Author Archives: IAMERS

Does Radiation from X-rays and CT Scans Really Cause Cancer?

In recent years, there has been widespread media coverage of studies purporting to show that radiation from X-Rays, computed tomography (CT) scans and other medical imaging causes cancer. But such studies have serious flaws, including their reliance on an unproven statistical model, according to a recent article in the journal Technology in Cancer Research & Treatment. Corresponding author is Loyola University Medical Center radiation oncologist James Welsh, M.D., MS. 
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No news for imaging is good news in June MedPAC report

June 16, 2015 — Recommendations for medical imaging are noticeably absent in the Medicare Payment Advisory Commission’s (MedPAC) June report to Congress — a welcome break from the usual scrutiny that radiology receives from policymakers.

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White House Threatens to Veto Repeal of Medical Device Tax

As the House Rules Committee met on Monday to consider a bill repealing the Affordable Care Act’s medical device tax, the Obama administration vowed to preserve the funding source to help finance health reform and offset the cost of the ACA. 
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MU Has Led to Digital Divide

A study of New York providers participating in the Meaningful Use (MU) incentive program found “systematic differences” between early adopters of EHRs and those who did not use EHRs before implementation of the program.

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Lawmakers to CMS: Create an ICD-10 Contingency Plan

An ICD-10 contingency plan is needed in case the Centers for Medicare & Medicaid Services (CMS) is unable to process the new codes, members of Congress said in a letter to Acting Administrator Andy Slavitt.

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How much does IR improve low-dose CT imaging quality? It depends on the scanner

Iterative reconstruction (IR) makes it possible to reduce radiation dosage without a reduction in imaging quality in low-contrast CT examinations, but its effectiveness varies with different doses and vendors, according to study results published online May 19 in the journal Radiology.

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AMA chief throws support behind bill to delay ICD-10, says US should wait for ICD-11

ICD-10 should not only be delayed, but scrapped, said Steven Stack, the incoming president of the American Medical Association, throwing his organization’s support behind a bill by Texas Republican Rep. Ted Poe delaying its rollout.  “We support Rep. Poe’s bill,” he said. “We strongly support that.”  Instead, Stack said the United States should wait to change its diagnostic medical coding system until the implementation of ICD-11, Stack said.

Read more here.

 

Pictures from the IAMERS Annual Meeting

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Lynette and Stuart Latimer (Trisonics, Inc) and Rob Kerwin

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Don Bogutski (DiagnostixPlus) and Jason Shina (Absolute Imaging Solutions)

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Patrick Hiney (De Lage Landen) and Frank Lewis (All Parts Medical)

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Mike Kane (De Lage Landen) and Mike Schmit (GE)

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Rick Hart (Elite Medical Technology), Voldoymyr Markevych (Vomark Technologies) and Jason Block (Block Imaging International)

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Christophe Sitzer (Hegele Logistic) and Ed Sloan (Ed Sloan & Associates)

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Carolyn and John Shaw (Northeast Electronics)

Josh Block

 

 

 

 

 

 

 

Josh Block – Block Imaging International








Seven High Points from the IAMERS Annual Meeting

Philby Philip F. Jacobus , President of DOTmed

Last week, I attended the annual meeting of the International Association of Medical Equipment Remarketers and Servicers (IAMERS) in Washington, DC. It was a great meeting and I was alert throughout the entire event. Sometimes, when you attend these meetings just for the sake of networking, you want to fall asleep during the lectures — but not so this time.

Some of the high points included:

1. Sean Cavanaugh, the director of CMS, gave us a review of the present but also some predictions about the future. It was extremely interesting.

2. Derek Guest, the executive director of the Remanufacturing Industries Council, talked about protocols his organization had developed so the definition of “remanufacturing” is the same everywhere. Because of the FDA it does not fit perfectly, but I think we all learned a lot.

3. Congressman Ron Kind, Democrat from Wisconsin, spoke to us at lunch. Normally, I would run from the room rather than listen to a politician but this guy was great. He tailored his talk to our industry and was amazingly conversant on any topic that anyone asked him about. Very impressive.

4. Michael Mabry, the executive director of the Radiology Business Management Association (RBMA), spoke about the challenges that radiology managers face and what his organization is doing to help them. It was also an extremely interesting talk.

5. Daniel Vukelich, the executive director of the Association of Medical Device Reprocessors, talked about the evolution of reprocessing in the U.S. and in Europe and the positive impact surrounding reprocessing. It is green, it saves money and many would feel it is just logical.

6. And no IAMERS meeting would be complete without Wayne Webster and his mixture of humor and cynicism. This year, Wayne discussed the challenges of XR‐29 and left me feeling like it may not be as big of a deal as we thought it was.

