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Rochester, NY- April 4th, 2017 – HIGHPOWER Validation Testing & Lab Services Inc. (HIGHPOWER Labs) hosted 30 visitors from the Delta Chapter of the Medical Device Reprocessing Association of Ontario on Saturday, April 1st at their corporate headquarters. The visit featured device reprocessing professionals from six different facilities located throughout the providence.

Canadian Education Dayjpg

The day offered presentations by HIGHPOWER Labs’ President, Gary Socola and Validation Manager, Donald Tumminelli on the “Validation of Reusable Medical Devices.” Chuck Hughes, Retired Founder of SPSmedical Supply Corporation, also discussed a program on “Reprocessing Medical Devices – Issues & Solutions.”

The group was given a tour of HIGHPOWER’s state-of-the-Art laboratory and newly renovated low temperature sterilization laboratory. This enabled the healthcare professionals to get a first-hand learning experience about validation test protocols for cleaning, packaging, sterilization and storage of reusable medical devices.

“HIGHPOWER has a long history of education whether it be end users or the product development team. We can tailor a program for just about anyone in between”, said Socola. “Combined, our staff has well over 100 years of experience in the field of reusable medical device validation and regulatory compliance.”

MDRAO Delta Chapter President, Tony Leite, said that “the trip to HIGHPOWER was a great success. Our participants walked away with a better understanding of the testing and validation required before reusable instruments can touch the hands of an MDR technician. Our host’s presentation was thorough and intriguing allowing for an opportunity for questions and answers. We will encourage our other chapters in Ontario to visit HIGHPOWER.”

HIGHPOWER Labs, an A2LA ISO 17025 accredited facility (certificate no. 3718.01) has been providing exceptional device cleaning, packaging and sterilization validation services to our customers for 30 years, with every major FDA cleared sterilization process in-house, our scientists and technicians can assist device manufacturers in all of their validation needs.

To find out more about HIGHPOWER Labs and their available services, please contact HIGHPOWER Validation Testing & Lab Services Inc, located at 125 Highpower Road, Rochester, NY 14623 USA. • Ph: (585) 743-1930 • Fax: (585) 697-1506 • Toll Free: (888) 722-1529 • E-mail: esocola@highpowervtls.com or by visiting the internet at www.highpowervtls.com

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April 20th, 2015

Association for the Advancement of Medical Instrumentation
4301 N Fairfax Drive Suite 301
Arlington, VA 22203-1633 USA

RE: Current FDA Resistance Requirements for Steam Biological Indicators Used in Validation

Dear AAMI,

In recent conversations with FDA, we became aware that there are now different requirements for the resistance characteristics (D-value and Z-value) of steam biological indicators being used in reusable medical device efficacy validations than those commonly being used and accepted by the medical industry. Such a change has the potential to cause significant issues for not only medical device manufacturers but also the validation laboratories performing studies on their behalf.

Specifically, the FDA is now requiring biological indicators used in steam validation studies to match the minimum resistance requirements of healthcare BI’s as identified in the FDA guidance document entitled “Guidance for Industry and FDA Staff Biological Indicator (BI) Premarket Notification [510(k)] Submissions”. The FDA is referring to Table 3 in the guidance document, which list the minimum requirements for BI’s used to monitor routine steam sterilization cycles in healthcare facilities at various sterilization temperatures. Please see Table 3 below for your review.

Table 3 – Recommended Minimum Populations and Resistance Characteristics

fda bi requirement

In our opinion, Table 3 was not created to be applied to steam biological indicators used in the sterilization efficacy validations of reusable medical devices. The guidance document issued on October 4th, 2007 is meant for biological indicator manufacturers trying to secure clearance for their healthcare biological indicators. We have AAMI and ISO standards which provide guidance for the use of biological indicators to be used in medical device validations.

The resistance characteristics in Table 3 typically apply to self-contained biological indicators which are primarily used throughout healthcare. Steam self-contained biological indicators have filters, small access holes and are encapsulated within plastic housings, which make it more difficult for the steam molecules to reach the spore strips located at the bottom of the self-contained BI’s vial. This torturous path adds to the resistance characteristics of healthcare biological indicators. However, in steam validation work, we typically use “naked BI’s” such as spore strips, inoculated wires, threads, coupons or spore suspension directly inoculated on devices. It will be nearly impossible for biological indicator manufacturers to make these type of validation BI’s as resistant as the characteristics the FDA is requiring for healthcare BI’s at temperature of 132°C-135°C.

Two actual steam BI’s considered to be very resistant based on their 121°C D-values are shown below. Example 1 is a 106 spore strip and example 2 is a suspension. Both have 121°C D-values greater than 2.0 minutes, but after reviewing their resistance data at 132°C, neither meet the FDA’s healthcare biological indicator requirement for a D-value of no less than 10 seconds at 132°C.

1. 106 Spore Strip with a 121°C D-value of 2.5 minutes (132.2°C D-value is 6.6 seconds)
2. 106 Suspension with a 121°C D-value of 2.1 minutes (132.2°C D-value is 6.7 seconds)

If the FDA requires compliance of the resistance characteristics of biological indicators used in steam validation to equal those of biological indicators used in healthcare at temperatures such as 132-135°C, it can cause major issues for device manufacturers trying to validate their products in steam sterilization cycles.

