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In 1991, a major medical training hospital made the national news after the wrong leg was amputated twice in one week. Despite “an abundance of care” two unfortunate people entered the hospital expecting to lose one leg and walk out with a prosthesis and ended up loosing

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

both legs and leaving in a wheelchair.

In 1999, the Institute of Medicine published a landmark report on patient safety titled: To Err is Human and the Joint Commission for the Accreditation of Healthcare Organizations (JCAHO) began championing the cause of patient saf

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ety and the prevention of wrong site surgery. Over the past 16 years, hospitals, doctors, nurses and many, many others have developed and implemented procedures designed to stem the rising tide of tragic errors.

In 2007 at a conference on patient safety, the CEO of JCAH

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

disclosed that despite tremendous effort, expense and study, the number of wrong site surgeries has risen unabated and exponentially since 1991. Every attempt to change this horrific reality has failed!

How can this be?

The title of the 1999 report summed it up: To Er

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

r is Human.

Think about modern surgery. You, the patient, are moved to an operating room. Your identification band confirms that you are the patient scheduled for surgery.

This is the first possible point of error, wrong name on the surgery schedule.

Once the operatin

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

room staff ensures you are you, the site of surgery is confirmed in the chart and marked. You may even be asked to confirm that they are marking the correct spot.

This is the next possible point of error, wrong site listed in the chart or told to you.

Once your surger

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

y site is marked, you receive medication (if you didn’t earlier). Your surgery site is washed and “prepped” further entrenching this as the “correct side.” Then your entire body is covered by surgical drapes and other items that reduce you to an unidentifiable pile of cl

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

th with a small window of skin.

This is an opportunity to reinforce prior error by eliminating the ability of the surgeon to recheck each of the above steps easily.

The surgeon arrives and prepares to begin cutting. The surgeon confirms that you were identified and the

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

correct surgical site was marked. The amputation is completed and the surgery team removes the surgical drapes and discovers your diseased leg was NOT amputated!

So is there a solution?

Perhaps, imagine if you could mark the surgical site days or even weeks before sur

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ery without risk of changing the marking. Imagine a pre-operative marking system that provided a unique identifier for the surgical site that is not affected by the process of washing, prepping and draping. Imagine a patient and surgical identifier that can be checked re

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

peatedly from the point of admission through the pre-operative procedure, during the operation and even after the correct limb were amputated.

Impossible?

Technology has the solution. Implantable RFID chips are currently in use as unique medical record identifiers for

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

patients and disaster responders world wide. Contrary to popular myth, there is no GPS tracking system or other privacy issue created by these passive electronic numbers.

RFID chips are biologically inert and implanted through a small needle as easily as giving an antib

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

otic shot. These are the ideal characteristics for a wrong site surgery solution.

Think about RFID assisted surgery. You, the patient, see your doctor weeks before the surgery. Your regular doctor has determined that you require surgery. An RFID chip is implanted in the

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

fat of the diseased leg and you are sent to see the surgeon.

You see the surgeon several days later, but your medical records have not yet arrived. Instead of rescheduling your appointment, the surgeon scans your leg with an RFID receiver and gets your medical record n

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

mber. You authorize immediate release of the medical records and your surgeon schedules surgery.

You are admitted to the hospital and the first human error occurs as your healthy leg is entered into the medical record as requiring surgery.

The day of your surgery, the

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

second human error occurs as your roommate is moved to the operating room. Instead of amputating the wrong leg from the wrong person, your roommate is scanned for an RFID chip and the unique identifier reveals that you and your roommate received the same wristband.

You

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

re moved to the operating room. Your identification band confirms that you are the patient scheduled for surgery. Once the operating room staff ensures you are you, the site of surgery is confirmed in the chart and marked. You may even be asked to confirm that they are m

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

arking the correct spot. The chart indicates your healthy leg is the surgery site. You have already received medication and agree as a result of the sedation.

Once your healthy leg is marked, your healthy leg is washed and “prepped” further entrenching this as the “corr

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ct side.” Then your entire body is covered by surgical drapes and other items that reduce you to an unidentifiable pile of cloth with a small window of skin.

The surgeon arrives and prepares to begin cutting when the final RFID chip scan is performed. No RFID chip can b

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

e found in the leg about to be amputated. The surgery team immediately removes all the surgical drapes and scans your diseased leg. The RFID chip is found and the correct leg is washed, prepped, draped and amputated.

Tragedy averted!

To Err is Human – RFID may be Divin

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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Keep the following tips in mind as you put together your trade show plans you should avoid any major surprises and be well on your way to a successful show.

We all have heard of Data Mining and we have all seen the abilities it can produce, but we also know how tedious the collection of data can be. It is the same for a little small company with a few customers as it is for a large company with millions of customers. Additionally how do you keep your data safe?

The development of federal statutes and the underlying reasons that led to the criminalization of psycho-active substances in American society began at the turn of the twentieth century. Society reacted to the detriment that resulted from unchecked promotion and use of heroin and cocaine by addicts, paving the way for the government to begin drug regulation. The problem had grown during the end of the nineteenth century due to the new methods of ingestion and the isolation of active compounds. In responding to these developments some powerful Americans would learn early on that under the guise of tackling the risks and crippling effects of addiction they could promote corporate monopolies, a single world order, and pacification of liberty. Addiction’s impact on society was a small factor when compared to the actions of a powerful few who saw the masses as only pawns.

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