7. Josh Block started out the morning talking about what important things we should all keep in mind to be successful business people and humans.

Sadly, I missed Linda Comisar because I had to be back in New York on Friday, but having spoken with her at the Thursday dinner, I am sure she gave an invigorating presentation.

This year was a great event and I am glad I was able to attend.

My compliments to Diana Upton for putting together a great meeting.

Pre-owned Medical Importation – by Country

Used and Refurbished Medical Equipment

Australia: Importation is allowed however there is not a strong demand.

Austria: Importation of used and refurbished medical equipment is permitted, but the products must meet the European certification requirements and be CE marked. There is not a strong market for such equipment. 

Brazil: Importation is not allowed. Refurbishment must be done locally on equipment that was imported as new. 

Bulgaria: Importation of used and refurbished medical equipment is permitted, but the products must meet local requirements listed on the web site of the Bulgarian Drug Agency (www.bda.bg) and should comply with the European certification requirements and CE mark. An important requirement is contracts to be secured with servicing and maintenance.

Canada: Importation is allowed, however, there are many regulations they must comply with and the demand is not high. There may be some success with individual hospitals and private clinics.  

Chile: Importation of used/refurbished medical equipment is allowed, however, market potential is limited and maintenance and technical service may be an issue.

China: No importation of used and refurbished medical equipment is allowed.

Colombia: Importation is allowed but must meet a significant amount of requirements.

Croatia: Used and Refurbished Medical Equipment can be imported to Croatia and CE mark has to be obtained. Due to the lack of market opportunities, this market segment is mostly attractive to the products with CE within EU.

Denmark: In general, there are no specific laws prohibiting the import of used medical equipment other than general ones regarding health, safety and environmental issues.  However, the products must meet the European certification requirements and be CE-marked. There is not a strong market for such equipment.

Ecuador: Importation is only allowed in private clinics and hospitals, estimated to occupy 30% of the market. Any used equipment must be refurbished and have at least a one year warranty.

Egypt: No importation of used and refurbished medical equipment is allowed.

France: Importation of used and refurbished medical equipment is permitted, but the products must meet the European certification requirements and be CE marked. There is not a strong market for such equipment.

Germany: Importation is allowed and there is market potential. 

Guatemala: Importation of used/refurbished medical equipment is allowed and there are no restrictions. It is preferable that the equipment has FDA or CE certifications. 

Hong KongThe same restrictions and tariffs are applied to used and new medical equipment. Hong Kong agents and distributors in this industry prefer to source the ‘newest and latest’ equipment. There is limited market for used and refurbished medical equipment. Public hospitals, private hospitals and health institutes in Hong Kong do not buy used medical devices.

Hungary: Used medical equipment can be sold, however it needs a CE mark. Further, there is little demand for used medical devices.

Indonesia: No Importation of used and refurbished medical equipment is allowed.

Israel: Importation is allowed, however, there are many regulations they must comply with and there is no demand.

Jordan: No importation of used and refurbished medical equipment is allowed.

Korea: Importation of used and refurbished medical equipment is allowed.  Procedures to obtain a pre-market license for a used medical equipment are the same in general as those for a new medical equipment.  However, used medical equipment (each imported unit) is subject to 100% inspection (test) at importers’ facilities with the companies’ quality control criteria, while new medical equipment is not required to test all the same products. The market for used medical equipment is limited in Korea though.    

Kuwait: No importation of used and refurbished medical equipment is allowed.

Malaysia: Importation of used medical equipment is allowed. Demand for this comes from the small healthcare practitioners. The public healthcare sector does not procure used medical equipment.  

Mexico: There is a strong market for refurbished medical equipment when it is accompanied by a warranty and technical support. 

Morocco: Importation of refurbished equipment is allowed. The Moroccan law does not forbid government entities –the main buyers– to buy refurbished medical equipment. However, for Used medical equipment a new law has been submitted banning the purchase of used medical devices and equipment. This law is expected to be implemented late 2015 or early 2016 since it has already been voted for. This is expected to improve the quality of medical equipment and offer a better quality of medical care to patients treated in Morocco. Refurbished equipment has a market with private entities.

New Zealand: Refurbished medical equipment is currently sold in NZ along with obtaining a Medsafe (WAND registry – for clearing medical devices) listing. There is a very small market though, with uptake only in the private sector. However, it is common for District Health Boards (Public Health System) to obtain refurbished equipment when they are on a Replacement loan equipment/repair contract with supplier.

Nigeria: Used medical equipment is allowed entry into Nigeria at zero duty charged.