To clarify even further, we can apply the Fbio formula to various BI’s at 121°C in order to compare individual BI resistance characteristics. The Fbio formula is as follows; Fbio = log (initial population) x D value

Below are the calculations and a Table depicting the minimum resistance characteristics of a validation BI, a healthcare BI and BI examples 1 and 2 as have been shown above:

Validation BI:
Spore population = 1 x 106
D value = 1.0 minutes
Fbio = log (initial population) x D value
= 106 x 1.0
= 6 x 1
= 6
Healthcare BI:
Spore population = 1 x 105
D value = 1.5 minutes
Fbio = log (initial population) x D value
= log 105 x 1.5
= 5 x 1.5
= 7.5
Example 1 BI:
Spore population = 1 x 106
D value = 2.5 minutes

Fbio = log (initial population) x D value
= 106 x 1.5
= 6 x 2.5
= 15.0
Example 2 BI:
Spore population = 1 x 106
D value = 2.1 minutes
Fbio = log (initial population) x D value
= 106 x 1.5
= 6 x 2.1
= 12.6


Comparison Table of Resistance Characteristics of Various BI’s

bi table 2

The Table above shows that BI’s 1 and 2 are not only extremely resistant BI’s but that they also have significantly higher Fbio’s than are now required for steam sterilization efficacy validation work. However, if the FDA continues on this path, neither would be accepted for use if validating instruments in steam sterilization cycles running at 132-135°C.

With all the progress made to reduce extended steam cycles in healthcare facilities, the results of steam validations using biological indicators with healthcare BI resistance characteristics may end up creating the same cycles we have tried to eliminate for years. If pursued by the FDA, this change would affect the medical device industry as a whole and therefore, we felt obligated to bring this issue to your attention in the hope that we may be able to discuss it at the upcoming AAMI Spring meetings.

Respectfully Submitted,

Gary J. Socola
President
HIGHPOWER Validation Testing & Lab Services Inc.

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Getinge

Rochester, NY- June 10th, 2015 – HIGHPOWER Validation Testing & Lab Services Inc. (HIGHPOWER Labs) is announcing the addition of a new state-of-the-art steam sterilizer manufactured by Getinge USA Inc. The new Getinge Model 553HC-E is used to validate the sterilization efficacy of reusable medical devices for device manufacturers seeking FDA 510k clearances for their device.

“Many people consider Rochester, NY to be the cradle of sterilization here in the U.S.” said HIGHPOWER Labs President, Gary Socola. “Wilmot Castle & Company created one of the first steam sterilizers that was put into practical use by medical professionals over 100 years ago. Called the Rochester Steam Sterilizer in the early days it was sold to physicians and other professionals. We have one of these early sterilizers in a reception area.” The Rochester Steam Sterilizer may no longer be in production but its quality lives on through its predecessor Getinge. “HIGHPOWER is lucky to have such a quality sterilizer manufacturer located just down the road from our laboratory. Getinge is known worldwide as a producer of quality products and services and we are proud to add one of their sterilizers to our lab”, said Socola.

On March 17th of 2015, the FDA released a much-anticipated guidance document entitled, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff.” Don Tumminelli, HIGHPOWER’s Manager of Validation and Testing Services stated, “We’ve had a number of customers contact us about the new FDA guidance document and request quotes for additional testing. Because our Getinge sterilizer has very flexible programming, we can use it for customers seeking either three or four vacuum pulses in the steam vacuum cycles they want validated.”

HIGHPOWER has recently added an additional mechanical washer and cleaning marker (hemoglobin) to their medical device cleaning program. Recent medical publications and FDA adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duoendoscopes, even when manufacturer’s reprocessing instructions were followed correctly. Validating a reproducible, manual, or mechanical cleaning process for reusable medical devices has never been more important for device manufacturers and HIGHPOWER is here to provide guidance to our customers along the way.

HP at Getinge

Testing performed by HIGHPOWER Labs supports the design, development, and production of safe reusable medical devices used in healthcare facilities around the world. HIGHPOWER is known for high quality services and attention to detail, and the increased capacity of their sterilization efficacy program should allow more flexibility to those customers seeking to validate either a US or European steam sterilization cycle.

To find out more about HIGHPOWER Labs and their available services, please contact HIGHPOWER Validation Testing & Lab Services Inc, located at 125 Highpower Road, Rochester, NY 14623 USA. • Phone: (585) 743-1930 • Fax: (585) 697-1506 • Toll Free: (888) 722-1529 • E-mail: info@highpowervtls.com or by visiting the internet at www.highpowervtls.com.

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Rochester, NY – January 7, 2014 – HIGHPOWER Validation Testing & Lab Services Inc. (HIGHPOWER Labs) is announcing the addition of two new pieces of equipment to assist medical device manufacturers in validating their device cleaning protocols. Since moving into their newly renovated 16,000 sq. ft. facility in 2012, HIGHPOWER Labs has more than doubled the space and equipment utilized in their device cleaning validation program.

