Surgical Services Contract Crib Sheet
March 29, 2011
Our contract crib sheets are a checklist of recent clinical contract announcements from Premier. For more detail, refer to Supply Chain Advisor or www.premierinc.com.
q Terumo Cardiovascular Systems agrees to FDA consent decree
Existing customers must sign a CN
Terumo CVS has entered into a consent decree agreement with the FDA over products manufactured at its Ann Arbor plant. This decree affects items contracted under the perfusion agreement PP-OR-509 with Premier. It is important to note this is not a recall. The attached documents were provided by Terumo to fully explain the situation and to provide guidance on what everyone can expect.
Products manufactured at the plant include heart-lung machines and cannulae used in cardiac surgery.
In addition, Terumo CVS will fully restrict two products that are not part of its current product portfolio: CDI™ 101 Hematocrit/Oxygen Saturation Monitoring System (until the updated device receives a 510(k) clearance)
Tenderflow™ Pediatric Arterial Cannula
q Contract Launch: Ophthalmology Products
Products included in this portfolio are used for surgeries of the eye. They include intraocular lenses (IOLs), phacoemulsification units, viscoelastics, disposables, ophthalmic blades, instruments and suture.
The Awarded Suppliers
Premier’s Surgical Services Committee is pleased to announce new agreements for ophthalmology products have been awarded to incumbents Ambler Surgical LLC, Bausch & Lomb Incorporated, Beaver-Visitec International Inc. and Surgical Specialties Corporation dba Angiotech, as well as new suppliers PSI/Eye-KO Inc. dba Anodyne and Strategic Business Holdings Inc. Agreements are effective July 1, 2011, through June 30, 2014.
Current agreements with Ambler Surgical, AMO, Angiotech, Bausch & Lomb and Becton Dickinson expire on June 30, 2011.
Previous Updates
q Companies with manufacturing operations in Japan indicate no substantial delays or shortages due to tsunami
In the past week, Premier has contacted all suppliers in the medical/surgical portfolio that indicated in their RFI that products on the respective contracts were manufactured in Japan. Suppliers contacted included BD, Fujifilm, Iris Diagnostics, Nihon Kohden, Olympus, Roche Diagnostics, Skytron, Sysmex America, and Toshiba. All suppliers contacted indicated that they did not expect severe product shipment delays in the short term. Many suppliers indicated that there is substantial inventory on hand in the U.S.
Several suppliers have already sent letters to their customers to provide an update on the status of their manufacturing operations and shipments during this difficult time in Japan. As you are aware, the situation in Japan is still very fluid with the ongoing nuclear situation. Premier will continue to work closely with contracted suppliers to monitor product availability and will communicate updates via a file posted on the home page of Supply Chain Advisor®.
If you have additional questions or concerns about specific contracts, please contact the Premier Solution Center at 877.777.1552.
q Group Buy Program – Current Event
Please refer to the Group Buy Website at www.premierinc.com/groupbuy.
o Anesthesia Equipment and Physiological Monitoring (Datex Ohmeda Inc., a GE Healthcare business) – Dates 3/1/11 – 5/15/11
§ 2% discount above volume tier on anesthesia equipment and physiological monitors.
§ 3% discount above volume tier on anesthesia equipment when purchased together with physiological monitors during this group buy.
q Surgical Services: Price increase by Olympus for surgical endoscopy and video equipment products
Olympus America Inc. notified Premier of its right per the terms and conditions to implement an annual price increase for the Surgical Endoscopy products agreement (PP-OR-505), effective April 1, 2011. The pending price increase affects all tiers and is a weighted average increase of 2.71 percent.
q Surgical Services: Premier Contract Launch: Breast Implants, Tissue Expanders and Related Products – (this is in addition to the already existing GNYHA Direct Agreement with Allergan.)
IMPORTANT NOTE: this new Premier agreement is IN ADDITION to the existing GNYHA Direct agreement GNYHA OR-010. Work with your Client Service Executive to identify which program (or hybrid) would work best for them, based on facility product mix.
Premier is pleased to announce its new agreement with Breast Implants, Tissue Expanders and Related Products. The 35.5-month agreement has been awarded to Allergan USA Inc. and is effective February 15,2011, through January 31, 2014.
q Johnson & Johnson – Gas Plasma Sterilization
CONTRACT EXTENSION: The Gas Plasma Sterilization contract with Johnson & Johnson (PP-OR-526) has been extended until February 29, 2012. This contract was originally set to expire February 28, 2011. The extension includes a weighted average price increase to the consumables on this contract of 2.6 percent. The price on the capital equipment for this contract will not change. The overall weighted average price increase (capital and consumables) is 1.6 percent.