Pakistan: Importation of used and refurbished equipment is allowed. Import of Radioactive materials and apparatus is subject to the prior approval of Pakistan Nuclear Regulatory Authority.

Palestinian Territories: Used and refurbished medical equipment is allowed to be imported; however, there is no demand due to specifications of international donor agencies that fund the Healthcare sector. 

Peru: No importation of used and refurbished medical equipment is allowed. Only physicians requiring equipment for their own use will be permitted to import one type of equipment per year.

The Philippines: Importation is allowed only in the private sector, which makes up approximately 65% of the market. Importation of radiation-emitting devices is not permitted. 

Poland: There are no restrictions in Poland on imports and/or the purchase of used medical equipment by either state-owned or private health care facilities. Used equipment purchases are made but no specific buying pattern has been identified. 

Please note that products must meet the European certification requirements and be CE marked.  Also, price is the main factor considered by all buyers of medical products in Poland. Important too is the local availability of services and spare parts. Quality is usually the next element considered. 

Romania: There are no restrictions on the sales and import of refurbished medical devices in Romania. The medical equipment must meet the European certification requirements and have the CE mark. Duties and taxes are applicable at the same rates to both new and refurbished equipment. The key end-user groups for this category are private hospitals, clinics and specialized ambulatory care segments.

Russia: Importation is allowed, but the products must hold a valid registration certificate of Ministry of Health, certificate of conformity and hygienic certificate. The market is limited to private clinics mostly. Only new equipment is allowed for sale through government tenders.

Serbia: Importation of used and refurbished medical equipment is permitted, but the products must meet local certification requirements in the form of local sales license, that is marketing approval issued by local State Regulatory Agency, based on European certification requirements and CE mark. There is a strong market potential for such equipment in private sector.

Singapore: Importation of used and refurbished medical equipment is permitted, but these must meet the regulatory requirements based on recommendations of the Global Harmonization Task Force (GHTF). The regulatory organizations that are considered independent reference agencies by the Singapore Health Sciences Authority are the U.S. Food & Drug Administration (USFDA), European Union (EU), Health Canada, Therapeutic Goods Administration (TGA), Health Canada and the Japan Ministry of Health, Labor & Welfare (MHLW). There is currently limited or no demand for used equipment. 

Slovak Republic: Importation of used and refurbished medical equipment is permitted, but the products must meet local certification issued by State Regulatory Agency (Slovak Institute for Drug Control), based on European certification requirements and CE mark.  

South Africa: Import is allowed, but local party will need importer’s certificate. Products must be FDA approved and/or CE mark. There is very limited market potential. Refurbished equipment will be subject to registration once the draft regulations become law.

Spain: Importation of used and refurbished medical equipment is permitted, but the products must meet the European certification requirements and be CE marked. There is not a strong market for such equipment.

Sweden: Importation of used and refurbished medical equipment is permitted, as long as the products meet the European certification requirements and be CE marked. However, there is currently no demand for used equipment.

Switzerland: Importation is allowed, but the market is close to non-existent. 

Taiwan: Imports of used equipment are treated as the same as new equipment. Prior to obtain import license, a premarket registration approval is required by the Department of Health. Due to the expectation that all medical equipment will be backed by an extended maintenance contract, there is virtually no market for refurbished items. The market for used/refurbished medical devices is very limited.

Thailand: No importation of used and refurbished medical equipment is allowed. 

Turkey: No importation of used and refurbished medical equipment is allowed. 

UAE: Importation is permitted, but government entities, the major buyers in this market, are prohibited to buy used and refurbished medical equipment.

Ukraine: Import of used and refurbished equipment is allowed, but the products must hold a valid registration. The public healthcare sector does not procure used medical equipment, the market is limited to private clinics mostly.

United Kingdom: Imports are permitted. There is not a lot of demand as agencies within the public healthcare sector, which is the largest purchaser of medical products, don’t buy used or refurbished medical equipment. 

Uruguay: Imports of refurbished medical equipment are authorized. All medical equipment, new, refurbished and/or recycled need to be registered by a local company and approved by the Ministry of Public Health prior to importation. Refurbished equipment needs to have a Technical/Refurbishing Protocol (full contact information of the company which refurbished the equipment must be provided).

Venezuela: Importation is allowed, but Government organizations, who are one of the major buyers, are not allowed to purchase them.

Vietnam: Import of used and refurbished medical equipment is strictly controlled by the Vietnam Ministry of Health (MOH). The Ministry of Science, Technology, and Environment must inspect and certify all imports of used medical equipment. In practical terms, MOH accepts used equipment for donation purposes only.

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