HIGHPOWER Validation Testing & Lab Services
Validating Reusable Medical Devices Made Easy

“On any given day, about one in 31 hospital patients acquire at least one healthcare-associated infection (HAI).” – Centers for Disease Control and Prevention (CDC).

As astonishing as the fact is, it is also providing the entire healthcare fraternity with its much-needed impetus for a resonant call to action against HAIs. And not in vain! Today, medical device manufacturers are readily doubling down their efforts to validate the cleaning, disinfecting, and sterilizing processes of their reusable medical devices before being put into use in a healthcare setting. To no surprise, even government agencies—like CDC and FDA—are constantly ramping up their regulatory standards and benchmark for industry practices to serve the best interests of the patients. However, for a medical device manufacturer working with a lot of equipment simultaneously, paying strict attention to each of their regulatory guidelines and complying with every protocol can become quite overwhelming. And it ultimately delays their product validation timelines.

This is where NY-based, HIGHPOWER Validation Testing & Lab Services helps reusable medical device manufacturers overcome their impediments with a wide range of verification, validation, and testing services. HIGHPOWER leverages more than three decades of experience—working with the FDA and other regulatory bodies worldwide—to offer full-service support to its clients throughout each phase of device sterilization, validation, and regulatory approval. In all its pursuits, the aim is to avert any untoward incidence of HAIs and ensure greater patient safety.

“As a leading validation and testing laboratory, we understand the ever-changing world of reusable medical devices. These devices have to go through a proper decontamination, packaging and sterilization process in order to be reused between patients,” says Gary Socola, president of HIGHPOWER Validation Testing & Lab Services. “Our experts can assist you in streamlining the cleaning, sterilization and packaging processes of reusable medical devices and ensure they are all validated in a timely manner,” Socola emphasizes.

How It All Started

The journey of HIGHPOWER Validation Testing & Lab Services began in 1987 as part of SPS Medical Supply Corp. During the early days, SPS offered biological and chemical indicators as well as different wraps and packaging systems for the healthcare industry. SPS’s incredibly efficient product validation methods soon started generating demand among its existing clients, and many of them started seeking help from SPS in expediting their 501 (k) approval process. The company took this opportunity and set up an exclusive validation lab in 1993, and this lab in time became HIGHPOWER. Under Socola’s leadership, HIGHPOWER gradually expanded over the years to take account of sterilizer validations and testing capabilities for Class II and III medical devices. “But ever since SPS was acquired in 2012, we have been operating as a standalone company, and we continue to be on a positive growth trajectory,” states Socola.

HIGHPOWER is currently well-equipped with an ISO 17025 accredited laboratory to offer every major FDA-cleared sterilization process, namely, steam, Ethylene oxide (ETO), hydrogen peroxide, dry heat, and chemical vapor—all under one roof.

Our experts can assist you in streamlining the sterilization and packaging processes of reusable medical devices and ensure they are all validated in a timely manner

Additionally, the company’s experienced staffs are ASP factory-trained to perform STERRAD (a proven multiphase sterilization process) functionality and efficacy validation testing. This means HIGHPOWER can serve as a one-stop shop for all reusable medical device validation needs and cater to a wide range of medical devices. Nevertheless, as Socola points out, HIGHPOWER’s primary focus is reprocessing reusable steam devices, as steam sterilization covers over 90 percent of its market share, and low-temperature ETO gas and hydrogen peroxide sterilization contribute to the rest.

The HIGHPOWER Advantage

HIGHPOWER also serves several working groups within the Association for the Advancement of Medical Instrumentation (AAMI), ISO, and ASTM (American Society for Testing and Materials). These well-nurtured relationships enable HIGHPOWER to act as a knowledgeable consultant for clients, helping reduce possible delays in validation processes and regulatory approvals. When engaging with a client, HIGHPOWER works as an extension of its clients’ quality and regulatory departments by offering consulting services before, during, and even after the FDA 510(k) approval process. “We don’t really market ourselves as consultants; our years of experience lets us extend a consultative arm to our clients through every step of the validation process,” underscores Emily Barton, business manager at HIGHPOWER Validation Testing & Lab Services. Attending to the client’s best interest has always been HIGHPOWER’s forte. “And in that pursuit, if we can’t accomplish all the testing ourselves, we refer them to our contacts and help them achieve their requirements,” Emily adds.

Such proclivity for the public good is seen now in the company’s effort to battle the ongoing COVID-19 pandemic as well. HIGHPOWER is effectively helping frontline workers and hospitals across the U.S. with the necessary advice on reusing N-95 masks and PPE kits to alleviate the shortage of those products. Adjacently, HIGHPOWER is working with different clients to validate their sterilization processes so that they can start reusing the PPE kits and masks at a faster pace with FDA approval.

Steering ahead, HIGHPOWER is focused on controlled, steady growth. On that note, over the past few years, the company has tripled the size of its team. Additionally, the company has constantly expanded its resources and added more equipment to improve its efficacy validation testing. However, Socola mentions that HIGHPOWER’s growth strategies never undermine the quality of its services. “Our long-term goal is to continue being a world leader in sterilization efficacy, cleaning, and packaging services for reusable medical devices and pave the path for better risk-free patient care in the future,” concludes Socola.