Category history: On March 1, 2009, a new portfolio of agreements began for Gas Plasma Sterilization with Steris (PP-OR-527) and Johnson & Johnson (PP-OR-526). The Johnson & Johnson agreement was a 12-month agreement with an option of two one-year extensions. The contract was extended once from February 28, 2010, to February 28, 2011. As the agreement was set to expire February 28, 2011, the decision to extend the agreement for an additional one-year term, through February 29, 2012, has been mutually agreed upon between Premier and Johnson & Johnson.
q Johnson & Johnson – Automated Endoscopic Reprocessors
CONTRACT EXTENSION: The Automated Endoscopic Reprocessors contract with Johnson & Johnson (PP-OR-537) has been extended until February 29, 2012. This contract was originally set to expire April 30, 2011. The extension includes a 2.2 percent price increase to two consumables on the contract (item #s 20398, 22591). The price on all other products will not change. The overall weighted average price increase to the contract (capital and consumables) is .7 percent.
Category history: On March 1, 2009, a new portfolio of agreements began for Automated Endoscopic Reprocessors with Minntech (PP-OR-517) and Steris (PP-OR-516). The Johnson & Johnson agreement for this category began May 1, 2009, and was a 12-month agreement with an option of two one-year extensions. The agreement was extended once from April 30, 2010, to April 30, 2011. The decision to extend the agreement for an additional 10-month term, through February 29, 2012, has been mutually agreed upon between Premier and Johnson & Johnson. The 10-month extension will make the Johnson & Johnson agreement co-terminous with the other agreements in the category.
q Surgical Services – announcement of new agreements for Open Heart Disposable Supplies. Open heart disposable supplies are used during open heart surgeries such as coronary artery bypass grafting (CABG), valve procedures, and pediatric open heart procedures. The products include vein harvesting equipment, heart stabilizers, blower/misters, pacing wires, and accessories
May 1, 2011, through April 30, 2014.
Supplier / New Contract / Expiring ContractAlliant* / PP-OR-733 / PP-OR-379
Maquet / PP-OR-734 / New
Oscor* / PP-OR-731 / New
Sorin / PP-OR-730 / PP-OR-386
q RECALL Surgical Services – announcement that Davol Inc. (PP-OR-688) has issued a voluntary recall of the XenMatrix Surgical Graft.
The affected products are:
Product code Description
1161015 10 x 15 cm Rectangle
1161520 15 x 20 cm Rectangle
1161928 19 x 28 cm Rectangle
1161935 19 x 35 cm Rectangle
The affected lots begin with the following four letters: HUTF, HUTI, HUTJ, HUTK, HUTL, HUUA, HUUB, HUUC, HUUD, HUUE, HUUF, HUUG, HUUH, HUUI, and HUUJ.
The voluntary recall has been initiated because testing cannot ensure that all units of the XenMatrix Surgical Graft are within FDA guidelines for endotoxin requirements. No patient injuries or complications have been reported that have been linked to elevated endotoxin levels.
q RECALL Surgical Services – announcement that ConMed Electrosurgery (PP-OR-665) has issued a recall on System 2450 Electrosurgical Generator.
ConMed Electrosurgery has determined a component within the System 2450 may cease to perform properly, which may, given the completion of a number of events, result in an electrical burn to the ESU operator or patient.
The following devices are affected:
Catalog number Device name
60-2450-100 System 2450 100V
60-2450-120 System 2450 120V
q Surgical Services – announcement of new agreements for Vascular Grafts.
The existing contracts with Atrium (PP-OR-448), Maquet (PP-OR-449), Terumo (PP-OR-450) and W.L. Gore (PP-OR-451) expire March 31, 2011.
Effective April 1, 2011 though March 31, 2014
Supplier / New contract number / Expiring contract numberAtrium / PP-OR-723 / PP-OR-448
Maquet / PP-OR-724 / PP-OR-449
Terumo / PP-OR-725 / PP-OR-450
WL Gore / PP-OR-726 / PP-OR-451
q Surgical Services RECALL – announcement that ConMed Linvatec (PP-OR-639) has issued a recall of a Micro Sagittal Blade, catalog # 5032-138. These products may have a breach in the seal between the Tyvek lid and tray, which could potentially comprise the sterility of the device.
q Surgical Services RECALL – announcement that Integra Surgical (PP-OR-611) has issued a voluntary recall of specific part numbers of the Jarit Secure-Cut Reposable Scissors.
