D. Nicole Meyers, M.Eng., University of Texas – Houston, Dental Branch, and Yong-Keun Lee, D.D.S., Ph.D., Asst. Professor, Seoul National University, College of Dentistry, published a peer review article entitled Percutaneous Injuries and Needlestick Prevention Strategies for Health Care Workers.2 This article provided an overview of the medical risks faced by healthcare workers from accidental needlesticks with contaminated needles, and the evolution of the regulations addressing this risk. This article also provided a comprehensive critical analysis of the methods and equipment available as options for providing the required protection. The authors reported the statistical effectiveness of the procedures and equipment available, and stated conclusions regarding the suitability for use by healthcare workers. This article discussed the following types of equipment designed for protection against injuries during use:3

Latex and Synthetic Gloves

Glove Liners and Finger Guards

Mechanically Engineered Syringes

Mechanical Phlebotomy Devices

Blunt Suturing Needles

The authors discussed the benefits and limitations of each of the current available methods and protective equipment for reducing the risk of infection to healthcare workers from accidental needlesticks. They report, however, that despite the use of these procedures and protective devices, needle sticks continue to be reported. They cite studies showing that as many as 93% of these reported needlestick injuries occur on the hand, typically on the finger or thumb of the non-dominant hand. They concluded that “this finding suggests, protective wear such as finger wraps, thimbles, or other types of finger guards could protect HCWs [healthcare workers] from injury. They further cautioned, however, based upon their evaluations of existing finger guard devices, that “such finger protectors must be designed to protect without causing losses [of] manual dexterity and sensitivity.”

Patents 

The patents issued for Percuguard include:

1. Design patent # D373,656 Sep 10, 1996
2. Utility patent #  5,450,626 Sep19,1995
3. Broader utility patent, which should effectively eliminate competition from engineering around the patents.#  6,807,681 Oct 26,2004
4. Plus possible future international patents

OSHA

As a result of existing anti-needlestick legislation ( Needlestick Safety and Prevention Act) OSHA is compelled to require health care workers to evaluate products such as Percuguard for possible implementation.

Regulatory Requirements Regarding the Use of Protective Equipment to Prevent the Spread of Blood Borne Pathogens.

In 1998 OSHA estimated that over 5.6 million healthcare workers in the United States were at risk to occupational exposure to bloodborne pathogen seroconversions resulting from accidental inoculation.. Accidental sticks with a contaminated needle or other sharps instrument presented the greatest risk of infection with a bloodborne pathogen. A needle or sharps injury becomes contaminated once it comes in contact with the patient’s blood or bodily fluids. While over 20 different potential infections can be transmitted through bloodborne pathogens, HIV, Hepatitis B and Hepatitis C are the most common. With the awareness of the rapid spread of HIV, OSHA began developing a series of regulations regarding the reporting and prevention of accidental sticks and infections.

By 1999 there were over 1.2 million reported incidents of accidental needlesticks. As a result of these findings, Congress began the process of passing legislation directing OSHA to develop specific regulations for the prevention of accidental needlesticks. In 2001 the Needlestick Safety and Prevention Act became law, and OSHA revised its existing regulations to include provisions requiring the use of personal protective equipment proven to be effective in reducing the risk of infection to the healthcare worker as a result of accidental needlesticks.

Bloodborne Pathogens Standard 

The Bloodborne Pathogens Standard 1910.1030 provides at its relevant part as follows:

(7) Engineering and work practice controls shall be used to eliminate or minimize employee exposure. Where occupational exposure remains after institution of these controls, personal protective equipment shall also be used.

(8) Personal Protective Equipment –

(a) Provision. When there is occupational exposure, the employer shall provide, at no cost to the employee, appropriate personal protective equipment such as, but not limited to, gloves, gowns, laboratory coats, face shields or masks and eye protection, and mouthpieces, resuscitation bags, pocket masks, or other ventilation devices. Personal protective equipment will be considered “appropriate” only if it does not permit blood or other potentially infectious materials to pass through to or reach the employee’s work clothes, street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time which the protective equipment will be used.

(b) Use. The employer shall ensure that the employee uses appropriate personal protective equipment unless the employer shows that the employee temporarily and briefly declined to use personal protective equipment when, under rare and extraordinary circumstances, it was the employee’s professional judgment that in the specific instance its use would have prevented the delivery of health care or public safety services or would have posed an increased hazard to the safety of the worker or coworker. When the employee makes this judgment, the circumstances shall be investigated and documented in order to determine whether changes can be instituted to prevent such occurrences in the future.

(c) Accessibility. The employer shall ensure that appropriate personal protective equipment

Civil Liability

Percuguard addresses an additional area of risk pertinent to civil liability. If an employee is injured and the employer failed to provide protection, knowing such protection exists, the employer may be found legally liable.

The Market

According to American Dental Association and CDC (Center for Disease Control) statistics, there are 150,000 practicing dentists in the U.S.A. and Canada, each performing approximately 4,000 procedures a year each for which some form of needlestick protection would be indicated (i.e. where local anesthesia is administered). This translates into approximately 600 Million procedures per year. This number includes all US dental health care workers – dentists, hygienists, dental assistants and various specialists. OSHA currently requires the evaluation and implementation of safe and effective needlestick prevention devices and modalities.

Application in related fields exists in the medical field for healthcare workers who draw blood and any other procedures requiring the use of “sharps”, in close proximity to the health care worker’s finger or thumb.

Therefore, there is a minimum target market for

Percuguard of 600 Million applications in dentistry, plus other medical procedures requiring “sharp” protection, which could be extrapolated further into one billion plus per year. This would be in the US alone and Golden Valley Development intends global distribution immediately with its distribution channels and the potential market worldwide is potentially in the tens of billions devices per year. The FDA has required that this device be labeled “Single Use Only.” Thus there is a very large market for this potentially life-saving device.

Percuguard addresses three areas of risk: inadvertent needlesticks to health care workers including the costs and consequences, OSHA regulatory requirements and civil liability.