AdvaMed Rearranges FDA’s Priority List

The medical device trade group tells FDA which guidance topics should be tackled first.

The Advanced Medical Technology Association (AdvaMed) has voiced its opinion on which topics the medtech industry believes should be FDA’s highest priorities.

In early January, FDA’s Centers for Device and Radiological Health (CDRH) released its Fiscal Year 2015 Proposed Guidance Development. This set out a prioritized list of topics for which CDRH may issue draft and final guidance documents in FY15. The topics are broken down into two lists–the A-list and the B-list. CDRH intends to publish guidance on A-list topics in FY15, while guidance on B-list topics will be published “as…resources permit.” The window for comments on the proposal closed earlier this month.

In a comment posted last week, AdvaMed sounded off on the CDRH list, giving the agency its own take on which topics are most important. This meant the trade group would like to see some of the A-list topics reshuffled according to priority, some B-list topics moved to the A-list grouping and vice versa, as well as a few new topics added…

The trade group also wants to see several guidance documents updated, including guidance on “Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software” and “Pilot Program to Evaluate a Proposed Globablly Harmonized Alternative for Premarket Procedures.”

FDA has already made progress on its list since the comment period closed earlier this month. On March 12, FDA released its finalized guidance on medical device reprocessing in the health care setting.

The agency does not get to all of the A-list topics each year. Some topics such as “Applying Human Factors and Usability Engineering to Optimize Medical Device Design” have been carried over from the FY14 priority list and made AdvaMed’s FY14 high priority list as well.

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Sustainability in the Operating Room

… Sustainability in the OR is a multipronged initiative that can include, but is not limited to, recycling and reprocessing equipment; reducing prescription drug waste; properly disposing of medical waste; and choosing and managing anesthetics to reduce the overall amount of inhalants used and dispersed into the atmosphere.

“Sustainability in the OR involves changing habits in a culture that needs to be so exacting,” says Susan Ryan, M.D., clinical professor of anesthesiology at UCSF Medical Center, San Francisco. Surgeons, anesthesiologists and perioperative nurses are cautious, Abenstein acknowledges. “There is a fear of the unknown, of anything that can put the patient at risk.”

Lauren Berkow, M.D., associate chief of the division of neuroanesthesia at Johns Hopkins Health System, Baltimore, says educating physicians on the financial and environmental impacts of OR sustainability will go a long way toward achieving buy-in.

Her organization saved more than $5 million on an OR reprocessing program between 2010 and 2013. “It’s important to show results to build on your success,” Berkow adds…

Key Steps in Greening the OR

…Dedicate a Green Team focused on sustainability in the operating room. Create a multidisciplinary team to oversee sustainability initiatives in the OR. Participants may include representatives from nursing, materials management, anesthesiology, environmental services and surgery, among others.

Educate OR staff on the benefits of sustainability.
Spell out to operating room staff the importance of sustainability. Getting buy-in up front will help to ensure the program’s success.

Tackle waste. Conduct a waste audit to help identify ways to streamline medical waste disposal. Preventing items from unnecessarily being placed in the regulated medical waste stream, which is more costly to dispose, can result in significant savings.

Purchase reprocessed medical devices. Partner with an approved third-party processor to purchase reprocessed medical devices, and reprocess eligible devices….

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Three Ways to Sell your Hospital on Sustainability

Despite popular perceptions that sustainability measures will financially drain hospitals and health systems, they can drive savings when organizations take certain steps,according to a new report from the University of Pennsylvania.

There are numerous ways that hospitals can make operations greener, such as conserving water and sourcing food locally, but part of what holds back many providers from implementing sustainability initiatives is their focus on the short-term bottom line.

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The 2014 Practice Greenhealth Sustainability Benchmark Report

Check out the just released 2014 Practice GreenHealth Sustainability Benchmark Report (members only). The report again highlights that award-winning hospitals adopt SUD reprocessing as a means to cut regulated medical waste. In fact, according to the report, “eighty-eight percent of facilities have implemented reprocessing programs, saving a total of $49.2 million and diverting 847 tons of waste out of the regulated medical waste stream.”

This is the only report that shows comprehensive data illustrating the progress of sustainability across the health care sector in such detail. In addition to reporting out on metrics, the report shares sustainability trends and emerging areas of focus, such as the Greening the OR® Initiative.

Read more on p. 34, 36-37, 50-51 of the Report.

Keep Vendors and Their Surprises Out of Your ORs and Your Contracts

… The Story:

You’re doing all you can to reduce your expenses, but then a vendor shows up in the operating room with a “surprise” implant. Or an expensive piece of technology breaks down, and you have to call in the vendor to repair it. Ambulatory surgery programs are getting creative in how to address these problems, which can blow up your budget before your year has barely begun…

This month’s issue is one of the most anticipated by our readers because it’s full of cost-saving ideas. We tell you how to keep vendors and their “surprise” devices out of the ORs. We share how to control your equipment expenses. We tell you how one facility cut about $10,000 worth of inventory at its bedsides. Columnist Steve Earnhart has 10 money-related ideas. We tell you how to save money by reprocessing single-use devices. We also share how to improve collections by moving financial counseling to the front end…

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Reprocessed Medical Devices Market Expected to Reach USD 2.58 Billion Globally in 2020 : Transparency Market Research

According to a new market report published by Transparency Market Research, “Reprocessed Medical Devices Market – Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2014 – 2020,” the global reprocessed medical devices market was valued at USD 0.78 billion in 2013 and is expected to grow at a CAGR of 19.3% from 2014 to 2020, to reach USD 2.58 billion in 2020.

