Getinge expands production capacity of DPTE-BetaBag to the U.S.

Getinge is introducing production of DPTE-BetaBag at its existing manufacturing site in Merrimack, N.H., in the U.S.

Three Heart Surgeons Discuss How to Beat Aortic Dissection’s Ticking Clock

Participating in this Q&A article are Bilal Shafi, MD, from Sutter Health in Santa Cruz, California; Wilson Szeto, MD, from Penn Presbyterian Medical Center in Philadelphia, Pennsylvania; and Grayson H. Wheatley III, MD, Wheatley Surgical in Nashville, Tennessee.

The Joint Commission, Joint Commission Resources Launch Data Transparency Initiative

The Joint Commission and Joint Commission Resources (JCR) Inc. have announced a new data transparency initiative – Data Analytics for Safe Healthcare (DASH).

Aerobiotix Announces FDA 510(k) Clearance of Medical Ultraviolet Air Filtration System

Aerobiotix Inc., a manufacturer of air treatment devices for hospitals and health care, has announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the Aerocure-MD medical air purification system.

Sterilization Market Faces Challenges

The global sterilization services market is projected to reach $3.31 billion by 2022, according to MarketandMarkets. This indicates a compound annual growth rate (CAGR) of 6.7% from 2017 to 2022.

The growth of the market can be attributed to factors such as an increasing focus on the outsourcing of sterilization processes among pharmaceutical companies, hospitals and medical device manufacturers; increasing prevalence of hospital-acquired infections; growing number of surgical procedures and an increased focus on food sterilization.

A Grand View Research study also predicts market growth.

The global medical device cleaning market size was valued at $9.74 billion in 2017. It is projected to witness a CAGR of 6.3% through 2025, according to Grand View Research.

“Increasing adoption of preventive measures to reduce hospital-acquired infections coupled with introduction of advanced materials and methods for reprocessing of medical equipment is augmenting the market,” the report states. “Strict regulations for reprocessing reusable medical equipment to reduce incidences of hospital-acquired infections are playing a significant role in propelling the market. This, combined with an increasing number of hospitals and clinics, is expected to generate strong demand for medical device reprocessing materials.”

However, recent developments may have a negative impact on market growth.

The recent closure of sterilization plants due to ethylene oxide (EtO) concerns are impacting the U.S. market.

Medline Industries closed one of its sterilization facilities in Waukegan, Illinois, in December 2019, because it failed to meet new state standards for ethylene oxide, according to MedTech Dive.

A Lake County Health Department update on January 17 reports that Medline began installing additional pollution controls in late November, but did not finish by the end of 2019. The facility reported it expects to resume operations after the testing of millions of dollars worth of new emissions controls.

In late January 2020, the FDA issued a report stating “The FDA is closely monitoring the supply chain effects of closures and potential closures of certain facilities that use ethylene oxide to sterilize medical devices prior to their use. The Agency is concerned about the future availability of sterile medical devices and the potential for medical device shortages that might impact patient care.”

“Additionally, the FDA is working with device manufacturers and health care delivery organizations to ensure they are aware of the issues and preparing to reduce the patient impact if medical devices sterilized at these sterilization facilities become unavailable,” the report adds.

Grand View Research indicates that the North America market is the largest.

“North America dominated the market in 2017. Presence of well-established health care infrastructure, strict regulations for infection control at health care facilities and high adoption of advanced infection prevention solutions are among the primary factors contributing to the dominance of the region,” Grand View Research states.

“Europe followed North America in 2017 in terms of revenue. The region witnessed lucrative growth in demand for sterilization equipment in hospitals. Presence of major market players in Germany is one of the key factors driving the regional market,” the report adds. “Asia Pacific is expected to emerge as fastest growing region during the forecast period. Rapid economic growth, coupled with rising disposable income and increasing demand for world-class health care facilities, is playing an important role in boosting the demand for advanced infection prevention methods in health care facilities of Asia Pacific.”



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