Effective immediately, members should cease using all products with the affected associated product codes. The impacted product codes are 625-050 and 625-051. This recall has been initiated as Integra Surgical has received reports instances where the outer shaft sheath has advanced forward during reprocessing and thus occluded access to the threads where the disposable scissor tips would attach. Tip part numbers 625-060, 625-061, 625-062, 625-063 are rendered obsolete and discontinued due to the handle recall.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
q Surgical Services – announcement that Prestige Ameritech as added it new ProGear N95 Respirator to agreement PP-OR-705. This N95 respirator has the highest fluid-resistance rating available.
q Surgical Services – reminder that Angiodynamics (PP-OR-728) has been added to the Implantable Infusion Ports agreement, effective December 1, 2010. PMDF or price activation is required.
q Surgical Services – announcement that Premier has been notified by Integra LifeSciences (PP-OR-478) of their intention to implement an annual price increase of 3% effective January 1, 2011.
q Recall Surgical Services – announcement that Covidien (PP-OR-664), formerly Valleylab) has issued a voluntary recall of specific lot numbers of their Ligasure Blunt tip Laparoscopic Sealer/Divider.
Effective immediately, members should cease using all products with the affected lot numbers and associated product codes. The impacted product codes 188856, 190048, 190107,190307 and 193333. This recall has been initiated as Covidien has received reports that during surgical procedures, the device may energize when clamping without pushing the activation button.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Customers who have been shipped product from any of the affected lots have been notified of this recall.
Suggested actions:
· Stop using affected product immediately.
· Quarantine and remove all stock on hand.
· Arrange for product returns.
· Complete the Domestic Response Form.
q Surgical Services – announcement that Davol Inc. (PP-OR-673) will increase Tier 1 prices for their Surgical Mesh effective January 1, 2011. The increase will be 3% for all but 9 products.
q Surgical Services – announcement of new agreements for Arthroscopy Fluid Waste Management has been awarded, effective March 1, 2011 through February 28, 2014.
Supplier / New contract number / Expiring contract numberAspen / PP-OR-719 / PP-OR-441
ConMed / PP-OR-720 / PP-OR-440
LDI Corporation / PP-OR-721 / New
These products included in this category include suction devices, accessories and absorbent floor pads. These devices are used to remove fluid from the operating room floor during the surgical procedure. These products keep the area dry, prevent equipment damage, keep the area free of contamination, and help prevent staff falls on wet floors. The suction devices tubing is purchased separately and attaches to the suction canister.
q Surgical Services – announcement that Davol Inc. has added Ventalight ST surgical mesh to agreement PP-OR-673. This offering for those surgeons who clinically support the need for lighter weight mesh (below 52 grams per metered square) for the repair of ventral hernias.
q Surgical Services – announcement that B. Braun has been added to the Regional Anesthesia Trays and Related Products agreement effective November 22, 2010 along with Arrow International, BD and Company and Smith Medical. All agreements expire January 31, 2013.
q Surgical Services – announcement that B. Braun has been added to the Pain Management – Local Anesthesia agreement effective November 22, 2010 along with Curlin Medical, I-Flow Corp, MPS Acacia and Stryker instruments. All agreements expire in May 31, 2010.
q Surgical Services – announcement that AngioDynamics Inc., PP-OR-728, has been added to the Implantable Infusion Port agreement along with Bard
Access Systems, Medical Components, Navilyst Medical and Smith Medical. These agreements are effective through October 31, 2013.
q Surgical Services – announcement that Ecolab Inc. (PP-OR-534) will discontinue ENDURE 450 Waterless Hand Scrub. This will immediately affect the following product codes:
· Item # 61094501: Endure 450 6-1000mL
· Item # 61094510: Endure 450 72-4oz
· Item # 61094520 : Endure 450 6-1000mL (bag)
There are several viable alternatives on Premier agreements. Refer to the Cross Reference in Supply Chain Advisor.
q Surgical Services – announcement that Covidien Price Protection on previous surgical energy agreement ends November 30, 2010. Effective December 1, 2010, pricing at Tier 1 will change and will be subject to future price increases.
Pricing is firm for the first two years, with a 2 percent increase in the third year. The agreement allows for a 5 percent increase for Tier 1 and a 3 percent increase for Tiers 2-4 in the fourth year. Today, some products at Tier 1 pricing will be lower than the higher tiers. There are no changes to Tier 2, Tier 3 and Tier 4 prices in the new surgical energy agreement, PP-OR-664.
q Surgical Services – announcement that Surgical and Specialty Blades agreements are transitioning away from BD.
In a letter dated June 8, 2010, Becton, Dickinson and Company (BD) announced its intent to sell certain assets of the BD Medical segment, including its surgical and specialty blades platforms. The surgical and specialty blades business has now been sold to Roundtable Healthcare Partners. Two of Roundtable’s subsidiaries, Aspen Surgical Products and Beaver-Visitec International, will assume contracts PP-OR-653 (surgical blades) and PP-OR-468 (ophthalmology) in full with no changes in terms. The contract assignment to Aspen Surgical for PP-OR-653 has been completed and the assignment to Beaver-Visitec for PP-OR-468 will be completed. Members should continue to operate as normal in regards to both agreements.