Medical device reprocessing refers to the practice of inspecting, cleaning, testing, sterilizing and packaging of used and expired medical devices, such that the devices are usable and safe for their appropriate clinical application. Reprocessing of medical devices has been observed for over two decades; however, several events have changed both practitioner and regulatory views of the occasionally-maligned medical devices. Generally, there are three types of medical device reprocessing methods: third party reprocessing, non-compliant reprocessors (by health clinics) and in-house reprocessing (by laboratories and hospitals). All the reprocessed medical devices are subject to the regulatory requirements and must meet strict functionality, cleaning sterility and safety standards prior to commercialization…
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Redmond Company to Expand: Medical Device Company Intends to Construct New Building

Medline Industries has signed a letter of intent to purchase 12 acres in the Desert Rise industrial area on the east side of Redmond, with the intention of building a 50,000-square-foot building.

The building would replace the company’s existing location on SW Sixth Street.

“This is very exciting for Redmond and Central Oregon,” Roger Lee, the executive director of Economic Development for Central Oregon (EDCO), said Thursday. “This sort of project shows that we can compete with anyone for these types of companies.”

Medline, based in Mundelein, Illinois, bills itself as the largest privately held manufacturer and distributor of health care supplies in the U.S. It employs more than 12,000 people throughout its operations in 25 countries, according to its website.

In 2012, Medline bought Medisiss, a Redmond company that reprocesses medical devices, and maintained the business in Redmond.

As of March 2014, Medline had about 125 employees in Redmond, according to EDCO.

Lee said that Medline is leasing its current location. The land it plans to buy, located on NE Hemlock Avenue, is owned by the city of Redmond through an agreement with Deschutes County, according to county records.

Lee said the Medline project would bring dozens of new jobs to Redmond.

“This market segment is growing so quickly that those numbers are a safe assumption,” Lee said.

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Join Us in Portland for CleanMed 2015

RESTON, VA–(Marketwired – January 28, 2015) – As we move into 2015, CleanMed is coming up — and the early-bird deadline is looming just one month away! If you have been to CleanMed, you know the outstanding value that it is, and the incredible takeaways you will bring back to your organization to save money as well as the environment. If you haven’t attended, and you play any role in the sustainability process in your organization, you will find it invaluable. What you learn at CleanMed can be shared with your team once you return, and can really make you shine as a responsible member of your green team.

CleanMed is the premier national environmental conference for leaders in health care sustainability, fueling passion for green health care and inspiring new ideas and the means to success. It’s the one time each year for businesses with environmentally preferable products and services or nutritious, sustainable foods to connect with the health care leaders who make purchasing decisions for their facilities.

Here are five reasons why you need to join us for CleanMed 2015 on May 12-14 in Portland, Oregon.

  1. Cutting-edge education sessions with practical takeaways
  2. New approaches to today’s issues
  3. Unmatched exhibits with the latest products and services
  4. Networking with leaders in the field
  5. Inspiration from professionals like you who face similar challenge

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Miele Professional to Showcase Latest Medical Products

“…[R]esearch in the US has noted that recycling and reusing medical equipment wherever possible can generate savings between $100,000 to $1.5 million in just 12 months, and also adds to the environmental benefits.

Research by Johns Hopkins Medicine has also highlighted the multi-million dollar savings hospitals could make by cleaning, recycling and reusing medical equipment instead of opting for disposable equipment. In many parts of the developed world, medical waste is a significant contributor to landfill, second only to the food industry in the gross amount of waste created.

‘Resterilisation and retesting could decrease the amount of needless waste from hospitals. Indeed a recent study by the US Government Accountability Office concluded that reprocessed devices do not present an increased health risk over new devices,’ Rashnavadi said.”

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2013 Milestone Report Shows Hospitals Going Healthier

Big trends around local, sustainable food and healthier beverages top the figures released recently in the Healthier Hospitals Initiative (HHI) 2013 Milestone Report released Aug. 6, 2014.

Launched in April 2012, HHI is a national campaign to promote a more sustainable business model for health care while addressing the health and environmental impacts of the industry.

“Hospitals nationwide are transforming their purchasing practices to avoid toxic chemicals, buy healthier food and beverages and become energy efficient and less wasteful,” says Gary Cohen, president of Health Care Without Harm and founder of HHI. “Clear trends have emerged, and innovative hospitals are implementing strategies to reduce costs, improve their environmental performance and support broader environmental health goals”… More than $45 million was saved as a result of single-use device reprocessing, a 33 percent increase in 2012…

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