“Many people don’t realize that our lab has been involved in medical device cleaning studies for almost 15 years,” said HIGHPOWER Labs President, Gary Socola. The additional U.S. Food and Drug Administration (FDA) device cleaning requirements have many medical device manufacturers seeking data which was notnecessarily required from them in the past. To keep up with customer demands and stay ahead of the curve, HIGHPOWER decided to upgrade their device cleaning program. “We now have three full-size mechanical washer disinfectors and have added a state of the art ‘Sonic Irrigator’ which is manufactured by Medisafe America,” stated Socola. Mechanical cleaning studies have been increasing, as are the manual cleaning studies being requested by device manufacturers. HIGHPOWER sees this trend continuing.

Medisafe PCF Sonic Irrigator“We are really excited about our increased cleaning capabilities and especially our Medisafe PCF Sonic Irrigator,” said Don Tumminelli, Manager of Validation and Testing Services at HIGHPOWER Labs. “Many people associate its use with the cleaning of robotic instruments, but the machine itself can do so much more. The PCF is actually a sonic, an irrigator, a washer, and a disinfector. It can be used as a sonic only, a sonic irrigator, or a sonic irrigator-washer disinfector, as is currently being done with certain robotic instruments. In a facility such as a surgery center, it can do it all.” Besides cleaning MIS instruments, the PCF is being used successfully in ophthalmic, orthopedics and many other facets of medical device cleaning.

HIGHPOWER has also ordered a second Hamo washer disinfector to join the existing unit and the lab’s STERIS 444. “Hamo washers have fully programmable parameters which give us more flexibility to meet the needs of both our European and North American customers,” said Tumminelli. “Most of our customers require protein and total organic carbon markers for their studies but we are also looking to add hemoglobin in the near future.”

Testing performed by HIGHPOWER Labs supports the design, development and production of safe reusable medical devices used in healthcare facilities around the world. HIGHPOWER is known for high quality services and attention to detail, therefore the increased capacity of their cleaning program should allow more cleaning studies to be performed for customers in a shorter period of time.

To find out more about HIGHPOWER Labs and their available services, please contact HIGHPOWER Validation Testing & Lab Services Inc, located at 125 Highpower Road, Rochester, NY 14623 USA. • Ph: (585) 743-1930 • Fax: (585) 697-1506 • Toll Free: (888) 722-1529 • E-mail: info@highpowervtls.com or by visiting the internet at www.highpowervtls.com.

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Rochester, NY 2/28/13 – The former SPSmedical Test and Validation Lab is now HIGHPOWER Validation Testing & Lab Services Inc. (HIGHPOWER Labs). HIGHPOWER Labs is announcing the opening of their new facility for the companies expanding validation and testing services. The new facility provides increased laboratory and testing space to accommodate growth within the company, as well as the growth being seen within the medical industry.

HIGHPOWER Lab Facilities Much of HIGHPOWER Labs recent growth is attributed to the additional testing requirements now being placed on medical device manufacturers around the world; but particularly here in the United States by the Food and Drug Administration (FDA). “We are excited about the new opportunities for growth in medical device validation testing,” said HIGHPOWER Labs President, Gary Socola. “This facility will go a long way in helping us meet the growing demand for sterilization validation, device cleaning and material compatibility testing by our customers.”

“There has been a shift in the medical device marketplace by users requesting validation data to support a products’ Instructions for Use. Couple this with the FDA’s new philosophy on cleaning and sterilization of reusable medical devices and the timing was right for us to move into our own facility,” said Don Tumminelli, Manager, Validation and Testing Services at HIGHPOWER Labs. “Many people don’t realize that our lab has been involved in medical device validations for over 25 years.”

HIGHPOWER SterilizersThe recently renovated 16,000 sq. ft. facility accommodates the immediate and future requirements for capacity and new capabilities. New Steam, EO Gas and Vaporized Hydrogen Peroxide sterilizers have been installed and are validated for use. The equipment used to validate the cleaning and disinfection of medial devices has been greatly expanded along with equipment that challenges the integrity of packaging systems such as sterilization pouches, wraps and rigid containers. “We have more than doubled the space and equipment utilized in device cleaning validations. This will allow us to have some of the best turnaround times in the industry,” said Tumminelli.

Testing performed by HIGHPOWER Labs supports the design, development and production of safe reusable medical devices used in healthcare facilities. “Our lab has always been known for high quality services and attention to detail, our customers deserve nothing less. We’re committed to continuing the high quality services that our customers have relied upon at our new HIGHPOWER facility,” stated Socola.

SPSmedical Supply Corp. was acquired by Crosstex International in 2012. HIGHPOWER Labs was incorporated in August 2012 and was not part of the acquisition.

To find out more about HIGHPOWER Labs and their available services, please contact them at HIGHPOWER Validation Testing & Lab Services Inc, located at 125 Highpower Road, Rochester, NY 14623 USA. • Ph: (585) 743-1930 • Fax: (585) 697-1506 • Toll Free: (888) 722-1529 • E-mail: info@highpowervtls.com or by visiting their website at www.highpowervtls.com.