“This impressive record of continuing full compliance with the federal Quality Systems Regulation demonstrates the commitment this company has to providing its customers with safe, effective reprocessed medical devices,” said Don Selvey, international-recognized expert in medical device reprocessing and ReNu Medical Board Director. “ReNu Medical continues to work diligently to reprocess non-sterile medical devices according to best practices, and to exceed customer expectations for quality medical devices.”

Since the inception of the company in 2000, ReNu Medical has been inspected by the FDA on a regular basis, in accordance with the federal laws for medical device manufacturers. Consistently, the FDA inspectors find the company to be in full compliance with all requirements.

When a deficiency is found in an inspection, FDA provides formal notice of violation and requires the company to provide a written plan to correct problems. If a company fails to correct the violation, FDA may seek sanctions against the company, up to an including civil and criminal charges. Companies with serious violations can be found through public records on the FDA website, located here.

“Consistently receiving Establishment Inspection Report’s (EIR) with zero deficiencies from the FDA, is the best assurance we can give our hospital customers and their patients, that ReNu Medical provides the safest, highest quality reprocessed products possible in the industry,” said Randy Long, ReNu Medical CEO.

ReNu recommends to hospitals that as part of any current contract review, or prior to executing a new contract with a medical device manufacturer or reprocessing company, they review the history of Warning Letters and Establishment Inspection Reports (EIR) from each company. These reports provide a clear indication to hospital purchasing agents and quality assurance authorities how that company values quality in their products.

“We follow the strictest safety protocols,” said Bruce Pierson, ReNu Medical COO. “It’s very gratifying to have the FDA recognize our proprietary methodology and protocols meet their high standards for reprocessed medical devices. Our trained professionals ensure that full regulatory compliance is employed in every step of the process delivering a 100% non-toxic, safe, quality alternative to healthcare facilities nationwide.”

ReNu continues its long standing focus on patient safety and cost savings while maintaining the highest levels of compliance with FDA guidelines and standards.

Source:
ReNu Medical

“Thanks to the hard work of thousands of talented associates, we are the largest and strongest medical device company in the world today, and poised to continue advancing patient care in the future,” said Alex Gorsky, worldwide chairman of Johnson & Johnson’s Medical Devices & Diagnostics segment.

The company’s MD&D business segment, which generated $23.6 billion in sales in 2009 and became Johnson & Johnson’s largest business segment, holds the No. 1 or 2 market positions in the majority of its markets. It includes seven global franchises:

- Cordis: a leader in the treatment of cardiovascular disease;
- DePuy: a leader in orthopaedics, spinal care, sports medicine and neurosurgical devices;
- Diabetes Care: a leader in products that allow people with diabetes to monitor and control their blood glucose levels;
- Ethicon: a leader in sutures, tissue repair and reinforcement products, women’s health, aesthetics and conditions of the ear, nose and throat;
- Ethicon Endo-Surgery: a leader in surgical device solutions for minimally invasive and open surgery; and Advanced Sterilization Products, a leading developer of solutions for the reduction of healthcare-associated infections;
- Ortho Clinical Diagnostics: a leader in medical diagnostic products;
- Vision Care: a leader in the global contact lens market.

“Our MD&D businesses compete in a number of large, well-established and under-penetrated markets like joint replacement, contact lenses and sutures — markets where we can grow through the introduction of more advanced products and continued geographic expansion,” said Gorsky. “At the same time, we are expanding into other high-growth markets such as biosurgicals, energy, electrophysiology and other surgical specialties. We are using our own pipeline, as well as licensing agreements and select acquisitions, to bring us new capabilities.”

Launching New Products

Today’s presentations will highlight a number of products that have either launched this year or are continuing their global roll-outs in 2010.

Ethicon Endo-Surgery, for example, continues to introduce new energy instruments as part of its HARMONIC® family of technology that delivers precise ultrasonic energy to minimize thermal tissue damage to the patient, while providing surgical efficiency. Diabetes Care is rolling out a new blood glucose monitoring system, OneTouch® Verio ™ that provides the next generation of accuracy and precision, the number one need for diabetes patients. Meanwhile, Vision Care continues rolling out its 1-DAY ACUVUE® TruEye™ Brand Contact Lenses, the world’s first daily disposable silicone hydrogel lens on the market, which is currently available in Europe and Japan and is expected to launch in the U.S. later this year.